EMTRIVA Drug Patent Profile

When do Emtriva patents expire, and what generic alternatives are available?

Emtriva is a drug marketed by Gilead and is included in two NDAs.

The generic ingredient in EMTRIVA is emtricitabine. There are eighteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the emtricitabine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Emtriva

A generic version of EMTRIVA was approved as emtricitabine by CIPLA on July 2^nd, 2018.

Summary for EMTRIVA

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	13
Patent Applications:	5,194
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for EMTRIVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EMTRIVA
What excipients (inactive ingredients) are in EMTRIVA?	EMTRIVA excipients list
DailyMed Link:	EMTRIVA at DailyMed

See drug prices for EMTRIVA

Recent Clinical Trials for EMTRIVA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Brown University	Phase 1
Butler Hospital	Phase 1
Alzheimer's Association	Phase 1

See all EMTRIVA clinical trials

Pharmacology for EMTRIVA

Drug Class	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for EMTRIVA

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for EMTRIVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EMTRIVA	Capsules	emtricitabine	200 mg	021500	1	2012-07-16

US Patents and Regulatory Information for EMTRIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003	AB	RX	Yes	Yes
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005		RX	Yes	Yes

Expired US Patents for EMTRIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005
Gilead	EMTRIVA	emtricitabine	SOLUTION;ORAL	021896-001	Sep 28, 2005
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003
Gilead	EMTRIVA	emtricitabine	CAPSULE;ORAL	021500-001	Jul 2, 2003

EU/EMA Drug Approvals for EMTRIVA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Emtriva	emtricitabine	EMEA/H/C/000533 Emtriva is indicated for the treatment of HIV-1 infected adults and children in combination with other antiretroviral agents.This indication is based on studies in treatment-naive patients and treatment-experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens.When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.	Authorised	no	no	no	2003-10-24

International Patents for EMTRIVA

See the table below for patents covering EMTRIVA around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9215308
Australia	2010201878
Canada	2105486	NUCLEOSIDES THERAPEUTIQUES (THERAPEUTIC NUCLEOSIDES)
South Korea	100270806

Supplementary Protection Certificates for EMTRIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	92855	Luxembourg		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE , TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL, ET L'EMTRICITABINE.
3150586	132020000000055	Italy		PRODUCT NAME: COBICISTAT O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, DARUNAVIR O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO, E EMTRICITABINE O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO(SYMTUZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1225, 20170925
1632232	SPC/GB17/008	United Kingdom		PRODUCT NAME: A COMBINATION OF RILPIVIRINE HYDROCHLORIDE, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE.; REGISTERED: UK EU/1/16/1112 (NI) 20160623; UK PLGB 11972/0019 20160623
1632232	93384	Luxembourg		PRODUCT NAME: COMBINAISON DE CHLORHYDRATE DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE