CARVEDILOL | N020297 | WAYLIS THERAPEUTICS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
GlaxoSmithKline LLC et al v. Teva Pharmaceuticals USA Inc. 2 patentsANDA 76-373carvedilol | D. Del. | 2014-07-03 | Terminated 2026-02-10 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Reference 1 Package insert for Coreg re Suitability Petition from Emprise Pha... FDA-2020-P-2166 · 8 docket documents Emprise Pharma LLC, on behalf of New Time Pharmaceutical Co, Ltd, filed a suitability petition regarding the reference package insert for Coreg, seeking FDA confirmation that the reference product's labeling is appropriate for use in developing an abbreviated new drug application or generic equivale | Suitability | 2020-11-05 | Withdrawn | New Time Pharmaceutical Co, Ltd |
Flamel Technologies S.A. (Frommer Lawrence & Haug LLP) - Citizen Petition FDA-2010-P-0216 · 21 docket documents Flamel Technologies S.A., represented by Frommer Lawrence & Haug LLP, filed this citizen petition on April 19, 2010, pursuant to Sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA require all ANDAs and 505(b)(2) NDAs for generic formulations of Coreg CR ( | 505(q) | 2010-04-26 | Partially Denied | — |
Citizen Petition from Keller And Heckman LLP FDA-2007-P-0058 · 11 docket documents Keller and Heckman LLP filed this suitability petition under Section 505(j)(2)(C) requesting FDA approval to file an ANDA for carvedilol phosphate in extended-release tablet form, which would differ from the reference listed drug Coreg CR (carvedilol phosphate extended-release capsules) only in dosa | Other | 2008-07-10 | Withdrawn | Keller And Heckman LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.