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Last Updated: August 10, 2020

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Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details

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What are the generic sources for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate and what is the scope of patent protection?

Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are thirteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate has five hundred and ninety-four patent family members in fifty-four countries.

There are five drug master file entries for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate. One supplier is listed for this compound.

Recent Clinical Trials for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

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

SponsorPhase
University of California, Los AngelesPhase 1/Phase 2
Gilead SciencesPhase 1/Phase 2
Brigham and Women's HospitalN/A

See all cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate clinical trials

Paragraph IV (Patent) Challenges for COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Tradename Dosage Ingredient NDA Submissiondate
STRIBILD TABLET;ORAL cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate 203100 2018-10-04

US Patents and Regulatory Information for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

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 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 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 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 cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

Supplementary Protection Certificates for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0513200 C00513200/01 Switzerland   Start Trial PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
2487162 93352 Luxembourg   Start Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SOLVAT DE CELUI-CI ET DARUNAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN SPLVAT DE CELUI-CI, EN PARTICULIER L'ETHANOLATE DE DARUNAVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/967
2487166 1790001-0 Sweden   Start Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061 20151123
2487166 300860 Netherlands   Start Trial PRODUCT NAME: COBICISTAT, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN TENOFOVIR-ALAFENAMIDE, DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIR-ALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/15/1061 20151123
0513200 122004000015 Germany   Start Trial PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024
2049506 132015000080648 Italy   Start Trial PRODUCT NAME: COBICISTAT O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(STRIBILD); AUTHORISATION NUMBER(S) AND DATE(S): C(2013)3210, 20130527
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
McKinsey
Dow
Express Scripts
Boehringer Ingelheim

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.