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Last Updated: September 30, 2022

TRUVADA Drug Patent 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 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. Twenty-four 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV

Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1

Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

Compositions and methods for combination antiviral therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-001 Aug 2, 2004 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-003 Mar 10, 2016 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Gilead TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752-004 Mar 10, 2016 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

International Patents for TRUVADA

When does loss-of-exclusivity occur for TRUVADA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 89
Estimated Expiration: See Plans and Pricing

Argentina

Patent: 0805
Estimated Expiration: See Plans and Pricing

Patent: 3332
Estimated Expiration: See Plans and Pricing

Patent: 1679
Estimated Expiration: See Plans and Pricing

Australia

Patent: 04206821
Estimated Expiration: See Plans and Pricing

Patent: 04206827
Estimated Expiration: See Plans and Pricing

Patent: 09200414
Estimated Expiration: See Plans and Pricing

Austria

Patent: 8455
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0406760
Estimated Expiration: See Plans and Pricing

Canada

Patent: 12319
Estimated Expiration: See Plans and Pricing

Patent: 12475
Estimated Expiration: See Plans and Pricing

China

Patent: 38628
Estimated Expiration: See Plans and Pricing

Patent: 2670629
Estimated Expiration: See Plans and Pricing

Patent: 5596356
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0050619
Estimated Expiration: See Plans and Pricing

Patent: 0140379
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 08355
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 83542
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 5145
Estimated Expiration: See Plans and Pricing

Patent: 0501134
Estimated Expiration: See Plans and Pricing

Patent: 1100293
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 83542
Estimated Expiration: See Plans and Pricing

Patent: 85527
Estimated Expiration: See Plans and Pricing

Patent: 23063
Estimated Expiration: See Plans and Pricing

Patent: 25718
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2004014470
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 79122
Estimated Expiration: See Plans and Pricing

Iceland

Patent: 77
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9243
Estimated Expiration: See Plans and Pricing

Japan

Patent: 96241
Estimated Expiration: See Plans and Pricing

Patent: 06515624
Estimated Expiration: See Plans and Pricing

Patent: 06516570
Estimated Expiration: See Plans and Pricing

Patent: 10120957
Estimated Expiration: See Plans and Pricing

Patent: 14037430
Estimated Expiration: See Plans and Pricing

Patent: 15098488
Estimated Expiration: See Plans and Pricing

Patent: 17057232
Estimated Expiration: See Plans and Pricing

Patent: 19052174
Estimated Expiration: See Plans and Pricing

Patent: 21004264
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05007016
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0728
Estimated Expiration: See Plans and Pricing

Norway

Patent: 7917
Estimated Expiration: See Plans and Pricing

Patent: 0951
Estimated Expiration: See Plans and Pricing

Patent: 053817
Estimated Expiration: See Plans and Pricing

Patent: 150656
Estimated Expiration: See Plans and Pricing

Patent: 160777
Estimated Expiration: See Plans and Pricing

Patent: 171193
Estimated Expiration: See Plans and Pricing

Poland

Patent: 8368
Estimated Expiration: See Plans and Pricing

Patent: 8254
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 83542
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 83542
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0505852
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 0860136
Estimated Expiration: See Plans and Pricing

Patent: 050092755
Estimated Expiration: See Plans and Pricing

Patent: 080032014
Estimated Expiration: See Plans and Pricing

Patent: 090053867
Estimated Expiration: See Plans and Pricing

Spain

Patent: 08136
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 55270
Estimated Expiration: See Plans and Pricing

Patent: 0423946
Estimated Expiration: See Plans and Pricing

Patent: 0425895
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 797
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRUVADA around the world.

Country Patent Number Title Estimated Expiration
India 190780 A process for preparation of fumarate salt of 9-Ä2-(r)-ÄÄbisÄÄ(isopropoxycarbonyl)oxyÜmethoxyÜphosphinoylÜmethoxyÜpropylÜ-adenine See Plans and Pricing
Japan 2021004264 組み合わせ抗ウイルス治療のための組成物および方法 (COMPOSITION AND METHOD FOR COMBINATION ANTIVIRAL TREATMENT) See Plans and Pricing
Bulgaria 62236 See Plans and Pricing
South Korea 0172590 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TRUVADA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 300851 Netherlands See Plans and Pricing PRODUCT NAME: COMBINATIE VAN: - RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
0915894 91433 Luxembourg See Plans and Pricing 91433, EXPIRES: 20220725
0915894 SPC018/2008 Ireland See Plans and Pricing SPC018/2008: 20090811, EXPIRES: 20220724
0915894 91178 Luxembourg See Plans and Pricing 91178, EXPIRES: 20200221
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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.