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Last Updated: January 23, 2020

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DESCOVY Drug Profile

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Which patents cover Descovy, 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.

This drug has three hundred and six 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.

US ANDA Litigation and 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 thirteen 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

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
CONRADPhase 2
Ludwig-Maximilians - University of MunichPhase 2
Imperial College LondonPhase 2

See all DESCOVY clinical trials

Recent Litigation for DESCOVY

Identify potential future generic entrants

District Court Litigation
Case NameDate
GILEAD SCIENCES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC.2019-01-15
GILEAD SCIENCES, INC. v. STRIDES PHARMA, INC.2018-06-27
Gilead Sciences, Inc. v. Aurobindo Pharma Ltd.2018-05-18

See all DESCOVY litigation

Synonyms for DESCOVY
731772-56-8
Emtricitabine / Tenofovir Alafenamide
Emtricitabine and Tenofovir Alafenamide
Emtricitabine mixture with Tenofovir Alafenamide
Tenofovir Alafenamide / Emtricitabine
Tenofovir Alafenamide and Emtricitabine
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   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016 RX Yes Yes   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Gilead Sciences Inc DESCOVY emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 208215-001 Apr 4, 2016   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for DESCOVY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1301519 C 2016 011 Romania   Start 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 PA2016009,C1301519 Lithuania   Start Trial PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS ARBA JO DRUSKA ARBA SOLVATAS, YPATINGAI TENOFOVIRO ALAFENAMIDO FUMARATAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
0513200 SPC/GB04/016 United Kingdom   Start Trial PRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024
1301519 C01301519/01 Switzerland   Start Trial PRODUCT NAME: TENOFOVIRALAFENAMID; REGISTRATION NO/DATE: SWISSMEDIC AUTHORISATION 65793 01.09.2016
0513200 122004000015 Germany   Start Trial PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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