| Rx0000068 |
Egalet US, Inc. |
03/31/2019 |
42211010111 |
Oral Suspension Indocin 25 mg/5mL (237mL per Bottle) |
02/01/2019 |
891.98 |
1783.96 |
None |
Non-innovator Multiple Source Drug |
4588 |
None |
None |
1 |
None |
1 |
01/31/2019 |
Iroko Pharmaceuticals, Inc. |
87000000 |
None |
What Egalet US Inc. has provided in Field #16 is an estimate of a portion of the purchase price of the product acquired from Iroko. This does not include the following additional costs:
- Significant ongoing royalty payments on net sales
- Additional debt burden of $55M and royalty payments associated with this debt
- Cost of acquired inventory
- Bankruptcy restructuring costs in connection with acquisition
- Assumption of additional liabilities in connection with acquisition
- Post-marketing and development costs
- Commercial infrastructure costs
- Intellectual Property litigation and maintenance costs
- Costs to comply with regulatory requirements
- Significant increase in manufacturing costs |
891.98 |
None |
1985 |
232.17 |
None |
Comment on #20 and #21:
Egalet utilized its access to pricing compendia (as well as solicited the assistance of a consultant to do so) in order to provide values for these requests. Based on these searches, Egalet is unable to access WAC pricing for this product when introduced to the market. Therefore:
- Egalet provided the FDA Approval Date per the Orange Book for Year Drug Introduced to Market for #20
- Egalet provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 4/2/2013) for #21
General Comment on report:
Egalet US Inc. has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2018 and 2017, we reported a net loss of approximately $95.5 million and $69.4 million, respectively. |
| Rx0000068 |
Egalet US, Inc. |
03/31/2019 |
69344011311 |
Oxaydo 5 mg/1 Tablet (100 per Bottle) |
01/01/2019 |
66.15 |
734.34 |
03/16/2025 |
Innovator Multiple Source Drug |
7461 |
None |
None |
1 |
None |
1 |
01/07/2015 |
Acura Pharmaceuticals, Inc. |
7500000 |
None |
In addition to the upfront cash payment of $7.5M, Egalet US Inc. is also required to pay royalty of single-digit to double-digit percent based on sales thresholds. Upfront acquisition payment also does not include the following additional expenses associated with the purchase and ongoing maintenance of the product:
- Significant sales milestone payments
- Significant post-marketing requirement and development costs
- Debt burden, maintenance and servicing costs to finance the original purchase
- Second debt burden, maintenance and servicing costs, along with additional royalty payments on sales, associated with financing ongoing operations
- Commercial infrastructure costs
- Intellectual Property litigation and maintenance costs
- Costs to comply with regulatory requirements
- Co-payment assistance program utilization costs
- Manufacturing costs |
425.00 |
None |
2011 |
425.00 |
None |
Comment on #20 and #21:
Egalet utilized its access to pricing compendia (as well as solicited the assistance of a consultant to do so) in order to provide values for these requests. Based on these searches, Egalet is unable to access WAC pricing for this product when introduced to the market. Therefore:
- Egalet provided the FDA Approval Date per the Orange Book for Year Drug Introduced to Market for #20
- Egalet provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 9/11/2015) for #21
General Comment on report:
Egalet US Inc. has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2018 and 2017, we reported a net loss of approximately $95.5 million and $69.4 million, respectively. |
| Rx0000068 |
Egalet US, Inc. |
03/31/2019 |
69344021311 |
Oxaydo 7.5mg/1 Tablet (100 per Bottle) |
01/01/2019 |
99.12 |
1100.31 |
03/16/2025 |
Innovator Multiple Source Drug |
15438 |
None |
None |
1 |
None |
1 |
01/07/2015 |
Acura Pharmaceuticals, Inc. |
7500000 |
None |
In addition to the upfront cash payment of $7.5M, Egalet US Inc. is also required to pay royalty of single-digit to double-digit percent based on sales thresholds. Upfront acquisition payment also does not include the following additional expenses associated with the purchase and ongoing maintenance of the product:
- Significant sales milestone payments
- Significant post-marketing requirement and development costs
- Debt burden, maintenance and servicing costs to finance the purchase
- Second debt burden, maintenance and servicing costs, along with additional royalty payments on sales, associated with financing ongoing operations
- Commercial infrastructure costs
- Intellectual Property litigation and maintenance costs
- Costs to comply with regulatory requirements
- Co-payment assistance program utilization costs
- Manufacturing costs |
638.00 |
None |
2011 |
638.00 |
None |
Comment on #20 and #21:
Egalet utilized its access to pricing compendia (as well as solicited the assistance of a consultant to do so) in order to provide values for these requests. Based on these searches, Egalet is unable to access WAC pricing for this product when introduced to the market. Therefore:
- Egalet provided the FDA Approval Date per the Orange Book for Year Drug Introduced to Market for #20
- Egalet provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 9/11/2015) for #21
General Comment on report:
Egalet US Inc. has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2018 and 2017, we reported a net loss of approximately $95.5 million and $69.4 million, respectively. |
| Rx0000068 |
Egalet US, Inc. |
03/31/2019 |
69344014443 |
Sprix 15.75mg/1 Spray, Metered (5 Bottles per Carton) |
01/01/2019 |
160.94 |
1786.64 |
None |
Innovator Multiple Source Drug |
11677 |
None |
None |
1 |
None |
1 |
01/08/2015 |
Luitpold Pharmaceuticals, Inc. |
7000000 |
None |
In addition to the upfront cash payment of $7M, Egalet US Inc. is also required to pay a fixed, single-digit royalty on net sales. Upfront acquisition payment also does not include the following additional expenses associated with the purchase and ongoing maintenance of the product:
- Transition services
- Debt burden, maintenance and servicing costs to finance the purchase
- Second debt burden, maintenance and servicing costs, along with additional royalty payments on sales, associated with financing ongoing operations
commercial infrastructure costs
- Intellectual Property litigation and maintenance costs
- Costs to comply with regulatory requirements
- Co-payment assistance program utilization costs
- Component and manufacturing costs |
1413.00 |
None |
2010 |
1413.00 |
None |
Comment on #20 and #21:
Egalet utilized its access to pricing compendia (as well as solicited the assistance of a consultant to do so) in order to provide values for these requests. Based on these searches, Egalet is unable to access WAC pricing for this product when introduced to the market. Therefore:
- Egalet provided the FDA Approval Date per the Orange Book for Year Drug Introduced to Market for #20
- Egalet provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 9/15/2015) for #21
General Comment on report:
Egalet US Inc. has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2018 and 2017, we reported a net loss of approximately $95.5 million and $69.4 million, respectively. |
| Rx0000068 |
Egalet US, Inc. |
03/31/2019 |
42211010243 |
Suppository Indocin 50mg/1 (30 Supp in Box) |
02/01/2019 |
2550.00 |
5100.00 |
None |
Non-innovator Multiple Source Drug |
12923 |
None |
None |
1 |
None |
1 |
01/31/2019 |
Iroko Pharmaceuticals, Inc. |
87000000 |
None |
What Egalet US Inc. has provided in Field #16 is an estimate of a portion of the purchase price of the product acquired from Iroko. This does not include the following additional costs:
- Significant ongoing royalty payments on net sales
- Additional debt burden of $55M and royalty payments associated with this debt
- Cost of acquired inventory
- Bankruptcy restructuring costs in connection with acquisition
- Assumption of additional liabilities in connection with acquisition
- Post-marketing and development costs
- Commercial infrastructure costs
- Intellectual Property litigation and maintenance costs
- Costs to comply with regulatory requirements
- Significant increase in manufacturing costs |
2550.00 |
None |
1984 |
309.62 |
None |
Comment on #20 and #21:
Egalet utilized its access to pricing compendia (as well as solicited the assistance of a consultant to do so) in order to provide values for these requests. Based on these searches, Egalet is unable to access WAC pricing for this product when introduced to the market. Therefore:
- Egalet provided the FDA Approval Date per the Orange Book for Year Drug Introduced to Market for #20
- Egalet provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 4/2/2013) for #21
General Comment on report:
Egalet US Inc. has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2018 and 2017, we reported a net loss of approximately $95.5 million and $69.4 million, respectively. |
| Rx0000068 |
Egalet US, Inc. |
03/31/2019 |
42211020129 |
Tivorbex 20mg/1 Capsule (90 per Bottle) |
02/01/2019 |
193.36 |
650.00 |
04/23/2030 |
Innovator Multiple Source Drug |
1962 |
None |
None |
1 |
None |
1 |
01/31/2019 |
Iroko Pharmaceuticals, Inc. |
87000000 |
None |
What Egalet US Inc. has provided in Field #16 is an estimate of a portion of the purchase price of the product acquired from Iroko. This does not include the following additional costs:
- Significant ongoing royalty payments on net sales
- Additional debt burden of $55M and royalty payments associated with this debt
- Cost of acquired inventory
- Bankruptcy restructuring costs in connection with acquisition
- Assumption of additional liabilities in connection with acquisition
- Post-marketing and development costs
- Commercial infrastructure costs
- Intellectual Property litigation and maintenance costs
- Costs to comply with regulatory requirements
- Co-payment assistance program utilization costs
- Significant increase in manufacturing costs |
456.64 |
None |
2014 |
292.50 |
None |
Comment on #20 and #21:
Egalet utilized its access to pricing compendia (as well as solicited the assistance of a consultant to do so) in order to provide values for these requests. Based on these searches, Egalet is unable to access WAC pricing for this product when introduced to the market. Therefore:
- Egalet provided the FDA Approval Date per the Orange Book for Year Drug Introduced to Market for #20
- Egalet provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 5/4/2015) for #21
General Comment on report:
Egalet US Inc. has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2018 and 2017, we reported a net loss of approximately $95.5 million and $69.4 million, respectively. |
| Rx0000068 |
Egalet US, Inc. |
03/31/2019 |
42211020229 |
Tivorbex 40mg/1 Capsule (90 per Bottle) |
02/01/2019 |
193.36 |
650.00 |
04/23/2030 |
Innovator Multiple Source Drug |
4476 |
None |
None |
1 |
None |
1 |
01/31/2019 |
Iroko Pharmaceuticals, Inc. |
87000000 |
None |
What Egalet US Inc. has provided in Field #16 is an estimate of a portion of the purchase price of the product acquired from Iroko. This does not include the following additional costs:
- Significant ongoing royalty payments on net sales
- Additional debt burden of $55M and royalty payments associated with this debt
- Cost of acquired inventory
- Bankruptcy restructuring costs in connection with acquisition
- Assumption of additional liabilities in connection with acquisition
- Post-marketing and development costs
- Commercial infrastructure costs
- Intellectual Property litigation and maintenance costs
- Costs to comply with regulatory requirements
- Co-payment assistance program utilization costs
- Significant increase in manufacturing costs |
456.64 |
None |
2014 |
292.50 |
None |
Comment on #20 and #21:
Egalet utilized its access to pricing compendia (as well as solicited the assistance of a consultant to do so) in order to provide values for these requests. Based on these searches, Egalet is unable to access WAC pricing for this product when introduced to the market. Therefore:
- Egalet provided the FDA Approval Date per the Orange Book for Year Drug Introduced to Market for #20
- Egalet provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 5/4/2015) for #21
General Comment on report:
Egalet US Inc. has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2018 and 2017, we reported a net loss of approximately $95.5 million and $69.4 million, respectively. |
| Rx0000068 |
Egalet US, Inc. |
03/31/2019 |
42211020329 |
Zorvolex 18mg/1 Capsule (90 per Bottle) |
02/01/2019 |
266.95 |
650.00 |
04/23/2030 |
Innovator Multiple Source Drug |
15537 |
None |
None |
1 |
None |
1 |
01/31/2019 |
Iroko Pharmaceuticals, Inc. |
87000000 |
None |
What Egalet US Inc. has provided in Field #16 is an estimate of a portion of the purchase price of the product acquired from Iroko. This does not include the following additional costs:
- Significant ongoing royalty payments on net sales
- Additional debt burden of $55M and royalty payments associated with this debt
- Cost of acquired inventory
- Bankruptcy restructuring costs in connection with acquisition
- Assumption of additional liabilities in connection with acquisition
- Post-marketing and development costs
- Commercial infrastructure costs
- Intellectual Property litigation and maintenance costs
- Costs to comply with regulatory requirements
- Co-payment assistance program utilization costs
- Significant increase in manufacturing costs |
383.05 |
None |
2013 |
225.00 |
None |
Comment on #20 and #21:
Egalet utilized its access to pricing compendia (as well as solicited the assistance of a consultant to do so) in order to provide values for these requests. Based on these searches, Egalet is unable to access WAC pricing for this product when introduced to the market. Therefore:
- Egalet provided the FDA Approval Date per the Orange Book for Year Drug Introduced to Market for #20
- Egalet provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 10/28/2013) for #21
General Comment on report:
Egalet US Inc. has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2018 and 2017, we reported a net loss of approximately $95.5 million and $69.4 million, respectively. |
| Rx0000068 |
Egalet US, Inc. |
03/31/2019 |
42211020429 |
Zorvolex 35mg/1 Capsule (90 per Bottle) |
02/01/2019 |
266.95 |
650.00 |
04/23/2030 |
Innovator Multiple Source Drug |
87468 |
None |
None |
1 |
None |
1 |
01/31/2019 |
Iroko Pharmaceuticals, Inc. |
87000000 |
None |
What Egalet US Inc. has provided in Field #16 is an estimate of a portion of the purchase price of the product acquired from Iroko. This does not include the following additional costs:
- Significant ongoing royalty payments on net sales
- Additional debt burden of $55M and royalty payments associated with this debt
- Cost of acquired inventory
- Bankruptcy restructuring costs in connection with acquisition
- Assumption of additional liabilities in connection with acquisition
- Post-marketing and development costs
- Commercial infrastructure costs
- Intellectual Property litigation and maintenance costs
- Costs to comply with regulatory requirements
- Co-payment assistance program utilization costs
- Significant increase in manufacturing costs |
383.05 |
None |
2013 |
225.00 |
None |
Comment on #20 and #21:
Egalet utilized its access to pricing compendia (as well as solicited the assistance of a consultant to do so) in order to provide values for these requests. Based on these searches, Egalet is unable to access WAC pricing for this product when introduced to the market. Therefore:
- Egalet provided the FDA Approval Date per the Orange Book for Year Drug Introduced to Market for #20
- Egalet provided the earliest WAC price readily accessible via pricing compendia portals for the NDC (in this case, 10/28/2013) for #21
General Comment on report:
Egalet US Inc. has generated substantial net losses and negative cash flow from operations since inception, filed for bankruptcy protection and continues to incur significant expenses related to ongoing operations for its products. For the years ended December 31, 2018 and 2017, we reported a net loss of approximately $95.5 million and $69.4 million, respectively. |
| Rx0000076 |
Eisai Inc. |
03/31/2019 |
62856058252 |
BANZEL (rufinamide) 200MG TABLET; bottles of 120 |
03/08/2019 |
58.00 |
1442.00 |
05/14/2023 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Fields related to product acquired within the previous five year period are not applicable. |
| Rx0000076 |
Eisai Inc. |
03/31/2019 |
62856058446 |
BANZEL (rufinamide) 40 mg/mL SUSPENSION ORAL; bottle of 460mL |
03/08/2019 |
63.00 |
1600.00 |
05/14/2023 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Fields related to product acquired within the previous five year period are not applicable. |
| Rx0000076 |
Eisai Inc. |
03/31/2019 |
62856058352 |
BANZEL (rufinamide) 400MG TABLET; bottles of 120 |
03/08/2019 |
116.00 |
2884.00 |
05/14/2023 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Fields related to product acquired within the previous five year period are not applicable. |
| Rx0000076 |
Eisai Inc. |
03/31/2019 |
62856052960 |
BELVIQ (lorcaserin hydrochloride) 10-mg tablets for oral use CIV; bottle of 60 |
03/08/2019 |
19.96 |
299.60 |
02/07/2033 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Fields related to product acquired within the previous five year period are not applicable. |
| Rx0000076 |
Eisai Inc. |
03/31/2019 |
62856053530 |
BELVIQ XR (lorcaserin hydrochloride) 20-mg extended-release tablets for oral use CIV; bottle of 30 |
03/08/2019 |
19.96 |
299.60 |
02/07/2033 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Fields related to product acquired within the previous five year period are not applicable. |
| Rx0000076 |
Eisai Inc. |
06/30/2019 |
62856071030 |
LENVIMA (lenvatinib) 10 mg/day (10 mg x 1) 30 day supply |
06/19/2019 |
819.00 |
18374.00 |
08/26/2035 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Fields related to product acquired within the previous five year period are not applicable. |
| Rx0000076 |
Eisai Inc. |
06/30/2019 |
62856071430 |
LENVIMA (lenvatinib) 14 mg/day (10 mg x 1 and 4 mg x 1) 30 day supply |
06/19/2019 |
819.00 |
18374.00 |
08/26/2035 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Fields related to product acquired within the previous five year period are not applicable. |
| Rx0000076 |
Eisai Inc. |
06/30/2019 |
62856071830 |
LENVIMA (lenvatinib) 18 mg/day (10 mg x 1 and 4 mg x 2) 30 day supply |
06/19/2019 |
819.00 |
18374.00 |
08/26/2035 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Fields related to product acquired within the previous five year period are not applicable. |
| Rx0000076 |
Eisai Inc. |
06/30/2019 |
62856072030 |
LENVIMA (lenvatinib) 20 mg/day (10 mg x 2) 30 day supply |
06/19/2019 |
819.00 |
18374.00 |
08/26/2035 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Fields related to product acquired within the previous five year period are not applicable. |
| Rx0000076 |
Eisai Inc. |
06/30/2019 |
62856072430 |
LENVIMA (lenvatinib) 24 mg/day (10 mg x 2 and 4 mg x 1) 30 day supply |
06/19/2019 |
819.00 |
18374.00 |
08/26/2035 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Fields related to product acquired within the previous five year period are not applicable. |
| Rx0000076 |
Eisai Inc. |
06/30/2019 |
62856070830 |
LENVIMA (lenvatinib) 8 mg/day (4 mg x 2) 30 day supply |
06/19/2019 |
819.00 |
18374.00 |
08/26/2035 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Fields related to product acquired within the previous five year period are not applicable. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
52244040410 |
Acrivastine & Pseudoephedrine 8-60 MG Capsule 100 EA |
01/04/2019 |
49.15 |
545.60 |
None |
Single Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
01/29/2015 |
Auxilium Pharmaceuticals |
None |
None |
1) Endo acquired Auxilium Pharmaceuticals on 1/29/15. As a part of Endo’s acquisition of Auxilium Pharmaceuticals, Endo acquired this product. However, Endo is unable to provide the purchase price for this product since Endo does not have a methodology to allocate the purchase price of Auxilium Pharmaceuticals to the individual assets or products acquired from Auxilium Pharmaceuticals. As a result, Endo has left the “Acquisition Price” field for this product blank. 2) For “Year Introduced”, Endo is providing the year in which first price point is published in the pricing compendia database for the labeler code / product / product presentation. |
339.70 |
None |
1995 |
39.52 |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
12/31/2019 |
67979051143 |
Aveed, 750 mg/3mL (250mg/1mL) solution, single use vial |
10/07/2019 |
56.86 |
1229.17 |
03/14/2027 |
Single Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug. |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The patent expiration date contained in this report is limited to the patent information reported in the federal Food and Drug Administration’s Orange Book, as of 1/17/2020. As a result, the reported patent expiration date is limited to issued U.S. patents. Further, the reported patent expiration date does not reflect any pending patents, patent term extensions, pediatric exclusivity, or patent-related litigation, each of which is speculative and which may extend or shorten the reported expiration date. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
06/30/2019 |
67979051143 |
Aveed,750 mg/3 mL single use inj. |
04/01/2019 |
54.23 |
1172.31 |
03/14/2027 |
Single Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The patent expiration date contained in this report is limited to the patent information reported in the federal Food and Drug Administration’s Orange Book, as of 8/5/19. As a result, the reported patent expiration date is limited to issued U.S. patents. Further, the reported patent expiration date does not reflect any pending patents, patent term extensions, pediatric exclusivity, or patent-related litigation, each of which is speculative and which may extend or shorten the reported expiration date. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
49884027082 |
Cyanocobalamin 500 MCG/0.1ML Solution 1 EA UU |
01/04/2019 |
27.36 |
585.78 |
08/01/2024 |
Single Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
09/28/2015 |
PAR Pharmaceuticals |
None |
None |
1) Endo acquired PAR Pharmaceuticals on 9/25/15. As a part of Endo’s acquisition of PAR Pharmaceuticals, Endo acquired this product. However, Endo is unable to provide the purchase price for this product since Endo does not have a methodology to allocate the purchase price of PAR Pharmaceuticals to the individual assets or products acquired from PAR Pharmaceuticals. As a result, Endo has left the “Acquisition Price” field for this product blank. 2) For “Year Introduced”, Endo is providing the year in which first price point is published in the pricing compendia database for the labeler code / product / product presentation. |
396.88 |
None |
2014 |
361.13 |
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 Endo believes is otherwise in the public domain or publicly available. (2) The patent expiration date contained in this report is limited to the patent information reported in the federal Food and Drug Administration’s Orange Book, as of 4/24/19. As a result, the reported patent expiration date is limited to issued U.S. patents. Further, the reported patent expiration date does not reflect any pending patents, patent term extensions, pediatric exclusivity, or patent-related litigation, each of which is speculative and which may extend or shorten the reported expiration date. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
63481002509 |
Frovatriptan Succinate 2.5 MG Tablet 9 EA UU |
01/04/2019 |
72.10 |
800.39 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the patent expiration date field for this product blank. 3) This NDC was not acquired within the last five years. As a result, Endo left the "acquisition" related fields for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
52244092010 |
Isosorbide Dinitrate 40 MG Capsule Extended Release 100 EA |
01/04/2019 |
38.19 |
423.93 |
None |
Single Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the “Patent Expiration Date” field for this product blank. 3) This NDC was not acquired within the last five years. As a result, Endo left the "acquisition" related fields for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
63481068706 |
Lidocaine 5 % Patch 30 EA UU |
01/04/2019 |
71.10 |
545.11 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the “Patent Expiration Date” field for this product blank. 3) This NDC was not acquired within the last five years. As a result, Endo left the "acquisition" related fields for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
63481016038 |
Megestrol Acetate (Appetite) 625 MG/5ML Suspension 150 ML UU |
01/04/2019 |
109.34 |
1213.78 |
04/22/2024 |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
09/28/2015 |
PAR Pharmaceuticals |
None |
None |
1) Endo acquired PAR Pharmaceuticals on 9/25/15. As a part of Endo’s acquisition of PAR Pharmaceuticals, Endo acquired this product. However, Endo is unable to provide the purchase price for this product since Endo does not have a methodology to allocate the purchase price of PAR Pharmaceuticals to the individual assets or products acquired from PAR Pharmaceuticals. As a result, Endo has left the “Acquisition Price” field for this product blank. 2) For “Year Introduced”, Endo is providing the year in which first price point is published in the pricing compendia database for the labeler code / product / product presentation. |
832.05 |
None |
2005 |
390.00 |
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 Endo believes is otherwise in the public domain or publicly available. (2) The patent expiration date contained in this report is limited to the patent information reported in the federal Food and Drug Administration’s Orange Book, as of 4/24/19. As a result, the reported patent expiration date is limited to issued U.S. patents. Further, the reported patent expiration date does not reflect any pending patents, patent term extensions, pediatric exclusivity, or patent-related litigation, each of which is speculative and which may extend or shorten the reported expiration date. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
52244042910 |
Methocarbamol 500 MG Tablet 100 EA |
01/04/2019 |
16.96 |
188.24 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
01/29/2015 |
Auxilium Pharmaceuticals |
None |
None |
1) Endo acquired Auxilium Pharmaceuticals on 1/29/15. As a part of Endo’s acquisition of Auxilium Pharmaceuticals, Endo acquired this product. However, Endo is unable to provide the purchase price for this product since Endo does not have a methodology to allocate the purchase price of Auxilium Pharmaceuticals to the individual assets or products acquired from Auxilium Pharmaceuticals. As a result, Endo has left the “Acquisition Price” field for this product blank. 2) For “Year Introduced”, Endo is providing the year in which first price point is published in the pricing compendia database for the labeler code / product / product presentation. |
141.81 |
None |
2003 |
62.53 |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
52244044910 |
Methocarbamol 750 MG Tablet 100 EA |
01/04/2019 |
24.24 |
269.08 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
01/29/2015 |
Auxilium Pharmaceuticals |
None |
None |
1) Endo acquired Auxilium Pharmaceuticals on 1/29/15. As a part of Endo’s acquisition of Auxilium Pharmaceuticals, Endo acquired this product. However, Endo is unable to provide the purchase price for this product since Endo does not have a methodology to allocate the purchase price of Auxilium Pharmaceuticals to the individual assets or products acquired from Auxilium Pharmaceuticals. As a result, Endo has left the “Acquisition Price” field for this product blank. 2) For “Year Introduced”, Endo is providing the year in which first price point is published in the pricing compendia database for the labeler code / product / product presentation. |
202.71 |
None |
2002 |
89.37 |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
63481042105 |
Neomycin-Colistin-HC-Thonzonium 3.3-3-10-0.5 MG/ML Suspension 10 ML UU |
01/04/2019 |
20.87 |
231.65 |
None |
Single Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
09/28/2015 |
PAR Pharmaceuticals |
None |
None |
1) Endo acquired PAR Pharmaceuticals on 9/25/15. As a part of Endo’s acquisition of PAR Pharmaceuticals, Endo acquired this product. However, Endo is unable to provide the purchase price for this product since Endo does not have a methodology to allocate the purchase price of PAR Pharmaceuticals to the individual assets or products acquired from PAR Pharmaceuticals. As a result, Endo has left the “Acquisition Price” field for this product blank. 2) For “Year Introduced”, Endo is providing the year in which first price point is published in the pricing compendia database for the labeler code / product / product presentation. |
158.79 |
None |
1998 |
27.50 |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the patent expiration date field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
63481062970 |
Oxycodone w/ Acetaminophen 10-325 MG Tablet 100 EA |
01/04/2019 |
305.49 |
2342.06 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the “Patent Expiration Date” field for this product blank. 3) This NDC was not acquired within the last five years. As a result, Endo left the "acquisition" related fields for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
63481062770 |
Oxycodone w/ Acetaminophen 2.5-325 MG Tablet 100 EA |
01/04/2019 |
154.51 |
1184.57 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the “Patent Expiration Date” field for this product blank. 3) This NDC was not acquired within the last five years. As a result, Endo left the "acquisition" related fields for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
63481062370 |
Oxycodone w/ Acetaminophen 5-325 MG Tablet 100 EA |
01/04/2019 |
216.25 |
1657.89 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the “Patent Expiration Date” field for this product blank. 3) This NDC was not acquired within the last five years. As a result, Endo left the "acquisition" related fields for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
63481062385 |
Oxycodone w/ Acetaminophen 5-325 MG Tablet 500 EA |
01/04/2019 |
1054.03 |
8080.91 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the “Patent Expiration Date” field for this product blank. 3) This NDC was not acquired within the last five years. As a result, Endo left the "acquisition" related fields for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
63481062870 |
Oxycodone w/ Acetaminophen 7.5-325 MG Tablet 100 EA |
01/04/2019 |
233.63 |
1791.13 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the “Patent Expiration Date” field for this product blank. 3) This NDC was not acquired within the last five years. As a result, Endo left the "acquisition" related fields for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
63481061370 |
Oxymorphone HCl 10 MG Tablet 100 EA |
01/04/2019 |
123.72 |
1373.40 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the “Patent Expiration Date” field for this product blank. 3) This NDC was not acquired within the last five years. As a result, Endo left the "acquisition" related fields for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
63481061270 |
Oxymorphone HCl 5 MG Tablet 100 EA |
01/04/2019 |
68.14 |
756.42 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the patent expiration date field for this product blank. 3) This NDC was not acquired within the last five years. As a result, Endo left the "acquisition" related fields for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
12/31/2019 |
67979000201 |
Supprelin LA, 50 mg implant, ea |
10/07/2019 |
1727.52 |
37346.56 |
06/16/2026 |
Single Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug. |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The patent expiration date contained in this report is limited to the patent information reported in the federal Food and Drug Administration’s Orange Book, as of 1/17/2020. As a result, the reported patent expiration date is limited to issued U.S. patents. Further, the reported patent expiration date does not reflect any pending patents, patent term extensions, pediatric exclusivity, or patent-related litigation, each of which is speculative and which may extend or shorten the reported expiration date. (3) Endo did not acquire this product from another manufacturer within the previous five years. As a result, Endo has left columns N-U blank because they are not applicable to this product. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
06/30/2019 |
67979000201 |
Supprelin LA, 50mg Kit |
04/01/2019 |
1647.61 |
35619.04 |
06/16/2026 |
Single Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The patent expiration date contained in this report is limited to the patent information reported in the federal Food and Drug Administration’s Orange Book, as of 8/5/19. As a result, the reported patent expiration date is limited to issued U.S. patents. Further, the reported patent expiration date does not reflect any pending patents, patent term extensions, pediatric exclusivity, or patent-related litigation, each of which is speculative and which may extend or shorten the reported expiration date. (3) Endo did not acquire this product from another manufacturer within the previous five years. As a result, Endo has left columns N-U blank because they are not applicable to this product. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
52244003060 |
Testosterone 30 MG Miscellaneous 60 EA |
01/04/2019 |
71.75 |
796.53 |
08/23/2019 |
Single Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
01/29/2015 |
Auxilium Pharmaceuticals |
None |
None |
1) Endo acquired Auxilium Pharmaceuticals on 1/29/15. As a part of Endo’s acquisition of Auxilium Pharmaceuticals, Endo acquired this product. However, Endo is unable to provide the purchase price for this product since Endo does not have a methodology to allocate the purchase price of Auxilium Pharmaceuticals to the individual assets or products acquired from Auxilium Pharmaceuticals. As a result, Endo has left the “Acquisition Price” field for this product blank. 2) For “Year Introduced”, Endo is providing the year in which first price point is published in the pricing compendia database for the labeler code / product / product presentation. |
495.94 |
None |
2003 |
152.24 |
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 Endo believes is otherwise in the public domain or publicly available. (2) The patent expiration date contained in this report is limited to the patent information reported in the federal Food and Drug Administration’s Orange Book, as of 4/24/19. As a result, the reported patent expiration date is limited to issued U.S. patents. Further, the reported patent expiration date does not reflect any pending patents, patent term extensions, pediatric exclusivity, or patent-related litigation, each of which is speculative and which may extend or shorten the reported expiration date. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
52244010010 |
Theophylline 100 MG Capsule Extended Release 24 Hour 100 EA |
01/04/2019 |
19.78 |
219.60 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
01/29/2015 |
Auxilium Pharmaceuticals |
None |
None |
1) Endo acquired Auxilium Pharmaceuticals on 1/29/15. As a part of Endo’s acquisition of Auxilium Pharmaceuticals, Endo acquired this product. However, Endo is unable to provide the purchase price for this product since Endo does not have a methodology to allocate the purchase price of Auxilium Pharmaceuticals to the individual assets or products acquired from Auxilium Pharmaceuticals. As a result, Endo has left the “Acquisition Price” field for this product blank. 2) For “Year Introduced”, Endo is providing the year in which first price point is published in the pricing compendia database for the labeler code / product / product presentation. |
136.73 |
None |
1994 |
17.04 |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the patent expiration date field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
52244020010 |
Theophylline 200 MG Capsule Extended Release 24 Hour 100 EA |
01/04/2019 |
29.40 |
326.37 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
01/29/2015 |
Auxilium Pharmaceuticals |
None |
None |
1) Endo acquired Auxilium Pharmaceuticals on 1/29/15. As a part of Endo’s acquisition of Auxilium Pharmaceuticals, Endo acquired this product. However, Endo is unable to provide the purchase price for this product since Endo does not have a methodology to allocate the purchase price of Auxilium Pharmaceuticals to the individual assets or products acquired from Auxilium Pharmaceuticals. 2) For “Year Introduced”, Endo is providing the year in which first price point is published in the pricing compendia database for the labeler code / product / product presentation. |
203.21 |
None |
1994 |
25.41 |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
52244030010 |
Theophylline 300 MG Capsule Extended Release 24 Hour 100 EA |
01/04/2019 |
36.14 |
401.14 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
01/29/2015 |
Auxilium Pharmaceuticals |
None |
None |
1) Endo acquired Auxilium Pharmaceuticals on 1/29/15. As a part of Endo’s acquisition of Auxilium Pharmaceuticals, Endo acquired this product. However, Endo is unable to provide the purchase price for this product since Endo does not have a methodology to allocate the purchase price of Auxilium Pharmaceuticals to the individual assets or products acquired from Auxilium Pharmaceuticals. As a result, Endo has left the “Acquisition Price” field for this product blank. 2) For “Year Introduced”, Endo is providing the year in which first price point is published in the pricing compendia database for the labeler code / product / product presentation. |
249.75 |
None |
1994 |
30.15 |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the patent expiration date field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2019 |
52244040010 |
Theophylline 400 MG Capsule Extended Release 24 Hour 100 EA |
01/04/2019 |
50.85 |
564.45 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
01/29/2015 |
Auxilium Pharmaceuticals |
None |
None |
1) Endo acquired Auxilium Pharmaceuticals on 1/29/15. As a part of Endo’s acquisition of Auxilium Pharmaceuticals, Endo acquired this product. However, Endo is unable to provide the purchase price for this product since Endo does not have a methodology to allocate the purchase price of Auxilium Pharmaceuticals to the individual assets or products acquired from Auxilium Pharmaceuticals. As a result, Endo has left the “Acquisition Price” field for this product blank. 2) For “Year Introduced”, Endo is providing the year in which first price point is published in the pricing compendia database for the labeler code / product / product presentation. |
351.43 |
None |
1994 |
42.68 |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 4/24/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
12/31/2019 |
67979000101 |
Valstar, 40 mg/1ml solution, 4x5mL |
10/07/2019 |
281.20 |
6079.14 |
None |
Single Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug. |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 1/17/2020, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the patent expiration date field for this product blank.(3) Endo did not acquire this product from another manufacturer within the previous five years. As a result, Endo has left columns N-U blank because they are not applicable to this product. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
06/30/2019 |
67979000101 |
Valstar, 4x5mL vials |
04/01/2019 |
268.19 |
5797.94 |
None |
Single Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 8/5/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the patent expiration date field for this product blank.(3) Endo did not acquire this product from another manufacturer within the previous five years. As a result, Endo has left columns N-U blank because they are not applicable to this product. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
06/30/2019 |
67979050001 |
Vantas, 50 mg implant |
04/01/2019 |
195.59 |
4228.32 |
None |
Single Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 8/5/19, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the patent expiration date field for this product blank. (3) Endo did not acquire this product from another manufacturer within the previous five years. As a result, Endo has left columns N-U blank because they are not applicable to this product.” |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
12/31/2019 |
67979050001 |
Vantas, 50 mg implant, ea |
10/07/2019 |
205.07 |
4433.39 |
None |
Single Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug. |
None |
None |
None |
None |
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 Endo believes is otherwise in the public domain or publicly available. (2) The Orange Book indicates that, as of 1/17/2020, the Orange Book database does not contain unexpired patents for this product. As a result, Endo has left the patent expiration date field for this product blank. (3) Endo did not acquire this product from another manufacturer within the previous five years. As a result, Endo has left columns N-U blank because they are not applicable to this product.” |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
06/30/2019 |
66887000301 |
Xiaflex, 0.9 mg Vial |
04/01/2019 |
168.58 |
4491.19 |
None |
Single Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug |
None |
01/29/2015 |
Auxilium Pharmaceuticals |
None |
None |
Endo acquired Auxilium Pharmaceuticals on 1/29/15. As a part of Endo’s acquisition of Auxilium Pharmaceuticals, Endo acquired this product. However, Endo is unable to provide the purchase price for this product since Endo does not have a methodology to allocate the purchase price of Auxilium Pharmaceuticals to the individual assets or products acquired from Auxilium Pharmaceuticals. As a result, Endo has left the “Acquisition Price” field for this product blank. |
3331.25 |
3331.25 |
2010 |
3250.00 |
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 Endo believes is otherwise in the public domain or publicly available. (2) The federal Food and Drug Administration’s Purple Book does not require the listing of patents or their expiration dates for any product, including Xiaflex. The patent expiration date for any patent potentially associated with Xiaflex would also depend on pending patents, patent term extensions, pediatric exclusivity, or patent-related litigation, each of which is speculative and which may extend or shorten such an expiration date. As a result, Endo has left the patent expiration date field for this product blank. (3) For “Year Introduced”, Endo is providing the year in which first price point is published in the pricing compendia database for the labeler code / product / product presentation. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
12/31/2019 |
66887000301 |
Xiaflex, 0.9mg powder for solution, single use vial |
10/07/2019 |
175.16 |
4666.35 |
None |
Single Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug. |
None |
01/29/2015 |
Auxilium Pharmaceuticals |
None |
None |
Endo acquired Auxilium Pharmaceuticals on 1/29/15. As a part of Endo’s acquisition of Auxilium Pharmaceuticals, Endo acquired this product. However, Endo is unable to provide the purchase price for this product since Endo does not have a methodology to allocate the purchase price of Auxilium Pharmaceuticals to the individual assets or products acquired from Auxilium Pharmaceuticals. As a result, Endo has left the “Acquisition Price” field for this product blank. |
3331.25 |
3331.25 |
2010 |
3250.00 |
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 Endo believes is otherwise in the public domain or publicly available. (2) The federal Food and Drug Administration’s Purple Book does not require the listing of patents or their expiration dates for any product, including Xiaflex. The patent expiration date for any patent potentially associated with Xiaflex would also depend on pending patents, patent term extensions, pediatric exclusivity, or patent-related litigation, each of which is speculative and which may extend or shorten such an expiration date. As a result, Endo has left the patent expiration date field for this product blank. (3) For “Year Introduced”, Endo is providing the year in which first price point is published in the pricing compendia database for the labeler code / product / product presentation. |
| Rx0000094 |
Epic Pharma |
03/31/2019 |
42806008101 |
Benzphetamine Hydrochloride 50mg Oral tablet |
02/17/2019 |
122.65 |
210.00 |
None |
Non-innovator Multiple Source Drug |
1595 |
None |
Change in market dynamics. |
None |
Change in market dynamics. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Drug is developed by Epic Pharma. |
| Rx0000094 |
Epic Pharma |
03/31/2019 |
42806008130 |
Benzphetamine Hydrochloride 50mg Oral tablet |
02/17/2019 |
48.80 |
75.00 |
None |
Non-innovator Multiple Source Drug |
2214 |
None |
Change in market dynamics. |
None |
Change in market dynamics. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Drug is developed by Epic Pharma. |
| Rx0000094 |
Epic Pharma |
12/31/2019 |
42806014301 |
Demeclocycline HCL 150mg 100 Tab Epic |
11/15/2019 |
633.15 |
1266.30 |
None |
Non-innovator Multiple Source Drug |
2172 |
None |
Change in market dynamics |
None |
No change / improvement made to drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Epic Pharma developed these drugs |
| Rx0000094 |
Epic Pharma |
12/31/2019 |
42806014448 |
Demeclocycline HCL 300mg 48 Tab Epic |
11/15/2019 |
550.20 |
1100.40 |
None |
Non-innovator Multiple Source Drug |
4092 |
None |
Change in market dynamics |
None |
No change / improvement made to drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Epic Pharma developed these drugs |
| Rx0000094 |
Epic Pharma |
03/31/2019 |
42806005801 |
Flavoxate Hydrochloride 100mg Oral tablet |
02/17/2019 |
70.00 |
160.00 |
None |
Non-innovator Multiple Source Drug |
4152 |
None |
Change in market dynamics. |
None |
Change in market dynamics. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Drug is developed by Epic Pharma. |
| Rx0000094 |
Epic Pharma |
06/30/2019 |
42806050109 |
Nicardipine Hydrochloride 20mg Oral capsule |
06/28/2019 |
637.16 |
796.85 |
None |
Non-innovator Multiple Source Drug |
3157 |
None |
Change in market dynamics |
None |
No change / improvement made to drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Drug was not acquired. |
| Rx0000094 |
Epic Pharma |
06/30/2019 |
42806050209 |
Nicardipine Hydrochloride 30mg Oral capsule |
06/28/2019 |
912.55 |
1141.26 |
None |
Non-innovator Multiple Source Drug |
1308 |
None |
Change in market dynamics |
None |
No change / improvement made to drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Drug was not acquired. |
| Rx0000094 |
Epic Pharma |
03/31/2019 |
42806001396 |
Sodium Polystyrene Sulfonate 453.6g Powder for Oral susp/PWD |
02/17/2019 |
26.49 |
131.49 |
None |
Non-innovator Multiple Source Drug |
1368 |
None |
Change in market dynamics. |
None |
Change in market dynamics. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Drug is developed by Epic Pharma. |
| Rx0000094 |
Epic Pharma |
12/31/2019 |
42806012201 |
Sotalol Hcl (AF) 120mg 100 Tab Epic |
11/15/2019 |
78.39 |
130.65 |
None |
Non-innovator Multiple Source Drug |
5303 |
None |
Change in market dynamics |
None |
No change / improvement made to drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Epic Pharma developed these drugs |
| Rx0000094 |
Epic Pharma |
12/31/2019 |
42806012301 |
Sotalol Hcl (AF) 160mg 100 Tab Epic |
11/15/2019 |
98.03 |
163.38 |
None |
Non-innovator Multiple Source Drug |
1980 |
None |
Change in market dynamics |
None |
No change / improvement made to drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Epic Pharma developed these drugs |
| Rx0000094 |
Epic Pharma |
12/31/2019 |
42806012101 |
Sotalol Hcl (AF) 80mg 100 Tab Epic |
11/15/2019 |
58.77 |
97.95 |
None |
Non-innovator Multiple Source Drug |
12719 |
None |
Change in market dynamics |
None |
No change / improvement made to drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Epic Pharma developed these drugs |
| Rx0000104 |
EUSA Pharma (US) LLC |
12/31/2019 |
57894042001 |
SYLVANT 100MG VIAL US |
10/01/2019 |
92.96 |
1071.47 |
08/01/2027 |
Single Source Drug |
4342 |
None |
No factors to report |
None |
No change improvements |
None |
12/22/2018 |
Janssen Biotech |
115000000 |
None |
Acquisition price of $115,000,000 ($115 Million) includes both NDCs 57894-0420-01 and 57894-0421-01 |
910.24 |
883.73 |
2014 |
833.00 |
None |
None |
| Rx0000104 |
EUSA Pharma (US) LLC |
12/31/2019 |
57894042101 |
SYLVANT 400MG VIAL US |
10/01/2019 |
371.83 |
4285.87 |
08/01/2027 |
Single Source Drug |
5536 |
None |
No factors to report |
None |
No change improvements |
None |
12/22/2018 |
Janssen Biotech |
115000000 |
None |
Acquisition price of $115,000,000 ($115 Million) includes both NDCs 57894-0420-01 and 57894-0421-01 |
3640.96 |
3534.92 |
2014 |
3332.00 |
None |
None |
| Rx0000010 |
Exelixis, Inc. |
09/30/2019 |
42388002426 |
CABOMETYX 20MG 30 TAB BTL EACH |
07/01/2019 |
826.44 |
19191.85 |
07/09/2033 |
Single Source Drug |
None |
1 |
Exelixis' Mission: Exelixis strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. That mission, however, entails tremendous risk of failure and research and development costs that total in the billions of dollars. At the present time, CABOMETYX and COMETRIQ are the only products that Exelixis sells and comprise the vast majority of Exelixis' revenue. Exelixis is committed to spending the largest portion of this revenue on drug discovery research and clinical development, and to pricing CABOMETYX consistent with its value when compared to competitive products approved for similar conditions.
Drug Discovery Factors: Having recently constructed new laboratory facilities, Exelixis re-launched its drug discovery activities in 2018 and is working to discover the next generation of cancer therapies. Exelixis considered the investments necessary to undertake and support these drug discovery efforts when it contemplated changes to CABOMETYX's wholesale acquisition cost.
CABOMETYX Development Factors: Since the initial commercial launch of CABOMETYX, Exelixis has received extensive additional data demonstrating that cabozantinib shows activity in an extremely broad and diverse collection of additional cancers. Alone and in combination with other therapies, it is currently being studied in over 100 clinical trials for over 20 different forms of cancer. Exelixis considered the cost of this clinical development program, and the need to expand it to reach CABOMETYX's full potential for treating the largest number of cancer patients, when it contemplated changes to the wholesale acquisition cost of CABOMETYX.
CABOMETYX Value Factors: CABOMETYX has been approved by the FDA to treat patients with liver and kidney cancer and has shown impressive efficacy relative to its competitors in treating patients with these life threatening diseases. It is the only drug of its kind to improve overall survival in a statistically significant manner in both kidney and liver cancer. When Exelixis contemplated a change to the wholesale acquisition cost for CABOMETYX, Exelixis considered the clinical value proposition of CABOMETYX relative to its competitor prescription drugs, as well as the competitive market generally and the existing price points of competitors.
CABOMETYX Cost Factors: At Exelixis, we are committed to ensuring that all patients in need can access our medicines. To ensure that the supply of CABOMETYX for our customers, and ultimately, patients is safe and uninterrupted, Exelixis has expanded its supply chain network, establishing redundancies to prevent supply disruption. In addition, Exelixis has and continues to incur increasing costs in manufacturing due to volatility in the cost of raw materials and other inputs. When Exelixis contemplated changes to the wholesale acquisition cost of CABOMETYX, Exelixis considered these investments in expanding and improving our manufacturing capabilities and supply chain, as well as rising manufacturing costs. |
None |
It is Exelixis' stated mission to develop innovative, effective, tolerable and durable treatments for patients with cancer. To accomplish this, Exelixis has and continues to increase our investments in innovative research and development activities. In pre-clinical and clinical testing, Cabometyx (cabozantinib) has shown promising activity against many forms of cancer and Exelixis is therefore engaged in a very broad clinical development program aimed at improving Cabometyx by exploring the medicine's full therapeutic potential to help patients. To fund that program, and otherwise support our other research, development and business operations, it is necessary for Exelixis to increase the wholesale acquisition cost of Cabometyx when market conditions permit such an increase. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Exelixis did not acquire this product from another manufacturer within the previous five years. As a result, Exelixis has left columns N-U blank because they are not applicable to this product. The patent expiration date contained in this report is limited to the patent information reported in the federal Food and Drug Administration's Orange Book, as of 10/30/19. As a result, the reported patent expiration date is limited to issued U.S. patents. Further, the reported patent expiration date does not reflect any pending patents, patent term extensions, pediatric exclusivity, or patent-related litigation, each of which is speculative and which may extend or shorten the reported expiration date |
| Rx0000010 |
Exelixis, Inc. |
09/30/2019 |
42388002526 |
CABOMETYX 40MG 30 TAB BTL EACH |
07/01/2019 |
826.44 |
19191.85 |
07/09/2033 |
Single Source Drug |
None |
1 |
Exelixis' Mission: Exelixis strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. That mission, however, entails tremendous risk of failure and research and development costs that total in the billions of dollars. At the present time, CABOMETYX and COMETRIQ are the only products that Exelixis sells and comprise the vast majority of Exelixis' revenue. Exelixis is committed to spending the largest portion of this revenue on drug discovery research and clinical development, and to pricing CABOMETYX consistent with its value when compared to competitive products approved for similar conditions.
Drug Discovery Factors: Having recently constructed new laboratory facilities, Exelixis re-launched its drug discovery activities in 2018 and is working to discover the next generation of cancer therapies. Exelixis considered the investments necessary to undertake and support these drug discovery efforts when it contemplated changes to CABOMETYX's wholesale acquisition cost.
CABOMETYX Development Factors: Since the initial commercial launch of CABOMETYX, Exelixis has received extensive additional data demonstrating that cabozantinib shows activity in an extremely broad and diverse collection of additional cancers. Alone and in combination with other therapies, it is currently being studied in over 100 clinical trials for over 20 different forms of cancer. Exelixis considered the cost of this clinical development program, and the need to expand it to reach CABOMETYX's full potential for treating the largest number of cancer patients, when it contemplated changes to the wholesale acquisition cost of CABOMETYX.
CABOMETYX Value Factors: CABOMETYX has been approved by the FDA to treat patients with liver and kidney cancer and has shown impressive efficacy relative to its competitors in treating patients with these life threatening diseases. It is the only drug of its kind to improve overall survival in a statistically significant manner in both kidney and liver cancer. When Exelixis contemplated a change to the wholesale acquisition cost for CABOMETYX, Exelixis considered the clinical value proposition of CABOMETYX relative to its competitor prescription drugs, as well as the competitive market generally and the existing price points of competitors.
CABOMETYX Cost Factors: At Exelixis, we are committed to ensuring that all patients in need can access our medicines. To ensure that the supply of CABOMETYX for our customers, and ultimately, patients is safe and uninterrupted, Exelixis has expanded its supply chain network, establishing redundancies to prevent supply disruption. In addition, Exelixis has and continues to incur increasing costs in manufacturing due to volatility in the cost of raw materials and other inputs. When Exelixis contemplated changes to the wholesale acquisition cost of CABOMETYX, Exelixis considered these investments in expanding and improving our manufacturing capabilities and supply chain, as well as rising manufacturing costs. |
None |
It is Exelixis' stated mission to develop innovative, effective, tolerable and durable treatments for patients with cancer. To accomplish this, Exelixis has and continues to increase our investments in innovative research and development activities. In pre-clinical and clinical testing, Cabometyx (cabozantinib) has shown promising activity against many forms of cancer and Exelixis is therefore engaged in a very broad clinical development program aimed at improving Cabometyx by exploring the medicine's full therapeutic potential to help patients. To fund that program, and otherwise support our other research, development and business operations, it is necessary for Exelixis to increase the wholesale acquisition cost of Cabometyx when market conditions permit such an increase. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Exelixis did not acquire this product from another manufacturer within the previous five years. As a result, Exelixis has left columns N-U blank because they are not applicable to this product. The patent expiration date contained in this report is limited to the patent information reported in the federal Food and Drug Administration's Orange Book, as of 10/30/19. As a result, the reported patent expiration date is limited to issued U.S. patents. Further, the reported patent expiration date does not reflect any pending patents, patent term extensions, pediatric exclusivity, or patent-related litigation, each of which is speculative and which may extend or shorten the reported expiration date |
| Rx0000010 |
Exelixis, Inc. |
09/30/2019 |
42388002326 |
CABOMETYX 60MG 30 TAB BTL EACH |
07/01/2019 |
826.44 |
19191.85 |
07/09/2033 |
Single Source Drug |
None |
1 |
Exelixis' Mission: Exelixis strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. That mission, however, entails tremendous risk of failure and research and development costs that total in the billions of dollars. At the present time, CABOMETYX and COMETRIQ are the only products that Exelixis sells and comprise the vast majority of Exelixis' revenue. Exelixis is committed to spending the largest portion of this revenue on drug discovery research and clinical development, and to pricing CABOMETYX consistent with its value when compared to competitive products approved for similar conditions.
Drug Discovery Factors: Having recently constructed new laboratory facilities, Exelixis re-launched its drug discovery activities in 2018 and is working to discover the next generation of cancer therapies. Exelixis considered the investments necessary to undertake and support these drug discovery efforts when it contemplated changes to CABOMETYX's wholesale acquisition cost.
CABOMETYX Development Factors: Since the initial commercial launch of CABOMETYX, Exelixis has received extensive additional data demonstrating that cabozantinib shows activity in an extremely broad and diverse collection of additional cancers. Alone and in combination with other therapies, it is currently being studied in over 100 clinical trials for over 20 different forms of cancer. Exelixis considered the cost of this clinical development program, and the need to expand it to reach CABOMETYX's full potential for treating the largest number of cancer patients, when it contemplated changes to the wholesale acquisition cost of CABOMETYX.
CABOMETYX Value Factors: CABOMETYX has been approved by the FDA to treat patients with liver and kidney cancer and has shown impressive efficacy relative to its competitors in treating patients with these life threatening diseases. It is the only drug of its kind to improve overall survival in a statistically significant manner in both kidney and liver cancer. When Exelixis contemplated a change to the wholesale acquisition cost for CABOMETYX, Exelixis considered the clinical value proposition of CABOMETYX relative to its competitor prescription drugs, as well as the competitive market generally and the existing price points of competitors.
CABOMETYX Cost Factors: At Exelixis, we are committed to ensuring that all patients in need can access our medicines. To ensure that the supply of CABOMETYX for our customers, and ultimately, patients is safe and uninterrupted, Exelixis has expanded its supply chain network, establishing redundancies to prevent supply disruption. In addition, Exelixis has and continues to incur increasing costs in manufacturing due to volatility in the cost of raw materials and other inputs. When Exelixis contemplated changes to the wholesale acquisition cost of CABOMETYX, Exelixis considered these investments in expanding and improving our manufacturing capabilities and supply chain, as well as rising manufacturing costs. |
None |
It is Exelixis' stated mission to develop innovative, effective, tolerable and durable treatments for patients with cancer. To accomplish this, Exelixis has and continues to increase our investments in innovative research and development activities. In pre-clinical and clinical testing, Cabometyx (cabozantinib) has shown promising activity against many forms of cancer and Exelixis is therefore engaged in a very broad clinical development program aimed at improving Cabometyx by exploring the medicine's full therapeutic potential to help patients. To fund that program, and otherwise support our other research, development and business operations, it is necessary for Exelixis to increase the wholesale acquisition cost of Cabometyx when market conditions permit such an increase. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Exelixis did not acquire this product from another manufacturer within the previous five years. As a result, Exelixis has left columns N-U blank because they are not applicable to this product. The patent expiration date contained in this report is limited to the patent information reported in the federal Food and Drug Administration's Orange Book, as of 10/30/19. As a result, the reported patent expiration date is limited to issued U.S. patents. Further, the reported patent expiration date does not reflect any pending patents, patent term extensions, pediatric exclusivity, or patent-related litigation, each of which is speculative and which may extend or shorten the reported expiration date |