Generic Sirturo Availability
Last updated on Apr 10, 2025.
Sirturo is a brand name of bedaquiline, approved by the FDA in the following formulation(s):
SIRTURO (bedaquiline fumarate - tablet;oral)
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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]
Is there a generic version of Sirturo available?
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.
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Mycobacterial inhibitors
Patent 7,498,343
Issued: March 3, 2009
Inventor(s): Van Gestel; Jozef Frans Elisabetha et al.
Assignee(s): Janssen Pharmaceutica N.V. (Beerse, BE)The present invention relates to novel substituted quinoline derivatives according to the general Formula (Ia) or the general Formula (Ib) ##STR00001## 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, R.sup.1 is bromo, p=1, R.sup.2 is alkyloxy, R.sup.3 is optionally substituted naphthyl or phenyl, q=1, R.sup.4 and R.sup.5 each independently are hydrogen, methyl or ethyl, R.sup.6 is hydrogen, r is equal to 0 or 1 and R.sup.7 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✓✓✓
- December 1, 2026
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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
Inventor(s): Hegyi Jean François Alexandre Lucas & Aelterman Wim Albert Alex & Lang Yolande Lydia & Stokbroekx Sigrid Carl Maria & Leys Carina & Van Remoortere Peter Jozef Maria & Faure Anne
Assignee(s): Janssen Pharmaceutica NVThe 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✓✓✓
- March 19, 2029
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, 2026 - INDICATED AS PART OF COMBINATION THERAPY IN THE TREATMENT OF PEDIATRIC PATIENTS (12 TO LESS THAN 18 YEARS OF AGE AND WEIGHING AT LEAST 30 KG) WITH PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS
- May 27, 2027 - INDICATED AS PART OF COMBINATION THERAPY IN THE TREATMENT OF PEDIATRIC PATIENTS 5 YEARS AND OLDER TO LESS THAN 12 YEARS OF AGE AND WEIGHING AT LEAST 15 KG WITH PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS (MDR-TB)
- June 21, 2027 - REVISIONS TO THE LABELING TO REFLECT THE RESULTS OF A CLINICAL STUDY TO FULFILL POST MARKETING REQUIREMENT 1988-001
More about Sirturo (bedaquiline)
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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.