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DESCOVY Drug Patent Profile

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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-two patent family members in fifty 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.

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

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Summary for DESCOVY

International Patents:	132
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	17
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

Drug patent expirations by year for DESCOVY

Recent Clinical Trials for DESCOVY

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

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

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 three FDA Regulatory Exclusivities.

Patents protecting DESCOVY

Prodrugs of phosphonate nucleotide analogues
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Tenofovir alafenamide hemifumarate
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting DESCOVY

TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 14 KG TO LESS THAN 25 KG
Exclusivity Expiration: ⤷ Sign Up

IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS OTHER THAN PROTEASE INHIBITORS THAT REQUIRE A CYP3A INHIBITOR, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 25KG AND LESS THAN 35KG
Exclusivity Expiration: ⤷ Sign Up

IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 35KG
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Glossary

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

Expired US Patents for DESCOVY

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

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)

Patent: 39
Patent: TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Estimated Expiration: ⤷ Sign Up

Argentina

Patent: 7546
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 12296622
Patent: Tenofovir alafenamide hemifumarate
Estimated Expiration: ⤷ Sign Up

Patent: 14271320
Patent: TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2014003420
Patent: hemifumarato de tenofovir alafenamida
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 45553
Patent: HEMIFUMARATE DE TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 14000370
Patent: Hemifumarato de tenofovir alafenamida; metodo de preparación; composicion farmaceutica que lo comprende; metodo para preparar la composicion farmaceutica; y uso en el tratamiento de una infeccion por hiv.
Estimated Expiration: ⤷ Sign Up

China

Patent: 3732594
Patent: Tenofovir alafenamide hemifumarate
Estimated Expiration: ⤷ Sign Up

Patent: 0343135
Patent: 替诺福韦艾拉酚胺(TENOFOVIR ALAFENAMIDE)半反丁烯二酸盐 (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Sign Up

Colombia

Patent: 80063
Patent: Hemifumarato de tenofovir alafenamida
Estimated Expiration: ⤷ Sign Up

Costa Rica

Patent: 140072
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA
Estimated Expiration: ⤷ Sign Up

Croatia

Patent: 0161696
Estimated Expiration: ⤷ Sign Up

Cyprus

Patent: 18385
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 44810
Estimated Expiration: ⤷ Sign Up

Ecuador

Patent: 14013206
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 7768
Patent: ТЕНОФОВИР АЛАФЕНАМИДА ГЕМИФУМАРАТ (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Sign Up

Patent: 1490208
Patent: ТЕНОФОВИР АЛАФЕНАМИДА ГЕМИФУМАРАТ
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 44810
Patent: HÉMIFUMARATE DE TÉNOFOVIR ALAFÉNAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Sign Up

Patent: 70088
Patent: TÉNOFOVIR ALAFENAMIDE HÉMIFUMARATE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Sign Up

Patent: 31832
Patent: TÉNOFOVIR ALAFENAMIDE HÉMIFUMARATE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Sign Up

Finland

Patent: 44810
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 99026
Patent: 替諾福韋艾拉酚胺半反丁烯二酸鹽 (TENOFOVIR ALAFENAMIDE HEMIFUMARATE (TENOFOVIRALAFENAMIDE))
Estimated Expiration: ⤷ Sign Up

Hungary

Patent: 31253
Estimated Expiration: ⤷ Sign Up

India

Patent: 12DEN2014
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 0949
Patent: טנופוביר אלאפנאמיד המיפומאראט (Tenofovir alafenamide hemifumarate)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 51275
Estimated Expiration: ⤷ Sign Up

Patent: 56537
Estimated Expiration: ⤷ Sign Up

Patent: 80162
Estimated Expiration: ⤷ Sign Up

Patent: 14528924
Patent: テノホビルアラフェナミドヘミフマレート
Estimated Expiration: ⤷ Sign Up

Patent: 15038149
Patent: テノホビルアラフェナミドヘミフマレート (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Sign Up

Patent: 16169228
Patent: テノホビルアラフェナミドヘミフマレート (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Sign Up

Patent: 18065870
Patent: テノホビルアラフェナミドヘミフマレート (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Sign Up

Patent: 20040972
Patent: テノホビルアラフェナミドヘミフマレート (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Sign Up

Lithuania

Patent: 44810
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 6627
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA. (TENOFOVIR ALAFENAMIDE HEMIFUMARATE.)
Estimated Expiration: ⤷ Sign Up

Patent: 14001549
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA. (TENOFOVIR ALAFENAMIDE HEMIFUMARATE.)
Estimated Expiration: ⤷ Sign Up

Moldova, Republic of

Patent: 08
Patent: Hemifumarat de tenofovir alafenamidă şi utilizările sale medicale (Tenofovir alafenamide hemifumarate and its medical uses)
Estimated Expiration: ⤷ Sign Up

Patent: 140011
Patent: Tenofovir alafenamid hemifumarat (Tenofovir alafenamide hemifumarate)
Estimated Expiration: ⤷ Sign Up

Montenegro

Patent: 612
Patent: TENOFOVIR ALAFENAMID HEMIFUMARAT (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Sign Up

Morocco

Patent: 350
Patent: Hemifumarate de tenofovir alafenamide
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 0421
Patent: Tenofovir alafenamide hemifumarate
Estimated Expiration: ⤷ Sign Up

Peru

Patent: 141328
Patent: TENOFOVIR ALAFENAMIDA HEMIFUMARATO
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 44810
Estimated Expiration: ⤷ Sign Up

Portugal

Patent: 44810
Estimated Expiration: ⤷ Sign Up

San Marino

Patent: 01600476
Patent: TENOFOVIR ALAFENAMMIDE EMIFUMARATO
Estimated Expiration: ⤷ Sign Up

Serbia

Patent: 353
Patent: TENOFOVIR ALAFENAMID HEMIFUMARAT (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 14011548
Patent: TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Estimated Expiration: ⤷ Sign Up

Slovenia

Patent: 44810
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 1400582
Patent: TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 1612642
Estimated Expiration: ⤷ Sign Up

Patent: 140054068
Patent: TENOFOVIR ALAFENAMIDE HEMIFUMARATE
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 08871
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 16499
Estimated Expiration: ⤷ Sign Up

Patent: 1321396
Patent: Tenofovir alafenamide hemifumarate
Estimated Expiration: ⤷ Sign Up

Ukraine

Patent: 5311
Patent: ГЕМІФУМАРАТ ТЕНОФОВІРУ АЛАФЕНАМІДУ (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)
Estimated Expiration: ⤷ Sign Up

Uruguay

Patent: 262
Patent: HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA, SUS COMPOSICIONES, MÉTODO DE PREPARACIÓN, MÉTODOS PARA TRATAR INFECCIONES VIRALES Y SU USO PARA PREPARAR MEDI CAMENTOS
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Argentina	087546	HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA	⤷ Sign Up
Spain	2345102		⤷ Sign Up
Ukraine	115311	ГЕМІФУМАРАТ ТЕНОФОВІРУ АЛАФЕНАМІДУ (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)	⤷ Sign Up
Chile	2014000370	Hemifumarato de tenofovir alafenamida; metodo de preparación; composicion farmaceutica que lo comprende; metodo para preparar la composicion farmaceutica; y uso en el tratamiento de una infeccion por hiv.	⤷ Sign Up
Canada	2845553	HEMIFUMARATE DE TENOFOVIR ALAFENAMIDE (TENOFOVIR ALAFENAMIDE HEMIFUMARATE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DESCOVY

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1301519	132016000035069	Italy	⤷ Sign Up	PRODUCT NAME: TENOFOVIR ALAFENAMIDE O UN SUO SALE O UN SOLVATO DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123
1301519	PA2016009	Lithuania	⤷ Sign Up	PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
1663240	2015/053	Ireland	⤷ Sign Up	PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
3808743	2290034-4	Sweden	⤷ Sign Up	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
0513200	7/2004	Austria	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

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Questions you can ask:

Summary for DESCOVY

Recent Clinical Trials for DESCOVY

Pharmacology for DESCOVY

Paragraph IV (Patent) Challenges for DESCOVY

Patents protecting DESCOVY

FDA Regulatory Exclusivity protecting DESCOVY

When does loss-of-exclusivity occur for DESCOVY?

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