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Generic Tafinlar Availability

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

TAFINLAR (dabrafenib mesylate - capsule;oral)

  • Manufacturer: NOVARTIS PHARMS CORP
    Approval date: May 29, 2013
    Strength(s): EQ 50MG BASE, EQ 75MG BASE [RLD]

Has a generic version of Tafinlar been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tafinlar. 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: About generic drugs.

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.

  • Benzene sulfonamide thiazole and oxazole compounds
    Patent 7,994,185
    Issued: August 9, 2011
    Inventor(s): Rheault; Tara Renae
    Assignee(s): Glaxo Smith Kline LLC
    The present invention provides thiazole sulfonamide and oxazole sulfonamide compounds, compositions containing the same, as well as processes for the preparation and methods for their use as pharmaceutical agents.
    Patent expiration dates:
    • January 20, 2030
      ✓ 
      Patent use: TREATMENT OF MELANOMA
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      Drug substance
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      Drug product
  • Benzene sulfonamide thiazole and oxazole compounds
    Patent 8,415,345
    Issued: April 9, 2013
    Assignee(s): Glaxo SmithKline LLC
    The present invention provides thiazole sulfonamide and oxazole sulfonamide compounds, compositions containing the same, as well as processes for the preparation and methods for their use as pharmaceutical agents.
    Patent expiration dates:
    • January 20, 2030
      ✓ 
      Patent use: TREATMENT OF MELANOMA
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      Drug substance
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      Drug product
  • Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
    Patent 8,703,781
    Issued: April 22, 2014
    Assignee(s): GlaxoSmithKline LLC
    A novel combination comprising the MEK inhibitor N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)6,8-dimethyl;-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide, or a pharmaceutically acceptable salt or solvate thereof, with a B-Raf inhibitor, particularly N-{3-[5-(2-Amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2-fluorophen-}-2,6-difluorobenzenesulfonamide or a pharmaceutically acceptable salt thereof, pharmaceutical compositions comprising the same and methods of using such combinations and compositions in the treatment of conditions in which the inhibition of MEK and/or B-Raf is beneficial, eg. cancer.
    Patent expiration dates:
    • October 15, 2030
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      Patent use: TAFINLAR IN COMBINATION WITH TRAMETINIB FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA
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      Drug substance
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      Drug product
  • Benzene sulfonamide thiazole and oxazole compounds
    Patent 9,233,956
    Issued: January 12, 2016
    Assignee(s): Novartis AG
    The present invention provides thiazole sulfonamide and oxazole sulfonamide compounds, compositions containing the same, as well as processes for the preparation and methods for their use as pharmaceutical agents.
    Patent expiration dates:
    • May 4, 2029
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      Patent use: TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E MUTATIONS AFTER CONFIRMING THE PRESENCE OF BRAF V600E MUTATION

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:
    • January 8, 2017 - TRAMETINIB, IN COMBINATION WITH DABRAFENIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
    • May 29, 2018 - NEW CHEMICAL ENTITY
    • November 20, 2018 - INFORMATION ADDED TO THE CLINICAL STUDIES SECTION REGARDING USE FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
    • May 29, 2020 - ORPHAN DRUG EXCLUSIVITY
    • January 9, 2021 - ORPHAN DRUG EXCLUSIVITY

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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