BIKTARVY Drug Patent Profile
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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
Summary for BIKTARVY
International Patents: | 334 |
US Patents: | 12 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Clinical Trials: | 34 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for BIKTARVY |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BIKTARVY |
What excipients (inactive ingredients) are in BIKTARVY? | BIKTARVY excipients list |
DailyMed Link: | BIKTARVY at DailyMed |


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
Sponsor | Phase |
---|---|
University of Nairobi | Phase 3 |
LAMBERT ASSOUMOU/ UNITE 1136 INSERM | Phase 4 |
THOMAS STEHL/ HENRI MONDOR HOSPITAL-Department of Nephrology | Phase 4 |
Pharmacology for BIKTARVY
Anatomical Therapeutic Chemical (ATC) Classes for BIKTARVY
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-002 | Oct 7, 2021 | See Plans and Pricing | See Plans and Pricing |
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | See Plans and Pricing | See Plans and Pricing |
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | See Plans and Pricing | See Plans and Pricing |
Gilead Sciences Inc | BIKTARVY | bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate | TABLET;ORAL | 210251-001 | Feb 7, 2018 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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 |