| Pfizer |
00409111201 |
Busulfan Injection 60 mg/10mL (6mg/mL) |
2019-02-28 |
7786.0000 |
None |
1 |
70000 |
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 number entered in field 7 is the estimated number of patients in the U.S. for 2010. The projected number of patients in the U.S. for 2030 is 144,000. Patients with this condition may or may not use this product. Source: https://www.cancernetwork.com/chronic-myeloid-leukemia/chronic-myeloid-leukemia Comment regarding Fields 10-13 - The product was not acquired. |
None |
| Pfizer |
00069197540 |
VYNDAQEL® (tafamidis meglumine) 20MG CAP 4X30 BLST US |
2019-05-06 |
187500.0000 |
None |
1 |
None |
1 |
1 |
2010-10-06 |
None |
1 |
On October 6, 2010, we completed our acquisition of FoldRx Pharmaceuticals, Inc. (FoldRx), a privately held drug discovery and clinical development company, whose portfolio included clinical and preclinical programs for investigational compounds to treat diseases caused by protein misfolding. The total consideration for the acquisition was approximately $400 million, which consisted of an upfront payment to FoldRx’s shareholders of about $200 million and contingent consideration with an estimated acquisition-date fair value of about $200 million. The contingent consideration consists of up to $455 million in additional payments that are contingent upon the attainment of future regulatory and commercial milestones. |
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 - ATTR-CM is significantly under or misdiagnosed, and as a result, it is difficult to characterize prevalence. Based on our internal estimates and existing literature, we believe U.S. prevalence is approximately 100,000 with a diagnosis range of approximately 1-2%. |
None |
| Pfizer |
00069873030 |
VYNDAMAX™ 61MG CAP 3X10 BLST US |
2019-08-27 |
18750.0000 |
None |
1 |
3000 |
None |
None |
2010-10-06 |
None |
1 |
On October 6, 2010, we completed our acquisition of FoldRx Pharmaceuticals, Inc. (FoldRx), a privately held drug discovery and clinical development company, whose portfolio included clinical and preclinical programs for investigational compounds to treat diseases caused by protein misfolding. The total consideration for the acquisition was approximately $400 million, which consisted of an upfront payment to FoldRx’s shareholders of about $200 million and contingent consideration with an estimated acquisition-date fair value of about $200 million. The contingent consideration consists of up to $455 million in additional payments that are contingent upon the attainment of future regulatory and commercial milestones. |
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 - ATTR-CM is significantly under or misdiagnosed, and as a result, it is difficult to characterize prevalence. Based on our internal estimates and existing literature, we believe U.S. prevalence is approximately 100,000 with a diagnosis range of approximately 3%. |
None |
| Pfizer |
00409139051 |
MEROPENEM 500mg SPO 1x10 GVIAL US |
2019-10-08 |
145.0000 |
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 solely for Meropenem is not available. |
None |
| Pfizer |
00409139122 |
MEROPENEM 1gm SPO 1x10 GVIAL US |
2019-10-08 |
291.4000 |
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 solely for Meropenem is not available. |
None |
| Pfizer |
00409110301 |
CISATRACURIUM 200MG/20ML SSOL 1X10 GVL |
2019-11-06 |
2705.0000 |
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 solely for Cisatracurium is not available. Comment regarding Fields 10 -13: The cost for Cisatracurium Besylate Injection alone is not available. On September 3, 2015, Pfizer acquired Hospira, a leading provider of sterile injectable drugs and infusion technologies as well as a provider of biosimilars, for approximately $16.1 billion in cash ($15.7 billion, net of cash acquired). The acquisition cost of $16,100,000,000 reflects the total cost of the entire Hospira acquisition. Cisatracurium Besylate Injection received FDA approval associated with a new ANDA. |
None |
| Pfizer |
00069034201 |
ZIRABEV™ 400MG/16ML SSOL 1x1 GVL US |
2019-12-31 |
2453.6000 |
None |
1 |
75000 |
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 bevacizumab market based on Avastin's usage across tumor types, we estimate 85,000 patients currently being treated on Avastin. Note this includes ovarian cancer; please note that Zirabev is not indicated for use in that patient population (12% of patients). Comment regarding Fields 10-13: Zirabev was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Pfizer |
00069031501 |
ZIRABEV™ 100MG/4ML SSOL 1X1 GVL US |
2019-12-31 |
613.4000 |
None |
1 |
75000 |
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 bevacizumab market based on Avastin's usage across tumor types, we estimate 85,000 patients currently being treated on Avastin. Note this includes ovarian cancer; please note that Zirabev is not indicated for use in that patient population (12% of patients). Comment regarding Fields 10-13: Zirabev was not acquired; therefore, Columns 10 – 13 are intentionally left blank. |
None |
| Paratek Pharmaceuticals, Inc. |
71715000221 |
NUZYRA 150mg omadacycline tablets 6ct blister pack |
2019-02-01 |
1185.0000 |
None |
1 |
12000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Paratek Pharmaceuticals, Inc. |
71715000223 |
NUZYRA 150mg omadacycline tablets 14ct Blister Pack |
2019-02-01 |
2765.0000 |
None |
1 |
12000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Paratek Pharmaceuticals, Inc. |
71715000224 |
NUZYRA 150mg omadacycline tablets 16ct blister pack |
2019-02-01 |
3160.0000 |
None |
1 |
12000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Paratek Pharmaceuticals, Inc. |
71715000102 |
NUZYRA 150mg single dose vial 10ct carton |
2019-02-01 |
3450.0000 |
None |
1 |
12000 |
None |
1 |
None |
None |
None |
None |
None |
None |
| Par Pharmaceutical |
49884082011 |
Alosetron HCl Tablets 1mg 30s |
2019-04-12 |
950.0000 |
None |
1 |
None |
1 |
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 Pharmaceutical |
49884035362 |
Ambrisentan Oral Tablet 5 MG 10s |
2019-04-29 |
2588.8200 |
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 Pharmaceutical |
49884035311 |
Ambrisentan Oral Tablet 5 MG 30s |
2019-04-29 |
7766.4700 |
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 Pharmaceutical |
49884035462 |
Ambrisentan Oral Tablet 10 MG 10s |
2019-04-29 |
2588.8200 |
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 Pharmaceutical |
49884035411 |
Ambrisentan Oral Tablet 10 MG 30s |
2019-04-29 |
7766.4700 |
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 Pharmaceutical |
49884005802 |
Bosentan Tablets 62.5mg 60s |
2019-06-03 |
1163.1600 |
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 Pharmaceutical |
49884005902 |
Bosentan Tablets 125mg 60s |
2019-06-03 |
1163.1600 |
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 Pharmaceutical |
00254302002 |
Nitisinone Capsules 2 mg 60 Capsules |
2019-09-20 |
4359.5100 |
None |
1 |
150 |
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 Pharmaceutical |
00254302102 |
Nitisinone Capsules 5 mg 60 Capsules |
2019-09-20 |
10898.7100 |
None |
1 |
150 |
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 Pharmaceutical |
00254302202 |
Nitisinone Capsules 10 mg 60 Capsules |
2019-09-20 |
21797.4500 |
None |
1 |
150 |
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 Pharmaceutical |
42023020601 |
Treprostinil Injection 20 mg/20 mL (1 mg/mL) |
2019-09-25 |
1209.6500 |
None |
1 |
750 |
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 Pharmaceutical |
42023020701 |
Treprostinil Injection 50 mg/20 mL (2.5 mg/mL) |
2019-09-25 |
3024.1400 |
None |
1 |
750 |
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 Pharmaceutical |
42023020801 |
Treprostinil Injection 100 mg/20 mL (5 mg/mL) |
2019-09-25 |
6048.2700 |
None |
1 |
750 |
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 Pharmaceutical |
42023020901 |
Treprostinil Injection 200 mg/20 mL (10 mg/mL) |
2019-09-25 |
12096.5400 |
None |
1 |
750 |
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 Pharmaceutical |
49884006001 |
Trientine Hydrochloride Capsules, USP 250 mg 100 Capsules |
2019-10-07 |
5000.0000 |
None |
1 |
2500 |
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 Pharmaceutical |
49884011991 |
Everolimus Tablets 2.5mg 28s |
2019-12-10 |
12012.9800 |
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 Pharmaceutical |
49984012591 |
Everolimus Tablets 5mg 28s |
2019-12-10 |
12565.3700 |
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 Pharmaceutical |
49884012791 |
Everolimus Tablets 7.5mg 28s |
2019-12-10 |
12565.3700 |
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 Pharmaceutical |
49884072308 |
Zileuton Extended Release Tablets 600mg 120s |
2019-12-16 |
3007.2300 |
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) |
| Progenics Pharmaceuticals, Inc. |
71258001502 |
AZEDRA (iobenguane I 131) injection |
2019-06-03 |
9060.0000 |
None |
1 |
380 |
1 |
1 |
None |
None |
None |
None |
Azedra is priced at $302 per mCi. 71258001502 is a dosimetric presentation containing 30 mCi at calibration time Estimated of the average number of patients who will be prescribed AZERDA: AZEDRA is the first and only FDA-approved systemic treatment for advanced PPGL and the only drug approved by the FDA to treat PPGL that cannot be surgically removed (i.e., are unresectable), are locally advanced, or have spread beyond the original tumor site, and require systemic anticancer therapy. Prior to FDA’s approval of AZEDRA, patients with advanced PPGL had no FDA-approved treatment option for systemic anticancer therapy. As FDA stated in its Review Summary for AZEDRA, “Clearly, there is a patient population who could potentially benefit from effective systemic therapy. To date, there are limited options for such patients (e.g., either compounded I-131 MIBG or off- label cytotoxic chemotherapy).” PPGL are ultra-rare tumors, and the ultra-rare category is that with the smallest of patient populations. We estimate there will be approximately 400-800 Azedra-eligible patients in the US each year (or 32-65 per month), based on the following epidemiology statistics: • |
US population of approximately 330M (US Census Bureau) • |
| Progenics Pharmaceuticals, Inc. |
71258001522 |
AZEDRA (iobenguane I 131) injection |
2019-06-03 |
101925.0000 |
None |
1 |
380 |
1 |
1 |
None |
None |
None |
None |
Azedra is priced at $302 per mCi. 71258001502 is a therapeutic presentation containing 337.5 mCi at calibration time Estimated of the average number of patients who will be prescribed AZERDA: AZEDRA is the first and only FDA-approved systemic treatment for advanced PPGL and the only drug approved by the FDA to treat PPGL that cannot be surgically removed (i.e., are unresectable), are locally advanced, or have spread beyond the original tumor site, and require systemic anticancer therapy. Prior to FDA’s approval of AZEDRA, patients with advanced PPGL had no FDA-approved treatment option for systemic anticancer therapy. As FDA stated in its Review Summary for AZEDRA, “Clearly, there is a patient population who could potentially benefit from effective systemic therapy. To date, there are limited options for such patients (e.g., either compounded I-131 MIBG or off- label cytotoxic chemotherapy).” PPGL are ultra-rare tumors, and the ultra-rare category is that with the smallest of patient populations. We estimate there will be approximately 400-800 Azedra-eligible patients in the US each year (or 32-65 per month), based on the following epidemiology statistics: • |
US population of approximately 330M (US Census Bureau) • |
| Perrigo Pharmaceuticals |
45802004475 |
Acyclovir 5% Cream 5gm |
2019-02-11 |
759.8600 |
None |
1 |
23360000 |
None |
None |
None |
None |
None |
None |
Perrigo developed this product. It was not an acquisition. |
None |
| Pharmaceutical Associates, Inc |
00121168040 |
Potassium Chloride Oral Solution |
2019-04-05 |
507.2000 |
Marketing is done periodically in Pharmaceutical Trade Magazines Pricing plan is to remain competitive as determined by our pricing committee |
None |
None |
None |
None |
None |
None |
None |
None |
Pharmaceutical Associates, Inc did not acquire the drug. This is our formulation that we submitted an ANDA to manufacture |
None |
| Pharmaceutical Associates, Inc |
00121168000 |
Potassium Chloride Oral Solution |
2019-04-05 |
1205.0000 |
Marketing is done periodically in Pharmaceutical Trade Magazines Pricing plan is to remain competitive as determined by our pricing committee |
None |
None |
None |
None |
None |
None |
None |
None |
Pharmaceutical Associates, Inc did not acquire the drug. This is our formulation that we submitted an ANDA to manufacture |
None |
| Pharmaceutical Associates, Inc |
00121252000 |
Potassium Chloride Oral Solution |
2019-04-05 |
1849.0000 |
Marketing is done periodically in Pharmaceutical Trade Magazines Pricing plan is to remain competitive as determined by our pricing committee |
None |
None |
None |
None |
None |
None |
None |
None |
Pharmaceutical Associates, Inc did not acquire the drug. This is our formulation that we submitted an ANDA to manufacture |
None |
| Pharmaceutical Associates, Inc |
00121252040 |
Potassium Chloride Oral Solution |
2019-04-05 |
779.6000 |
Marketing is done periodically in Pharmaceutical Trade Magazines Pricing plan is to remain competitive as determined by our pricing committee |
None |
None |
None |
None |
None |
None |
None |
None |
Pharmaceutical Associates, Inc did not acquire the drug. This is our formulation that we submitted an ANDA to manufacture |
None |