METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE | N022044 | MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2020-00040 | 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 |
|---|---|---|---|---|
| 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 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products from 246.7 ng per day to 37 ng per day, withdraw products exceeding the lower limit | 505(q) | 2023-10-20 | Withdrawn | Zydus Pharmaceuticals (USA) Inc. |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 | $2.51 | 2026-10-21 |
| 00006057562JANUMET 50-500 MG TABLET | $5.28 | EA | Brand | $2.51 | 2026-10-21 |
| 00006057582JANUMET 50-500 MG TABLET | $5.28 | EA | Brand | $2.51 | 2026-10-21 |
| 00006057761JANUMET 50-1,000 MG TABLET | $5.28 | EA | Brand | $2.51 | 2026-10-21 |
| 00006057762JANUMET 50-1,000 MG TABLET | $5.28 | EA | Brand | $2.51 | 2026-10-21 |
| 00006057782JANUMET 50-1,000 MG TABLET | $5.28 | EA | Brand | $2.51 | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.