Table: q1_q4_2020_prescription_drugs_wac_increases , manufacturer_name like M*

A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z  *

oshpd_id manufacturer_name date_reported ndc_number drug_product_description wac_effective_date wac_increase_amount wac_after_increase patent_expiration_date drug_source_type unit_sales_volume_in_us unit_sales_volume_non_public_indicator cost_increase_factors cost_increase_factors_non_public_indicator change_improvement_description change_improvement_non_public_indicator acquisition_date company_acquired_from acquisition_price acquisition_price_non_public_indicator acquisition_price_comment wac_at_acquisition wac_year_prior_to_acquisition year_drug_introduced_to_market wac_at_intro_to_market supporting_documents general_comments
Rx0000052 Mallinckrodt Hospital Products Inc. 03/31/2020 43825010201 OFIRMEV INJECTION 1000MG/100ML (10mg/ml) (24 vials/case) 01/02/2020 93.87 1136.87 03/11/2032 Single Source Drug None 1 None 1 Mallinckrodt has voluntarily made a public pledge on responsible drug pricing and innovation which is our social contract to those we serve and which can be found at https://www.mallinckrodt.com/corporate-responsibility/pledge-on-drug-pricing--innovation/. Our commitment is to price our innovative products responsibly while providing broad patient access. In so doing, we continue to invest in innovation that brings value to patients, providers, and the U.S. healthcare system through research and development, quality manufacturing, as well as through patient education and disease awareness. The current price increase for Ofirmev is not necessitated by a change or improvement to the drug but by the larger principles set forth in our pledge. None 03/19/2014 Cadence Pharmaceuticals, Inc. 1400000000 None Acquisition Price field reflects the total price paid for all of Cadence inclusive of Ofirmev 354.00 None 2011 258.00 None None
Rx0000072 Mayne Pharma Inc 03/31/2020 51862006410 DIAZEPAM 10MG TABLETS 1000 01/03/2020 90.80 181.60 None Non-innovator Multiple Source Drug 10676 None CHANGING MARKET DYNAMICS None NONE None 08/03/2016 ALLERGAN None None Diazepam was acquired as part of a portfolio of drugs from Allergan and Teva with at a total cost of $652 million. 36.32 36.32 2005 36.32 None None
Rx0000072 Mayne Pharma Inc 03/31/2020 51862094310 DIAZEPAM 10MG TABLETS 1000 (NEW MAYNE NDC) 01/03/2020 90.80 181.60 None Non-innovator Multiple Source Drug 10676 None CHANGING MARKET DYNAMICS None NONE None 08/03/2016 ALLERGAN None None Diazepam was acquired as part of a portfolio of drugs from Allergan and Teva with at a total cost of $652 million. 36.32 36.32 2005 36.32 None NEW PRODUCT NDC
Rx0000072 Mayne Pharma Inc 03/31/2020 51862006405 DIAZEPAM 10MG TABLETS 500 01/03/2020 46.33 92.66 None Non-innovator Multiple Source Drug 9676 None CHANGING MARKET DYNAMICS None NONE None 08/03/2016 ALLERGAN None None Diazepam was acquired as part of a portfolio of drugs from Allergan and Teva with at a total cost of $652 million. 18.53 18.53 2005 18.53 None None
Rx0000072 Mayne Pharma Inc 03/31/2020 51862094305 DIAZEPAM 10MG TABLETS 500 (NEW MAYNE NDC) 01/03/2020 46.33 92.66 None Non-innovator Multiple Source Drug 455 None CHANGING MARKET DYNAMICS None NONE None None None None None None None None None None None NEW PRODUCT NDC
Rx0000072 Mayne Pharma Inc 03/31/2020 51862006205 DIAZEPAM 2MG TABLETS 500 01/03/2020 34.20 68.40 None Non-innovator Multiple Source Drug 9040 None CHANGING MARKET DYNAMICS None NONE None 08/03/2016 ALLERGAN None None Diazepam was acquired as part of a portfolio of drugs from Allergan and Teva with at a total cost of $652 million. 13.68 13.68 2005 13.68 None None
Rx0000072 Mayne Pharma Inc 03/31/2020 51862006310 DIAZEPAM 5MG TABLETS 1000 01/03/2020 69.85 139.70 None Non-innovator Multiple Source Drug 4444 None CHANGING MARKET DYNAMICS None NONE None 08/03/2016 ALLERGAN None None Diazepam was acquired as part of a portfolio of drugs from Allergan and Teva with at a total cost of $652 million. 27.94 27.94 2001 42.95 None None
Rx0000072 Mayne Pharma Inc 03/31/2020 51862094210 DIAZEPAM 5MG TABLETS 1000 (NEW MAYNE NDC) 01/03/2020 69.85 139.70 None Non-innovator Multiple Source Drug 1 None CHANGING MARKET DYNAMICS None NONE None None None None None None None None None None None NEW PRODUCT NDC, NO SALES AS OF 04-30-2020; USED 1 AS A PLACEHOLDER TO SUBMIT INCREASE
Rx0000072 Mayne Pharma Inc 03/31/2020 51862006305 DIAZEPAM 5MG TABLETS 500 01/03/2020 35.65 71.30 None Non-innovator Multiple Source Drug 35620 None CHANGING MARKET DYNAMICS None NONE None 08/03/2016 ALLERGAN None None Diazepam was acquired as part of a portfolio of drugs from Allergan and Teva with at a total cost of $652 million. 14.26 14.26 2005 14.26 None None
Rx0000072 Mayne Pharma Inc 03/31/2020 51862094205 DIAZEPAM 5MG TABLETS 500 (NEW MAYNE NDC) 01/03/2020 35.65 71.30 None Non-innovator Multiple Source Drug 11479 None CHANGING MARKET DYNAMICS None NONE None None None None None None None None None None None NEW PRODUCT NDC
Rx0000072 Mayne Pharma Inc 03/31/2020 51862029510 Fabior External Foam 0.1 % 100g Can 01/13/2020 80.65 1155.94 02/24/2030 Single Source Drug 11455 None None 1 None None 08/17/2016 GlaxoSmithKline LLC None 1 None 830.32 722.02 2014 607.76 None Product NDC at WAC Introduction in 2014 was 00145-0020-02. Product WAC Introduction for current 51862-0295-10 NDC was $830.32 on 03/17/2017. Unit Sales reported for calendar year 2019.
Rx0000072 Mayne Pharma Inc 03/31/2020 51862029550 Fabior External Foam 0.1 % 50g Can 01/13/2020 40.32 577.96 02/24/2030 Single Source Drug 96108 None None 1 None None 08/17/2016 GlaxoSmithKline LLC None 1 None 415.16 361.01 2014 303.88 None Product NDC at WAC Introduction in 2014 was 00145-0020-03. Product WAC Introduction for current 51862-0295-50 NDC was $415.16 on 03/03/2017. Unit Sales reported for calendar year 2019.
Rx0000072 Mayne Pharma Inc 03/31/2020 51862015904 Hydrocortisone Butyrate External Lotion 0.1 % 118ML PER BOTTLE 01/28/2020 439.45 894.10 None Non-innovator Multiple Source Drug 279 None Initial launch price listed on 8/23/2019 was for a different pack size. Price change is to update to correct pack size. None None None None None None None None None None None None None Product was not acquired; this is a licensing deal with Teligent.
Rx0000072 Mayne Pharma Inc 03/31/2020 51862037612 Sorilux External Foam 0.005 % 120g Can 01/13/2020 110.51 1583.97 05/07/2028 Single Source Drug 4615 None None 1 None None 08/17/2016 GlaxoSmithKline LLC None 1 None 1240.18 1078.42 2012 650.00 None Product NDC at WAC Introduction in 2012 was 00145-2130-07. Product WAC Introduction for current 51862-0376-12 NDC was $1240.18 on 05/11/2017. Unit Sales reported for calendar year 2019.
Rx0000072 Mayne Pharma Inc 03/31/2020 51862037660 Sorilux External Foam 0.005 % 60g Can 01/13/2020 57.80 828.52 05/07/2028 Single Source Drug 29204 None None 1 None None 08/17/2016 GlaxoSmithKline LLC None 1 None 648.70 564.09 2012 340.00 None Product NDC at WAC Introduction in 2012 was 00145-2130-06. Product WAC Introduction for current 51862-0376-60 NDC was $648.7 on 05/11/2017. Unit Sales reported for calendar year 2019.
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538050106 Ciclodan Kit, 8%, TOPSOL, 34.60 ML 07/31/2020 10.85 444.88 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538050006 Ciclodan Topical Solution, 8%, TOPSOL, 6.60 ML 07/31/2020 10.85 444.88 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538017360 Clindacin ETZ Kit, 1%, TOPCMB, 1 EA 07/31/2020 15.20 623.14 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538017260 Clindacin ETZ, 1%, SGPDSW, 60 EA 07/31/2020 15.20 623.14 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538017069 Clindacin P, 1%, SGPDSW, 69 EA 07/31/2020 15.20 623.14 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538017169 Clindacin Pac, 1%, TOPCMB, 1 EA 07/31/2020 15.20 623.14 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538095104 Clodan Kit, 0.05%, TOPCMB, 1 EA 07/31/2020 15.22 623.90 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538095004 Clodan Shampoo, 0.05%, TOPSHMPO, 118 ML 07/31/2020 15.22 623.90 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538051112 Genadur Kit, 2500MCG, COMB, 1 EA 07/31/2020 12.48 511.67 None Single Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538051012 Genadur, TOPLIQ, 12 ML 07/31/2020 12.48 511.67 None Single Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538094160 Neo-Synalar Cream Kit, 0.5-0.025%, EXTCRM, 315 GM 07/31/2020 20.11 824.25 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538094060 Neo-Synalar Cream, 0.5-0.025%, EXTCRM, 60 GM 07/31/2020 20.11 824.25 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538017645 Neuac Gel, 1.2(1)%-5%, TOPGEL, 45 GM 07/31/2020 14.79 606.52 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538017745 Neuac Kit, 1.2(1)%-5%, TOPCMB, 130 GM 07/31/2020 14.79 606.52 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538044060 Nicadan, 800-10-100, TAB, 60 EA 07/31/2020 11.29 463.17 None Single Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538018145 Rosadan Cream Kit, 0.75%, RCTCMB, 1 EA 07/31/2020 11.93 489.26 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538018045 Rosadan Cream, 0.75%, EXTCRM, 45 GM 07/31/2020 11.93 489.26 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538018345 Rosadan Gel Kit, 0.75%, TOPCMB, 1 EA 07/31/2020 11.93 489.27 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538018245 Rosadan Gel, 0.75%, TOPGEL, 45 GM 07/31/2020 11.93 489.27 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538019116 Sumadan Kit, 9%-4.5%, TOPCMB, 1 EA 07/31/2020 19.98 818.87 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538019016 Sumadan Wash, 9%-4.5%, TOPCLNSR, 454 GM 07/31/2020 19.98 818.87 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538019216 Sumadan XLT, 9%-4.5%, TOPCMB, 539 GM 07/31/2020 19.98 818.87 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538010060 Sumaxin Cleansing Pad, 10%-4%, SGPDSW, 60 EA 07/31/2020 20.48 839.49 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538010160 Sumaxin CP Kit, 10%-4%, TOPCMB, 1 EA 07/31/2020 20.48 839.49 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538016016 Sumaxin TS, 8%-4%, TOPSUSP, 473 ML 07/31/2020 15.73 644.97 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538013016 Sumaxin Wash, 9%-4%, TOPCLNSR, 454 GM 07/31/2020 17.84 731.32 None Non-innovator Multiple Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538090112 Synalar Cream Kit, 0.025%, EXTCRM, 375 GM 07/31/2020 14.01 574.46 None Single Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538090012 Synalar Cream, 0.025%, EXTCRM, 120 GM 07/31/2020 14.01 574.46 None Single Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538091112 Synalar Ointment Kit, 0.025%, TOPCMB, 375 GM 07/31/2020 14.01 574.46 None Single Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000202 Medimetriks Pharmaceuticals, Inc 09/30/2020 43538091012 Synalar Ointment, 0.025%, EXTONT, 120 GM 07/31/2020 14.01 574.46 None Single Source Drug None 1 Increase in operating costs, inflation, changes in the market None No changes or improvements were made to this drug None None None None None None None None None None None This product was not acquired within the last 5 years
Rx0000138 Merck & Co., Inc. 03/31/2020 00006003330 BELSOMRA 10 mg Tablets 30 01/03/2020 17.40 365.70 05/29/2033 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years).
Rx0000138 Merck & Co., Inc. 03/31/2020 00006032530 BELSOMRA 15 mg Tablets 30 01/03/2020 17.40 365.70 05/29/2033 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years).
Rx0000138 Merck & Co., Inc. 03/31/2020 00006033530 BELSOMRA 20 mg Tablets 30 01/03/2020 17.40 365.70 05/29/2033 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years).
Rx0000138 Merck & Co., Inc. 03/31/2020 00006000530 BELSOMRA 5 mg Tablets 30 01/03/2020 17.40 365.70 05/29/2033 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years).
Rx0000138 Merck & Co., Inc. 03/31/2020 67919002010 ENTEREG 12 mg Capsules 30 01/03/2020 242.70 5195.40 02/12/2030 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years).
Rx0000138 Merck & Co., Inc. 03/31/2020 00052031301 FOLLISTIM AQ 300 unit/0.36 mL CARTRIDGE (ML) 0.42 01/03/2020 36.00 792.00 None Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank for products that were not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00052031601 FOLLISTIM AQ 600 unit/0.72 mL deliverable (833 unit/mL) CARTRIDGE (ML) 0.78 01/03/2020 72.00 1584.00 None Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years).
Rx0000138 Merck & Co., Inc. 03/31/2020 00052032601 FOLLISTIM AQ 900 unit/1.08 mL CARTRIDGE (ML) 1.17 01/03/2020 108.00 2376.00 None Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years).
Rx0000138 Merck & Co., Inc. 12/31/2020 00006412102 GARDASIL 9 0.5 mL Syringes 10 11/12/2020 113.59 2385.40 12/10/2028 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years).
Rx0000138 Merck & Co., Inc. 12/31/2020 00006411903 GARDASIL 9 0.5 mL Vials 10 11/12/2020 113.59 2385.40 12/10/2028 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years).
Rx0000138 Merck & Co., Inc. 03/31/2020 00006047761 ISENTRESS 100 mg Chewable Tablets 60 01/03/2020 19.68 413.28 09/11/2029 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years); (3) the patent expiration date for this product includes 6 month pediatric exclusivity.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006047361 ISENTRESS 25 mg Chewable Tablets 60 01/03/2020 4.92 103.32 09/11/2029 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years); (3) the patent expiration date for this product includes 6 month pediatric exclusivity.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006022761 ISENTRESS 400 mg Tablets 60 01/03/2020 78.72 1653.12 09/11/2029 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years); (3) the patent expiration date for this product includes 6 month pediatric exclusivity.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006308001 ISENTRESS HD 600 mg Tablets 60 01/03/2020 78.72 1653.12 04/21/2031 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years); (3) the patent expiration date for this product includes 6 month pediatric exclusivity.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006057782 JANUMET 50 mg-1000 mg Tablets 1000 01/03/2020 370.00 7890.00 07/21/2028 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006057762 JANUMET 50 mg-1000 mg Tablets 180 01/03/2020 66.60 1420.20 07/21/2028 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006057761 JANUMET 50 mg-1000 mg Tablets 60 01/03/2020 22.20 473.40 07/21/2028 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006057582 JANUMET 50 mg-500 mg Tablets 1000 01/03/2020 370.00 7890.00 07/21/2028 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006057562 JANUMET 50 mg-500 mg Tablets 180 01/03/2020 66.60 1420.20 07/21/2028 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006057561 JANUMET 50 mg-500 mg Tablets 60 01/03/2020 22.20 473.40 07/21/2028 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006008182 JANUMET XR 100 mg-1000 mg Tablets 1000 01/03/2020 740.00 15780.00 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006008131 JANUMET XR 100 mg-1000 mg Tablets 30 01/03/2020 22.20 473.40 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006008154 JANUMET XR 100 mg-1000 mg Tablets 90 01/03/2020 66.60 1420.20 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006008082 JANUMET XR 50 mg-1000 mg Tablets 1000 01/03/2020 370.00 7890.00 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006008062 JANUMET XR 50 mg-1000 mg Tablets 180 01/03/2020 66.60 1420.20 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006008061 JANUMET XR 50 mg-1000 mg Tablets 60 01/03/2020 22.20 473.40 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006007882 JANUMET XR 50 mg-500 mg Tablets 1000 01/03/2020 370.00 7890.00 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006007862 JANUMET XR 50 mg-500 mg Tablets 180 01/03/2020 66.60 1420.20 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2 )the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006007861 JANUMET XR 50 mg-500 mg Tablets 60 01/03/2020 22.20 473.40 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006027728 JANUVIA 100 mg Tablets 100 01/03/2020 74.00 1578.00 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006027782 JANUVIA 100 mg Tablets 1000 01/03/2020 740.00 15780.00 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank because the product was not acquired by Merck or not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006027731 JANUVIA 100 mg Tablets 30 01/03/2020 22.20 473.40 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank for products that were not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006027754 JANUVIA 100 mg Tablets 90 01/03/2020 66.60 1420.20 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank for products that were not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006022128 JANUVIA 25 mg Tablets 100 01/03/2020 74.00 1578.00 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank for products that were not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006022131 JANUVIA 25 mg Tablets 30 01/03/2020 22.20 473.40 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank for products that were not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006022154 JANUVIA 25 mg Tablets 90 01/03/2020 66.60 1420.20 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank for products that were not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006011228 JANUVIA 50 mg Tablets 100 01/03/2020 74.00 1578.00 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank for products that were not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006011231 JANUVIA 50 mg Tablets 30 01/03/2020 22.20 473.40 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank for products that were not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 03/31/2020 00006011254 JANUVIA 50 mg Tablets 90 01/03/2020 66.60 1420.20 11/24/2026 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank for products that were not acquired by Merck in the previous five years.
Rx0000138 Merck & Co., Inc. 12/31/2020 00006468100 M-M-R II 0.5 mL Vials 10 11/12/2020 38.21 802.49 None Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years).
Rx0000138 Merck & Co., Inc. 12/31/2020 00006483703 PNEUMOVAX 23 0.5 mL Syringes 10 11/12/2020 52.60 1104.54 None Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years).
Rx0000138 Merck & Co., Inc. 12/31/2020 00006494300 PNEUMOVAX 23 0.5 mL Vials 10 11/12/2020 52.60 1104.54 None Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years).
Rx0000138 Merck & Co., Inc. 12/31/2020 00006417100 PROQUAD 0.5 mL Vials 10 11/12/2020 110.97 2330.34 None Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years).
Rx0000138 Merck & Co., Inc. 12/31/2020 00006482700 VARIVAX 0.5 mL Vials 10 11/12/2020 67.49 1417.24 None Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677) (collectively, SB 17), the information provided is limited to information Merck believes is in the public domain; Pursuant to the OSHPD User Manual, Merck has included a value of "1" in all public indicator columns when the requested information is not in the public domain or publicly available; (2) the columns requiring information relating to product acquisition are left blank because the product does not meet the criteria set forth in SB 17 (i.e., disclosure required if acquired by a manufacturer in the previous five years).
Rx0000138 Merck & Co., Inc. 03/31/2020 67919003001 ZERBAXA 1.5 gram Vial 10 01/03/2020 112.80 1252.20 08/14/2035 Single Source Drug None 1 Merck periodically increases the list price of our medicines, including those reported in Merck’s annual price increase report, to recognize the value they provide to patients, recoup the cost of inflation, adapt to changing market conditions and competitive considerations, and most importantly, to help fund research and development and bring forward new medicines. In addition to reflecting the steadily escalating cost of doing business, our price actions are critical to funding: •capital investments in the U.S. of more than $5 billion in the last five years, with planned investment of $9 billion more in the U.S. over the next few years to increase manufacturing capacity and to open two new discovery research centers. •investments in research and development that last year alone totaled nearly $10 billion ($70 billion since 2010), focused on cancer and infectious diseases, as well as other major health challenges that affect large numbers of people. Merck does not maintain records that reflect how these factors were applied in the context of any particular product or price increase. None There is no specific change or improvement to the listed product that would “necessitate” a change in the product’s Wholesale Acquisition Cost. Merck's goal is to set prices at levels that allow patients to access medicines prescribed for them, while allowing for sustained funding of research and development. None None None None None None None None None None None Merck’s submission to OSHPD is subject to the following assumptions and context: (1) pursuant to California Senate Bill 17 and the laws it implements (including Cal. Health & Safety Code § 127677), the information provided is limited to information Merck believes is in the public domain, unless otherwise indicated; (2) the columns requiring information relating to product acquisition are left blank for products that were not acquired by Merck in the previous five years.
Rx0000051 MILLICENT U.S., INC. 03/31/2020 72495020105 FEMRING 0.05MG/DAY (ESTRADIOL ACETATE VAGINAL RING) for 3 months usage, package size 1 01/01/2020 46.12 531.49 None Single Source Drug None 1 None 1 None 1 05/18/2018 Allergan None 1 None 443.67 None 2003 76.50 None None
Rx0000051 MILLICENT U.S., INC. 03/31/2020 72495020210 FEMRING 0.10MG/DAY (ESTRADIOL ACETATE VAGINAL RING) for 3 months usage, package size 1 01/01/2020 49.14 566.37 None Single Source Drug None 1 None 1 None 1 05/18/2018 Allergan None 1 None 472.79 None 2003 81.50 None None
Rx0000318 Mission Pharmacal Company 12/31/2020 00178074001 URIBEL, methenamine 118mg, sodium phosphate monobasic 40.8mg, phenyl salicylate 10mg, methylene blue 10mg, and hyoscyamine sulfate capsule 0.12mg, 100 capsules 10/01/2020 26.33 355.44 None Non-innovator Multiple Source Drug None 1 Product was acquired from another labeler None No formulation changes were made, just Labeler change None 01/01/2019 Star Pharmaceuticals, LLC None 1 Additional Information is needed, no enough or clear information is provided in the sample form 313.44 290.22 2010 170.00 None None
Rx0000296 MOLECULAR BIOLOGICALS INC 09/30/2020 71474030310 KERAMATRIX WOUND DRESSING 10CMX10CM 10'S 07/01/2020 22485.00 29980.00 None Single Source Drug 100 None COMPETITIVE MARKET ANALYSIS None No change None None None None None None None None None None None None
Rx0000296 MOLECULAR BIOLOGICALS INC 09/30/2020 71474030350 KERAMATRIX WOUND DRESSING 10CMX10CM 5'S 07/01/2020 11242.50 14990.00 None Single Source Drug 100 None COMPETITIVE MARKET ANALYSIS None No change None None None None None None None None None None None None
Rx0000296 MOLECULAR BIOLOGICALS INC 09/30/2020 71474030301 KERAMATRIX WOUND DRESSING 10CMX10CM SINGLE 07/01/2020 2248.50 2998.00 None Single Source Drug 100 None COMPETITIVE MARKET ANALYSIS None No change None None None None None None None None None None None None
Rx0000296 MOLECULAR BIOLOGICALS INC 09/30/2020 71474030351 KERAMATRIX WOUND DRESSING 5CMX5CM 10'S 07/01/2020 3970.10 7495.00 None Single Source Drug 100 None COMPETITIVE MARKET ANALYSIS None No change None None None None None None None None None None None None
Rx0000296 MOLECULAR BIOLOGICALS INC 09/30/2020 71474030355 KERAMATRIX WOUND DRESSING 5CMX5CM 5'S 07/01/2020 1985.05 3747.50 None Single Source Drug 100 None COMPETITIVE MARKET ANALYSIS None No change None None None None None None None None None None None None
Rx0000296 MOLECULAR BIOLOGICALS INC 09/30/2020 71474030305 KERAMATRIX WOUND DRESSING 5CMX5CM SINGLE 07/01/2020 397.01 749.50 None Single Source Drug 100 None COMPETITIVE MARKET ANALYSIS None No change None None None None None None None None None None None None
Rx0000044 Mylan Institutional Inc 09/30/2020 67457022005 Isosulfan Blue 1% 50mg/5mL Liq 6s SUV 07/21/2020 288.68 6062.23 12/15/2028 Non-innovator Multiple Source Drug None 1 None 1 None 1 None None None None None None None None None None (1)NDC 67457-0220-00 is an innerpack of the NDC 67457-0220-05. As defined in the CA Code of Regulations Title 22, Divsion 7, Chapters 9.5 ("Regulations"), “Wholesale Acquisition Cost (“WAC”)” means a manufacturer’s published list price for a prescription drug product with a unique NDC. Because the innerpack is not commercially available for sale by Mylan, Mylan does not submit pricing to the pricing compendium and has no control on what the pricing compendium posts for these innerpack NDCs. Therefore, since there is no applicable WAC as defined in the Regulations for the innerpack NDC, Mylan is reporting only for the commercially available NDC 67457-0220-05. (2)FDA publishes, in the Orange Book, patent information for drugs approved under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FFDCA) as a NDA. Mylan’s product was approved under section 505(j) of the FFDCA as an ANDA. (3) Mylan Institutional Inc. owns and sells the product through Mylan Institutional LLC, and the product has been owned and sold by Mylan Institutional LLC for the past five years. Mylan Institutional Inc. and Mylan Institutional LLC are both indirectly wholly-owned subsidiaries of Mylan N.V.
Rx0000044 Mylan Institutional Inc 09/30/2020 67457025905 Isosulfan Blue N+ 1% 50mg/5mL Liq 6s SUV 07/21/2020 288.68 6062.23 12/15/2028 Non-innovator Multiple Source Drug None 1 None 1 None 1 None None None None None None None None None None (1) FDA publishes, in the Orange Book, patent information for drugs approved under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FFDCA) as a NDA. Mylan’s product was approved under section 505(j) of the FFDCA as an ANDA. (2) Mylan Institutional Inc. owns and sells the product through Mylan Institutional LLC, and the product has been owned and sold by Mylan Institutional LLC for the past five years. Mylan Institutional Inc. and Mylan Institutional LLC are both indirectly wholly-owned subsidiaries of Mylan N.V.
Rx0000044 Mylan Institutional Inc 09/30/2020 67457058605 Isosulfan Blue PRX 1% 50mg/5mL Liq 6s SUV 07/21/2020 288.68 6062.23 12/15/2028 Non-innovator Multiple Source Drug None 1 None 1 None 1 None None None None None None None None None None (1) NDC 67457-0586-00 is an innerpack of the NDC 67457-0586-05. As defined in the CA Code of Regulations Title 22, Divsion 7, Chapters 9.5 ("Regulations"), “Wholesale Acquisition Cost (“WAC”)” means a manufacturer’s published list price for a prescription drug product with a unique NDC. Because the innerpack is not commercially available for sale by Mylan, Mylan does not submit pricing to the pricing compendium and has no control on what the pricing compendium posts for these innerpack NDCs. Therefore, since there is no applicable WAC as defined in the Regulations for the innerpack NDC, Mylan is reporting only for the commercially available NDC 67457-0586-05. (2) FDA publishes, in the Orange Book, patent information for drugs approved under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FFDCA) as a NDA. Mylan’s product was approved under section 505(j) of the FFDCA as an ANDA. (3) Mylan Institutional Inc. owns and sells the product through Mylan Institutional LLC, and the product has been owned and sold by Mylan Institutional LLC for the past five years. Mylan Institutional Inc. and Mylan Institutional LLC are both indirectly wholly-owned subsidiaries of Mylan N.V.