SITAGLIPTIN PHOSPHATE | N021995 | MERCK SHARP AND DOHME LLC
| 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. | 2021-11-15 | Terminated 2021-11-22 | — | |
| D. Del. | 2021-08-12 | Terminated 2021-12-07 | — | |
| D. Del. | 2021-08-12 | Terminated 2022-01-07 | — | |
| D. Del. | 2021-07-15 | Terminated 2021-10-05 | — | |
Merck Sharp & Dohme Corp. v. Annora Pharma Private Limited et al 1 patentANDA 215894sitagliptin phosphate | D. Del. | 2021-07-09 | Terminated 2022-02-10 | — |
| D. Del. | 2021-06-04 | Terminated 2021-12-10 | — | |
| D. Del. | 2021-02-10 | Terminated 2021-08-16 | — | |
| D. Del. | 2020-11-04 | Terminated 2021-09-15 | — | |
| D. Del. | 2020-09-15 | Terminated 2020-12-10 | — | |
| D. Del. | 2020-06-24 | Terminated 2021-10-05 | — | |
| D. Del. | 2020-06-17 | Terminated 2021-09-15 | — | |
| D. Del. | 2020-06-09 | Terminated 2021-02-01 | — | |
| D. Del. | 2020-06-03 | Terminated 2021-09-29 | — | |
| D. Del. | 2019-11-25 | Terminated 2020-03-27 | — | |
| D. Del. | 2019-05-09 | Terminated 2020-02-19 | — | |
| D. Del. | 2019-02-13 | Terminated 2020-07-16 | — | |
| D. Del. | 2019-02-13 | Terminated 2020-04-28 | — | |
| D. Del. | 2019-02-13 | Terminated 2020-02-19 | — | |
| D. Del. | 2019-02-13 | Terminated 2020-05-28 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Jingwei Pharmaceutical Company, Ltd. FDA-2024-P-3479 · 3 docket documents Jingwei Pharmaceutical Company, Ltd. filed this citizen petition under 21 U.S.C. § 355 requesting that the FDA require generic drug manufacturers seeking approval of drug products containing sitagliptin API manufactured via a biocatalytic process to submit comprehensive documentation including a com | 505(q) | 2024-07-25 | Denied | Jingwei Pharmaceutical Company, Ltd. |
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
$10.56
per ea
Lowest NADAC/Unit
$10.55
per ea
Brand NDCs
10
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00006027754JANUVIA 100 MG TABLET | $10.56 | EA | Brand | — | 2026-06-17 |
| 00006027728JANUVIA 100 MG TABLET | $10.56 | EA | Brand | — | 2026-06-17 |
| 00006027731JANUVIA 100 MG TABLET | $10.56 | EA | Brand | — | 2026-06-17 |
| 00006027782JANUVIA 100 MG TABLET | $10.56 | EA | Brand | — | 2026-06-17 |
| 00006011254JANUVIA 50 MG TABLET | $10.55 | EA | Brand | — | 2026-06-17 |
| 00006011228JANUVIA 50 MG TABLET | $10.55 | EA | Brand | — | 2026-06-17 |
Showing 6 of 10 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 | — |