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Last Updated: June 28, 2022

VIREAD Drug Patent Profile


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When do Viread patents expire, and when can generic versions of Viread launch?

Viread is a drug marketed by Gilead Sciences Inc and is included in two NDAs.

The generic ingredient in VIREAD is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.

Paragraph IV (Patent) Challenges for VIREAD
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VIREAD Tablets tenofovir disoproxil fumarate 150 mg, 200 mg, and 250 mg 021356 1 2012-05-17
VIREAD Tablets tenofovir disoproxil fumarate 300 mg 021356 1 2010-01-26

US Patents and Regulatory Information for VIREAD

VIREAD is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting VIREAD

PEDIATRIC EXCLUSIVITY
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 VIREAD tenofovir disoproxil fumarate POWDER;ORAL 022577-001 Jan 18, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-004 Jan 18, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-002 Jan 18, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-003 Jan 18, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-001 Oct 26, 2001 AB RX Yes Yes See Plans and Pricing See Plans and Pricing 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 VIREAD

International Patents for VIREAD

See the table below for patents covering VIREAD around the world.

Country Patent Number Title Estimated Expiration
Japan 2010280694 NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD See Plans and Pricing
Taiwan 470748 See Plans and Pricing
Japan 2014159450 NUCLEOTIDE ANALOGS See Plans and Pricing
Singapore 106656 NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD See Plans and Pricing
Slovenia 1243593 See Plans and Pricing
Hong Kong 1029793 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VIREAD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1419152 C 2012 016 Romania See Plans and Pricing PRODUCT NAME: COMBINATIE DE RILPIVIRINA SI TOATE FORMELE ECHIVALENTETERAPEUTIC ALE ACESTEIA CUM AR FI SARURILE DE ADITIE ALE RILPIVIRINEI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREARILPIVIRINEI CU ACIDUL CLORHIDRIC, SI TENOFOVIR, IN PARTICULAR FUMARAT DE TENOFOVIRDISOPROXIL; NATIONAL AUTHORISATION NUMBER: EU/1/11/737/001, EU/1/11/737/002; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/737/001, EU/1/11/737/002; DATE OF FIRST AUTHORISATION IN EEA: 20111128
1663240 300768 Netherlands See Plans and Pricing 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 PA2015037 Lithuania See Plans and Pricing PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001 2011 11 28, EU/1/11/737/002 20111128
1632232 132016000129226 Italy See Plans and Pricing PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA CLORIDRATO O UNA SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, EMTRICITABINA E TENOFOVIR ALAFENAMIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL TENOFOVIR ALAFENAMIDE EMIFUMARATO(ODEFSEY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1112, 20160623
1663240 300850 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; EN -TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
2487166 132017000002828 Italy See Plans and Pricing PRODUCT NAME: COBICISTAT O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO E TENOFOVIR ALAFENAMIDE O UN SALE FARMACEUTICAMENTE ACCETTABILE DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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