Viewing data from:

EMTRIVA

NDA

EMTRICITABINE | N021500 | 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
GILEAD SCIENCES, INC. et al v. AUROBINDO PHARMA LTD. et al 1:2016cv03722 2 patentsANDA 79-188emtricitabine	D.N.J.	2016-06-23	Terminated 2016-09-16	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

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

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Participants (MK-4646)NCT07532304	Phase 1	Active	Merck Sharp & Dohme LLC	16	2026-05-11 → 2026-07-21
Safety and Efficacy of B/F/TAF in Pregnancy NCT07666386	—	By Invitation	Shi Zou	50	2026-02-09 → 2027-06-30
Immediate ART in Subjects With Opportunistic Diseases NCT03825523	N/A	Completed	Gustavo Reyes-Teran	114	2018-01-29 → 2025-08-05
Simplified Model of Linkage and Retention to Care, Using a Mobile Unit and a Same-day Test and Treat Approach Among Excluded Population. (SIMPLIFIED)NCT05405751	Phase 4	Completed	Fundacion SEIMC-GESIDA	101	2022-07-04 → 2024-06-12

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

Medicare Part D Spending

CMS annual spending data for Emtriva (2023)

Total Spending

$312K

Total Claims

608

Beneficiaries

123

Avg Cost/Unit

$14.92

Spending Trend

$7.2M(2019)→$5.4M(2020)→$1.7M(2021)→$543K(2022)→$312K(2023)

YoY Change:-5.6%

5yr CAGR:-4.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

10 letters from Drugs@FDA

Date	Submission	Document
Dec 20, 2018	SUPPL -29	View Letter (PDF)
Apr 3, 2013	SUPPL -21	View Letter (PDF)
Jul 25, 2012	SUPPL -19	View Letter (PDF)
Nov 22, 2011	SUPPL -18	View Letter (PDF)
May 21, 2008	SUPPL -11	View Letter (PDF)
Apr 9, 2008	SUPPL -10	View Letter (PDF)
Jan 8, 2007	SUPPL -7	View Letter (PDF)
Dec 13, 2005	SUPPL -3	View Letter (PDF)
Jun 14, 2005	SUPPL -2	View Letter (PDF)
Jul 8, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jul 2, 2003

No patent or exclusivity listings for this strength.