Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

AstraZeneca
Merck
Mallinckrodt
Express Scripts
McKesson
Boehringer Ingelheim

Last Updated: May 20, 2022

BIKTARVY Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

Which patents cover Biktarvy, and what generic alternatives are available?

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

This drug has three hundred and thirty-four patent family members in fifty-four countries.

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

DrugPatentWatch® Generic Entry Outlook for Biktarvy

Biktarvy was eligible for patent challenges on February 7, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 8, 2036. This may change due to patent challenges or generic licensing.

There have been seventeen 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

< Available with Subscription >

  Sign up for a Free Trial

Drug patent expirations by year for BIKTARVY
Drug Prices for BIKTARVY

See drug prices for BIKTARVY

DrugPatentWatch® Estimated 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

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

SponsorPhase
University of NairobiPhase 3
LAMBERT ASSOUMOU/ UNITE 1136 INSERMPhase 4
THOMAS STEHL/ HENRI MONDOR HOSPITAL-Department of NephrologyPhase 4

See all BIKTARVY clinical trials

Paragraph IV (Patent) Challenges for BIKTARVY
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BIKTARVY Tablets bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate 50 mg/200 mg/ 25 mg 210251 3 2022-02-07

US Patents and Regulatory Information for BIKTARVY

BIKTARVY is protected by twelve US patents and five FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BIKTARVY is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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 BIKTARVY

Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,- 5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxa- zepin-8-olate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

Therapeutic compositions for treatment of human immunodeficiency virus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prodrugs of phosphonate nucleotide analogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prodrugs of phosphonate nucleotide analogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Prodrugs of phosphonate nucoleotide analogues
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

Tenofovir alafenamide hemifumarate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

Tenofovir alafenamide hemifumarate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazepin- es and methods for treating viral infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tenofovir alafenamide hemifumarate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION

Tenofovir alafenamide hemifumarate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,- 5,7,9,13,13a-octahydro-2,5-methanopyrido[1',2':4,5]pyrazino[2, 1-b][1, 3]oxazepin-8-olate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1',2':4,5]pyrazino[2,1-b][1,3]OXAZEPIN- ES and methods for treating viral infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting BIKTARVY

A COMPLETE REGIMEN FOR THE TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTS WEIGHING 14 KG TO LESS THAN 25 KG WHO HAVE NO ANTIRETROVIRAL TREATMENT HISTORY OR TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY-SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO HISTORY OF TREATMENT FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INDIVIDUAL COMPONENTS OF BIKTARVY
Exclusivity Expiration: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

FOR HIV-1 INFECTION IN PEDIATRIC PTS AT LEAST 25 KG W/ NO ANTIRETROVIRAL (ARV) TX HX OR TO REPLACE CURRENT ARV REGIMEN FOR VIROLOGICALLY-SUPPRESSED ON STABLE ARV W/ NO HX TX FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED W/ RESISTANCE TO BIC, FTC, OR TAF
Exclusivity Expiration: See Plans and Pricing

LABELING REVISIONS RELATED TO CLINICAL STUDIES
Exclusivity Expiration: 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
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-002 Oct 7, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-001 Feb 7, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-002 Oct 7, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Gilead Sciences Inc BIKTARVY bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210251-002 Oct 7, 2021 RX Yes No See Plans and Pricing See Plans and Pricing 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 BIKTARVY

International Patents for BIKTARVY

When does loss-of-exclusivity occur for BIKTARVY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 6645
Estimated Expiration: See Plans and Pricing

Australia

Patent: 16354007
Estimated Expiration: See Plans and Pricing

Patent: 20200995
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2016026127
Estimated Expiration: See Plans and Pricing

Canada

Patent: 48021
Estimated Expiration: See Plans and Pricing

Chile

Patent: 18001199
Estimated Expiration: See Plans and Pricing

China

Patent: 8348473
Estimated Expiration: See Plans and Pricing

Patent: 3546052
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 18004776
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 180253
Estimated Expiration: See Plans and Pricing

Cuba

Patent: 180036
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 18033723
Estimated Expiration: See Plans and Pricing

El Salvador

Patent: 18005682
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1890654
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 46995
Estimated Expiration: See Plans and Pricing

Patent: 32415
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 56093
Estimated Expiration: See Plans and Pricing

Patent: 56903
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8459
Estimated Expiration: See Plans and Pricing

Japan

Patent: 21933
Estimated Expiration: See Plans and Pricing

Patent: 18532811
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 18005729
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1957
Estimated Expiration: See Plans and Pricing

Peru

Patent: 181207
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 018501001
Estimated Expiration: See Plans and Pricing

Poland

Patent: 46995
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 46995
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201802983T
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 46995
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2153996
Estimated Expiration: See Plans and Pricing

Patent: 180067702
Estimated Expiration: See Plans and Pricing

Patent: 200106222
Estimated Expiration: See Plans and Pricing

Spain

Patent: 57560
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 37647
Estimated Expiration: See Plans and Pricing

Patent: 1726139
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 981
Estimated Expiration: See Plans and Pricing

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 BIKTARVY around the world.

Country Patent Number Title Estimated Expiration
Uruguay 34262 HEMIFUMARATO DE TENOFOVIR ALAFENAMIDA, SUS COMPOSICIONES, MÉTODO DE PREPARACIÓN, MÉTODOS PARA TRATAR INFECCIONES VIRALES Y SU USO PARA PREPARAR MEDI CAMENTOS See Plans and Pricing
Netherlands 300148 See Plans and Pricing
Portugal 1301519 See Plans and Pricing
Denmark 1439177 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BIKTARVY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0513200 7/2004 Austria See Plans and Pricing PRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003
2822954 PA2018511,C2822954 Lithuania See Plans and Pricing PRODUCT NAME: BIKTEGRAVIRAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, YPAC NATRIO BIKTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/18/1289 20180621
1301519 132016000035069 Italy See Plans and Pricing PRODUCT NAME: TENOFOVIR ALAFENAMIDE O UN SUO SALE O UN SOLVATO DELLO STESSO, IN PARTICOLARE TENOFOVIR ALAFENAMIDE FUMARATO(GENVOYA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1061, 20151123
1301519 CR 2016 00012 Denmark See Plans and Pricing PRODUCT NAME: TENOFOVIRALAFENAMID ELLER ET SALT ELLER SOLVAT DERAF, I SAERDELESHED TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/15/1061/001-002 20151123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
Johnson and Johnson
Boehringer Ingelheim
Medtronic
Mallinckrodt

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.