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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
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Healthtrust
Chubb
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Mallinckrodt
Merck
Julphar
Farmers Insurance

Generated: December 17, 2018

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TRUVADA Drug Profile

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

Truvada is a drug marketed by Gilead and is included in one NDA. There are eleven patents protecting this drug and two Paragraph IV challenges.

This drug has three hundred and twenty-three patent family members in forty-five countries.

The generic ingredient in TRUVADA is emtricitabine; tenofovir disoproxil fumarate. There are seventeen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.

US Patents and Regulatory Information for TRUVADA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-002 Mar 10, 2016 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-004 Mar 10, 2016 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 TRUVADA

Paragraph IV (Patent) Challenges for TRUVADA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 100 mg/150 mg, 133 mg/200 mg, and 167 mg/250 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Tablets 200 mg/300 mg ➤ Subscribe ➤ Try a Free Trial

International Patents for TRUVADA

Supplementary Protection Certificates for TRUVADA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0915894/02 Switzerland ➤ Try a Free Trial PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
0781 Netherlands ➤ Try a Free Trial 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
C0073 France ➤ Try a Free Trial 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
0768 Netherlands ➤ Try a Free Trial 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
0852 Netherlands ➤ Try a Free Trial PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
C0032 France ➤ Try a Free Trial PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Harvard Business School
Healthtrust
Chubb
McKinsey
Mallinckrodt
Merck
Julphar
Farmers Insurance

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