SACUBITRIL; VALSARTAN | N207620 | NOVARTIS PHARMACEUTICALS CORP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2024-12-23 | Terminated 2025-01-02 | — | |
| D. Del. | 2024-09-18 | Terminated 2024-11-26 | — | |
Novartis Pharmaceuticals Corporation v. Nanjing Noratech Pharmaceutical Co., Limited 2 patentsANDA 213671sacubitril/valsartan | D. Del. | 2023-04-10 | Terminated 2025-06-17 | — |
Novartis Pharmaceuticals Corporation v. MSN Pharmaceuticals Inc., et al 1 patentANDA 213682, 213605, 213748, 213646, 213671sacubitril/valsartan | D. Del. | 2022-10-24 | Terminated 2025-07-11 | — |
| D. Del. | 2022-04-01 | Terminated 2022-09-16 | — | |
| D. Del. | 2022-02-10 | Terminated 2022-09-16 | — | |
| D. Del. | 2022-01-21 | Terminated 2022-10-03 | — | |
Novartis Pharmaceuticals Corporation v. Alkem Laboratories Ltd. 1 patentANDA 213764sacubitril/valsartan | D. Del. | 2022-01-07 | Terminated 2022-11-21 | — |
| D. Del. | 2021-12-22 | Terminated 2022-11-14 | — | |
Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc. et al 2 patentssacubitril/valsartan | D. Del. | 2021-12-22 | Terminated 2024-07-08 | — |
| D. Del. | 2021-12-16 | Terminated 2024-06-21 | — | |
| D. Del. | 2021-10-14 | Terminated 2023-05-30 | — | |
| D. Del. | 2021-10-01 | Terminated 2023-04-11 | — | |
| D. Del. | 2021-09-24 | Terminated 2022-11-14 | — | |
| D. Del. | 2021-09-20 | Terminated 2024-07-08 | — | |
| D. Del. | 2021-02-18 | Terminated 2022-02-09 | — | |
| D. Del. | 2020-03-27 | Active | — | |
| D. Del. | 2020-03-24 | Terminated 2022-02-09 | — | |
Novartis Pharmaceuticals Corporation v. Alembic Pharmaceuticals Limited et al 4 patentsANDA 213682sacubitril/valsartan | D. Del. | 2020-01-17 | Terminated 2024-02-07 | — |
Novartis Pharmaceuticals Corporation v. Mylan Pharmaceuticals Inc. et al 4 patentsANDA 213646sacubitril/valsartan | N.D. W. Va. | 2019-10-30 | Terminated 2024-02-26 | — |
| D. Del. | 2019-10-29 | Terminated 2025-06-17 | — | |
NOVARTIS PHARMACEUTICALS CORPORATION v. MACLEODS PHARMACEUTICALS LTD. et al 3 patentsANDA 213728sacubitril/valsartan | D.N.J. | 2019-10-25 | Terminated 2019-11-19 | — |
Novartis Pharmaceuticals Corporation v. Alembic Pharmaceuticals Limited et al 4 patentsANDA 213682, 213728, 213689sacubitril/valsartan | D. Del. | 2019-10-24 | Terminated 2025-07-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Novartis Pharmaceuticals Corporation FDA-2022-P-2228 · 15 docket documents Novartis Pharmaceuticals Corporation filed this petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that FDA refrain from approving abbreviated new drug applications referencing ENTRESTO (sacubitril and valsartan) oral tablets during the 3-year exclusivity period coveri | 505(q) | 2022-09-13 | Partially Denied | Novartis Pharmaceuticals Corporation |
Citizen Petition from Novartis Pharmaceuticals Corporation FDA-2021-P-1286 · 14 docket documents Novartis Pharmaceuticals Corporation filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refrain from approving abbreviated new drug applications referencing ENTRESTO (sacubitril and valsartan) during the three-year exclusivity period exp | 505(q) | 2021-12-03 | Denied | Novartis Pharmaceuticals Corporation |
Citizen Petition from Novartis Pharmaceuticals Corporation FDA-2019-P-1893 · 10 docket documents Novartis Pharmaceuticals Corporation filed this citizen petition on April 18, 2019, requesting that the FDA require abbreviated new drug applications for generic sacubitril/valsartan (ENTRESTO) to demonstrate that the active ingredients have the same chemical structure as the reference listed drug, | 505(q) | 2019-04-19 | Denied | Novartis Pharmaceuticals Corporation |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$11.60
per ea
Lowest NADAC/Unit
$11.55
per ea
Brand NDCs
6
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00078069620ENTRESTO 97 MG-103 MG TABLET | $11.60 | EA | Brand | $0.5859 | 2026-06-17 |
| 00078069667ENTRESTO 97 MG-103 MG TABLET | $11.60 | EA | Brand | $0.5859 | 2026-06-17 |
| 00078065920ENTRESTO 24 MG-26 MG TABLET | $11.59 | EA | Brand | $0.5306 | 2026-06-17 |
| 00078065967ENTRESTO 24 MG-26 MG TABLET | $11.59 | EA | Brand | $0.5306 | 2026-06-17 |
| 00078077720ENTRESTO 49 MG-51 MG TABLET | $11.55 | EA | Brand | $0.5485 | 2026-06-17 |
| 00078077767ENTRESTO 49 MG-51 MG TABLET | $11.55 | EA | Brand | $0.5485 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.