LINAGLIPTIN | N201280 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2016-01563 | 8673927 | IPR | Mylan Pharmaceuticals Inc. et al. | Terminated | 2016-08-10 | — |
| IPR2016-01564 | 8846695 | IPR | Mylan Pharmaceuticals Inc. et al. | Terminated | 2016-08-10 | — |
| IPR2016-01565 | 8853156 | IPR | Mylan Pharmaceuticals Inc. et al. | Terminated | 2016-08-10 | — |
| IPR2016-01566 | 9173859Delisted | IPR | Mylan Pharmaceuticals Inc. et al. | Institution Denied | 2016-08-10 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Boehringer Ingelheim Pharmaceuticals Inc. et al v. Ipca Laboratories Ltd. 3 patentsANDA 220564linagliptin | D. Del. | 2026-03-26 | Terminated 2026-06-10 | — |
Boehringer Ingelheim Pharmaceuticals Inc. et al v. Biocon Limited et al 4 patentsANDA 220117linagliptin | D. Del. | 2025-04-30 | Terminated 2025-10-28 | — |
Boehringer Ingelheim Pharmaceuticals Inc. et al v. Mylan Pharmaceuticals Inc. et al 1 patentANDA 208431, 208430linagliptin | N.D. W. Va. | 2024-08-29 | Terminated 2025-11-24 | — |
| D. Del. | 2024-06-25 | Terminated 2024-10-16 | — | |
| D. Del. | 2023-06-28 | Terminated 2023-10-10 | — | |
| D. Del. | 2023-06-23 | Active | — | |
| N.D. W. Va. | 2020-02-05 | Terminated 2025-11-24 | — | |
| D. Del. | 2019-09-20 | Terminated 2020-04-14 | — | |
BOEHRINGER INGELHEIM PHARMACEUTICALS INC. et al v. SUN PHARMACEUTICAL INDUSTRIES LTD et al 1 patentANDA 208455, 208454linagliptin; linagliptin and metformin hydrochloride | D.N.J. | 2016-03-29 | Terminated 2016-04-19 | — |
Boehringer Ingelheim Pharmaceuticals, Inc. et al v. Mylan Pharmaceuticals Inc. et al 3 patentsANDA 208431, 208430linagliptin | N.D. W. Va. | 2015-08-25 | Terminated 2016-07-27 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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Capsules in 10 mg/5 mg and 25 mg/5 mg strengths, which would differ from the reference product G | Other | 2017-04-28 | Withdrawn | Foley & Lardner LLP |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
$16.80
per ea
Lowest NADAC/Unit
$16.80
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00597014030TRADJENTA 5 MG TABLET | $16.80 | EA | Brand | — | 2026-06-17 |
| 00597014061TRADJENTA 5 MG TABLET | $16.80 | EA | Brand | — | 2026-06-17 |
| 00597014090TRADJENTA 5 MG TABLET | $16.80 | 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 |
|---|---|---|---|---|---|---|
| 8673927 | May 4, 2027PED: Nov 4, 2027 | PED | — | — | Delisted | |
| 8846695 | Jun 4, 2030PED: Dec 4, 2030 | PED | — | — | Delisted | |
| 8853156 | Mar 5, 2031PED: Sep 5, 2031 | PED | — | Yes | — | |
| 8883805 | Nov 26, 2025PED: May 26, 2026 | PED | — | Yes | — | — |
| 9486526 | Aug 5, 2029PED: Feb 5, 2030 | PED | — | — | — | |
| 10034877 | Aug 5, 2029PED: Feb 5, 2030 | PED | — | — | — | |
| 11033552 | May 4, 2027PED: Nov 4, 2027 | PED | — | Yes | — | — |
| 11911388 | Apr 10, 2030 | — | — | — | — | |
| 12178819 | May 4, 2027 | — | — | Yes | — | — |
| 12364700 | Jun 8, 2037PED: Dec 8, 2037 | PED | — | — | — |
| Code | Date | Status |
|---|---|---|
| M-295 | Jun 20, 2026 | Expired |
| PED | Dec 20, 2026 | < 1 year |