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VITEKTA

NDA

ELVITEGRAVIR | N203093 | GILEAD SCIENCES INC

2 strengths3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Expiring < 1yr (3)TodayPED (+6 mo)

2027

Today

7176220

Feb. 27, 2027

7635704

Apr. 26, 2027

8981103

Apr. 26, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs

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

GILEAD SCIENCES INCELVITEGRAVIR

DMF 251872011

MATRIX PHARMACORP PRIVATE LTDELVITEGRAVIR

DMF 277272013

MATRIX PHARMACORP PRIVATE LTDELVITEGRAVIR (PROCESS-II)

DMF 295582015

MSN LIFE SCIENCES PRIVATE LTDELVITEGRAVIR (FORM-II)

DMF 307722016

MSN LIFE SCIENCES PRIVATE LTDELVITEGRAVIR (FORM-I)

DMF 310902016

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDELVITEGRAVIR

DMF 324562017

ALEMBIC PHARMACEUTICALS LTDELVITEGRAVIR

DMF 346492020

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 28, 2015	SUPPL -2	View Letter (PDF)
Sep 26, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 85MG

RLD

3 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 24, 2014

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7176220	Aug 27, 2026PED: Feb 27, 2027	PED	Yes	Yes		—
7635704	Oct 26, 2026PED: Apr 26, 2027	PED	Yes	Yes		—
8981103	Oct 26, 2026PED: Apr 26, 2027	PED	Yes	Yes	—	—

#002 — 150MG

RLD

3 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 24, 2014