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EMTRIVA

NDA

EMTRICITABINE | N021896 | GILEAD SCIENCES INC

1 strength0 unique patents0 unique exclusivities

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

290 trials from ClinicalTrials.gov — 11 recruiting, 8 active, 219 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy NCT05979311	Phase 3	Active	ViiV Healthcare	307	2024-02-21 → 2027-02-23
PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study)NCT03255915	Early Phase 1	Active	Oak Crest Institute of Science	15	2018-09-20 → 2026-12-31
Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection NCT02656511	Phase 4	Active	University of California, San Francisco	74	2015-12 → 2028-05
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) in Prevention of HIV in Cisgender Women in the United States (HPTN 102)NCT06101329	Phase 2	Active	Gilead Sciences	253	2023-11-17 → 2028-01
Study of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103)NCT06101342	Phase 2	Active	Gilead Sciences	181	2023-12-13 → 2028-01
Safety Of Nrtis for Alzheimer's Therapeutic Advancement in Singapore Study NCT07210528	Phase 1	Active	National University Hospital, Singapore	48	2025-06-30 → 2026-09
Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women NCT03164564	Phase 3	Active	National Institute of Allergy and Infectious Diseases (NIAID)	3,224	2017-11-07 → 2026-10-17
Accelerated ART Initiation for PWHIV Who Are Out of Care NCT06374758	Phase 4	Active	University of Missouri-Columbia	120	2024-04-29 → 2027-08-09
Repurposing a Combination Antiretroviral Drug Therapy to Target Retrotransposons and Treat Early Alzheimer's Disease NCT07795307	Phase 1	Not Yet Recruiting	Brigham and Women's Hospital	20	2026-12 → 2028-09
An Adaptive Platform Trial for Evaluation of Novel Treatment Regimens in Children and Adolescents With HIV in Africa NCT07792096	Phase 3	Not Yet Recruiting	University College, London	800	2026-11 → 2029-12

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$94.64

Highest Price

$98.58

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61958-0602-01EMTRIVA 10MG/ML ORAL SOLN	$94.64	Big4	Gilead Sciences, Inc.	09/29/2026
61958-0602-01EMTRIVA 10MG/ML ORAL SOLN	$98.58	FSS	Gilead Sciences, Inc.	09/29/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain14 active DMFs6 inactive

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

MATRIX PHARMACORP PRIVATE LTDEMTRICITABINE USP

DMF 195662006

CIPLA LTDEMTRICITABINE

DMF 197852006

APITORIA PHARMA PRIVATE LTDEMTRICITABINE (NON-STERILE) DRUG SUBSTANCE

DMF 207082007

HETERO LABS LTDEMTRICITABINE

DMF 216122008

LUPIN LTDEMTRICITABINE

DMF 229442009

LAURUS LABS LTDEMTRICITABINE

DMF 237732010

MACLEODS PHARMACEUTICALS LTDEMTRICITABINE

DMF 250012011

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDEMTRICITABINE

DMF 256172011

MATRIX PHARMACORP PRIVATE LTDEMTRICITABINE (PROCESS-II)

DMF 274552013

MATRIX PHARMACORP PRIVATE LTDEMTRICITABINE (PROCESS-III)

DMF 314572017

VIVIN DRUGS AND PHARMACEUTICALS LTDEMTRICITABINE

DMF 320962017

HETERO LABS LTDEMTRICITABINE (PROCESS-II)

DMF 330682018

ARENE LIFE SCIENCES PRIVATE LTDEMTRICITABINE

DMF 341052019

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO LTDEMTRICITABINE

DMF 425572025

RANBAXY LABORATORIES LTDInactiveEMTRICITABINE DRUG SUBSTANCE

DMF 217062008

EMCURE PHARMACEUTICALS LTDInactiveEMTRICITABINE

DMF 231842009

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO LTDInactiveEMTRICITABINE

DMF 249752011

ADARE PHARMACEUTICALS INCInactiveEMTRICITABINE RAPIDLY DISINTEGRATING TABLETS, 40 MG

DMF 261612012

ADARE PHARMACEUTICALS INCInactiveEMTRICITABINE AND TENOFOVIR RAPIDLY DISINTEGRATING TABLETS, 40 MG/40 MG

DMF 261622012

HONOUR LAB LTDInactiveEMTRICITABINE

DMF 285052014

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Dec 20, 2018	SUPPL -26	View Letter (PDF)
Apr 3, 2013	SUPPL -18	View Letter (PDF)
Jul 25, 2012	SUPPL -16	View Letter (PDF)
Nov 22, 2011	SUPPL -15	View Letter (PDF)
May 21, 2008	SUPPL -5	View Letter (PDF)
Apr 9, 2008	SUPPL -4	View Letter (PDF)
Jan 8, 2007	SUPPL -1	View Letter (PDF)
Oct 20, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML

RLD

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Sep 28, 2005

No patent or exclusivity listings for this strength.