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Last Updated: May 12, 2021

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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 six patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and thirty-eight patent family members in forty-two countries.

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

Paragraph IV (Patent) Challenges for TRUVADA
Tradename Dosage Ingredient NDA Submissiondate
TRUVADA TABLET;ORAL emtricitabine; tenofovir disoproxil fumarate 021752 2017-05-19
TRUVADA TABLET;ORAL emtricitabine; tenofovir disoproxil fumarate 021752 2008-09-26

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 021752-002 Mar 10, 2016 AB RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-003 Mar 10, 2016 AB RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TRUVADA

Supplementary Protection Certificates for TRUVADA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0915894 05C0032 France   Get Started for $10 PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
0513200 C00513200/01 Switzerland   Get Started for $10 PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
0915894 91433 Luxembourg   Get Started for $10 91433, EXPIRES: 20220725
0513200 122004000015 Germany   Get Started for $10 PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024
0915894 SPC018/2008 Ireland   Get Started for $10 SPC018/2008: 20090811, EXPIRES: 20220724
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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