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:

Medtronic
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Last Updated: October 19, 2019

DrugPatentWatch Database Preview

BIKTARVY Drug Profile

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When do Biktarvy patents expire, and when can generic versions of Biktarvy launch?

Biktarvy is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are ten patents protecting this drug.

This drug has four hundred and nineteen patent family members in sixty-four countries.

The generic ingredient in BIKTARVY is bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate. One supplier is listed for this compound. Additional details are available on the bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate profile page.

Drug patent expirations by year for BIKTARVY
Drug Prices for BIKTARVY

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Generic Entry Opportunity Date for BIKTARVY
Generic Entry Date for BIKTARVY*:
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 BIKTARVY

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SponsorPhase
University of NebraskaPhase 4
Professor Saye Khoo MD, FRCPPhase 4
Emory UniversityPhase 4

See all BIKTARVY clinical trials

Recent Litigation for BIKTARVY

Identify potential future generic entrants

District Court Litigation
Case NameDate
GILEAD SCIENCES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC.2019-01-15
GILEAD SCIENCES, INC. v. STRIDES PHARMA, INC.2018-06-27
Gilead Sciences, Inc. v. Aurobindo Pharma Ltd.2018-05-18

See all BIKTARVY litigation

US Patents and Regulatory Information for BIKTARVY

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 BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes   Start Trial   Start Trial Y 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

Supplementary Protection Certificates for BIKTARVY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2822954 LUC00083 Luxembourg   Start Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
2822954 C20180024 00269 Estonia   Start Trial PRODUCT NAME: BIKTEGRAVIIR;REG NO/DATE: EU/1/18/1289 25.06.2018
2822954 300947 Netherlands   Start Trial PRODUCT NAME: BICTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BICTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
2822954 C201830044 Spain   Start Trial PRODUCT NAME: BICTEGRAVIR O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR BICTEGRAVIR SODIO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1289; DATE OF AUTHORISATION: 20180621; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1289; DATE OF FIRST AUTHORISATION IN EEA: 20180621
0513200 300148 Netherlands   Start Trial 300148, 20110131, EXPIRES: 20160130
1301519 300803 Netherlands   Start Trial PRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123
2822954 1890030-8 Sweden   Start Trial PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
McKesson
AstraZeneca
Johnson and Johnson
Mallinckrodt
Express Scripts

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