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Deloitte
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Healthtrust
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Mallinckrodt
Merck
Julphar
Farmers Insurance

Generated: September 24, 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.

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 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 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 021752-002 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 ➤ 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
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
2008 00023 Denmark ➤ Try a Free Trial
178 Luxembourg ➤ Try a Free Trial 91178, EXPIRES: 20200221
C/GB08/033 United Kingdom ➤ Try a Free Trial 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
C021/2005 Ireland ➤ Try a Free Trial SPC021/2005: 20090811, EXPIRES: 20200220
0148 Netherlands ➤ Try a Free Trial 300148, 20110131, EXPIRES: 20160130
2004000015 Germany ➤ Try a Free Trial PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024
7/2004 Austria ➤ Try a Free Trial
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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