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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Fish and Richardson
Boehringer Ingelheim
US Army
Federal Trade Commission
Harvard Business School
Queensland Health
Merck

Generated: June 20, 2018

DrugPatentWatch Database Preview

TRUVADA Drug Profile

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Which patents cover Truvada, and when can generic versions of Truvada launch?

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. Eleven 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
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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-002 Mar 10, 2016 ➤ Try a Free Trial ➤ Try a Free Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-004 Mar 10, 2016 ➤ Try a Free Trial ➤ Try a Free Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for TRUVADA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 100 mg/150 mg, 133 mg/200 mg, and 167 mg/250 mg ➤ Subscribe 2017-05-19
➤ Subscribe Tablets 200 mg/300 mg ➤ Subscribe 2008-09-26

Non-Orange Book US Patents for TRUVADA

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
5,539,116 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Try a Free Trial
6,069,249 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability ➤ Try a Free Trial
7,468,436 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers ➤ Try a Free Trial
RE38333 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for TRUVADA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0513200/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
C0032 France ➤ Try a Free Trial PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
7/2004 Austria ➤ Try a Free Trial
2004000015 Germany ➤ Try a Free Trial PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Johnson and Johnson
AstraZeneca
QuintilesIMS
Deloitte
US Army
Accenture
Harvard Business School
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.