METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | N202270 | MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2020-00040 | 7326708 | IPR | Mylan Pharmaceuticals, Inc. | Final Written Decision | 2019-10-30 | 2023-09-06 |
| 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 | — |
| 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 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products from 246.7 ng per day to 37 ng per day, withdraw products exceeding the lower limit | 505(q) | 2023-10-20 | Withdrawn | Zydus Pharmaceuticals (USA) Inc. |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 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
$10.55
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 | $10.55 | EA | Brand | $8.34 | 2026-10-21 |
| 00006008131JANUMET XR 100-1,000 MG TABLET | $10.55 | EA | Brand | $8.34 | 2026-10-21 |
| 00006008154JANUMET XR 100-1,000 MG TABLET | $10.55 | EA | Brand | $8.34 | 2026-10-21 |
| 00006007882JANUMET XR 50-500 MG TABLET | $5.28 | EA | Brand | $3.74 | 2026-10-21 |
| 00006007861JANUMET XR 50-500 MG TABLET | $5.28 | EA | Brand | $3.74 | 2026-10-21 |
| 00006007862JANUMET XR 50-500 MG TABLET | $5.28 | EA | Brand | $3.74 | 2026-10-21 |
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 | — |