ROSUVASTATIN CALCIUM | N021366 | ASTRAZENECA UK LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
AstraZeneca Pharmaceuticals LP v. Palmetto Pharmaceuticals LLC 1 patentrosuvastatin calcium | D. Del. | 2011-04-07 | Terminated 2014-05-16 | — |
Palmetto Pharmaceuticals LLC v. AstraZeneca Pharmaceuticals LP 1 patentrosuvastatin calcium | SCD | 2011-04-05 | Terminated 2015-12-10 | — |
AstraZeneca UK Limited et al v. Watson Pharmaceuticals Inc. et al 1 patentrosuvastatin calcium | D. Del. | 2010-10-26 | Terminated 2013-03-26 | — |
AstraZeneca Pharmaceuticals LP et al v. Apotex Inc. et al 1 patentANDA 79-145rosuvastatin calcium | S.D. Fla. | 2010-04-27 | Terminated 2013-05-24 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-5994 Hyman, Phelps & McNamara, P.C., on behalf of an unnamed client, filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Rosuvastatin Calcium Tablets in 7.5 mg, 15 mg, 25 mg, 30 mg, and 35 mg strengths suitable for submission | Suitability | 2026-05-28 | Open | Hyman |
Suitability Petition from Newcastle Bioscience LLC FDA-2024-P-2932 Newcastle Bioscience LLC filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Rosuvastatin Calcium Orally Disintegrating Tablets in strengths of 5 mg, 10 mg, 20 mg, and 40 mg suitable for submission as an ANDA, with th | Suitability | 2024-06-20 | Open | Newcastle Bioscience LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.