Generic Biktarvy Availability
Last updated on Dec 12, 2024.
Biktarvy is a brand name of bictegravir/emtricitabine/tenofovir alafenamide, approved by the FDA in the following formulation(s):
BIKTARVY (bictegravir sodium; emtricitabine; tenofovir alafenamide fumarate - tablet;oral)
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Manufacturer: GILEAD SCIENCES INC
Approval date: February 7, 2018
Strength(s): EQ 50MG BASE;200MG;EQ 25MG BASE [RLD] -
Manufacturer: GILEAD SCIENCES INC
Approval date: October 7, 2021
Strength(s): EQ 30MG BASE;120MG;EQ 15MG BASE [RLD]
Has a generic version of Biktarvy been approved?
No. There is currently no therapeutically equivalent version of Biktarvy available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Biktarvy. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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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 10,385,067
Issued: August 20, 2019
Inventor(s): Carra Ernest A. & Chen Irene & Zia Vahid
Assignee(s): Gilead Sciences, Inc.The present invention relates to 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 Form I, pharmaceutical formulations, and uses thereof for treating or prophylactically preventing an HIV infection.
Patent expiration dates:
- June 19, 2035✓
- June 19, 2035
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Therapeutic compositions for treatment of human immunodeficiency virus
Patent 10,548,846
Issued: February 4, 2020
Inventor(s): Collman Benjamin Micah & Hong Lei & Koziara Joanna M.
Assignee(s): Gilead Sciences, Inc.A solid oral dosage form is provided, comprising a compound of Formula I or a pharmaceutically acceptable salt thereof, tenofovir alafenamide or a pharmaceutically acceptable salt thereof, and emtricitabine or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- November 8, 2036✓
- November 8, 2036
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Patent 11,744,802
Patent expiration dates:
- November 8, 2036✓
- November 8, 2036
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Patent 7,390,791
Patent expiration dates:
- April 17, 2025✓✓
- April 17, 2025
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Patent 7390791*PED
Patent expiration dates:
- October 17, 2025✓
- October 17, 2025
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Tenofovir alafenamide hemifumarate
Patent 8,754,065
Issued: June 17, 2014
Inventor(s): Liu Dazhan & Shi Bing & Wang Fang & Yu Richard Hung Chiu
Assignee(s): Gilead Sciences, Inc.A hemifumarate form of 9-[(R)-2-[[(S)-[[(S)-1-(isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine (tenofovir alafenamide), and antiviral therapy using tenofovir alafenamide hemifumarate (e.g., anti-HIV and anti-HBV therapies).
Patent expiration dates:
- August 15, 2032✓✓✓
- August 15, 2032
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Tenofovir alafenamide hemifumarate
Patent 8754065*PED
Issued: June 17, 2014
Inventor(s): Liu Dazhan & Shi Bing & Wang Fang & Yu Richard Hung Chiu
Assignee(s): Gilead Sciences, Inc.A hemifumarate form of 9-[(R)-2-[[(S)-[[(S)-1-(isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine (tenofovir alafenamide), and antiviral therapy using tenofovir alafenamide hemifumarate (e.g., anti-HIV and anti-HBV therapies).
Patent expiration dates:
- February 15, 2033✓
- February 15, 2033
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Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]oxazepines and methods for treating viral infections
Patent 9,216,996
Issued: December 22, 2015
Inventor(s): Jin Haolun & Lazerwith Scott E. & Pyun Hyung-Jung
Assignee(s): Gilead Sciences, Inc.Compounds for use in the treatment of human immunodeficiency virus (HIV) infection are disclosed. The compounds have the following Formula (I):
Patent expiration dates:
- December 19, 2033✓✓
- December 19, 2033
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Tenofovir alafenamide hemifumarate
Patent 9,296,769
Issued: March 29, 2016
Inventor(s): Liu Dazhan & Shi Bing & Wang Fang & Yu Richard Hung Chiu
Assignee(s): Gilead Sciences, Inc.A hemifumarate form of 9-[(R)-2-[[(S)-[[(S)-1-(isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine (tenofovir alafenamide), and antiviral therapy using tenofovir alafenamide hemifumarate (e.g., anti-HIV and anti-HBV therapies).
Patent expiration dates:
- August 15, 2032✓✓✓
- August 15, 2032
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Tenofovir alafenamide hemifumarate
Patent 9296769*PED
Issued: March 29, 2016
Inventor(s): Liu Dazhan & Shi Bing & Wang Fang & Yu Richard Hung Chiu
Assignee(s): Gilead Sciences, Inc.A hemifumarate form of 9-[(R)-2-[[(S)-[[(S)-1-(isopropoxycarbonyl)ethyl]amino]phenoxyphosphinyl]methoxy]propyl]adenine (tenofovir alafenamide), and antiviral therapy using tenofovir alafenamide hemifumarate (e.g., anti-HIV and anti-HBV therapies).
Patent expiration dates:
- February 15, 2033✓
- February 15, 2033
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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 9,708,342
Issued: July 18, 2017
Inventor(s): Carra Ernest A. & Chen Irene & Zia Vahid
Assignee(s): Gilead Sciences, Inc.The present invention relates to 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 Form I and the therapeutic uses thereof.
Patent expiration dates:
- June 19, 2035✓✓
- June 19, 2035
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Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]OXAZEPINES and methods for treating viral infections
Patent 9,732,092
Issued: August 15, 2017
Inventor(s): Jin Haolun & Lazerwith Scott E. & Pyun Hyung-Jung & Bacon Elizabeth M. & Morganelli Philip Anthony & Ji Mingzhe
Assignee(s): Gilead Sciences, Inc.Compounds for use in the treatment of human immunodeficiency virus (HIV) infection are disclosed. The compounds have the following Formula (I):
Patent expiration dates:
- December 19, 2033✓✓
- December 19, 2033
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- February 24, 2024 - LABELING REVISIONS RELATED TO CLINICAL STUDIES
- June 18, 2026 - 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
- February 23, 2027 - EXPANSION OF INDICATION TO USE OF BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE FOR THE TREATMENT OF HIV-1 INFECTION IN VIROLOGICALLY SUPPRESSED ADULTS AND PEDIATRIC PATIENTS ON A STABLE HIV-1 TREATMENT REGIMEN WITH NO KNOWN RESISTANCE TO BICTEGRAVIR OR
- April 24, 2027 - REVISIONS TO THE LABELING TO INCLUDE INFORMATION FOR PREGNANT INDIVIDUALS
- October 7, 2028 - 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 WH
- February 23, 2031 - TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 14 KG TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANT
More about Biktarvy (bictegravir / emtricitabine / tenofovir alafenamide)
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- Drug class: antiviral combinations
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Patient resources
Professional resources
- Biktarvy prescribing information
- Bictegravir Sodium, Emtricitabine, and Tenofovir Alafenamide Fumarate (AHFS Monograph)
Related treatment guides
Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
