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Serving leading biopharmaceutical companies globally:

Merck
Fish and Richardson
Harvard Business School
Deloitte
Chubb
Mallinckrodt
Citi
Cipla
Argus Health
UBS

Generated: February 19, 2018

DrugPatentWatch Database Preview

VIREAD Drug Profile

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Which patents cover Viread, and what generic alternatives are available?

Viread is a drug marketed by Gilead Sciences Inc and is included in two NDAs. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-seven patent family members in twenty-two countries.

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

US Patents and Regulatory Information for VIREAD

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-001 Oct 26, 2001 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-002 Jan 18, 2012 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate POWDER;ORAL 022577-001 Jan 18, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-003 Jan 18, 2012 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-001 Oct 26, 2001 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-002 Jan 18, 2012 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-001 Oct 26, 2001 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-004 Jan 18, 2012 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356-004 Jan 18, 2012 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ 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 VIREAD

Paragraph IV (Patent) Challenges for VIREAD
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 150 mg, 200 mg, and 250 mg ➤ Subscribe 5/17/2012
➤ Subscribe Tablets 300 mg ➤ Subscribe 1/26/2010

Non-Orange Book US Patents for VIREAD

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
6,069,249 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability ➤ Sign Up
RE38333 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for VIREAD

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0853 Netherlands ➤ Sign Up PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
855 Luxembourg ➤ Sign Up PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE , TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL, ET L'EMTRICITABINE.
2005 00032 Denmark ➤ Sign Up
2015000088 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
0768 Netherlands ➤ Sign Up 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
C/GB08/033 United Kingdom ➤ Sign Up PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED
178 Luxembourg ➤ Sign Up 91178, EXPIRES: 20200221
16/061 Ireland ➤ Sign Up PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTRATION NO/DATE: EU/1/15/1061 20151119
2016000108 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
2016 00066 Denmark ➤ Sign Up PRODUCT NAME: EN KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, EMTRICITABIN OG TENOFOVIRALAFENAMID, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Express Scripts
QuintilesIMS
Harvard Business School
Queensland Health
Baxter
Teva
UBS
Dow

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