SITAGLIPTIN PHOSPHATE | N021995 | MERCK SHARP AND DOHME LLC
| 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. | 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 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 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
$10.55
per ea
Lowest NADAC/Unit
$10.54
per ea
Brand NDCs
10
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00006027754JANUVIA 100 MG TABLET | $10.55 | EA | Brand | $3.85 | 2026-10-21 |
| 00006027728JANUVIA 100 MG TABLET | $10.55 | EA | Brand | $3.85 | 2026-10-21 |
| 00006027731JANUVIA 100 MG TABLET | $10.55 | EA | Brand | $3.85 | 2026-10-21 |
| 00006027782JANUVIA 100 MG TABLET | $10.55 | EA | Brand | $3.85 | 2026-10-21 |
| 00006011254JANUVIA 50 MG TABLET | $10.55 | EA | Brand | $3.72 | 2026-10-21 |
| 00006011228JANUVIA 50 MG TABLET | $10.55 | EA | Brand | $3.72 | 2026-10-21 |
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 | — |