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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Viread
A generic version of VIREAD was approved as tenofovir disoproxil fumarate by TEVA PHARMS USA on March 18th, 2015.
Summary for VIREAD
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 77 |
Clinical Trials: | 90 |
Patent Applications: | 4,856 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for VIREAD |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VIREAD |
What excipients (inactive ingredients) are in VIREAD? | VIREAD excipients list |
DailyMed Link: | VIREAD at DailyMed |


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
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 |