METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | N202270 | MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2020-01045 | 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 |
| IPR2020-01060 | 7326708 | IPR | Dr. Reddy's Laboratories, Inc. et al. | Final Written Decision | 2020-06-11 | — |
| IPR2020-01072 | 7326708 | IPR | Sun Pharmaceutical Industries Ltd. et al. | Final Written Decision | 2020-06-12 | — |
| 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 | Denied | Zydus Pharmaceuticals (USA) Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7326708 | Nov 24, 2026PED: May 24, 2027 | PED | Yes | Yes | — |
JANUMET XR (metformin hydrochloride; sitagliptin phosphate) therapeutic equivalence code updated to AB, indicating the product is therapeutically equivalent to the reference listed drug.
New: AB
JANUMET XR (metformin hydrochloride and sitagliptin phosphate) received an AB therapeutic equivalence rating, permitting generic substitution.
New: AB
JANUMET XR (metformin hydrochloride; sitagliptin phosphate) received an AB therapeutic equivalence rating for NDA 202270, allowing generic substitution.
New: AB