ETONOGESTREL | N021529 | ORGANON USA LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
MERCK SHARP & DOHME B.V. et al v. XIROMED PHARMA ESPAA, S.L. et al 2 patentsANDA 217698etonogestrel | D.N.J. | 2025-04-02 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Organon USA, LLC FDA-2024-P-1378 · 3 docket documents Organon USA, LLC filed a citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require abbreviated new drug applications for generic etonogestrel implants citing NEXPLANON as the reference listed drug to establish bioequivalence through in vivo bioequ | 505(q) | 2024-03-21 | Open | Organon USA, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9757552 | Jul 28, 2030 | — | — | Yes | — |