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Last Updated: June 29, 2022

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 thirty-five patent family members in forty-seven 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 eighteen 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 Generic Entry Opportunity 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
University of California, Los AngelesPhase 1/Phase 2
Gilead SciencesPhase 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 See Plans and Pricing.

This potential generic entry date is based on patent 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.

Patents protecting STRIBILD

Use of solid carrier particles to improve the processability of a pharmaceutical agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

4-oxoquinoline compound and use thereof as pharmaceutical agent
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable crystal of 4-oxoquinoline compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modulators of pharmacokinetic properties of therapeutics
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

Combination therapy
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

Stable crystal of 4-oxoquinoline compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

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

Patent: 50
Estimated Expiration: See Plans and Pricing

Argentina

Patent: 5369
Estimated Expiration: See Plans and Pricing

Australia

Patent: 09242451
Estimated Expiration: See Plans and Pricing

Patent: 10210598
Estimated Expiration: See Plans and Pricing

Patent: 14221210
Estimated Expiration: See Plans and Pricing

Patent: 15200637
Estimated Expiration: See Plans and Pricing

Patent: 16250470
Estimated Expiration: See Plans and Pricing

Patent: 17201473
Estimated Expiration: See Plans and Pricing

Patent: 18267573
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0911871
Estimated Expiration: See Plans and Pricing

Patent: 1008664
Estimated Expiration: See Plans and Pricing

Canada

Patent: 20856
Estimated Expiration: See Plans and Pricing

Patent: 50521
Estimated Expiration: See Plans and Pricing

Chile

Patent: 11001885
Estimated Expiration: See Plans and Pricing

China

Patent: 2123700
Estimated Expiration: See Plans and Pricing

Patent: 2307573
Estimated Expiration: See Plans and Pricing

Patent: 3479584
Estimated Expiration: See Plans and Pricing

Patent: 4940937
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 21225
Estimated Expiration: See Plans and Pricing

Patent: 00187
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0151009
Estimated Expiration: See Plans and Pricing

Patent: 0151357
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 16852
Estimated Expiration: See Plans and Pricing

Patent: 17067
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 96633
Estimated Expiration: See Plans and Pricing

Patent: 93485
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 10010636
Estimated Expiration: See Plans and Pricing

Patent: 11011307
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1313
Estimated Expiration: See Plans and Pricing

Patent: 2950
Estimated Expiration: See Plans and Pricing

Patent: 0123
Estimated Expiration: See Plans and Pricing

Patent: 1071173
Estimated Expiration: See Plans and Pricing

Patent: 1190125
Estimated Expiration: See Plans and Pricing

Patent: 1491658
Estimated Expiration: See Plans and Pricing

Patent: 1591353
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 96633
Estimated Expiration: See Plans and Pricing

Patent: 93485
Estimated Expiration: See Plans and Pricing

Patent: 06032
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 53670
Estimated Expiration: See Plans and Pricing

Patent: 64737
Estimated Expiration: See Plans and Pricing

Patent: 15679
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 25822
Estimated Expiration: See Plans and Pricing

Patent: 26380
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8614
Estimated Expiration: See Plans and Pricing

Patent: 4227
Estimated Expiration: See Plans and Pricing

Patent: 7417
Estimated Expiration: See Plans and Pricing

Japan

Patent: 11242
Estimated Expiration: See Plans and Pricing

Patent: 22213
Estimated Expiration: See Plans and Pricing

Patent: 11927
Estimated Expiration: See Plans and Pricing

Patent: 25171
Estimated Expiration: See Plans and Pricing

Patent: 11522790
Estimated Expiration: See Plans and Pricing

Patent: 12517432
Estimated Expiration: See Plans and Pricing

Patent: 14012741
Estimated Expiration: See Plans and Pricing

Patent: 14221845
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 2377
Estimated Expiration: See Plans and Pricing

Patent: 10011963
Estimated Expiration: See Plans and Pricing

Patent: 11008289
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8978
Estimated Expiration: See Plans and Pricing

Patent: 4214
Estimated Expiration: See Plans and Pricing

Peru

Patent: 110994
Estimated Expiration: See Plans and Pricing

Poland

Patent: 96633
Estimated Expiration: See Plans and Pricing

Patent: 93485
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 96633
Estimated Expiration: See Plans and Pricing

Patent: 93485
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01500266
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 3544
Estimated Expiration: See Plans and Pricing

Patent: 0618
Estimated Expiration: See Plans and Pricing

Patent: 14007744
Estimated Expiration: See Plans and Pricing

Patent: 201609006W
Estimated Expiration: See Plans and Pricing

Patent: 201706215U
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 96633
Estimated Expiration: See Plans and Pricing

Patent: 93485
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1008007
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1645759
Estimated Expiration: See Plans and Pricing

Patent: 1659971
Estimated Expiration: See Plans and Pricing

Patent: 1738325
Estimated Expiration: See Plans and Pricing

Patent: 1784647
Estimated Expiration: See Plans and Pricing

Patent: 110015581
Estimated Expiration: See Plans and Pricing

Patent: 110122729
Estimated Expiration: See Plans and Pricing

Patent: 160093100
Estimated Expiration: See Plans and Pricing

Patent: 160114728
Estimated Expiration: See Plans and Pricing

Spain

Patent: 48886
Estimated Expiration: See Plans and Pricing

Patent: 53897
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 44367
Estimated Expiration: See Plans and Pricing

Patent: 1040142
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 1193
Estimated Expiration: See Plans and Pricing

Patent: 3224
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 424
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 STRIBILD around the world.

Country Patent Number Title Estimated Expiration
Japan 2006141408 METHOD AND COMPOSITION FOR SYNTHESIS OF BCH-189 AND RELATED COMPOUND See Plans and Pricing
Australia 2005245296 Stable crystal of 4-oxoquinoline compound See Plans and Pricing
South Korea 20110015581 THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT See Plans and Pricing
Lithuania C2487166 See Plans and Pricing
Japan 2007297406 NUCLEOTIDE ANALOG See Plans and Pricing
Denmark 0513200 See Plans and Pricing
Austria 219366 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for STRIBILD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049506 C20150046 00250 Estonia See Plans and Pricing PRODUCT NAME: KOBITSISTAAT;REG NO/DATE: EU/1/13/830/001-002 27.05.2013
3150586 18/2020 Austria See Plans and Pricing PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, DARUNAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT, UND EMTRICITABIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/17/1225 20170925
0915894 C00915894/02 Switzerland See Plans and Pricing PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
3150586 2090020-5 Sweden See Plans and Pricing PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE, AND EMTRICITABINE OR A PHARMACEUTICALLY ACCEBTABLE SALT OR SOLVATE THEREOF; REG. NO/DATE: EU/1/17/1225 20170925
2049506 300780 Netherlands See Plans and Pricing PRODUCT NAME: COBICISTAT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/830/001-002 20130527
0513200 7/2004 Austria See Plans and Pricing PRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003
2487162 1790003-6 Sweden See Plans and Pricing 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; REG. NO/DATE: EU/1/14/967 20141121
>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.