TRUVADA Drug Patent Profile

Which patents cover Truvada, and when can generic versions of Truvada launch?

Truvada is a drug marketed by Gilead and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-two patent family members in twenty-nine countries.

The generic ingredient in TRUVADA is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Truvada

A generic version of TRUVADA was approved as emtricitabine; tenofovir disoproxil fumarate by TEVA PHARMS USA on June 8^th, 2017.

Summary for TRUVADA

International Patents:	62
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	227
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TRUVADA
Drug Sales Revenues:	Drug sales revenues for TRUVADA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRUVADA
What excipients (inactive ingredients) are in TRUVADA?	TRUVADA excipients list
DailyMed Link:	TRUVADA at DailyMed

See drug prices for TRUVADA

See drug sales revenues for TRUVADA

Recent Clinical Trials for TRUVADA

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

Sponsor	Phase
Ministry of Health, Thailand	Phase 3
Chiang Mai University, Thailand	Phase 3
Assistance Publique - Hôpitaux de Paris, FRANCE	Phase 3

See all TRUVADA clinical trials

Pharmacology for TRUVADA

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

Anatomical Therapeutic Chemical (ATC) Classes for TRUVADA

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

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 TRUVADA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRUVADA	Tablets	emtricitabine; tenofovir disoproxil fumarate	100 mg/150 mg 133 mg/200 mg 167 mg/250 mg	021752	1	2017-05-19
TRUVADA	Tablets	emtricitabine; tenofovir disoproxil fumarate	200 mg/300 mg	021752	1	2008-09-26

US Patents and Regulatory Information for TRUVADA

TRUVADA is protected by six US patents.

Patents protecting TRUVADA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-002	Mar 10, 2016	AB	RX	Yes	No
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	AB	RX	Yes	Yes			Y
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-003	Mar 10, 2016	AB	RX	Yes	No
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016	AB	RX	Yes	No
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	AB	RX	Yes	Yes			Y
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	AB	RX	Yes	Yes			Y
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-001	Aug 2, 2004	AB	RX	Yes	Yes			Y

Expired US Patents for TRUVADA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-002	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-004	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-003	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-002	Mar 10, 2016
Gilead	TRUVADA	emtricitabine; tenofovir disoproxil fumarate	TABLET;ORAL	021752-002	Mar 10, 2016

International Patents for TRUVADA

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0998480	COMPOSITION D'ANALOGUES DE NUCLEOTIDES ET PROCEDE DE SYNTHESE (NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD)
Norway	324979
Canada	2512475	COMPOSITIONS ET METHODES DESTINEES A UNE THERAPIE DE COMBINAISON ANTIVIRALE (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY)
Japan	H06505725
European Patent Office	1585527	COMPOSITIONS ET METHODES DE POLYTHERAPIE ANTIVIRALE (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY)
Germany	122008000033
Japan	H06508605

Supplementary Protection Certificates for TRUVADA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3808743	301190	Netherlands		PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE OF EEN DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ADDITIEZOUT VAN RILPIVIRINE, MET INBEGRIP VAN HET HYDROCHLORIDE-ZOUT VAN RILPIVIRINE, EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1632232	300852	Netherlands		PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
0915894	CA 2005 00032	Denmark
0513200	SPC/GB04/016	United Kingdom		PRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024
1663240	1690062-3	Sweden		PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623
0513200	91073	Luxembourg		91073, EXPIRES: 20160131
3808743	2290034-4	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVRINE OR A THERAPEUTICALLY EQIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIC ACID SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737/001-002 20111128