DAPTOMYCIN | N021572 | CUBIST PHARMACEUTICALS LLC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2020-00193 | 9138456 | IPR | Amneal Pharmaceuticals LLC et al. | Institution Denied | 2019-11-27 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2020-03-23 | Terminated 2020-09-10 | — | |
| D.N.J. | 2019-05-24 | Terminated 2020-10-21 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Lachman Consultant Services Inc FDA-2023-P-0038 · 5 docket documents Lachman Consultant Services, Inc. filed this petition requesting that the FDA determine whether CUBICIN RF (daptomycin) Powder for Injection, 500 mg/vial, approved under NDA 021572 and held by Cubist Pharmaceuticals LLC, was voluntarily withdrawn from sale for reasons of safety or efficacy. The peti | 505(q) | 2023-01-04 | Granted | Lachman Consultant Services Inc |
Citizen Petition from Hyman, Phelps & McNamara, P.C. (on behalf of Xellia Pha... FDA-2017-P-6777 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this petition on behalf of Xellia Pharmaceutical ApS and Xellia Pharmaceuticals USA, LLC requesting that the FDA assign a therapeutic equivalence evaluation code of BX to Xellia's Daptomycin for Injection, 350 mg/vial, approved under NDA 209949 on October 20, 201 | Other | 2017-12-14 | Withdrawn | Xellia Pharmaceutical |
Citizen Petition from Florek & Endres PLLC FDA-2016-P-1319 · 6 docket documents Florek & Endres PLLC filed this suitability petition on behalf of an unnamed client under Section 505(j)(2)(C) requesting that the FDA declare a new strength of Daptomycin powder for intravenous injection of 350 mg/vial suitable for submission of an Abbreviated New Drug Application, with the referen | Other | 2016-05-25 | Denied | Florek & Endres PLLC |
Cubist Pharmaceuticals, Inc. - Citizen Petition FDA-2010-P-0624 · 8 docket documents Cubist Pharmaceuticals, Inc. filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act on December 3, 2010, requesting that the FDA refrain from approving any abbreviated new drug application for daptomycin (Cubicin, NDA 21-752) as a generic until applicants demons | 505(q) Stay Request | 2010-12-20 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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