Viewing data from:

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

270 trials from ClinicalTrials.gov — 1 recruiting, 2 active, 214 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
Immediate Initiation of Antiretroviral Therapy During "Hyperacute" HIV Infection NCT02656511	Phase 4	Active	University of California, San Francisco	74	2015-12 → 2028-05
ANCHORS Alcohol & Sexual Health Study: UH3 Project NCT04331704	Phase 4	Recruiting	University of Florida	88	2021-01-12 → 2026-06-30
An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis NCT01772823	Phase 2	Completed	University of North Carolina, Chapel Hill	200	2012-11 → 2015-11
Finding the Right Tenofovir/Emtricitabine Regimen for Pre-Exposure Prophylaxis (PrEP) in Transgender Women NCT03060785	Phase 1	Completed	Johns Hopkins University	16	2016-03-08 → 2018-05-31
Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression NCT03251690	N/A	Completed	Mahidol University	246	2016-10-27 → 2018-04-30
A Pharmacokinetic Evaluation of Tenofovir/Emtricitabine as HIV Pre-Exposure Prophylaxis in Transgender Women NCT03270969	Phase 1	Completed	University of Nebraska	15	2018-01-05 → 2018-09-10
Clinical Trial to Evaluate the Efficacy, Pharmacokinetics (PK) Interactions and Safety of Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in HIV-1-Infected Solid Organ Transplant Patients NCT03360682	Phase 4	Completed	Fundacion Clinic per a la Recerca Biomédica	19	2018-04-13 → 2020-05-21
GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection NCT00105079	Phase 3	Completed	Hoffmann-La Roche	337	2005-04 → 2008-07
Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects NCT00960622	Phase 4	Completed	St. Luke's-Roosevelt Hospital Center	17	2006-08 → 2009-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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

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

API Supply Chain15 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

APITORIA PHARMA PRIVATE LTDEMTRICITABINE USP (PROCESS-IV)

DMF 436642026

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.