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Generic Rukobia Availability

Last updated on Sep 8, 2021.

Rukobia is a brand name of fostemsavir, approved by the FDA in the following formulation(s):

RUKOBIA (fostemsavir tromethamine - tablet, extended release;oral)

  • Manufacturer: VIIV HLTHCARE
    Approval date: July 2, 2020
    Strength(s): EQ 600MG BASE [RLD]

Has a generic version of Rukobia been approved?

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

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

  • Prodrugs of piperazine and substituted piperidine antiviral agents
    Patent 7,745,625
    Issued: June 29, 2010
    Inventor(s): Ueda; Yasutsugu & Connolly; Timothy P. & Kadow; John F. & Meanwell; Nicholas A. & Wang; Tao & Chen; Chung-Pin H. & Yeung; Kap-Sun & Zhang; Zhongxing & Leahy; David Kenneth & Pack; Shawn K. & Soundararajan; Nachimuthu & Sirard; Pierre & Levesque; Kathia & Thoraval; Dominique
    Assignee(s): Bristol-Myers Squibb Company

    This invention provides for prodrug Compounds I, pharmaceutical compositions thereof, and their use in treating HIV infection. wherein: X is C or N with the proviso that when X is N, R1 does not exist; W is C or N with the proviso that when W is N, R2 does not exist; V is C; E is hydrogen or a pharmaceutically acceptable salt thereof; and Y is selected from the group consisting of Also, this invention provides for intermediate Compounds II useful in making prodrug Compounds I. wherein: L and M are independently selected from the group consisting of C1-C6 alkyl, phenyl, benzyl, trialkylsilyl, -2,2,2-trichloroethoxy and 2-trimethylsilylethoxy.

    Patent expiration dates:

    • November 19, 2027
      ✓ 
      Drug substance
  • Prodrugs of piperazine and substituted piperidine antiviral agents
    Patent 8,168,615
    Issued: May 1, 2012
    Inventor(s): Ueda; Yasutsugu & Connolly; Timothy P. & Kadow; John F. & Meanwell; Nicholas A. & Wang; Tao & Chen; Chung-Pin H. & Yeung; Kap-Sun & Zhang; Zhongxing & Leahy; David Kenneth & Pack; Shawn K. & Soundararajan; Nachimuthu & Sirard; Pierre & Levesque; Kathia & Thoraval; Dominique
    Assignee(s): Bristol-Myers Squibb Company

    This invention provides for prodrug Compounds I, pharmaceutical compositions thereof, and their use in treating HIV infection. wherein: X is C or N with the proviso that when X is N, R1 does not exist; W is C or N with the proviso that when W is N, R2 does not exist; V is C; E is hydrogen or a pharmaceutically acceptable salt thereof; and Y is selected from the group consisting of Also, this invention provides for intermediate Compounds II useful in making prodrug Compounds I. wherein: L and M are independently selected from the group consisting of C1-C6 alkyl, phenyl, benzyl, trialkylsilyl, -2,2,2-trichloroethoxy and 2-trimethylsilylethoxy.

    Patent expiration dates:

    • February 25, 2025
      ✓ 
      Drug product
  • Salts of prodrugs of piperazine and substituted piperidine antiviral agents
    Patent 8,461,333
    Issued: June 11, 2013
    Assignee(s): Bristol-Myers Squibb Company

    This invention provides for prodrug Compounds I, pharmaceutical compositions thereof, and their use in treating HIV infection. wherein: X is C or N with the proviso that when X is N, R1 does not exist; W is C or N with the proviso that when W is N, R2 does not exist; V is C; E is hydrogen or a pharmaceutically acceptable salt thereof; and Y is selected from the group consisting of Also, this invention provides for intermediate Compounds II useful in making prodrug Compounds I. wherein: L and M are independently selected from the group consisting of C1-C6 alkyl, phenyl, benzyl, trialkylsilyl, -2,2,2-trichloroethoxy and 2-trimethylsilylethoxy.

    Patent expiration dates:

    • February 25, 2025
      ✓ 
      Drug substance

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 2, 2025 - NEW CHEMICAL ENTITY

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.