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Last Updated: May 21, 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 fifty-six patent family members in forty-nine 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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Summary for STRIBILD
International Patents:456
US Patents:11
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 27
Patent Applications: 182
Formulation / Manufacturing:see details
Drug Prices: Drug price information for STRIBILD
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for STRIBILD
What excipients (inactive ingredients) are in STRIBILD?STRIBILD excipients list
DailyMed Link:STRIBILD at DailyMed
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*:
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Constraining patent/regulatory exclusivity:
⤷  Sign Up
NDA:
203100
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
ViiV HealthcareN/A

See all STRIBILD clinical trials

Pharmacology for STRIBILD
Drug ClassCytochrome P450 3A Inhibitor
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of ActionBreast Cancer Resistance Protein Inhibitors
Cytochrome P450 2C9 Inducers
Cytochrome P450 2D6 Inhibitors
Cytochrome P450 3A Inhibitors
HIV Integrase Inhibitors
Nucleoside Reverse Transcriptase Inhibitors
Organic Anion Transporting Polypeptide 1B1 Inhibitors
Organic Anion Transporting Polypeptide 1B3 Inhibitors
P-Glycoprotein Inhibitors
Anatomical Therapeutic Chemical (ATC) Classes for STRIBILD
J05AF Nucleoside and nucleotide reverse transcriptase inhibitors
J05A DIRECT ACTING ANTIVIRALS
J05 ANTIVIRALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
J05AF Nucleoside and nucleotide reverse transcriptase inhibitors
J05A DIRECT ACTING ANTIVIRALS
J05 ANTIVIRALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
J05AJ Integrase inhibitors
J05A DIRECT ACTING ANTIVIRALS
J05 ANTIVIRALS FOR SYSTEMIC USE
J Antiinfectives for systemic use
V03AX Other therapeutic products
V03A ALL OTHER THERAPEUTIC PRODUCTS
V03 ALL OTHER THERAPEUTIC PRODUCTS
V Various
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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

4-oxoquinoline compound and use thereof as pharmaceutical agent
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Stable crystal of 4-oxoquinoline compound
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HIV INFECTION

Combination therapy
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HIV INFECTION

Stable crystal of 4-oxoquinoline compound
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HIV INFECTION

Compositions and methods for combination antiviral therapy
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HIV INFECTION

Modulators of pharmacokinetic properties of therapeutics
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Glossary
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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Expired US Patents for STRIBILD

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 ⤷  Sign Up ⤷  Sign Up
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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: ⤷  Sign Up

Patent: 50
Estimated Expiration: ⤷  Sign Up

Argentina

Patent: 5369
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 09242451
Estimated Expiration: ⤷  Sign Up

Patent: 10210598
Estimated Expiration: ⤷  Sign Up

Patent: 14221210
Estimated Expiration: ⤷  Sign Up

Patent: 15200637
Estimated Expiration: ⤷  Sign Up

Patent: 16250470
Estimated Expiration: ⤷  Sign Up

Patent: 17201473
Estimated Expiration: ⤷  Sign Up

Patent: 18267573
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0911871
Estimated Expiration: ⤷  Sign Up

Patent: 1008664
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 20856
Estimated Expiration: ⤷  Sign Up

Patent: 50521
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 11001885
Estimated Expiration: ⤷  Sign Up

China

Patent: 2123700
Estimated Expiration: ⤷  Sign Up

Patent: 2307573
Estimated Expiration: ⤷  Sign Up

Patent: 3479584
Estimated Expiration: ⤷  Sign Up

Patent: 4940937
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 21225
Estimated Expiration: ⤷  Sign Up

Patent: 00187
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0151009
Estimated Expiration: ⤷  Sign Up

Patent: 0151357
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 16852
Estimated Expiration: ⤷  Sign Up

Patent: 17067
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 96633
Estimated Expiration: ⤷  Sign Up

Patent: 93485
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 10010636
Estimated Expiration: ⤷  Sign Up

Patent: 11011307
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1313
Estimated Expiration: ⤷  Sign Up

Patent: 2950
Estimated Expiration: ⤷  Sign Up

Patent: 0123
Estimated Expiration: ⤷  Sign Up

Patent: 1071173
Estimated Expiration: ⤷  Sign Up

Patent: 1190125
Estimated Expiration: ⤷  Sign Up

Patent: 1491658
Estimated Expiration: ⤷  Sign Up

Patent: 1591353
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 96633
Estimated Expiration: ⤷  Sign Up

Patent: 93485
Estimated Expiration: ⤷  Sign Up

Patent: 06032
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 53670
Estimated Expiration: ⤷  Sign Up

Patent: 64737
Estimated Expiration: ⤷  Sign Up

Patent: 15679
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 25822
Estimated Expiration: ⤷  Sign Up

Patent: 26380
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 8614
Estimated Expiration: ⤷  Sign Up

Patent: 4227
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 11242
Estimated Expiration: ⤷  Sign Up

Patent: 22213
Estimated Expiration: ⤷  Sign Up

Patent: 11927
Estimated Expiration: ⤷  Sign Up

Patent: 25171
Estimated Expiration: ⤷  Sign Up

Patent: 11522790
Estimated Expiration: ⤷  Sign Up

Patent: 12517432
Estimated Expiration: ⤷  Sign Up

Patent: 14012741
Estimated Expiration: ⤷  Sign Up

Patent: 14221845
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 2377
Estimated Expiration: ⤷  Sign Up

Patent: 10011963
Estimated Expiration: ⤷  Sign Up

Patent: 11008289
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 8978
Estimated Expiration: ⤷  Sign Up

Patent: 4214
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 110994
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 96633
Estimated Expiration: ⤷  Sign Up

Patent: 93485
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 96633
Estimated Expiration: ⤷  Sign Up

Patent: 93485
Estimated Expiration: ⤷  Sign Up

San Marino

Patent: 01500266
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 3544
Estimated Expiration: ⤷  Sign Up

Patent: 0618
Estimated Expiration: ⤷  Sign Up

Patent: 14007744
Estimated Expiration: ⤷  Sign Up

Patent: 201609006W
Estimated Expiration: ⤷  Sign Up

Patent: 201706215U
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 96633
Estimated Expiration: ⤷  Sign Up

Patent: 93485
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1008007
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1645759
Estimated Expiration: ⤷  Sign Up

Patent: 1659971
Estimated Expiration: ⤷  Sign Up

Patent: 1738325
Estimated Expiration: ⤷  Sign Up

Patent: 1784647
Estimated Expiration: ⤷  Sign Up

Patent: 110015581
Estimated Expiration: ⤷  Sign Up

Patent: 110122729
Estimated Expiration: ⤷  Sign Up

Patent: 160093100
Estimated Expiration: ⤷  Sign Up

Patent: 160114728
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 48886
Estimated Expiration: ⤷  Sign Up

Patent: 53897
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 44367
Estimated Expiration: ⤷  Sign Up

Patent: 1040142
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 1193
Estimated Expiration: ⤷  Sign Up

Patent: 3224
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 424
Estimated Expiration: ⤷  Sign Up

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
Denmark 0872237 ⤷  Sign Up
Lithuania PA2016040 ⤷  Sign Up
South Korea 100860136 ⤷  Sign Up
Canada 2678778 ⤷  Sign Up
Norway 20190528 Modulatorer av farmakokinetikkegenskaper til terapeutika ⤷  Sign Up
Luxembourg 91073 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Supplementary Protection Certificates for STRIBILD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487162 2016/063 Ireland ⤷  Sign Up 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
2049506 SPC/GB15/067 United Kingdom ⤷  Sign Up PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/830/001 20130527; UK EU/1/13/830/002 20130527
2049506 C20150046 Estonia ⤷  Sign Up PRODUCT NAME: KOBITSISTAAT; AUTHORISATION NO.: EMA/CHMP/596576/2017, AUTORISATION DATE: 20170914
3150586 2020/021 Ireland ⤷  Sign Up 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 ACCEPTABLE SALT OR SOLVATE THEREOF; REGISTRATION NO/DATE: EU/1/17/1225 20170925
2487166 PA2016038,C2487166 Lithuania ⤷  Sign Up PRODUCT NAME: KOBICISTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA IR TENOFOVIRO ALAFENAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC TENOFOVIRO ALAFENAMIDO FUMARATAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
0915894 SPC/GB05/041 United Kingdom ⤷  Sign Up SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020.
>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.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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