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Generic Sirturo Availability

Last updated on Oct 6, 2021.

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

SIRTURO (bedaquiline fumarate - tablet;oral)

  • Manufacturer: JANSSEN THERAP
    Approval date: December 28, 2012
    Strength(s): EQ 100MG BASE [RLD]
  • Manufacturer: JANSSEN THERAP
    Approval date: May 27, 2020
    Strength(s): EQ 20MG BASE [RLD]

Has a generic version of Sirturo been approved?

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

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

  • Mycobacterial inhibitors
    Patent 7,498,343
    Issued: March 3, 2009
    Inventor(s): Van Gestel; Jozef Frans Elisabetha & Guillemont; Jérôme Emile Georges & Venet; Marc Gaston & Poignet; Hervé Jean Joseph & Decrane; Laurence Françoise Bernadette & Vernier; Daniel F. J. & Odds; Frank Christopher
    Assignee(s): Janssen Pharmaceutica N.V.

    The present invention relates to novel substituted quinoline derivatives according to the general Formula (Ia) or the general Formula (Ib) the pharmaceutically acceptable acid or base addition salts thereof, the stereochemically isomeric forms thereof, the tautomeric forms thereof and the N-oxide forms thereof. The claimed compounds are useful for the treatment of mycobacterial diseases, particularly those diseases caused by pathogenic mycobacteria such as Mycobacterium tuberculosis, M. bovis, M. avium and M. marinum. In particular, compounds are claimed in which, independently from each other, R1 is bromo, p=1, R2 is alkyloxy, R3 is optionally substituted naphthyl or phenyl, q=1, R4 and R5 each independently are hydrogen, methyl or ethyl, R6 is hydrogen, r is equal to 0 or 1 and R7 is hydrogen. Also claimed is a composition comprising a pharmaceutically acceptable carrier and, as active ingredient, a therapeutically effective amount of the claimed compounds, the use of the claimed compounds or compositions for the manufacture of a medicament for the treatment of mycobacterial diseases and a process for preparing the claimed compounds.

    Patent expiration dates:

    • December 1, 2026
      Drug substance
      Drug product
  • Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol
    Patent 8,546,428
    Issued: October 1, 2013
    Assignee(s): Janssen Pharmaceutica NV

    The present invention relates to the fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-beta-phenyl-3-quinolineethanol, pharmaceutical compositions comprising as active ingredient said salt and to processes for their preparation.

    Patent expiration dates:

    • March 19, 2029
      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:

    • August 9, 2022 - NEW PATIENT POPULATION
    • August 9, 2026 -
    • May 27, 2027 -


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.