DESCOVY Drug Patent Profile

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

Descovy is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and thirty-one patent family members in forty-nine countries.

The generic ingredient in DESCOVY is emtricitabine; tenofovir alafenamide fumarate. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the emtricitabine; tenofovir alafenamide fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Descovy

Descovy was eligible for patent challenges on November 5, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 15, 2033. This may change due to patent challenges or generic licensing.

There have been seventeen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for DESCOVY

International Patents:	131
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	17
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DESCOVY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DESCOVY
What excipients (inactive ingredients) are in DESCOVY?	DESCOVY excipients list
DailyMed Link:	DESCOVY at DailyMed

See drug prices for DESCOVY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DESCOVY

NDA:

208215

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DESCOVY

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

Sponsor	Phase
Ministry of Health, Thailand	Phase 3
Assistance Publique - Hôpitaux de Paris, FRANCE	Phase 3
Gilead Sciences	Phase 3

See all DESCOVY clinical trials

Pharmacology for DESCOVY

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 DESCOVY

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 DESCOVY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DESCOVY	Tablets	emtricitabine; tenofovir alafenamide fumarate	120 mg/15 mg	208215	1	2022-10-31
DESCOVY	Tablets	emtricitabine; tenofovir alafenamide fumarate	200 mg/25 mg	208215	6	2019-11-05

US Patents and Regulatory Information for DESCOVY

DESCOVY is protected by three US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting DESCOVY

FDA Regulatory Exclusivity protecting DESCOVY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No					Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016		RX	Yes	Yes
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016		RX	Yes	Yes					Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No					Y
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-002	Jan 7, 2022		RX	Yes	No					Y

Expired US Patents for DESCOVY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016
Gilead Sciences Inc	DESCOVY	emtricitabine; tenofovir alafenamide fumarate	TABLET;ORAL	208215-001	Apr 4, 2016

International Patents for DESCOVY

When does loss-of-exclusivity occur for DESCOVY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

India

Israel

Japan

Lithuania

Mexico

Moldova, Republic of

Montenegro

Morocco

New Zealand

Peru

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DESCOVY around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	1367692
Japan	3530150
European Patent Office	0984013	Activité antivirale et résolution de 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane (Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1, 3-oxathiolane)
New Zealand	241625	1,3-OXATHIOLANE DERIVATIVES, ANTI-VIRAL COMPOSITIONS CONTAINING SUCH AND METHOD OF RESOLVING RACEMIC MIXTURE OF ENANTIOMERS
China	100396785

Supplementary Protection Certificates for DESCOVY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0513200	C00513200/01	Switzerland		PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
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
0513200	7/2004	Austria		PRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003
1301519	11/2016	Austria		PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061/001-002 (MITTEILUNG) 20151123
3808743	LUC00275	Luxembourg		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU D'UNE FORME THERAPEUTIQUEMENT EQUIVALENTE DE CELLE-CI PROTEGEE PAR LE BREVET DE BASE, TELLE QU'UN SEL D'ADDITION PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE, ET D'EMTRICITABINE; AUTHORISATION NUMBER AND DATE: EU/1/11/737/001-002 20111128