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Generic Symtuza Availability

Last updated on Sep 8, 2021.

Symtuza is a brand name of cobicistat/darunavir/emtricitabine/tenofovir alafenamide, approved by the FDA in the following formulation(s):

SYMTUZA (cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate - tablet;oral)

  • Manufacturer: JANSSEN PRODS
    Approval date: July 17, 2018
    Strength(s): 150MG;800MG;200MG;EQ 10MG BASE [RLD]

Has a generic version of Symtuza been approved?

No. There is currently no therapeutically equivalent version of Symtuza available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Symtuza. 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.

  • Use of solid carrier particles to improve the processability of a pharmaceutical agent
    Patent 10,039,718
    Issued: August 7, 2018
    Assignee(s): Gilead Sciences, Inc.

    The invention provides a composition comprising, a compound of formula (I): or a pharmaceutically acceptable salt thereof and a plurality of solid carrier particles, as well as methods for using the composition to inhibit the activity of cytochrome P-450.

    Patent expiration dates:

    • October 6, 2032
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  • Patent 10,786,518

    Patent expiration dates:

    • July 19, 2038
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      Patent use: TREATMENT OF HIV-1 INFECTION IN ADULT OR PEDIATRIC PATIENTS (>=40 KG) WITH <50 COPIES/ML HIV-1 RNA AFTER >= 6 MONTHS ON PRIOR ANTIRETROVIRAL REGIMEN AND NO KNOWN DARUNAVIR OR TENOFOVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS
  • Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers
    Patent 6,703,396
    Issued: March 9, 2004
    Inventor(s): Dennis C.; Liotta & Raymond F.; Schinazi & Woo-Baeg; Choi
    Assignee(s): Emory University

    A process for the resolution of a racemic mixture of nucleoside enantiomers that includes the step of exposing the racemic mixture to an enzyme that preferentially catalyzes a reaction in one of the enantiomers. The nucleoside enantiomer (−)-2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane is an effective antiviral agent against HIV, HBV, and other viruses replicating in a similar manner.

    Patent expiration dates:

    • March 9, 2021
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  • 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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  • Pseudopolymorphic forms of a HIV protease inhibitor
    Patent 7,700,645
    Issued: April 20, 2010
    Inventor(s): Vermeersch; Hans Wim Pieter & Thon&#xe9;; Daniel Joseph Christiaan & Janssens; Luc Donn&#xe9; Marie-Louise
    Assignee(s): Tibotec Pharmaceuticals Ltd.

    New pseudopolymorphic forms of (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl(1S,2R)-3-[[(4-aminophenyl)sulfonyl](isobutyl)amino]-1-benzyl-2-hydroxypropylcarbamate and processes for producing them are disclosed.

    Patent expiration dates:

    • December 26, 2026
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  • 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-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
    • February 2, 2022
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      Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
  • Modulators of pharmacokinetic properties of therapeutics
    Patent 8,148,374
    Issued: April 3, 2012
    Inventor(s): Desai; Manoj C. & Liu; Hongtao & Xu; Lianhong
    Assignee(s): Gilead Sciences, Inc.

    The present application provides for a compound of Formula IV, or a pharmaceutically acceptable salt, solvate, and/or ester thereof, compositions containing such compounds, therapeutic methods that include the administration of such compounds, and therapeutic methods and include the administration of such compounds with at least one additional therapeutic agent.

    Patent expiration dates:

    • September 3, 2029
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      Patent use: TX OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENATES IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
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    • September 3, 2029
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      Patent use: TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO HAVE NO PRIOR ARV TREATMENT HISTORY
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    • September 3, 2029
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      Patent use: TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MONTHS
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    • September 3, 2029
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      Patent use: TX OF HIV1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS & PEDIATRIC PATIENTS AT LEAST 40KG HAVING NO PRIOR ARV TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MO
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    • September 3, 2029
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      Patent use: TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY
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    • September 3, 2029
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      Patent use: TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
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  • Pseudopolymorphic forms of a HIV protease inhibitor
    Patent 8,518,987
    Issued: August 27, 2013
    Assignee(s): Janssen R&#x26;D Ireland

    New pseudopolymorphic forms of (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl (1S,2R)-3-[[(4-aminophenyl)sulfonyl](isobutyl)amino]-1-benzyl-2-hydroxypropylcarbamate and processes for producing them are disclosed.

    Patent expiration dates:

    • February 16, 2024
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  • 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-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
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    • August 15, 2032
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      Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
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  • 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-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
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      Drug substance
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    • August 15, 2032
      ✓ 
      Patent use: TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
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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:

    • July 17, 2021 - NEW COMBINATION

More about Symtuza (cobicistat / darunavir / emtricitabine / tenofovir alafenamide)

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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.