| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087122501 |
Cetrotide Subcutaneous Kit 0.25 MG Single |
01/15/2021 |
17.51 |
251.03 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087907001 |
Gonal-f Injection Solution Reconstituted 1050 UNIT Single |
01/15/2021 |
206.52 |
2960.18 |
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. |
03/31/2021 |
44087903001 |
Gonal-f Injection Solution Reconstituted 450 UNIT Single |
01/15/2021 |
88.51 |
1268.65 |
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. |
03/31/2021 |
44087111501 |
Gonal-f RFF Rediject Subcutaneous Solution 300 UNIT/0.5ML Single |
01/15/2021 |
59.01 |
845.77 |
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. |
03/31/2021 |
44087111601 |
Gonal-f RFF Rediject Subcutaneous Solution 450 UNT/0.75ML Single |
01/15/2021 |
88.51 |
1268.65 |
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. |
03/31/2021 |
44087111701 |
Gonal-f RFF Rediject Subcutaneous Solution 900 UNIT/1.5ML Single |
01/15/2021 |
177.02 |
2537.30 |
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. |
03/31/2021 |
44087900501 |
Gonal-f RFF Subcutaneous Solution Reconstituted 75 UNIT (1) Single |
01/15/2021 |
14.75 |
211.44 |
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. |
03/31/2021 |
44087900506 |
Gonal-f RFF Subcutaneous Solution Reconstituted 75 UNIT (10), 10 Pack |
01/15/2021 |
147.52 |
2114.42 |
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. |
03/31/2021 |
44087400000 |
Mavenclad (10 Tabs) Oral Tablet Therapy Pack 10 MG |
01/15/2021 |
4881.80 |
86244.30 |
10/16/2026 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087400004 |
Mavenclad (4 Tabs) Oral Tablet Therapy Pack 10 MG |
01/15/2021 |
1952.72 |
34497.72 |
10/16/2026 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087400005 |
Mavenclad (5 Tabs) Oral Tablet Therapy Pack 10 MG |
01/15/2021 |
2440.90 |
43122.15 |
10/16/2026 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087400006 |
Mavenclad (6 Tabs) Oral Tablet Therapy Pack 10 MG |
01/15/2021 |
2929.08 |
51746.58 |
10/16/2026 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087400007 |
Mavenclad (7 Tabs) Oral Tablet Therapy Pack 10 MG |
01/15/2021 |
3417.26 |
60371.01 |
10/16/2026 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087400008 |
Mavenclad (8 Tabs) Oral Tablet Therapy Pack 10 MG |
01/15/2021 |
3905.44 |
68995.44 |
10/16/2026 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087400009 |
Mavenclad (9 Tabs) Oral Tablet Therapy Pack 10 MG |
01/15/2021 |
4393.62 |
77619.87 |
10/16/2026 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087115001 |
Ovidrel Subcutaneous Injectable 250 MCG/0.5ML Prefilled Syringe |
01/15/2021 |
13.31 |
190.80 |
03/16/2021 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087332201 |
Rebif Rebidose Subcutaneous Solution Auto-injector 22 MCG/0.5ML (12 single use auto injector) |
01/15/2021 |
502.29 |
8873.74 |
02/08/2022 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087332209 |
Rebif Rebidose Subcutaneous Solution Auto-injector 22 MCG/0.5ML (Single) |
01/15/2021 |
41.86 |
739.48 |
02/08/2022 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087334401 |
Rebif Rebidose Subcutaneous Solution Auto-injector 44 MCG/0.5ML (12 single use auto injector) |
01/15/2021 |
502.29 |
8873.74 |
02/08/2022 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087334409 |
Rebif Rebidose Subcutaneous Solution Auto-injector 44 MCG/0.5ML (Single) |
01/15/2021 |
41.86 |
739.48 |
02/08/2022 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087018801 |
Rebif Rebidose Titration Pack Subcutaneous Solution Auto-injector 6X8.8 & 6X22 MCG (6 single use auto injector) |
01/15/2021 |
502.29 |
8873.74 |
02/08/2022 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087002203 |
Rebif Subcutaneous Solution Prefilled Syringe 22 MCG/0.5ML (12 pre-filled syringes) |
01/15/2021 |
502.29 |
8873.74 |
02/08/2022 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087002209 |
Rebif Subcutaneous Solution Prefilled Syringe 22 MCG/0.5ML (Single) |
01/15/2021 |
41.86 |
739.48 |
02/08/2022 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087004403 |
Rebif Subcutaneous Solution Prefilled Syringe 44 MCG/0.5ML (12 pre-filled syringes) |
01/15/2021 |
502.29 |
8873.74 |
02/08/2022 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087004409 |
Rebif Subcutaneous Solution Prefilled Syringe 44 MCG/0.5ML (Single) |
01/15/2021 |
41.86 |
739.48 |
02/08/2022 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087882201 |
Rebif Titration Pack Subcutaneous Solution Prefilled Syringe 6X8.8 & 6X22 MCG (6 pre-filled syringes) |
01/15/2021 |
502.29 |
8873.74 |
02/08/2022 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087100502 |
Saizen Injection Solution Reconstituted 5 MG, Single |
01/15/2021 |
39.50 |
697.60 |
04/27/2016 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087108801 |
Saizen Injection Solution Reconstituted 8.8 MG, Single |
01/15/2021 |
63.19 |
1116.16 |
04/27/2016 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087001601 |
Saizenprep Injection Solution Reconstituted 8.8 MG, Single |
01/15/2021 |
63.19 |
1116.16 |
04/27/2016 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087000407 |
Serostim Subcutaneous Solution Reconstituted 4 MG, 7 pack |
01/15/2021 |
161.88 |
2857.12 |
04/27/2016 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087000507 |
Serostim Subcutaneous Solution Reconstituted 5 MG, 7 pack |
01/15/2021 |
202.35 |
3571.40 |
04/27/2016 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000079 |
EMD Serono, Inc. |
03/31/2021 |
44087000607 |
Serostim Subcutaneous Solution Reconstituted 6 MG, 7 pack |
01/15/2021 |
242.82 |
4285.68 |
04/27/2016 |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
| Rx0000091 |
Endo Pharmaceuticals Inc. |
06/30/2021 |
67979051143 |
Aveed, 750 mg/3mL (250mg/1mL) solution, single use vial |
04/01/2021 |
65.54 |
1416.83 |
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 7/15/2021. 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. |
03/31/2021 |
52244001002 |
Edex, Alprostadil For Inj Kit 10 MCG, 2 |
01/01/2021 |
8.10 |
143.17 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Endo believes is otherwise in the public domain or publicly available. (2) The 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 4/19/2021. 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. 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. |
03/31/2021 |
52244001006 |
Edex, Alprostadil For Inj Kit 10 MCG, 6 |
01/01/2021 |
24.32 |
429.57 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Endo believes is otherwise in the public domain or publicly available. (2) The 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 4/19/2021. 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. 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. |
03/31/2021 |
52244002002 |
Edex, Alprostadil For Inj Kit 20 MCG, 2 |
01/01/2021 |
10.47 |
184.96 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Endo believes is otherwise in the public domain or publicly available. (2) The 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 4/19/2021. 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. 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. |
03/31/2021 |
52244002006 |
Edex, Alprostadil For Inj Kit 20 MCG, 6 |
01/01/2021 |
31.41 |
554.85 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Endo believes is otherwise in the public domain or publicly available. (2) The 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 4/19/2021. 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. 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. |
03/31/2021 |
52244004002 |
Edex, Alprostadil For Inj Kit 40 MCG, 2 |
01/01/2021 |
14.30 |
252.58 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Endo believes is otherwise in the public domain or publicly available. (2) The 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 4/19/2021. 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. 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. |
03/31/2021 |
52244004006 |
Edex, Alprostadil For Inj Kit 40 MCG, 6 |
01/01/2021 |
42.89 |
757.69 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Endo believes is otherwise in the public domain or publicly available. (2) The 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 4/19/2021. 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. 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. |
03/31/2021 |
63481002509 |
FROVA, Frovatriptan Succinate Tab 2.5 MG (Base Equivalent), 9 |
01/01/2021 |
87.08 |
966.71 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Endo believes is otherwise in the public domain or publicly available. (2) The 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 4/19/2021. 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. 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. |
03/31/2021 |
63481068706 |
LIDODERM, Lidocaine Patch 5%, 30 |
01/01/2021 |
59.31 |
658.39 |
None |
Innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Endo believes is otherwise in the public domain or publicly available. (2) The 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 4/19/2021. 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. 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. |
03/31/2021 |
63481062970 |
PERCOCET, Oxycodone w/ Acetaminophen Tab 10-325 MG, 100 |
01/01/2021 |
254.82 |
2828.74 |
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 4/19/2021. 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. 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. |
03/31/2021 |
63481062770 |
PERCOCET, Oxycodone w/ Acetaminophen Tab 2.5-325 MG, 100 |
01/01/2021 |
128.88 |
1430.72 |
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 4/19/2021. 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. 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. |
03/31/2021 |
63481062370 |
PERCOCET, Oxycodone w/ Acetaminophen Tab 5-325 MG, 100 |
01/01/2021 |
180.38 |
2002.40 |
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 4/19/2021. 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. 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. |
03/31/2021 |
63481062385 |
PERCOCET, Oxycodone w/ Acetaminophen Tab 5-325 MG, 500 |
01/01/2021 |
879.21 |
9760.13 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
None |
1 |
The price increase was not necessitated by a change or improvement in the drug. |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
The information contained in this report is subject to the following limitations and assumptions. (1) Consistent with the relevant statutes and regulations, all information contained in this report is limited to that which Endo believes is otherwise in the public domain or publicly available. (2) The 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 4/19/2021. 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. 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. |
03/31/2021 |
63481062870 |
PERCOCET, Oxycodone w/ Acetaminophen Tab 7.5-325 MG, 100 |
01/01/2021 |
194.88 |
2163.33 |
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 |
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 4/19/2021. 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. 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. |
06/30/2021 |
67979000201 |
Supprelin LA, 50 mg implant, ea |
04/01/2021 |
2011.79 |
43068.82 |
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 7/15/2021. 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. |
03/31/2021 |
52244010010 |
THEO-24, Theophylline Cap ER 24HR 100 MG, 100 |
01/01/2021 |
23.89 |
265.23 |
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 4/19/2021. 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. 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. |
03/31/2021 |
52244020010 |
THEO-24, Theophylline Cap ER 24HR 200 MG, 100 |
01/01/2021 |
35.51 |
394.19 |
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 4/19/2021. 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. 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. |
03/31/2021 |
52244030010 |
THEO-24, Theophylline Cap ER 24HR 300 MG, 100 |
01/01/2021 |
43.64 |
484.49 |
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 4/19/2021. 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. 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. |
03/31/2021 |
52244040010 |
THEO-24, Theophylline Cap ER 24HR 400 MG, 100 |
01/01/2021 |
61.41 |
681.74 |
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 4/19/2021. 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. 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. |
06/30/2021 |
67979000101 |
Valstar, 40 mg/1ml solution, 4x5mL |
04/01/2021 |
324.13 |
7007.25 |
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 7/15/2021, 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. |
06/30/2021 |
66887000301 |
Xiaflex, 0.9mg powder for solution, single use vial |
04/01/2021 |
196.46 |
5233.89 |
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 |
09/30/2021 |
42806008101 |
Benzphetamine Hydrochloride 50mg Oral 100 tablet |
07/01/2021 |
740.00 |
950.00 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
Market Dynamic Change |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Epic Pharma developed the product |
| Rx0000094 |
Epic Pharma |
09/30/2021 |
42806008130 |
Benzphetamine Hydrochloride 50mg Oral 30 tablet |
07/01/2021 |
315.00 |
390.00 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
Market Dynamic Change |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Epic Pharma developed the product |
| Rx0000094 |
Epic Pharma |
09/30/2021 |
42806026301 |
Isradipine 2.5mg Oral 100 capsule |
07/07/2021 |
406.37 |
976.37 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
Market Dynamic Change |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Epic Pharma developed the product |
| Rx0000094 |
Epic Pharma |
09/30/2021 |
42806026401 |
Isradipine 5mg Oral 100 capsule |
07/07/2021 |
147.53 |
987.53 |
None |
Non-innovator Multiple Source Drug |
None |
1 |
Market Dynamic Change |
None |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Epic Pharma developed the product |
| Rx0000104 |
EUSA Pharma (US) LLC |
12/31/2021 |
73090042101 |
SYLVANT 1 Vial of 400mg, intravenous powder for solution |
10/01/2021 |
143.99 |
4943.55 |
None |
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 |
| Rx0000104 |
EUSA Pharma (US) LLC |
12/31/2021 |
73090042001 |
SYLVANT 1 Vial of100mg, intravenous powder for solution |
10/01/2021 |
36.00 |
1235.89 |
None |
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 |
06/30/2021 |
73090042001 |
SYLVANT, 100mg, intravenous POW for solution |
05/01/2021 |
26.63 |
1199.89 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
12/22/2018 |
Janssen Biotech |
115000000 |
None |
Acquisition price is for both NDCs |
910.24 |
None |
2014 |
833.00 |
None |
EUSA Pharma transitioned SYLVANT's NDC from 57894-0420-01 to 73090-0420-01 and from 57894-0421-01 to 73090-0421-01 respectively. |
| Rx0000104 |
EUSA Pharma (US) LLC |
06/30/2021 |
73090042101 |
SYLVANT, 400mg, intravenous POW for solution |
05/01/2021 |
106.53 |
4799.56 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
12/22/2018 |
Janssen Biotech |
115000000 |
None |
Acquisition price is for both NDCs |
3640.96 |
None |
2014 |
3332.00 |
None |
EUSA Pharma transitioned SYLVANT's NDC from 57894-0420-01 to 73090-0420-01 and from 57894-0421-01 to 73090-0421-01 respectively. |
| Rx0000010 |
Exelixis, Inc. |
03/31/2021 |
42388002426 |
CABOMETYX 20MG 30 TAB BTL EACH |
01/01/2021 |
1511.36 |
21662.80 |
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 and Development 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. As part of these efforts, Exelixis has advanced three candidates to Phase 1 clinical trials, and anticipates filing INDs for up to two additional candidates in 2021. Exelixis considered the investments necessary to undertake and support these drug discovery and development 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, including a recent approval for the treatment of 1st line kidney cancer in combination with nivolumab, 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 4/13/2021. 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 |
| Rx0000010 |
Exelixis, Inc. |
03/31/2021 |
42388002526 |
CABOMETYX 40MG 30 TAB BTL EACH |
01/01/2021 |
1511.36 |
21662.80 |
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 and Development 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. As part of these efforts, Exelixis has advanced three candidates to Phase 1 clinical trials, and anticipates filing INDs for up to two additional candidates in 2021. Exelixis considered the investments necessary to undertake and support these drug discovery and development 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, including a recent approval for the treatment of 1st line kidney cancer in combination with nivolumab, 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 4/13/2021. 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 |
| Rx0000010 |
Exelixis, Inc. |
03/31/2021 |
42388002326 |
CABOMETYX 60MG 30 TAB BTL EACH |
01/01/2021 |
1511.36 |
21662.80 |
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 and Development 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. As part of these efforts, Exelixis has advanced three candidates to Phase 1 clinical trials, and anticipates filing INDs for up to two additional candidates in 2021. Exelixis considered the investments necessary to undertake and support these drug discovery and development 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, including a recent approval for the treatment of 1st line kidney cancer in combination with nivolumab, 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 4/13/2021. 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 |
| Rx0000205 |
Eyevance Pharmaceuticals LLC |
09/30/2021 |
71776010005 |
Flarex (fluorometholone acetate ophthalmic suspension 0.1%) 5mL Bottle Liquid |
08/03/2021 |
5.95 |
125.02 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
10/23/2018 |
Novartis AG |
None |
1 |
None |
70.01 |
66.05 |
1986 |
7.48 |
None |
Don't know WAC at introduction as product was purchased. Best estimate that has been provided is the original WAC under the Medicaid Drug Rebate Program which is from the 2nd quarter of 1992. |
| Rx0000205 |
Eyevance Pharmaceuticals LLC |
09/30/2021 |
00065064515 |
Natacyn (natamycin ophthalmic suspension 5.0%) 15mL Bottle Liquid |
08/03/2021 |
115.19 |
473.64 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
10/16/2019 |
Novartis AG |
None |
1 |
None |
329.17 |
310.54 |
1982 |
74.27 |
None |
Don't know WAC at introduction as product was purchased. Best estimate that has been provided is the original WAC under the Medicaid Drug Rebate Program which is from the 4th quarter of 1990. |
| Rx0000205 |
Eyevance Pharmaceuticals LLC |
09/30/2021 |
71776003505 |
TobraDex ST (tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05%) 5mL Bottle Liquid |
08/03/2021 |
11.33 |
237.90 |
None |
Single Source Drug |
None |
1 |
None |
1 |
None |
1 |
10/16/2019 |
Novartis AG |
None |
1 |
None |
207.11 |
199.91 |
2009 |
85.80 |
None |
Don't know WAC at introduction as product was purchased. Best estimate that has been provided is the original WAC under the Medicaid Drug Rebate Program which is from the 4th quarter of 2010 |