SITAGLIPTIN | N211566 | ZYDUS LIFESCIENCES GLOBAL FZE
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2021-03-01 | Terminated 2022-12-09 | — |
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 Foley & Lardner LLP FDA-2019-P-3024 · 7 docket documents Foley & Lardner LLP filed this citizen petition under 21 CFR § 314.93 and Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Sitagliptin Capsules in 25 mg, 50 mg, and 100 mg strengths, which would differ from the | Other | 2019-06-25 | Withdrawn | Foley & Lardner LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$10.09
per ea
Lowest NADAC/Unit
$10.04
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 70710124203ZITUVIO 100 MG TABLET | $10.09 | EA | Brand | — | 2026-06-17 |
| 70710124003ZITUVIO 25 MG TABLET | $10.06 | EA | Brand | — | 2026-06-17 |
| 70710124103ZITUVIO 50 MG TABLET | $10.04 | EA | Brand | — | 2026-06-17 |
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 |
|---|---|---|---|---|---|---|
| 10925871 | Feb 25, 2035 | — | — | Yes | — | — |