Viewing data from:

COBICISTAT

ANDA

COBICISTAT | A209986 | MYLAN LABORATORIES LTD

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Gilead Sciences, Inc. (Hogan Lovells US LLP) - Citizen Petition FDA-2013-P-0058 · 8 docket documents Gilead Sciences, Inc., through counsel, filed this citizen petition on January 8, 2013, requesting that the FDA Commissioner recognize 5-year exclusivity under sections 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii) of the Food, Drug, and Cosmetic Act for the new active moieties elvitegravir and cobicistat c	Other	2013-01-23	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain5 active DMFs

5 active API suppliers hold Drug Master Files for this ingredient.

GILEAD SCIENCES INCCOBICISTAT ON SILICON DIOXIDE

DMF 251882011

TIANISH LABORATORIES PRIVATE LTDCOBICISTAT ON SILICON DIOXIDE

DMF 284382014

MATRIX PHARMACORP PRIVATE LTDCOBICISTAT ON SILICON DIOXIDE (PROCESS-II)

DMF 296152015

HONOUR LAB LTDCOBICISTAT ON COLLOIDAL SILICON DIOXIDE

DMF 302872016

MSN LIFE SCIENCES PRIVATE LTDCOBICISTAT ON SILICON DIOXIDE

DMF 306502016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 7, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 150MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 7, 2024

No patent or exclusivity listings for this strength.