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Cipla
Baxter
Fuji
Colorcon
Express Scripts
Federal Trade Commission
Medtronic
Johnson and Johnson
Covington

Generated: February 16, 2019

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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 eighteen 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 021752-003 Mar 10, 2016 ➤ 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
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-004 Mar 10, 2016 ➤ 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 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

Supplementary Protection Certificates for TRUVADA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C018/2008 Ireland ➤ Try a Free Trial SPC018/2008: 20090811, EXPIRES: 20220724
C0021 France ➤ Try a Free Trial PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0148 Netherlands ➤ Try a Free Trial 300148, 20110131, EXPIRES: 20160130
433 Luxembourg ➤ Try a Free Trial 91433, EXPIRES: 20220725
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
McKinsey
Accenture
Chinese Patent Office
Chubb
Queensland Health
Daiichi Sankyo
US Army
Mallinckrodt

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