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 | D.S.C. | 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 · 6 docket documents Hyman, Phelps & McNamara, P.C. filed a suitability petition with the FDA regarding the acceptability of a manufacturing process, facility, or other aspect of drug development or production. The petition requests that the FDA determine whether a particular approach meets regulatory standards for appr | Suitability | 2026-05-28 | Open | Hyman, Phelps & McNamara, P.C. |
Suitability Petition from Newcastle Bioscience LLC FDA-2024-P-2932 · 7 docket documents 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 | DeniedDecision letter not yet read | Newcastle Bioscience LLC |
Citizen Petiton from AstraZeneca Pharmaceuticals LP FDA-2016-P-1485 · 6 docket documents AstraZeneca Pharmaceuticals LP filed this citizen petition pursuant to 21 U.S.C. section 355(q) requesting that the FDA Commissioner not approve any ANDA or section 505(b)(2) NDA referencing Crestor (rosuvastatin calcium) until expiration of orphan drug exclusivity for the pediatric treatment of hom | 505(q) Stay Request | 2016-06-06 | DeniedUnverified summary | — |
AstraZeneca Pharmaceuticals LP (Covington & Burling LLP) - Citizen Petition FDA-2011-P-0823 · 3 docket documents AstraZeneca Pharmaceuticals LP filed this citizen petition on November 14, 2011, requesting that the FDA not approve any rosuvastatin calcium abbreviated new drug applications (ANDAs) for which Crestor is the reference listed drug if the proposed labeling omits diabetes-related warning and adverse r | 505(q) | 2012-01-24 | DeniedUnverified summary | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$8.81
per ea
Lowest NADAC/Unit
$8.81
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00310757090CRESTOR 10 MG TABLET | $8.81 | EA | Brand | $0.0370 | 2026-08-19 |
| 00310756090CRESTOR 5 MG TABLET | $8.81 | EA | Brand | $0.0333 | 2026-08-19 |
| 00310758090CRESTOR 20 MG TABLET | $8.81 | EA | Brand | $0.0449 | 2026-08-19 |
| 00310759030CRESTOR 40 MG TABLET | $8.81 | EA | Brand | $0.0686 | 2026-08-19 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.