METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | N202270 | MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2020-01072 | 7326708 | IPR | Sun Pharmaceutical Industries Ltd. et al. | Final Written Decision | 2020-06-12 | — |
| IPR2020-01060 | 7326708 | IPR | Dr. Reddy's Laboratories, Inc. et al. | Final Written Decision | 2020-06-11 | — |
| IPR2020-01045 | 7326708 | IPR | Teva Pharmaceuticals USA, Inc. | Terminated-Settled | 2020-06-10 | — |
| IPR2020-00040 | 7326708 | IPR | Mylan Pharmaceuticals, Inc. | Final Written Decision | 2019-10-30 | 2023-09-06 |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Merck Sharp & Dohme LLC v. Aurobindo Pharma Limited et al 1 patentANDA 220279sitagliptin phosphate; metformin hydrochloride | D. Del. | 2025-04-11 | Terminated 2025-07-01 | — |
Merck Sharp & Dohme Corp. v. Anchen Pharmaceuticals, Inc., et al. 1 patentANDA 204144metformin hydrochloride; sitagliptin phosphate | D. Del. | 2019-02-13 | Terminated 2021-03-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2023-P-4616 · 7 docket documents Zydus Pharmaceuticals (USA) Inc. filed this citizen petition on October 18, 2023, requesting that the FDA lower the interim acceptable intake limit for the nitrosamine impurity NTTP in sitagliptin-containing products from 246.7 ng per day to 37 ng per day, withdraw products exceeding the lower limit | 505(q) | 2023-10-20 | Withdrawn | Zydus Pharmaceuticals (USA) Inc. |
Citizen Petition from Hyman, Phelps & McNamara PC FDA-2018-P-3786 · 6 docket documents The law firm Hyman, Phelps & McNamara PC, on behalf of a client, submitted a petition pursuant to Federal Food, Drug, and Cosmetic Act section 505(j)(2)(C) requesting that the FDA determine that Metformin Hydrochloride 750 mg and Sitagliptin Phosphate Extended-Release Tablets 50 mg is suitable for s | Other | 2018-10-04 | Granted | Hyman, Phelps & McNamara PC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$10.56
per ea
Lowest NADAC/Unit
$5.28
per ea
Brand NDCs
9
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00006008182JANUMET XR 100-1,000 MG TABLET | $10.56 | EA | Brand | — | 2026-06-17 |
| 00006008131JANUMET XR 100-1,000 MG TABLET | $10.56 | EA | Brand | — | 2026-06-17 |
| 00006008154JANUMET XR 100-1,000 MG TABLET | $10.56 | EA | Brand | — | 2026-06-17 |
| 00006007882JANUMET XR 50-500 MG TABLET | $5.28 | EA | Brand | — | 2026-06-17 |
| 00006007861JANUMET XR 50-500 MG TABLET | $5.28 | EA | Brand | — | 2026-06-17 |
| 00006007862JANUMET XR 50-500 MG TABLET | $5.28 | EA | Brand | — | 2026-06-17 |
Showing 6 of 9 NDCs.
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 |
|---|---|---|---|---|---|---|
| 7326708 | Nov 24, 2026PED: May 24, 2027 | PED | Yes | Yes | — |