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Last Updated: June 29, 2022

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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-two 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. Two suppliers are 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 sixteen 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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Drug patent expirations by year for DESCOVY
Drug Prices for DESCOVY

See drug prices for DESCOVY

DrugPatentWatch® Estimated Generic Entry Opportunity Date for DESCOVY
Generic Entry Date for DESCOVY*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
University of Colorado, DenverPhase 2/Phase 3
Kenya Medical Research InstitutePhase 2/Phase 3
University of WashingtonPhase 2/Phase 3

See all DESCOVY clinical trials

Paragraph IV (Patent) Challenges for DESCOVY
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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 seven US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DESCOVY is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Prodrugs of phosphonate nucleotide analogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prodrugs of phosphonate nucleotide analogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prodrugs of phosphonate nucoleotide analogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 INFECTION

Tenofovir alafenamide hemifumarate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 INFECTION

Tenofovir alafenamide hemifumarate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tenofovir alafenamide hemifumarate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 INFECTION

Tenofovir alafenamide hemifumarate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting DESCOVY

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: See Plans and Pricing

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
Exclusivity Expiration: See Plans and Pricing

FOR USE IN AT RISK ADULTS AND ADOLESCENTS WEIGHING AT LEAST 35 KG FOR PRE-EXPOSURE PROPHYLAXIS TO REDUCE THE RISK OF HIV-1 INFECTION FROM SEXUAL ACQUISITION, EXCLUDING INDIVIDUALS AT RISK FROM RECEPTIVE VAGINAL SEX
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-002 Jan 7, 2022 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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

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
Estimated Expiration: See Plans and Pricing

Argentina

Patent: 7546
Estimated Expiration: See Plans and Pricing

Australia

Patent: 12296622
Estimated Expiration: See Plans and Pricing

Patent: 14271320
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2014003420
Estimated Expiration: See Plans and Pricing

Canada

Patent: 45553
Estimated Expiration: See Plans and Pricing

Chile

Patent: 14000370
Estimated Expiration: See Plans and Pricing

China

Patent: 3732594
Estimated Expiration: See Plans and Pricing

Patent: 0343135
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 80063
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 140072
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0161696
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 18385
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 44810
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 14013206
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 7768
Estimated Expiration: See Plans and Pricing

Patent: 1490208
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 44810
Estimated Expiration: See Plans and Pricing

Patent: 70088
Estimated Expiration: See Plans and Pricing

Patent: 31832
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 99026
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 31253
Estimated Expiration: See Plans and Pricing

India

Patent: 12DEN2014
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0949
Estimated Expiration: See Plans and Pricing

Patent: 0649
Estimated Expiration: See Plans and Pricing

Japan

Patent: 51275
Estimated Expiration: See Plans and Pricing

Patent: 56537
Estimated Expiration: See Plans and Pricing

Patent: 80162
Estimated Expiration: See Plans and Pricing

Patent: 14528924
Estimated Expiration: See Plans and Pricing

Patent: 15038149
Estimated Expiration: See Plans and Pricing

Patent: 16169228
Estimated Expiration: See Plans and Pricing

Patent: 18065870
Estimated Expiration: See Plans and Pricing

Patent: 20040972
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 44810
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 6627
Estimated Expiration: See Plans and Pricing

Patent: 14001549
Estimated Expiration: See Plans and Pricing

Moldova, Republic of

Patent: 08
Estimated Expiration: See Plans and Pricing

Patent: 140011
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 612
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 350
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0421
Estimated Expiration: See Plans and Pricing

Peru

Patent: 141328
Estimated Expiration: See Plans and Pricing

Poland

Patent: 44810
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 44810
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01600476
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 353
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 14011548
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 44810
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1400582
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1612642
Estimated Expiration: See Plans and Pricing

Patent: 140054068
Estimated Expiration: See Plans and Pricing

Spain

Patent: 08871
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 16499
Estimated Expiration: See Plans and Pricing

Patent: 1321396
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 5311
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 262
Estimated Expiration: See Plans and Pricing

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
Uruguay 34262 HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA, SUS COMPOSICIONES, MÉTODO DE PREPARACIÓN, MÉTODOS PARA TRATAR INFECCIONES VIRALES Y SU USO PARA PREPARAR MEDI CAMENTOS See Plans and Pricing
Australia 2012296622 Tenofovir alafenamide hemifumarate See Plans and Pricing
Denmark 0984013 See Plans and Pricing
Norway 20065640 See Plans and Pricing
Cyprus 1118385 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DESCOVY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 300851 Netherlands See Plans and Pricing PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1301519 SPC/GB16/015 United Kingdom See Plans and Pricing PRODUCT NAME: TENOFOVIR ALAFENAMIDE OR A SALT OR SOLVATE THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTERED: UK EU/1/15/1061/001 20151123; UK EU/1/15/1061/002 20151123
1663240 1690062-3 Sweden See Plans and Pricing 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
1301519 122016000024 Germany See Plans and Pricing PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
1663240 2016/058 Ireland See Plans and Pricing PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A THERAPEUTICALLY EQUIVALENT FORM THEREOF PROTECTED BY THE BASIC PATENT, SUCH AS A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE.; NAT REGISTRATION NO/DATE: EU/1/16/1112 20160621; FIRST REGISTRATION NO/DATE: JOURNAL OF THE INTELLECTUAL PROPERTY OFFICE OF IRELAND (NO. 2457)
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Johnson and Johnson
Dow
Mallinckrodt
Boehringer Ingelheim
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.