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Last Updated: October 18, 2021

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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 six patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and eight patent family members in fifty-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 August 15, 2032. This may change due to patent challenges or generic licensing.

There have been fourteen 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

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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
Merck Sharp & Dohme Corp.Phase 3
Gilead SciencesPhase 2/Phase 3
HIV Prevention Trials NetworkPhase 2/Phase 3

See all descovy clinical trials

Paragraph IV (Patent) Challenges for DESCOVY
Tradename Dosage Ingredient NDA Submissiondate
DESCOVY TABLET;ORAL emtricitabine; tenofovir alafenamide fumarate 208215 2019-11-05

US Patents and Regulatory Information for 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 208215-001 Apr 4, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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

Supplementary Protection Certificates for descovy

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 15C0071 France ⤷  Free Forever 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
0915894 05C0032 France ⤷  Free Forever Trial PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
1301519 C 2016 011 Romania ⤷  Free Forever Trial PRODUCT NAME: TENOFOVIR ALAFENAMIDA SAU O SARE SAU SOLVAT AL ACESTUIA, IN SPECIAL FUMARAT DE TENOFOVIR ALAFENAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1061/001-002; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1061/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20151119
1301519 CA 2016 00012 Denmark ⤷  Free Forever Trial PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
1663240 300768 Netherlands ⤷  Free Forever Trial PRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN DIE BESCHERMD WORDT DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE. TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT. EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240 300851 Netherlands ⤷  Free Forever Trial 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
1663240 2015/052 Ireland ⤷  Free Forever Trial PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND 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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Serving leading biopharmaceutical companies globally:

Merck
Harvard Business School
McKinsey
Colorcon
Boehringer Ingelheim
Baxter

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.