BACLOFEN | N208193 | METACEL PHARMACEUTICALS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
METACEL PHARMACEUTICALS LLC v. RUBICON RESEARCH PRIVATE LIMITED 1 patentANDA 214445baclofen | D.N.J. | 2025-02-20 | Terminated 2025-05-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Novitium Pharma, LLC FDA-2026-P-6298 Novitium Pharma LLC filed a relisting petition under 21 C.F.R. § 10.25(a) and § 10.30 and sections 505(j) and 505(w) of the FDC Act requesting that the FDA determine whether the Reference Listed Drug OZOBAX (baclofen) oral solution 5mg/5ml, NDA 208193 owned by Metacel Pharmaceuticals LLC was volunta | 505(q) | 2026-06-03 | Open | Novitium Pharma |
Citizen Petition from Buchanan Ingersoll Rooney (on behalf of Metacel Pharmac... FDA-2023-P-3574 Buchanan Ingersoll Rooney, on behalf of Metacel Pharmaceuticals LLC, filed this citizen petition under 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require all ANDA sponsors using OZOBAX (baclofen) Oral Solution as the reference listed drug to conduct and provide the sa | 505(q) | 2023-08-21 | Denied | Buchanan Ingersoll Rooney (on behalf of Metacel Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 10610502 | Aug 30, 2039 | — | — | — | — |