EMPAGLIFLOZIN | N204629 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Boehringer Ingelheim Pharmaceuticals Inc. et al v. Ridhisidhi PLLC 5 patentsempagliflozin | D. Del. | 2026-04-03 | Active | — |
Boehringer Ingelheim Pharmaceuticals Inc. et al v. Ipca Laboratories Ltd. 2 patentsANDA 220640empagliflozin | D. Del. | 2025-09-29 | Terminated 2025-12-18 | — |
Boehringer Ingelheim Pharmaceuticals Inc. et al v. USV Private Limited 4 patentsANDA 220497empagliflozin | D. Del. | 2025-07-10 | Terminated 2025-12-19 | — |
Boehringer Ingelheim Pharmaceuticals Inc. et al v. Granules India Limited et al 4 patentsANDA 220408empagliflozin | D. Del. | 2025-05-29 | Terminated 2025-09-02 | — |
Boehringer Ingelheim Pharmaceuticals Inc. et al v. Dr. Reddy's Laboratories Ltd. et al 1 patentANDA 212336empagliflozin | D. Del. | 2022-08-22 | Active | — |
| D. Del. | 2022-02-18 | Terminated 2023-05-19 | — | |
| D. Del. | 2021-12-16 | Terminated 2023-02-14 | — | |
| D. Del. | 2021-11-05 | Terminated 2025-07-30 | — | |
| D. Del. | 2021-10-22 | Terminated 2025-07-30 | — | |
Boehringer Ingelheim Pharmaceuticals Inc. v. Lupin Ltd. et al 1 patentANDA 212331, 212335, 213654, 215072empagliflozin, empagliflozin/linagliptin, empagliflozin/metformin, empagliflozin/linagliptin/metformin | D. Del. | 2021-10-22 | Active | — |
| D. Del. | 2021-10-22 | Active | — | |
| D. Del. | 2020-11-23 | Terminated 2025-07-30 | — | |
| D. Del. | 2019-10-07 | Terminated 2021-04-28 | — | |
| D. Del. | 2019-10-03 | Terminated 2022-12-12 | — | |
| D. Del. | 2019-10-03 | Terminated 2020-09-03 | — | |
| D. Del. | 2019-10-03 | Terminated 2021-10-19 | — | |
| D. Del. | 2019-10-03 | Active | — | |
| D. Del. | 2019-08-28 | Terminated 2023-05-18 | — | |
| D. Del. | 2019-08-28 | Terminated 2020-11-10 | — | |
| D. Del. | 2019-08-09 | Terminated 2025-07-30 | — | |
| D. Del. | 2019-08-09 | Active | — | |
| D. Del. | 2019-08-09 | Terminated 2021-07-28 | — | |
| D. Del. | 2019-08-09 | Terminated 2021-05-25 | — | |
| D. Del. | 2019-08-09 | Terminated 2023-09-12 | — | |
| D. Del. | 2019-08-09 | Active | — | |
| D. Del. | 2019-08-09 | Terminated 2021-05-20 | — | |
| D. Del. | 2019-08-09 | Terminated 2021-07-27 | — | |
Boehringer Ingelheim Pharmaceuticals Inc. v. Mankind Pharma Ltd. et al 1 patentANDA 212283empagliflozin | D. Del. | 2019-08-09 | Terminated 2023-02-14 | — |
| D. Del. | 2019-08-09 | Terminated 2023-09-12 | — | |
| D. Del. | 2019-07-11 | Terminated 2021-07-27 | — | |
Boehringer Ingelheim Pharmaceuticals Inc. et al v. InvaGen Pharmaceuticals, Inc. 1 patentANDA 213330empagliflozin | D. Del. | 2018-11-13 | Terminated 2023-09-12 | — |
| D. Del. | 2018-11-13 | Terminated 2023-09-12 | — | |
| D. Del. | 2018-11-13 | Terminated 2020-11-10 | — | |
| D. Del. | 2018-11-13 | Terminated 2021-05-25 | — | |
| D. Del. | 2018-11-13 | Terminated 2021-10-19 | — | |
| D. Del. | 2018-11-13 | Terminated 2021-05-20 | — | |
| D. Del. | 2018-11-12 | Active | — | |
| D. Del. | 2018-11-08 | Terminated 2021-04-28 | — | |
| D. Del. | 2018-11-08 | Terminated 2025-07-30 | — | |
| D. Del. | 2018-11-08 | Terminated 2020-09-03 | — | |
| D. Del. | 2018-11-08 | Terminated 2021-07-27 | — | |
| D. Del. | 2018-11-07 | Terminated 2022-12-12 | — | |
| D. Del. | 2018-11-07 | Terminated 2023-05-18 | — | |
| D. Del. | 2018-11-02 | Terminated 2021-07-28 | — | |
| D. Del. | 2018-10-26 | Active | — | |
Boehringer Ingelheim Pharmaceuticals Inc. et al v. Lupin Ltd. et al 2 patentsANDA 212283empagliflozin | D. Del. | 2018-10-26 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Public Citizen's Health Research Group FDA-2020-P-1611 · 17 docket documents Public Citizen's Health Research Group filed this petition under Sections 502 and 505(o)(4) of the FDCA requesting that the FDA immediately add boxed warnings to all sodium-glucose cotransporter-2 inhibitor drugs (canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin) contraindicating their | Other | 2020-06-24 | Denied | Public Citizen's Health Research Group |
Citizen Petition from Foley & Lardner LLP FDA-2017-P-2661 · 7 docket documents Foley & Lardner LLP filed a citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Empagliflozin Capsules 10 mg and 25 mg suitable for submission as an ANDA, with Jardiance (Empagliflozin Tablets 10 mg and 25 mg) as the reference produ | Other | 2017-04-28 | Withdrawn | Foley & Lardner LLP |
Citizen Petition from Foley & Lardner LLP FDA-2017-P-2674 · 7 docket documents Foley & Lardner LLP filed this citizen petition under 21 CFR 10.30, 314.93, and Section 505(j)(2)(C) of the FD&C Act requesting that the FDA permit the filing of an ANDA for Empagliflozin and Linagliptin Capsules in 10 mg/5 mg and 25 mg/5 mg strengths, which would differ from the reference product G | Other | 2017-04-28 | Withdrawn | Foley & Lardner LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$11.19
per ea
Lowest NADAC/Unit
$11.19
per ea
Brand NDCs
6
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00597015330JARDIANCE 25 MG TABLET | $11.19 | EA | Brand | — | 2026-06-17 |
| 00597015337JARDIANCE 25 MG TABLET | $11.19 | EA | Brand | — | 2026-06-17 |
| 00597015390JARDIANCE 25 MG TABLET | $11.19 | EA | Brand | — | 2026-06-17 |
| 00597015230JARDIANCE 10 MG TABLET | $11.19 | EA | Brand | — | 2026-06-17 |
| 00597015237JARDIANCE 10 MG TABLET | $11.19 | EA | Brand | — | 2026-06-17 |
| 00597015290JARDIANCE 10 MG TABLET | $11.19 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7579449 | Aug 1, 2028PED: Feb 1, 2029 | PED | Yes | — | — | — |
| 7713938 | Apr 15, 2027PED: Oct 15, 2027 | PED | Yes | Yes | — | — |
| 8551957 | Oct 14, 2029PED: Apr 14, 2030 | PED | — | — | — | |
| 9949997 | May 17, 2034PED: Nov 17, 2034 | PED | — | — | — | |
| 9949998 | Jun 11, 2034PED: Dec 11, 2034 | PED | — | — | — | |
| 10258637 | Apr 3, 2034PED: Oct 3, 2034 | PED | — | — | — | |
| 11090323 | Apr 3, 2034PED: Oct 3, 2034 | PED | — | — | — | |
| 11666590 | Apr 3, 2034 | — | — | — | — | |
| 11813275 | Apr 3, 2034PED: Oct 3, 2034 | PED | — | — | — | |
| 11833166 | Apr 3, 2034PED: Oct 3, 2034 | PED | — | — | — | |
| 12115179 | Feb 11, 2030PED: Aug 11, 2030 | PED | — | — | — | |
| 12263153 | Apr 3, 2034 | — | — | — | — | |
| 12427162 | Apr 3, 2034 | — | — | — | — | |
| 12433906 | Apr 3, 2034PED: Oct 3, 2034 | PED | — | — | — | |
| 12527810 | Apr 22, 2033PED: Oct 22, 2033 | PED | — | — | — |
| Code | Date | Status |
|---|---|---|
| I-922 | Sep 21, 2026 | < 1 year |
| NPP | Jun 20, 2026 | Expired |
| PED | Dec 20, 2026 | < 1 year |