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Generic Biktarvy Availability

Last updated on May 11, 2022.

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)

  • 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.

  • Patent 10,385,067

    Patent expiration dates:

    • June 19, 2035
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      Patent use: TREATMENT OF HIV INFECTION
  • Patent 10,548,846

    Patent expiration dates:

    • November 8, 2036
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      Drug product
  • Prodrugs of phosphonate nucleotide analogues
    Patent 7,390,791
    Issued: June 24, 2008
    Inventor(s): Becker; Mark W. & Chapman; Harlan H. & Cihlar; Tomas & Eisenberg; Eugene J. & He; Gong-Xin & Kernan; Michael R. & Lee; William A. & Prisbe; Ernest J. & Rohloff; John C. & Sparacino; Mark L.
    Assignee(s): Gilead Sciences, Inc.

    A novel method has led to the identification of novel mixed ester-amidates of PMPA for retroviral or hepadnaviral therapy, including compounds of structure (5a) having substituent groups as defined herein. Compositions of these novel compounds in pharmaceutically acceptable excipients and their use in therapy and prophylaxis are provided.

    Patent expiration dates:

    • April 17, 2025
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      Drug substance
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      Drug product
    • October 17, 2025
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      Pediatric exclusivity
  • Prodrugs of phosphonate nucoleotide analogues
    Patent 7,803,788
    Issued: September 28, 2010
    Inventor(s): Becker; Mark W. & Chapman; Harlan H. & Cihlar; Tomas & Eisenberg; Eugene J. & He; Gong-Xin & Kernan; Michael R. & Lee; William A. & Prisbe; Ernest J. & Rohloff; John C. & Sparacino; Mark L.
    Assignee(s): Gilead Sciences, Inc.

    A novel method has led to the identification of novel mixed ester-amidates of PMPA for retroviral or hepadnaviral therapy, including compounds of structure (5a) having substituent groups as defined herein. Compositions of these novel compounds in pharmaceutically acceptable excipients and their use in therapy and prophylaxis are provided.

    Patent expiration dates:

    • February 2, 2022
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      Patent use: TREATMENT OF HIV INFECTION
  • Tenofovir alafenamide hemifumarate
    Patent 8,754,065
    Issued: June 17, 2014
    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
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      Patent use: TREATMENT OF HIV INFECTION
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • February 15, 2033
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      Pediatric exclusivity
  • 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
    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): including stereoisomers and pharmaceutically acceptable salts thereof, wherein R1, X, W, Y1, Y2, Z1, and Z4are as defined herein. Methods associated with preparation and use of such compounds, as well as pharmaceutical compositions comprising such compounds, are also disclosed.

    Patent expiration dates:

    • December 19, 2033
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      Drug substance
      ✓ 
      Drug product
  • Tenofovir alafenamide hemifumarate
    Patent 9,296,769
    Issued: March 29, 2016
    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
      ✓ 
      Patent use: TREATMENT OF HIV INFECTION
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • February 15, 2033
      ✓ 
      Pediatric exclusivity
  • 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
    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
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • 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
    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): including stereoisomers and pharmaceutically acceptable salts thereof, wherein R1, X, W, Y1, Y2, Z1, and Z4 are as defined herein. Methods associated with preparation and use of such compounds, as well as pharmaceutical compositions comprising such compounds, are also disclosed.

    Patent expiration dates:

    • December 19, 2033
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      Drug substance
      ✓ 
      Drug product

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:

    • June 18, 2022 - NEW PATIENT POPULATION
    • February 7, 2023 - NEW CHEMICAL ENTITY
    • February 24, 2024 - LABELING REVISIONS RELATED TO CLINICAL STUDIES
    • June 18, 2026 -
    • October 7, 2028 -

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.

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