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Last Updated: June 28, 2022

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 eleven 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 four hundred and thirty-five patent family members in forty-seven countries.

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
Gilead SciencesPhase 1/Phase 2
University of California, Los AngelesPhase 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 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 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 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 cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

International Patents for cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate

Country Patent Number Title Estimated Expiration
New Zealand 594214 TABLETS COMPRISING COBICISTAT, ELVITEGRAVIR, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE FOR COMBINATION THERAPY See Plans and Pricing
Japan 2021001236 治療薬の薬物動態特性の調節 (MODULATION OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS) See Plans and Pricing
Japan 5393665 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2004064845 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049506 SPC/GB15/067 United Kingdom See Plans and Pricing PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/830/001 20130527; UK EU/1/13/830/002 20130527
1564210 489 Finland See Plans and Pricing
1564210 CR 2013 00058 Denmark See Plans and Pricing PRODUCT NAME: ELVITEGRAVIR ELLER ET HYDRAT, ET SOLVAT, EN TAUTOMER ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
2487163 1790002-8 Sweden See Plans and Pricing PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND ATAZANAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ATAZANAVIR SULFATE; REG. NO/DATE: EU/1/15/1025 20150715
>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.