STRIBILD Drug Patent Profile
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When do Stribild patents expire, 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
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 |
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
Sponsor | Phase |
---|---|
University of California, Los Angeles | Phase 1/Phase 2 |
Gilead Sciences | Phase 1/Phase 2 |
Mills Clinical Research | N/A |
Pharmacology for STRIBILD
Anatomical Therapeutic Chemical (ATC) Classes for STRIBILD
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
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 | |||
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 |
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 |
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 |
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 |
---|---|---|---|
European Patent Office | 0984013 | Activité antivirale et résolution de 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane (Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1, 3-oxathiolane) | ⤷ Sign Up |
Canada | 2075189 | METHODE ET COMPOSITIONS POUR LA SYNTHESE DE BCH-189 ET DE COMPOSES APPARENTES (METHOD AND COMPOSITIONS FOR THE SYNTHESIS OF BCH-189 AND RELATED COMPOUNDS) | ⤷ Sign Up |
Germany | 69233379 | ⤷ Sign Up | |
Hong Kong | 1079122 | Compositions and methods for combination antiviraltherapy | ⤷ Sign Up |
Cyprus | 1118292 | ⤷ Sign Up | |
Austria | 288914 | ⤷ Sign Up | |
Canada | 2105486 | NUCLEOSIDES THERAPEUTIQUES (THERAPEUTIC NUCLEOSIDES) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for STRIBILD
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2487166 | 59/2016 | Austria | ⤷ Sign Up | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND TENOFOVIR ALAFENAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE TENOFOVIR ALAFENAMID FUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 (MITTEILUNG) 20151123 |
0915894 | CA 2005 00032 | Denmark | ⤷ Sign Up | |
2487162 | 122016000103 | Germany | ⤷ Sign Up | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/14/967 20141119 |
2487166 | PA2016038 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119 |
2487166 | CA 2017 00004 | Denmark | ⤷ Sign Up | PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG TENOFOVIRALAFENAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123 |
2049506 | C20150046 00250 | Estonia | ⤷ Sign Up | PRODUCT NAME: KOBITSISTAAT;REG NO/DATE: EU/1/13/830/001-002 27.05.2013 |
2049506 | 61/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 (MITTEILUNG) 20130527 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |