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Last Updated: March 29, 2024

TRUVADA Drug Patent Profile


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When do Truvada patents expire, and what generic alternatives are available?

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

This drug has sixty-two patent family members in twenty-nine countries.

The generic ingredient in TRUVADA is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Thirty 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 Strength NDA ANDAs Submitted Submissiondate
TRUVADA Tablets emtricitabine; tenofovir disoproxil fumarate 100 mg/150 mg 133 mg/200 mg 167 mg/250 mg 021752 1 2017-05-19
TRUVADA Tablets emtricitabine; tenofovir disoproxil fumarate 200 mg/300 mg 021752 1 2008-09-26

US Patents and Regulatory Information for TRUVADA

TRUVADA is protected by six US patents.

Patents protecting TRUVADA

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV INFECTION

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV INFECTION

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV INFECTION

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-003 Mar 10, 2016 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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

Supplementary Protection Certificates for TRUVADA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0915894 SPC021/2005 Ireland ⤷  Try a Trial SPC021/2005: 20090811, EXPIRES: 20200220
3808743 301190 Netherlands ⤷  Try a Trial PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE OF EEN DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ADDITIEZOUT VAN RILPIVIRINE, MET INBEGRIP VAN HET HYDROCHLORIDE-ZOUT VAN RILPIVIRINE, EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
0915894 C00915894/02 Switzerland ⤷  Try a Trial PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.