METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | N022044 | 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 |
|---|---|---|---|---|
| D. Del. | 2020-07-15 | Terminated 2021-09-30 | — | |
| D. Del. | 2019-08-09 | Terminated 2021-08-30 | — | |
| D. Del. | 2019-02-19 | Terminated 2021-02-01 | — | |
| D. Del. | 2019-02-13 | Terminated 2020-11-10 | — | |
| D. Del. | 2019-02-13 | Terminated 2021-09-28 | — | |
| D. Del. | 2019-02-13 | Terminated 2019-05-13 | — | |
| D. Del. | 2019-02-13 | Terminated 2020-11-10 | — | |
| D. Del. | 2019-02-13 | Terminated 2021-09-29 | — | |
| D. Del. | 2019-02-13 | Terminated 2021-09-30 | — | |
| D. Del. | 2019-02-13 | Terminated 2021-09-27 | — |
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products from 246.7 ng per day to 37 ng per day, withdraw products exceeding the lower limit | 505(q) | 2023-10-20 | Withdrawn | Zydus Pharmaceuticals (USA) Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$5.28
per ea
Lowest NADAC/Unit
$5.28
per ea
Brand NDCs
6
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00006057561JANUMET 50-500 MG TABLET | $5.28 | EA | Brand | — | 2026-06-17 |
| 00006057562JANUMET 50-500 MG TABLET | $5.28 | EA | Brand | — | 2026-06-17 |
| 00006057582JANUMET 50-500 MG TABLET | $5.28 | EA | Brand | — | 2026-06-17 |
| 00006057761JANUMET 50-1,000 MG TABLET | $5.28 | EA | Brand | — | 2026-06-17 |
| 00006057762JANUMET 50-1,000 MG TABLET | $5.28 | EA | Brand | — | 2026-06-17 |
| 00006057782JANUMET 50-1,000 MG TABLET | $5.28 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.