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Last Updated: March 19, 2024

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STRIBILD Drug Patent Profile


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

Stribild is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in STRIBILD is cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate profile page.

DrugPatentWatch® Generic Entry Outlook for Stribild

Stribild was eligible for patent challenges on August 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 6, 2033. This may change due to patent challenges or generic licensing.

There have been twenty-one patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for STRIBILD
Drug Prices for STRIBILD

See drug prices for STRIBILD

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for STRIBILD
Generic Entry Date for STRIBILD*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for STRIBILD

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Gilead SciencesPhase 1/Phase 2
University of California, Los AngelesPhase 1/Phase 2
Mills Clinical ResearchN/A

See all STRIBILD clinical trials

Paragraph IV (Patent) Challenges for STRIBILD
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
STRIBILD Tablets cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate 150 mg/150 mg/ 200 mg/300 mg 203100 1 2018-10-04

US Patents and Regulatory Information for STRIBILD

STRIBILD is protected by eleven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of STRIBILD is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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

Patents protecting STRIBILD

Use of solid carrier particles to improve the processability of a pharmaceutical agent
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

4-oxoquinoline compound and use thereof as pharmaceutical agent
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Stable crystal of 4-oxoquinoline compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Combination therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Stable crystal of 4-oxoquinoline compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 STRIBILD

International Patents for STRIBILD

When does loss-of-exclusivity occur for STRIBILD?

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: ⤷  Try a Trial

Patent: 50
Estimated Expiration: ⤷  Try a Trial

Argentina

Patent: 5369
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 09242451
Estimated Expiration: ⤷  Try a Trial

Patent: 10210598
Estimated Expiration: ⤷  Try a Trial

Patent: 14221210
Estimated Expiration: ⤷  Try a Trial

Patent: 15200637
Estimated Expiration: ⤷  Try a Trial

Patent: 16250470
Estimated Expiration: ⤷  Try a Trial

Patent: 17201473
Estimated Expiration: ⤷  Try a Trial

Patent: 18267573
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0911871
Estimated Expiration: ⤷  Try a Trial

Patent: 1008664
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 20856
Estimated Expiration: ⤷  Try a Trial

Patent: 50521
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 11001885
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2123700
Estimated Expiration: ⤷  Try a Trial

Patent: 2307573
Estimated Expiration: ⤷  Try a Trial

Patent: 3479584
Estimated Expiration: ⤷  Try a Trial

Patent: 4940937
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 21225
Estimated Expiration: ⤷  Try a Trial

Patent: 00187
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0151009
Estimated Expiration: ⤷  Try a Trial

Patent: 0151357
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 16852
Estimated Expiration: ⤷  Try a Trial

Patent: 17067
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 96633
Estimated Expiration: ⤷  Try a Trial

Patent: 93485
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 10010636
Estimated Expiration: ⤷  Try a Trial

Patent: 11011307
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 1313
Estimated Expiration: ⤷  Try a Trial

Patent: 2950
Estimated Expiration: ⤷  Try a Trial

Patent: 0123
Estimated Expiration: ⤷  Try a Trial

Patent: 1071173
Estimated Expiration: ⤷  Try a Trial

Patent: 1190125
Estimated Expiration: ⤷  Try a Trial

Patent: 1491658
Estimated Expiration: ⤷  Try a Trial

Patent: 1591353
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 96633
Estimated Expiration: ⤷  Try a Trial

Patent: 93485
Estimated Expiration: ⤷  Try a Trial

Patent: 06032
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 53670
Estimated Expiration: ⤷  Try a Trial

Patent: 64737
Estimated Expiration: ⤷  Try a Trial

Patent: 15679
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 25822
Estimated Expiration: ⤷  Try a Trial

Patent: 26380
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8614
Estimated Expiration: ⤷  Try a Trial

Patent: 4227
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 11242
Estimated Expiration: ⤷  Try a Trial

Patent: 22213
Estimated Expiration: ⤷  Try a Trial

Patent: 11927
Estimated Expiration: ⤷  Try a Trial

Patent: 25171
Estimated Expiration: ⤷  Try a Trial

Patent: 11522790
Estimated Expiration: ⤷  Try a Trial

Patent: 12517432
Estimated Expiration: ⤷  Try a Trial

Patent: 14012741
Estimated Expiration: ⤷  Try a Trial

Patent: 14221845
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 2377
Estimated Expiration: ⤷  Try a Trial

Patent: 10011963
Estimated Expiration: ⤷  Try a Trial

Patent: 11008289
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 8978
Estimated Expiration: ⤷  Try a Trial

Patent: 4214
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 110994
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 96633
Estimated Expiration: ⤷  Try a Trial

Patent: 93485
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 96633
Estimated Expiration: ⤷  Try a Trial

Patent: 93485
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 01500266
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 3544
Estimated Expiration: ⤷  Try a Trial

Patent: 0618
Estimated Expiration: ⤷  Try a Trial

Patent: 14007744
Estimated Expiration: ⤷  Try a Trial

Patent: 201609006W
Estimated Expiration: ⤷  Try a Trial

Patent: 201706215U
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 96633
Estimated Expiration: ⤷  Try a Trial

Patent: 93485
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1008007
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1645759
Estimated Expiration: ⤷  Try a Trial

Patent: 1659971
Estimated Expiration: ⤷  Try a Trial

Patent: 1738325
Estimated Expiration: ⤷  Try a Trial

Patent: 1784647
Estimated Expiration: ⤷  Try a Trial

Patent: 110015581
Estimated Expiration: ⤷  Try a Trial

Patent: 110122729
Estimated Expiration: ⤷  Try a Trial

Patent: 160093100
Estimated Expiration: ⤷  Try a Trial

Patent: 160114728
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 48886
Estimated Expiration: ⤷  Try a Trial

Patent: 53897
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 44367
Estimated Expiration: ⤷  Try a Trial

Patent: 1040142
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 1193
Estimated Expiration: ⤷  Try a Trial

Patent: 3224
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 424
Estimated Expiration: ⤷  Try a Trial

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 STRIBILD around the world.

Country Patent Number Title Estimated Expiration
Japan 2005002092 4-OXOQUINOLINE COMPOUND AND ITS USE AS HIV INTEGRASE INHIBITOR ⤷  Try a Trial
South Africa 200610647 Stable crystal of 4-oxoquinoline compound ⤷  Try a Trial
European Patent Office 0915894 ANALOGUES DE NUCLEOTIDES (NUCLEOTIDE ANALOGS) ⤷  Try a Trial
European Patent Office 2487162 Modulateurs de propriétés pharmacocinétiques d'agents thérapeutiques (Modulators of pharmacokinetic properties of therapeutics) ⤷  Try a Trial
African Regional IP Organization (ARIPO) 3915 Modulators of pharmacokinetic properties of therapeutics ⤷  Try a Trial
Taiwan 444020 ⤷  Try a Trial
Japan 2014221845 併用治療のための錠剤 (TABLETS FOR COMBINATION THERAPY) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for STRIBILD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487162 2016/063 Ireland ⤷  Try a Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE; REGISTRATION NO/DATE: EU/1/14/967 20141119
3150586 PA2020508 Lithuania ⤷  Try a Trial PRODUCT NAME: KOBICISTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, DARUNAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, YPAC DARUNAVIRO ETANOLATAS, IR EMTRICITABINAS, ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/17/1225 20170921
2487162 2016C/068 Belgium ⤷  Try a Trial PRODUCT NAME: COBICISTAT ET DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967 20141121
3150586 132020000000055 Italy ⤷  Try a Trial PRODUCT NAME: COBICISTAT O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, DARUNAVIR O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO, IN PARTICOLARE DARUNAVIR ETANOLATO, E EMTRICITABINE O UN SALE FARMACOLOGICAMENTE ACCETTABILE O UN SOLVATO DELLO STESSO(SYMTUZA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1225, 20170925
2487166 380 3-2017 Slovakia ⤷  Try a Trial PRODUCT NAME: KOBICISTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/TENOFOVIR ALAFENAMID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1061 20151123
2487166 PA2016038 Lithuania ⤷  Try a Trial PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
1564210 132013902209844 Italy ⤷  Try a Trial PRODUCT NAME: COMPRENDENTE IL PRODOTTO ELVITEGRAVIR COME UNO DEI PRINCIPI ATTIV(STRIBILD); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/830/001-002, 20130524
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.