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Last Updated: March 19, 2024

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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.

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

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Drug patent expirations by year for DESCOVY
Drug Prices for DESCOVY

See drug prices for DESCOVY

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Gilead SciencesPhase 3
ANRS, Emerging Infectious DiseasesPhase 3
Chiang Mai University, ThailandPhase 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 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DESCOVY is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tenofovir alafenamide hemifumarate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Tenofovir alafenamide hemifumarate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial

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: ⤷  Try a Trial

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: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-002 Jan 7, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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 ⤷  Try a Trial ⤷  Try a Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 ⤷  Try a Trial ⤷  Try a Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 ⤷  Try a Trial ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Argentina

Patent: 7546
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 12296622
Estimated Expiration: ⤷  Try a Trial

Patent: 14271320
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2014003420
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 45553
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 14000370
Estimated Expiration: ⤷  Try a Trial

China

Patent: 3732594
Estimated Expiration: ⤷  Try a Trial

Patent: 0343135
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 80063
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 140072
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0161696
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 18385
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 44810
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 14013206
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 7768
Estimated Expiration: ⤷  Try a Trial

Patent: 1490208
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 44810
Estimated Expiration: ⤷  Try a Trial

Patent: 70088
Estimated Expiration: ⤷  Try a Trial

Patent: 31832
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 44810
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 99026
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 31253
Estimated Expiration: ⤷  Try a Trial

India

Patent: 12DEN2014
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 0949
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 51275
Estimated Expiration: ⤷  Try a Trial

Patent: 56537
Estimated Expiration: ⤷  Try a Trial

Patent: 80162
Estimated Expiration: ⤷  Try a Trial

Patent: 14528924
Estimated Expiration: ⤷  Try a Trial

Patent: 15038149
Estimated Expiration: ⤷  Try a Trial

Patent: 16169228
Estimated Expiration: ⤷  Try a Trial

Patent: 18065870
Estimated Expiration: ⤷  Try a Trial

Patent: 20040972
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 44810
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 6627
Estimated Expiration: ⤷  Try a Trial

Patent: 14001549
Estimated Expiration: ⤷  Try a Trial

Moldova, Republic of

Patent: 08
Estimated Expiration: ⤷  Try a Trial

Patent: 140011
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 612
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 350
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0421
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 141328
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 44810
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 44810
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 01600476
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 353
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 14011548
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 44810
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1400582
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1612642
Estimated Expiration: ⤷  Try a Trial

Patent: 140054068
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 08871
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 16499
Estimated Expiration: ⤷  Try a Trial

Patent: 1321396
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 5311
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 262
Estimated Expiration: ⤷  Try a Trial

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
Romania 122814 PROCEDEU DE SEPARARE A UNUI AMESTEC DE DERIVAŢI DE 1,3-OXATIOLAN (PROCESS FOR SEPARATING A MIXTURE OF 1,3-OXATHIOLANE DERIVATIVES) ⤷  Try a Trial
Finland 933684 ⤷  Try a Trial
Slovenia 1301519 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DESCOVY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3808743 2290034-4 Sweden ⤷  Try a Trial 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
1663240 1690062-3 Sweden ⤷  Try a Trial 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
1663240 15C0071 France ⤷  Try a Trial PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.