| Rx0000297 |
MannKind Corporation |
12/31/2021 |
47918088018 |
AFREZZA INSULIN HUMAN INHL PWD 90X4UN/90X8UN |
10/04/2021 |
56.80 |
1192.86 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000297 |
MannKind Corporation |
12/31/2021 |
47918089818 |
AFREZZA INSULIN HUMAN INHL PWD 90X8UN/90X12UN |
10/04/2021 |
94.67 |
1988.10 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000297 |
MannKind Corporation |
12/31/2021 |
47918090218 |
AFREZZA INSULIN,HUMAN INHL PWD 4/8/12 UNIT |
10/04/2021 |
75.74 |
1590.49 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000297 |
MannKind Corporation |
12/31/2021 |
47918087890 |
AFREZZA INSULIN,HUMAN INHL PWD 90X 8UNITS |
10/04/2021 |
37.87 |
795.24 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000297 |
MannKind Corporation |
12/31/2021 |
47918089190 |
AFREZZA INSULIN,HUMAN INHL PWR 90X12UNIT |
10/04/2021 |
56.80 |
1192.86 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000072 |
Mayne Pharma Inc |
12/31/2021 |
68308025010 |
Erythromycin Base Oral Capsule Delayed Release Particles 250 MG 100 count |
10/01/2021 |
253.19 |
735.85 |
None |
Single Source Drug |
9600 |
None |
CHANGE IN MARKET DYNAMICS |
None |
NONE |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000072 |
Mayne Pharma Inc |
03/31/2021 |
51862029510 |
Fabior External Foam 0.1 % 100g Can |
02/01/2021 |
80.91 |
1236.85 |
02/24/2030 |
Single Source Drug |
7148 |
None |
Annual WAC increase. |
None |
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 2020. |
| Rx0000072 |
Mayne Pharma Inc |
03/31/2021 |
51862029550 |
Fabior External Foam 0.1 % 50g Can |
02/01/2021 |
40.46 |
618.42 |
02/24/2030 |
Single Source Drug |
73750 |
None |
Annual WAC increase. |
None |
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 2020. |
| Rx0000072 |
Mayne Pharma Inc |
12/31/2021 |
68308011501 |
Methamphetamine HCl Oral Tablet 5 MG 100 count |
10/01/2021 |
401.75 |
1615.52 |
None |
Non-innovator Multiple Source Drug |
10800 |
None |
CHANGE IN MARKET DYNAMICS |
None |
NONE |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000072 |
Mayne Pharma Inc |
03/31/2021 |
51862037612 |
Sorilux External Foam 0.005 % 120g Can |
02/01/2021 |
110.88 |
1694.85 |
05/07/2028 |
Single Source Drug |
2361 |
None |
Annual WAC increase. |
None |
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 2020. |
| Rx0000072 |
Mayne Pharma Inc |
03/31/2021 |
51862037660 |
Sorilux External Foam 0.005 % 60g Can |
02/01/2021 |
58.00 |
886.52 |
05/07/2028 |
Single Source Drug |
27947 |
None |
Annual WAC increase. |
None |
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 2020. |
| Rx0000072 |
Mayne Pharma Inc |
09/30/2021 |
51862048601 |
TRIMETHOPRIM 100MG TABLETS 100 |
09/08/2021 |
93.15 |
186.30 |
None |
Non-innovator Multiple Source Drug |
236488 |
None |
change in market dynamics |
None |
NONE |
None |
08/03/2016 |
ALLERGAN |
652000000 |
None |
Trimethoprim was acquired as part of a portfolio of drugs from Allergan and Teva with at a total cost of $652 million. |
31.05 |
31.05 |
2001 |
20.70 |
None |
None |
| Rx0000378 |
Medicure Pharma, Inc. |
06/30/2021 |
25208000305 |
Sodium Nitroprusside 50 mg/2mL vial |
05/26/2021 |
35.00 |
50.00 |
01/01/2017 |
Non-innovator Multiple Source Drug |
9867 |
None |
Medicure takes multiple factors into consideration to determine the price of pharmaceutical products. These factors include; acquisition or development cost, market dynamics and discounts provided to government and commercial customers. |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The WAC price was lowered on December 2, 2019 from $50 to $15 and then increased on April 26th from $15 to $50. The product was acquired before it was released into the market |
| Rx0000202 |
Medimetriks Pharmaceuticals, Inc |
03/31/2021 |
43538044060 |
Nicadan, 800-10-100, TAB, 60 EA |
02/26/2021 |
20.85 |
484.02 |
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 |
06/30/2021 |
43538044060 |
Nicadan, 800-10-100, TAB, 60 EA |
05/06/2021 |
17.42 |
501.44 |
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 |
| Rx0000382 |
Melinta Therapeutics, LLC |
09/30/2021 |
70842016010 |
MINOCIN (Minocycline-Hydrochloride) is administered via intravenous form and packaged as 10 VIAL in 1 CARTON > 1 INJECTION in 1 VIAL (1mg dose) |
07/01/2021 |
135.89 |
2071.00 |
05/12/2031 |
Single Source Drug |
None |
1 |
Melinta seeks to provide innovative therapies to people impacted by acute and life-threatening illnesses and our vision is ensure that all people who need our therapies will receive them. Melinta is committed to the responsible pricing of our products and our pricing methodology includes consideration of several financial and nonfinancial factors.
Initial pricing, as well as any change in pricing, aims to reflect the clinical value of the product to patients and the healthcare system, while at the same time ensuring patient access. Financial factors include both our current investments in MINOCIN (minocycline) for Injection, as well as consideration for potential future investments in research or other lifecycle related matters that may be necessary. |
None |
None - see cost increase factors statement. |
None |
01/05/2018 |
The Medicines Company |
None |
1 |
None |
1544.13 |
1544.13 |
2015 |
1470.60 |
None |
None |
| Rx0000138 |
Merck & Co., Inc. |
09/30/2021 |
00006412102 |
GARDASIL 9 0.5 mL Syringes 10 |
08/12/2021 |
143.12 |
2528.52 |
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 $6 billion in the last three years, with planned investment of >$10 billion in the U.S. between 2020 and 2024 to increase manufacturing capacity
• investments in research and development that last year alone totaled nearly $13.6 billion ($103 billion since 2010), on a GAAP basis, 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. |
09/30/2021 |
00006411903 |
GARDASIL 9 0.5 mL Vials 10 |
08/12/2021 |
143.12 |
2528.52 |
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 $6 billion in the last three years, with planned investment of >$10 billion in the U.S. between 2020 and 2024 to increase manufacturing capacity
• investments in research and development that last year alone totaled nearly $13.6 billion ($103 billion since 2010), on a GAAP basis, 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. |
09/30/2021 |
00006468100 |
M-M-R II 0.5 mL Vials 10 |
08/12/2021 |
48.15 |
850.64 |
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 $6 billion in the last three years, with planned investment of >$10 billion in the U.S. between 2020 and 2024 to increase manufacturing capacity
• investments in research and development that last year alone totaled nearly $13.6 billion ($103 billion since 2010), on a GAAP basis, 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. |
09/30/2021 |
00006483703 |
PNEUMOVAX 23 0.5 mL Syringes 10 |
08/12/2021 |
66.27 |
1170.81 |
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 $6 billion in the last three years, with planned investment of >$10 billion in the U.S. between 2020 and 2024 to increase manufacturing capacity
• investments in research and development that last year alone totaled nearly $13.6 billion ($103 billion since 2010), on a GAAP basis, 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. |
09/30/2021 |
00006494300 |
PNEUMOVAX 23 0.5 mL Vials 10 |
08/12/2021 |
66.27 |
1170.81 |
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 $6 billion in the last three years, with planned investment of >$10 billion in the U.S. between 2020 and 2024 to increase manufacturing capacity
• investments in research and development that last year alone totaled nearly $13.6 billion ($103 billion since 2010), on a GAAP basis, 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. |
09/30/2021 |
00006417100 |
PROQUAD 0.5 mL Vials 10 |
08/12/2021 |
139.82 |
2470.16 |
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 $6 billion in the last three years, with planned investment of >$10 billion in the U.S. between 2020 and 2024 to increase manufacturing capacity
• investments in research and development that last year alone totaled nearly $13.6 billion ($103 billion since 2010), on a GAAP basis, 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. |
09/30/2021 |
00006482700 |
VARIVAX 0.5 mL Vials 10 |
08/12/2021 |
85.03 |
1502.27 |
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 $6 billion in the last three years, with planned investment of >$10 billion in the U.S. between 2020 and 2024 to increase manufacturing capacity
• investments in research and development that last year alone totaled nearly $13.6 billion ($103 billion since 2010), on a GAAP basis, 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). |
| Rx0000051 |
MILLICENT U.S., INC. |
03/31/2021 |
72495020105 |
FEMRING 0.05MG/DAY (ESTRADIOL ACETATE VAGINAL RING) 1 RING FOR 3 MONTH'S USAGE |
01/01/2021 |
49.96 |
581.45 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
05/18/2018 |
Allergan |
None |
1 |
None |
485.37 |
443.67 |
2003 |
76.50 |
None |
None |
| Rx0000051 |
MILLICENT U.S., INC. |
03/31/2021 |
72495020210 |
FEMRING 0.10MG/DAY (ESTRADIOL ACETATE VAGINAL RING) 1 RING FOR 3 MONTH'S USAGEG |
01/01/2021 |
53.24 |
619.61 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
05/18/2018 |
Allergan |
None |
1 |
None |
517.23 |
472.79 |
2003 |
81.50 |
None |
None |
| Rx0000051 |
MILLICENT U.S., INC. |
09/30/2021 |
72495040128 |
INTRAROSA 6.5mg/DAY (28 PRASTERONE INSERTS) FOR 28 DAYS USAGE |
08/16/2021 |
7.43 |
226.10 |
03/19/2031 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
04/26/2020 |
AMAG |
None |
1 |
None |
212.30 |
202.00 |
2017 |
175.00 |
None |
Original NDC was changed from 64011060128 (AMAG) to 72495040128 (Millicent) in Q1 2021. Historical pricing from the AMAG NDC will be included in the history of the new Millicent NDC. |
| Rx0000051 |
MILLICENT U.S., INC. |
03/31/2021 |
64011060128 |
INTRAROSA 6.5mg/DAY (PRASTERONE INSERTS) 28 INSERTS FOR 28 DAYS USAGE |
01/01/2021 |
6.37 |
218.67 |
03/19/2031 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
04/26/2020 |
AMAG |
None |
1 |
None |
212.30 |
202.00 |
2017 |
175.00 |
None |
None |
| Rx0000044 |
Mylan Institutional Inc |
09/30/2021 |
67457022005 |
Isosulfan Blue 1% 50mg/5mL Liq 6s SUV |
07/01/2021 |
303.11 |
6365.34 |
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 Inc. |
| Rx0000044 |
Mylan Institutional Inc |
09/30/2021 |
67457025905 |
Isosulfan Blue N+ 1% 50mg/5mL Liq 6s SUV |
07/01/2021 |
303.11 |
6365.34 |
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 Inc. |
| Rx0000044 |
Mylan Institutional Inc |
09/30/2021 |
67457058605 |
Isosulfan Blue PRX 1% 50mg/5mL Liq 6s SUV |
07/01/2021 |
303.11 |
6365.34 |
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 Inc. |