Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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AstraZeneca
Baxter
Mallinckrodt

Last Updated: October 23, 2019

DrugPatentWatch Database Preview

STRIBILD Drug 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 thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has five hundred and eighty-two patent family members in fifty-four countries.

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

Drug patent expirations by year for STRIBILD
Drug Prices for STRIBILD

See drug prices for STRIBILD

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
Gilead SciencesPhase 1/Phase 2
University of California, Los AngelesPhase 1/Phase 2
ViiV HealthcareN/A

See all STRIBILD clinical trials

Recent Litigation for STRIBILD

Identify potential future generic entrants

District Court Litigation
Case NameDate
Japan Tobacco Inc. v. Mylan Pharmaceuticals Inc.2019-01-24
GILEAD SCIENCES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC.2019-01-15
GILEAD SCIENCES, INC. v. STRIDES PHARMA, INC.2018-06-27

See all STRIBILD litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2014-06-04

See all STRIBILD litigation

Synonyms for STRIBILD
1430117-57-9
Cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil
Cobicistat / elvitegravir / emtricitabine / tenofovir disoproxil fumarate
Cobicistat mixture with elvitegravir and emtricitabine and tenofovir disoproxil
Cobicistat mixture with elvitegravir, emtricitabine and tenofovir disoproxil fumarate
Cobicistat, elvitegravir, emtricitabine, tenofovir
Elvitegravir mixture with cobicistat and emtricitabine and tenofovir disoproxil fumarate
Elvitegravir-cobicistat-emtricitabine-tenofovir disoproxil fumarate
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
EVG-COBI-FTC-TDF
FMCLRHTZMTUYMI-JFQFMQNHSA-N
Quad
Quad pill
Quad Tablet

US Patents and Regulatory Information for STRIBILD

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   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start 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

Paragraph IV (Patent) Challenges for STRIBILD
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 150 mg, 150 mg, 200 mg, 300 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for STRIBILD

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2487162 CA 2017 00002 Denmark   Start Trial PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF OG DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIRETHANOLAT; REG. NO/DATE: EU/1/14/967/001 20141121
2049506 61/2015 Austria   Start Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/830 (MITTEILUNG) 20130527
2487163 PA2016039 Lithuania   Start Trial PRODUCT NAME: ATAZANAVIRAS + KOBICISTATAS; REGISTRATION NO/DATE: EU/1/15/1025 20150713
2049506 PA2015040 Lithuania   Start Trial PRODUCT NAME: COBICISTATUM; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
0513200 SPC/GB04/016 United Kingdom   Start Trial PRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024
1564210 C 2013 033 Romania   Start Trial PRODUCT NAME: ELVITEGRAVIR OPTIONAL SUB FORMA DE SARE, SOLVAT SAU HIDRATACCEPTABILFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/13/830/001, EU/1/13/830/002; DATE OF NATIONAL AUTHORISATION: 20130524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/830/001, EU/1/13/830/002; DATE OF FIRST AUTHORISATION IN EEA: 20130524
1564210 SPC/GB13/065 United Kingdom   Start Trial PRODUCT NAME: ELVITEGRAVIR; REGISTERED: UK EU/1/13/830/001 20130527; UK EU/1/13/830/002 20130527
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
Harvard Business School
McKesson
Medtronic
Boehringer Ingelheim

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