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Generic Tracleer Availability

Last updated on Sep 8, 2021.

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

TRACLEER (bosentan - tablet, for suspension;oral)

  • Manufacturer: ACTELION
    Approval date: September 5, 2017
    Strength(s): 32MG [RLD]

TRACLEER (bosentan - tablet;oral)

  • Manufacturer: ACTELION
    Approval date: November 20, 2001
    Strength(s): 62.5MG [RLD] [AB], 125MG [RLD] [AB]

Has a generic version of Tracleer been approved?

A generic version of Tracleer has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Tracleer and have been approved by the FDA:

bosentan tablet;oral

  • Manufacturer: AMNEAL PHARMS CO
    Approval date: April 26, 2019
    Strength(s): 62.5MG [AB], 125MG [AB]
  • Manufacturer: HIKMA PHARMS
    Approval date: April 26, 2019
    Strength(s): 62.5MG [AB], 125MG [AB]
  • Manufacturer: NATCO PHARMA LTD
    Approval date: April 26, 2019
    Strength(s): 62.5MG [AB], 125MG [AB]
  • Manufacturer: PAR PHARM INC
    Approval date: April 26, 2019
    Strength(s): 62.5MG [AB], 125MG [AB]
  • Manufacturer: SUN PHARM
    Approval date: April 26, 2019
    Strength(s): 62.5MG [AB], 125MG [AB]
  • Manufacturer: WATSON LABS INC
    Approval date: April 26, 2019
    Strength(s): 62.5MG [AB], 125MG [AB]
  • Manufacturer: ZYDUS PHARMS
    Approval date: April 26, 2019
    Strength(s): 62.5MG [AB], 125MG [AB]

Note: No generic formulation of the following product is available.

  • bosentan - tablet, for suspension;oral

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

  • Dispersible bosentan tablet
    Patent 7,959,945
    Issued: June 14, 2011
    Inventor(s): Holman; Lovelace & Trenktrog; Timm
    Assignee(s): Actelion Pharmaceuticals Ltd.

    The invention relates to dispersible tablets comprising the compound 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-2-(pyrimidin-2-yl)-pyrimidin-4-yl]-benzenesulfonamide.

    Patent expiration dates:

    • December 28, 2027
      ✓ 
      Drug product
  • Dispersible bosentan tablet
    Patent 8,309,126
    Issued: November 13, 2012
    Inventor(s): Holman; Lovelace & Trenktrog; Timm
    Assignee(s): Actelion Pharmaceuticals, Ltd.

    The invention relates to dispersible tablets comprising the compound 4-tert-butyl-N-[6-(2-hydroxy-ethoxy)-5-(2-methoxy-phenoxy)-2-(pyrimidin-2-yl)-pyrimidin-4-yl]-benzenesulfonamide.

    Patent expiration dates:

    • May 15, 2026
      ✓ 
      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:

    • September 5, 2024 - FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION S
    • September 5, 2024 -

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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.