SIMVASTATIN; SITAGLIPTIN PHOSPHATE | N202343 | MERCK SHARP AND DOHME CORP
| 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 |
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lachman Consultant Services, Inc. - Citizen Petition FDA-2012-P-1104 · 3 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA determine whether Juvisync (sitagliptin and simvastatin) Tablets in three strengths (NDA 202343, Products 004, 005, and 006) held by Merck Sharp Dohme Corp. have been voluntarily withdrawn from sale f | 505(q) | 2012-11-29 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7326708 | Apr 11, 2026PED: Oct 11, 2026 | PED | Yes | Yes | — |