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Generated: September 19, 2018

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DESCOVY Drug 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.

The generic ingredient in DESCOVY is emtricitabine; tenofovir alafenamide fumarate. There are seventeen 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.

Drug patent expirations by year 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.

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 ➤ 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 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 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 ➤ 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 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 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
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ 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

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Non-Orange Book US Patents for DESCOVY

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,914,400 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Sign Up
7,053,100 Therapeutic nucleosides ➤ Sign Up
6,069,252 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers ➤ Sign Up
6,812,233 Therapeutic nucleosides ➤ Sign Up
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Sign Up
5,700,937 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds ➤ Sign Up
7,160,999 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for DESCOVY

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0073 France ➤ Sign Up 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 DE TENOFOVIR EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
0781 Netherlands ➤ Sign Up PRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE, EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
073 Luxembourg ➤ Sign Up 91073, EXPIRES: 20160131
2016000024 Germany ➤ Sign Up PRODUCT NAME: TENOFOVIRALAFENAMID ODER EIN SALZ ODER SOLVAT DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 20151119
C0013 France ➤ Sign Up PRODUCT NAME: TENOFOVIR ALAFENAMIDE OU UN SEL OU UN SOLVATE DE TENOFOVIR ALAFENAMIDE,EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
0803 Netherlands ➤ Sign Up PRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123
0851 Netherlands ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Cipla
Healthtrust
US Department of Justice
Deloitte
Citi
AstraZeneca
Cerilliant
Argus Health

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