| Rx0000076 |
Eisai Inc. |
03/31/2020 |
62856070830 |
LENVIMA (lenvatinib mesylate) 8 mg/day (4 mg x 2) 60 count |
01/23/2020 |
647.00 |
19021.00 |
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. |
03/31/2020 |
62856071030 |
LENVIMA (lenvatinib mesylate)10 mg/day (10 mg x 1) 30 count |
01/23/2020 |
647.00 |
19021.00 |
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. |
03/31/2020 |
62856071430 |
LENVIMA (lenvatinib mesylate)14 mg/day (10 mg x 1 and 4 mg x 1) 60 count |
01/23/2020 |
647.00 |
19021.00 |
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. |
| Rx0000114 |
Eli Lilly and Company |
03/31/2020 |
00002144511 |
TALTZ™ 80 mg/mL disposable autoinjector (1 pack) |
01/31/2020 |
322.00 |
5690.00 |
12/06/2026 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. The reported patent expiration information relates to only one or more compound patents covering TALTZ™ and does not reflect pending possible patent extensions or patents, including pending patent applications, that may cover other aspects of TALTZ™. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. This product was not acquired within the last 5 years, therefore columns 14-21 are intentionally left blank. |
| Rx0000114 |
Eli Lilly and Company |
03/31/2020 |
00002144527 |
TALTZ™ 80 mg/mL disposable autoinjector (2 pack) |
01/31/2020 |
644.00 |
11380.00 |
12/06/2026 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. The reported patent expiration information relates to only one or more compound patents covering TALTZ™ and does not reflect pending possible patent extensions or patents, including pending patent applications, that may cover other aspects of TALTZ™. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. This product was not acquired within the last 5 years, therefore columns 14-21 are intentionally left blank. |
| Rx0000114 |
Eli Lilly and Company |
03/31/2020 |
00002144509 |
TALTZ™ 80 mg/mL disposable autoinjector (3 pack) |
01/31/2020 |
966.00 |
17070.00 |
12/06/2026 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. The reported patent expiration information relates to only one or more compound patents covering TALTZ™ and does not reflect pending possible patent extensions or patents, including pending patent applications, that may cover other aspects of TALTZ™. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. This product was not acquired within the last 5 years, therefore columns 14-21 are intentionally left blank. |
| Rx0000114 |
Eli Lilly and Company |
03/31/2020 |
00002772411 |
TALTZ™ 80 mg/mL disposable prefilled syringe (1 per carton) |
01/31/2020 |
322.00 |
5690.00 |
12/06/2026 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. The reported patent expiration information relates to only one or more compound patents covering TALTZ™ and does not reflect pending possible patent extensions or patents, including pending patent applications, that may cover other aspects of TALTZ™. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. This product was not acquired within the last 5 years, therefore columns 14-21 are intentionally left blank. |
| Rx0000114 |
Eli Lilly and Company |
03/31/2020 |
00002143380 |
TRULICITY™ 0.75 mg/0.5 mL carton of 4 single-dose pens |
01/31/2020 |
37.90 |
797.30 |
12/27/2027 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. The reported patent expiration information relates to only one or more compound patents covering TRULICITY™ and does not reflect pending possible patent extensions or patents, including pending patent applications, that may cover other aspects of TRULICITY™. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. This product was not acquired within the last 5 years, therefore columns 14-21 are intentionally left blank. |
| Rx0000114 |
Eli Lilly and Company |
03/31/2020 |
00002143480 |
TRULICITY™ 1.5 mg /0.5mL carton of 4 single-dose pens |
01/31/2020 |
37.90 |
797.30 |
12/27/2027 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
All information is provided by Eli Lilly and Company ("Lilly") to the best of our knowledge at the time of submission. Lilly provides this report consistent with its understanding and interpretation of California Health and Safety Code Chapter 9 §127675-127686 and its related provisions. In providing this report, Lilly does not waive any rights that it may have at law or in equity with respect to the applicability, interpretation, or application of California Health and Safety Code Chapter 9 §127675-127686 as it may relate to Lilly or any of its affiliates now or in the future. Lilly, on behalf of itself and affiliates, expressly reserves all such rights. The reported patent expiration information relates to only one or more compound patents covering TRULICITY™ and does not reflect pending possible patent extensions or patents, including pending patent applications, that may cover other aspects of TRULICITY™. Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Lilly believes is otherwise in the public domain or publicly available. This product was not acquired within the last 5 years, therefore columns 14-21 are intentionally left blank. |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2020 |
44087907001 |
Gonal-f Multi-Dose 1050IU (1) |
01/10/2020 |
192.08 |
2753.66 |
08/23/2019 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2020 |
44087903001 |
Gonal-f Multi-Dose 450IU (1) |
01/10/2020 |
82.32 |
1180.14 |
08/23/2019 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2020 |
44087900501 |
Gonal-f RFF* 75IU (1) |
01/10/2020 |
13.72 |
196.69 |
04/02/2024 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2020 |
44087900506 |
Gonal-f RFF* 75IU (10) |
01/10/2020 |
137.20 |
1966.90 |
04/02/2024 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2020 |
44087111501 |
Gonal-f RFF* Redi-ject™ 300IU (1) |
01/10/2020 |
54.88 |
786.76 |
04/02/2024 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2020 |
44087111601 |
Gonal-f RFF* Redi-ject™ 450IU (1) |
01/10/2020 |
82.32 |
1180.14 |
04/02/2024 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2020 |
44087111701 |
Gonal-f RFF* Redi-ject™ 900IU (1) |
01/10/2020 |
164.64 |
2360.28 |
04/02/2024 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2020 |
44087115001 |
Ovidrel Subcutaneous Injectable 250 MCG/0.5ML (1) |
01/10/2020 |
12.38 |
177.49 |
03/16/2021 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
06/30/2020 |
67979051143 |
Aveed, 750 mg/3mL (250mg/1mL) solution, single use vial |
04/01/2020 |
59.61 |
1288.78 |
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 7/20/2020. 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. |
12/31/2020 |
67979051143 |
Aveed, 750 mg/3mL (250mg/1mL) solution, single use vial |
10/01/2020 |
62.51 |
1351.29 |
05/08/2027 |
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 1/22/2021. 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. |
03/31/2020 |
52244092010 |
DILATRATE®, Isosorbide Dinitrate Cap ER 40 MG, 100 |
01/06/2020 |
41.97 |
465.90 |
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. |
302.93 |
275.64 |
2012 |
192.75 |
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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
52244001002 |
Edex®, Alprostadil For Inj Kit 10 MCG, 2 |
01/06/2020 |
7.65 |
135.07 |
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. |
99.06 |
90.14 |
2012 |
78.00 |
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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
52244001006 |
Edex®, Alprostadil For Inj Kit 10 MCG, 6 |
01/06/2020 |
22.94 |
405.25 |
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. |
297.19 |
270.42 |
2012 |
234.00 |
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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
52244002002 |
Edex®, Alprostadil For Inj Kit 20 MCG, 2 |
01/06/2020 |
9.88 |
174.49 |
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. |
127.96 |
116.43 |
2012 |
100.75 |
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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
52244002006 |
Edex®, Alprostadil For Inj Kit 20 MCG, 6 |
01/06/2020 |
29.63 |
523.44 |
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. |
383.87 |
349.29 |
2012 |
302.25 |
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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
52244004002 |
Edex®, Alprostadil For Inj Kit 40 MCG, 2 |
01/06/2020 |
13.49 |
238.28 |
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. |
174.75 |
159.01 |
2012 |
137.60 |
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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
52244004006 |
Edex®, Alprostadil For Inj Kit 40 MCG, 6 |
01/06/2020 |
40.46 |
714.80 |
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. |
524.21 |
476.99 |
2012 |
412.75 |
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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
63481002509 |
FROVA®, Frovatriptan Succinate Tab 2.5 MG (Base Equivalent), 9 |
01/06/2020 |
79.24 |
879.63 |
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 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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, 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 (i.e. 60 months). As a result, Endo has left columns N-U blank because they are not applicable to this product. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
63481068706 |
LIDODERM®, Lidocaine Patch 5%, 30 |
01/06/2020 |
53.97 |
599.08 |
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 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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, 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 (i.e. 60 months). As a result, Endo has left columns N-U blank because they are not applicable to this product. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
49884027082 |
NASCOBAL®, Cyanocobalamin Nasal Spray 500 MCG/0.1ML, 1 |
01/06/2020 |
28.70 |
614.48 |
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 Pharmaceutical |
None |
None |
1) Endo acquired Par Pharmaceutical on 9/25/15. As a part of Endo’s acquisition of Par Pharmaceutical, 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 Pharmaceutical to the individual assets or products acquired from Par Pharmaceutical. 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 |
361.13 |
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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
63481062970 |
PERCOCET®, Oxycodone w/ Acetaminophen Tab 10-325 MG, 100 |
01/06/2020 |
231.86 |
2573.92 |
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 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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, 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 (i.e. 60 months). As a result, Endo has left columns N-U blank because they are not applicable to this product. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
63481062770 |
PERCOCET®, Oxycodone w/ Acetaminophen Tab 2.5-325 MG, 100 |
01/06/2020 |
117.27 |
1301.84 |
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 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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, 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 (i.e. 60 months). As a result, Endo has left columns N-U blank because they are not applicable to this product. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
63481062370 |
PERCOCET®, Oxycodone w/ Acetaminophen Tab 5-325 MG, 100 |
01/06/2020 |
164.13 |
1822.02 |
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 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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, 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 (i.e. 60 months). As a result, Endo has left columns N-U blank because they are not applicable to this product. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
63481062385 |
PERCOCET®, Oxycodone w/ Acetaminophen Tab 5-325 MG, 500 |
01/06/2020 |
800.01 |
8880.92 |
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 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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, 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 (i.e. 60 months). As a result, Endo has left columns N-U blank because they are not applicable to this product. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
63481062870 |
PERCOCET®, Oxycodone w/ Acetaminophen Tab 7.5-325 MG, 100 |
01/06/2020 |
177.32 |
1968.45 |
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 |
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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, 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 (i.e. 60 months). As a result, Endo has left columns N-U blank because they are not applicable to this product. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
52244044910 |
ROBAXIN®, Methocarbamol Tab 750 MG, 100 |
01/06/2020 |
26.64 |
295.72 |
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 |
202.71 |
2011 |
233.00 |
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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
52244040410 |
SEMPREX®-D, Acrivastine & Pseudoephedrine Cap 8-60 MG, 100 |
01/06/2020 |
54.01 |
599.61 |
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 |
308.82 |
2012 |
212.50 |
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 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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
06/30/2020 |
67979000201 |
Supprelin LA, 50 mg implant, ea |
04/01/2020 |
1811.31 |
39157.87 |
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 7/20/2020. 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. |
12/31/2020 |
67979000201 |
Supprelin LA, 50 mg implant, ea |
10/01/2020 |
1899.16 |
41057.03 |
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 1/22/2021. 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. |
03/31/2020 |
52244010010 |
THEO-24®, Theophylline Cap ER 24HR 100 MG, 100 |
01/06/2020 |
21.74 |
241.34 |
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 |
0.00 |
2014 |
136.73 |
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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
52244020010 |
THEO-24®, Theophylline Cap ER 24HR 200 MG, 100 |
01/06/2020 |
32.31 |
358.68 |
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 |
0.00 |
2014 |
203.21 |
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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
52244030010 |
THEO-24®, Theophylline Cap ER 24HR 300 MG, 100 |
01/06/2020 |
39.71 |
440.85 |
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 |
0.00 |
2014 |
249.75 |
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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
03/31/2020 |
52244040010 |
THEO-24®, Theophylline Cap ER 24HR 400 MG, 100 |
01/06/2020 |
55.88 |
620.33 |
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 |
0.00 |
2014 |
351.43 |
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 4/22/2020. 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. If the Orange Book database does not contain any unexpired patents for this product, Endo has left the “Patent Expiration Date” field for this product blank. |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
06/30/2020 |
67979000101 |
Valstar, 40 mg/1ml solution, 4x5mL |
04/01/2020 |
294.84 |
6373.98 |
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 7/20/2020, 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. |
12/31/2020 |
67979000101 |
Valstar, 40 mg/1ml solution, 4x5mL |
10/01/2020 |
309.14 |
6683.12 |
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 1/22/2021, 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. |
06/30/2020 |
67979050001 |
Vantas, 50 mg implant, ea |
04/01/2020 |
215.02 |
4648.41 |
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 7/20/2020, 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. |
12/31/2020 |
67979050001 |
Vantas, 50 mg implant, ea |
10/01/2020 |
225.45 |
4873.86 |
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 1/22/2021, 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. |
06/30/2020 |
66887000301 |
Xiaflex, 0.9mg powder for solution, single use vial |
04/01/2020 |
181.99 |
4848.34 |
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 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. |
12/31/2020 |
66887000301 |
Xiaflex, 0.9mg powder for solution, single use vial |
10/01/2020 |
189.09 |
5037.43 |
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 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 |
06/30/2020 |
42806005030 |
Meperidine Hcl 50mg30 Tab Epic |
06/26/2020 |
234.90 |
1017.90 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
None |
1 |
07/13/2010 |
Mikah Pharma LLC |
None |
1 |
None |
783.00 |
783.00 |
2003 |
783.00 |
None |
Epic Pharma lauched this new size-30 count sku in 12/31/2019.Prior companies didn’t have WAC data for this new sku. |
| Rx0000094 |
Epic Pharma |
06/30/2020 |
42806033701 |
Molindone 10mg 100 Tab |
06/26/2020 |
223.50 |
968.50 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
None |
1 |
05/26/2017 |
CorePharma,LLC |
None |
1 |
None |
183.46 |
183.46 |
2015 |
183.46 |
None |
None |
| Rx0000094 |
Epic Pharma |
06/30/2020 |
42806033801 |
Molindone 25mg 100 Tab |
06/26/2020 |
249.00 |
1079.00 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
None |
1 |
05/26/2017 |
CorePharma,LLC |
None |
1 |
None |
215.48 |
215.48 |
2015 |
215.48 |
None |
None |
| Rx0000094 |
Epic Pharma |
06/30/2020 |
42806033601 |
Molindone 5mg 100 Tab |
06/26/2020 |
186.00 |
806.00 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
None |
1 |
05/26/2017 |
CorePharma,LLC |
None |
1 |
None |
127.60 |
127.60 |
2015 |
127.60 |
None |
None |
| Rx0000094 |
Epic Pharma |
06/30/2020 |
42806050109 |
Nicardipine Hcl 20mg90 Cap Epic |
06/26/2020 |
318.74 |
1115.59 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
None |
1 |
06/24/2010 |
Amneal Pharmaceuticals |
None |
1 |
None |
9.65 |
9.65 |
2006 |
9.65 |
None |
the original manufacture Genpharm/ lipha introduced the products on market in 2006, but there is no WAC. Amneal bought this product and then they introduced to maket with WAC $9.65 in 2008. |
| Rx0000094 |
Epic Pharma |
06/30/2020 |
42806050209 |
Nicardipine Hcl 30mg90 Cap Epic |
06/26/2020 |
456.50 |
1597.76 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
None |
1 |
06/24/2010 |
Amneal Pharmaceuticals |
None |
1 |
None |
14.90 |
14.90 |
2006 |
14.90 |
None |
the original manufacture Genpharm/ lipha introduced the products on market in 2006, but there is no WAC. Amneal bought this product and then they introduced to maket with WAC $14.9 in 2008. |
| Rx0000104 |
EUSA Pharma (US) LLC |
12/31/2020 |
57894042001 |
SYLVANT, 100mg, intravenous powder for solution |
10/01/2020 |
101.79 |
1173.26 |
08/01/2027 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
12/22/2018 |
Janssen Biotech |
115000000 |
None |
Acquisition price is for both NDCs |
910.24 |
883.73 |
2014 |
833.00 |
None |
None |
| Rx0000104 |
EUSA Pharma (US) LLC |
12/31/2020 |
57894042101 |
SYLVANT, 400mg, intravenous powder for solution |
10/01/2020 |
407.16 |
4693.03 |
08/01/2027 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
12/22/2018 |
Janssen Biotech |
115000000 |
None |
Acquisition price is for both NDCs |
3640.96 |
3534.92 |
2014 |
3332.00 |
None |
None |
| Rx0000010 |
Exelixis, Inc. |
03/31/2020 |
42388002426 |
CABOMETYX 20MG 30 TAB BTL EACH |
01/01/2020 |
959.59 |
20151.54 |
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?, both derived from the same molecule, cabozantinib, 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.
Cabozantinib Development Factors: Since the initial commercial launch of cabozantinib, 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 cabozantinib?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 secure that the supply of CABOMETYX for our customers, and ultimately, patients is safe and interrupted, 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, 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 cabozantinib 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. |
03/31/2020 |
42388002526 |
CABOMETYX 40MG 30 TAB BTL EACH |
01/01/2020 |
959.59 |
20151.54 |
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?, both derived from the same molecule, cabozantinib, 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.
Cabozantinib Development Factors: Since the initial commercial launch of cabozantinib, 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 cabozantinib?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 secure that the supply of CABOMETYX for our customers, and ultimately, patients is safe and interrupted, 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, 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 cabozantinib 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. |
03/31/2020 |
42388002326 |
CABOMETYX 60MG 30 TAB BTL EACH |
01/01/2020 |
959.59 |
20151.54 |
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?, both derived from the same molecule, cabozantinib, 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.
Cabozantinib Development Factors: Since the initial commercial launch of cabozantinib, 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 cabozantinib?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 secure that the supply of CABOMETYX for our customers, and ultimately, patients is safe and interrupted, 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, 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 cabozantinib 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. |
03/31/2020 |
42388001214 |
COMETRIQ 100 MG DAILY-DOSE PACK, 56 ct (4 X 14 ct Blister Cards Per Package) |
01/01/2020 |
857.11 |
17999.31 |
02/10/2032 |
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?, both derived from the same molecule, cabozantinib, 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 COMETRIQ 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 COMETRIQ?s wholesale acquisition cost.
Cabozantinib Development Factors: Since the initial commercial launch of cabozantinib, 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 cabozantinib?s full potential for treating the largest number of cancer patients, when it contemplated changes to the wholesale acquisition cost of COMETRIQ.
COMETRIQ Value Factors: COMETRIQ has been approved by the FDA to treat patients with medullary thyroid cancer and has shown impressive efficacy relative to its competitors in treating patients with this life-threatening disease. When Exelixis contemplated a change to the wholesale acquisition cost for COMETRIQ, Exelixis considered the clinical value proposition of COMETRIQ relative to its competitor prescription drugs, as well as the competitive market generally and the existing price points of competitors.
COMETRIQ Cost Factors: At Exelixis, we are committed to ensuring that all patients in need can access our medicines. To secure that the supply of COMETRIQ for our customers, and ultimately, patients is safe and interrupted, 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 COMETRIQ, 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, 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 cabozantinib 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 COMETRIQ? 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. |
03/31/2020 |
42388001114 |
COMETRIQ 140 MG DAILY-DOSE PACK, 112 ct (4 X 28 ct Blister Cards Per Package) |
01/01/2020 |
857.11 |
17999.31 |
02/10/2032 |
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?, both derived from the same molecule, cabozantinib, 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 COMETRIQ 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 COMETRIQ?s wholesale acquisition cost.
Cabozantinib Development Factors: Since the initial commercial launch of cabozantinib, 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 cabozantinib?s full potential for treating the largest number of cancer patients, when it contemplated changes to the wholesale acquisition cost of COMETRIQ.
COMETRIQ Value Factors: COMETRIQ has been approved by the FDA to treat patients with medullary thyroid cancer and has shown impressive efficacy relative to its competitors in treating patients with this life-threatening disease. When Exelixis contemplated a change to the wholesale acquisition cost for COMETRIQ, Exelixis considered the clinical value proposition of COMETRIQ relative to its competitor prescription drugs, as well as the competitive market generally and the existing price points of competitors.
COMETRIQ Cost Factors: At Exelixis, we are committed to ensuring that all patients in need can access our medicines. To secure that the supply of COMETRIQ for our customers, and ultimately, patients is safe and interrupted, 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 COMETRIQ, 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, 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 cabozantinib 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 COMETRIQ? 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. |
03/31/2020 |
42388001314 |
COMETRIQ 60 MG DAILY-DOSE PACK, 84 ct (4 X 21 ct Blister Cards Per Package) |
01/01/2020 |
857.11 |
17999.31 |
02/10/2032 |
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?, both derived from the same molecule, cabozantinib, 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 COMETRIQ 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 COMETRIQ?s wholesale acquisition cost.
Cabozantinib Development Factors: Since the initial commercial launch of cabozantinib, 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 cabozantinib?s full potential for treating the largest number of cancer patients, when it contemplated changes to the wholesale acquisition cost of COMETRIQ.
COMETRIQ Value Factors: COMETRIQ has been approved by the FDA to treat patients with medullary thyroid cancer and has shown impressive efficacy relative to its competitors in treating patients with this life-threatening disease. When Exelixis contemplated a change to the wholesale acquisition cost for COMETRIQ, Exelixis considered the clinical value proposition of COMETRIQ relative to its competitor prescription drugs, as well as the competitive market generally and the existing price points of competitors.
COMETRIQ Cost Factors: At Exelixis, we are committed to ensuring that all patients in need can access our medicines. To secure that the supply of COMETRIQ for our customers, and ultimately, patients is safe and interrupted, 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 COMETRIQ, Exelixis considered these investments in expanding and improving our manufacturing capabilities and supply chain, as well as rising manufacturing costs. |
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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, 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 cabozantinib 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 COMETRIQ? when market conditions permit such an increase. |
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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 |
| Rx0000205 |
Eyevance Pharmaceuticals LLC |
12/31/2020 |
71776010005 |
Flarex (fluorometholone acetate), ophthalmic suspension, 0.1%, 5mL |
10/24/2020 |
29.11 |
119.07 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
10/23/2018 |
Novartis AG |
None |
1 |
None |
70.01 |
70.01 |
1986 |
7.48 |
None |
(1) We do not have the actual price when the product was introduced as it was purchased. For this entry, we used the baseline Average Manufacturers Price (AMP) that was established for the product when the Medicaid Pricing Program began. This is the best estimation available for an introductory market price.
(2) The NDC# prior to the Eyevance NDC# was 00065-0096-05. In the 5 Year WAC history field we used the current Eyevance NDC# (71776-0100-05) although the WAC increases prior to 2020 were reflective of the old 00065-0096-05 NDC#. |