| Par Pharmaceutical |
49884014601 |
Penicillamine Capsules 250mg 100s |
2020-01-02 |
20950.9100 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is indicated for Wilson Disease, National Organization for Rare Disorders (“NORD”) indicates between 2,000 – 3,000 cases have been diagnosed in the United States. See https://rarediseases.org/rare-diseases/wilson-disease/. However, NORD indicates as many as 9,000 people in the United States may be actually affected by Wilson Disease. Further, NORD did not specify the number of patients diagnosed each month or year with Wilson Disease. Penicillamine is also indicated for excess cysteine excretion and severe rheumatoid arthritis unresponsive to other treatments. It is estimated that 1 in 10,000 people are affected by excess cysteine excretion in the United States. See https://ghr.nlm.nih.gov/condition/cystinuria#statistics. An estimated 1.3 million Americans suffer from rheumatoid arthritis. See https://www.rheumatoidarthritis.org/ra/facts-and-statistics/.
Because of the multiple indications of Penicillamine, and the absence of precise data about the various patient populations that have diseases for which Penicillamine is indicated, Par is unable to provide an estimate of the average number of patients who may be treated by this product.
Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that will be prescribed this product each month.
As a result, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
00254200001 |
Penicillamine Tablets 250mg 100s |
2020-01-02 |
4652.9200 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is indicated for Wilson Disease, National Organization for Rare Disorders (“NORD”) indicates between 2,000 – 3,000 cases have been diagnosed in the United States. See https://rarediseases.org/rare-diseases/wilson-disease/. However, NORD indicates as many as 9,000 people in the United States may be actually affected by Wilson Disease. Further, NORD did not specify the number of patients diagnosed each month or year with Wilson Disease. Penicillamine is also indicated for excess cysteine excretion and severe rheumatoid arthritis unresponsive to other treatments. It is estimated that 1 in 10,000 people are affected by excess cysteine excretion in the United States. See https://ghr.nlm.nih.gov/condition/cystinuria#statistics. An estimated 1.3 million Americans suffer from rheumatoid arthritis. See https://www.rheumatoidarthritis.org/ra/facts-and-statistics/.
Because of the multiple indications of Penicillamine, and the absence of precise data about the various patient populations that have diseases for which Penicillamine is indicated, Par is unable to provide an estimate of the average number of patients who may be treated by this product.
Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that will be prescribed this product each month.
As a result, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
00254101019 |
Diazoxide Oral Suspension 50mg/mL 30mL bottle |
2020-08-04 |
275.5200 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
(2) This product is indicated for management hypoglycemia due to hyperinsulinism associated with numerous different conditions. Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. Because of the product’s widespread indications, and because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level, Par is unable to provide an estimated number of patients who will be prescribed the products in the “estimated number of patients” data field. As a result, Par has left the estimated number of patients data field blank.
Because of the multiple indications of Diazoxide, and the absence of precise data about the various patient populations that have diseases for which Diazoxide is indicated, Par is unable to provide an estimate of the average number of patients who may be treated by this product.
Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that will be prescribed this product each month.
As a result, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
42023016410 |
Vasostrict® 1 mL x 10 Single Dose Vials |
2020-08-10 |
1975.6000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
(2) This product indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines. Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product.
Additionally, Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the number of patients who may be prescribed this product.
As a result, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
None |
| Par Pharmaceutical |
49884094872 |
Sapropterin Dihydrochloride Powder for OS 100mg 30s |
2020-08-28 |
967.2000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is a phenylalanine hydroxylase activator indicated to for hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). National Organization for Rare Disorders (“NORD”) indicates approximately 1 in 1,000,000 individuals may Tetrahydrobiopterin deficiencies in the general population. See https://rarediseases.org/rare-diseases/tetrahydrobiopterin-deficiency/. Further, NORD did not specify the number of patients diagnosed each month or year with Tetrahydrobiopterin deficiencies.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that may be prescribed this product.
As a result, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=448 |
| Par Pharmaceutical |
49884087372 |
Sapropterin Dihydrochloride Powder for OS 500mg 30s |
2020-08-28 |
4836.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is a phenylalanine hydroxylase activator indicated to for hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). National Organization for Rare Disorders (“NORD”) indicates approximately 1 in 1,000,000 individuals may Tetrahydrobiopterin deficiencies in the general population. See https://rarediseases.org/rare-diseases/tetrahydrobiopterin-deficiency/. Further, NORD did not specify the number of patients diagnosed each month or year with Tetrahydrobiopterin deficiencies.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that may be prescribed this product.
As a result, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=449 |
| Par Pharmaceutical |
49884072008 |
Sapropterin Dihydrochloride Tablets 100mg 120s |
2020-08-28 |
3868.8000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions.
(1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Par believes is otherwise in the public domain or publicly available, as of the date of this submission. As a result, Par has left the marketing and pricing plan description data field blank.
(2) Par did not conduct any epidemiologic studies or analyses on the incidence and prevalence of the conditions, at the patient level, treated by this product. However, Par notes that this product is a phenylalanine hydroxylase activator indicated to for hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU). National Organization for Rare Disorders (“NORD”) indicates approximately 1 in 1,000,000 individuals may Tetrahydrobiopterin deficiencies in the general population. See https://rarediseases.org/rare-diseases/tetrahydrobiopterin-deficiency/. Further, NORD did not specify the number of patients diagnosed each month or year with Tetrahydrobiopterin deficiencies.
Because Par does not know, and does not have access to, the prescribing patterns of healthcare practitioners at the patient level. Thus, Par is unable to provide an estimate of the average number of patients that may be prescribed this product.
As a result, Par has left the “estimated number of patients” data field blank.
(3) Par did not acquire this product. As a result, Par has left the acquisition related data fields blank. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=447 |
| Perrigo Pharmaceuticals |
45802088918 |
Calcipotriene-Betamethasone Dipropionate Topical Susp 0.005%/0.064% |
2020-10-09 |
1001.9500 |
We plan to market the product as a generic to the Brand reference drug primarily to regional and national wholesalers, warehousing retail chains, and hospital and LTC group purchasing organizations.
Product will be price to deliver value to the market as compared to the Brand reference drug. |
None |
8000000 |
None |
None |
None |
None |
None |
None |
Drug Product was not acquired by Perrigo so blank fields in 10 and 11 are intentional. |
None |
| Pfizer |
00069023801 |
RUXIENCE 10mg/ml SSOL 1x10mLGVL US |
2020-01-23 |
716.8000 |
None |
1 |
204000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Based on our internal estimates of the size of the rituximab market based on Rituxan's usage across therapeutic areas, we estimate 240,000 patients currently being treated on Avastin. Note this includes Rheumatoid Arthritis; please note that Ruxience is not indicated for use in that patient population (15% of patients). Comment regarding Fields 10-13: Ruxience was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069024901 |
RUXIENCE 10mg/ml SSOL 1x50mLGVL US |
2020-01-23 |
3584.0000 |
None |
1 |
204000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Based on our internal estimates of the size of the rituximab market based on Rituxan's usage across therapeutic areas, we estimate 240,000 patients currently being treated on Avastin. Note this includes Rheumatoid Arthritis; please note that Ruxience is not indicated for use in that patient population (15% of patients). Comment regarding Fields 10-13: Ruxience was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069030501 |
TRAZIMERA 420mg/30ml SFDPO 1x1 GVL US |
2020-02-18 |
3391.0800 |
None |
1 |
64000 |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - Based on our internal estimates of the size of the trastuzumab market based on Herceptin's usage across therapeutic areas, we estimate 64,000 patients currently being treated on Herceptin. Comment regarding Fields 10-13: Trazimera was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069024810 |
PROPOFOL EDTA 10mg/ml INJ 10x100ml VL US |
2020-09-17 |
213.8000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
Pfizer Inc. is the reporting manufacturer for this product launch based on the following information. Pfizer acquired InnoPharma in September 2014. The ANDA for Propofol EDTA was transferred to InnoPharma subsequent to the acquisition. There is no licensing agreement between InnoPharma and Pfizer Inc. for Propofol EDTA; Pfizer Inc. is the NDC holder. Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - The estimated number of patients who may be prescribed Propofol EDTA is unknown. Comment regarding Fields 10-13: Propofol EDTA was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069020910 |
PROPOFOL EDTA 10mg/ml INJ 10x20ml VL US |
2020-09-17 |
42.8000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
Pfizer Inc. is the reporting manufacturer for this product launch based on the following information. Pfizer acquired InnoPharma in September 2014. The ANDA for Propofol EDTA was transferred to InnoPharma subsequent to the acquisition. There is no licensing agreement between InnoPharma and Pfizer Inc. for Propofol EDTA; Pfizer Inc. is the NDC holder. Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - The estimated number of patients who may be prescribed Propofol EDTA is unknown. Comment regarding Fields 10-13: Propofol EDTA was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069023420 |
PROPOFOL EDTA 10mg/ml INJ 20x50ml VL US |
2020-09-17 |
213.8000 |
None |
1 |
None |
None |
1 |
None |
None |
None |
None |
Pfizer Inc. is the reporting manufacturer for this product launch based on the following information. Pfizer acquired InnoPharma in September 2014. The ANDA for Propofol EDTA was transferred to InnoPharma subsequent to the acquisition. There is no licensing agreement between InnoPharma and Pfizer Inc. for Propofol EDTA; Pfizer Inc. is the NDC holder. Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - The estimated number of patients who may be prescribed Propofol EDTA is unknown. Comment regarding Fields 10-13: Propofol EDTA was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00409351022 |
ERTAPENEM 1gm SPO 1x10 GVIAL US |
2020-09-29 |
1170.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Comment regarding Field 5 - Pfizer does not believe the Marketing/Pricing Plan information is publicly available and has not released this information in the public domain. Accordingly, Pfizer is limiting its response to this item pursuant to Cal. Health & Safety Code § 127681(c). Comment regarding Field 7 - The estimated number of patients who may be prescribed Ertapenem is unknown. Per 2020 IMS data, annual UoU is 3,584,259 (represents rolling 12 months). Comment regarding Fields 10-13: Ertapenem is licensed as part of a contract manufacturer relationship; Pfizer is not the ANDA holder. Because the product was not acquired, Fields 10 – 13 are intentionally left blank. |
None |