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Generic Mekinist Availability

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

MEKINIST (trametinib dimethyl sulfoxide - tablet;oral)

  • Manufacturer: NOVARTIS PHARMS CORP
    Approval date: May 29, 2013
    Strength(s): EQ 0.5MG, EQ 1MG, EQ 2MG [RLD]

Has a generic version of Mekinist been approved?

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

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

  • Pyrimidine compound and medical use thereof
    Patent 7,378,423
    Issued: May 27, 2008
    Inventor(s): Kawasaki; Hisashi & Abe; Hiroyuki & Hayakawa; Kazuhide & Iida; Tetsuya & Kikuchi; Shinichi & Yamaguchi; Takayuki & Nanayama; Toyomichi & Kurachi; Hironori & Tamaru; Masahiro & Hori; Yoshikazu & Takahashi; Mitsuru & Yoshida; Takayuki & Sakai; Toshiyuki
    Assignee(s): Japan Tobacco Inc.
    The present invention relates to a pyrimidine compound or a pharmaceutically acceptable salt thereof represented by the following formula [I] wherein each symbol is as defined in the specification and a method of therapeutically or prophylactically treating an undesirable cell proliferation, comprising administering such a compound. The compound of the present invention has superior activity in suppressing undesirable cell proliferation, particularly, an antitumor activity, and is useful as an antitumor agent for the prophylaxis or treatment of cancer, rheumatism, and the like. In addition, the compound of the present invention can be a more effective antitumor agent when used in combination with other antitumor agents such as an alkylating agent or metabolism antagonist.
    Patent expiration dates:
    • September 13, 2025
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      Drug substance
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      Drug product
  • Pharmaceutical composition
    Patent 8,580,304
    Issued: November 12, 2013
    Assignee(s): GlaxoSmithKline LLC
    Disclosed are novel pharmaceutical compositions containing 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 dimethyl sulfoxide solvate, methods of using the compositions in therapy and processes for preparing the same.
    Patent expiration dates:
    • January 28, 2032
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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: MEKENIST IN COMBINATION WITH DABRAFENIB FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA
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      Drug substance
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      Drug product
  • Pyrimidine compound and medical use thereof
    Patent 8,835,443
    Issued: September 16, 2014
    Assignee(s): Japan Tobacco Inc.
    The present invention relates to a pyrimidine compound or a pharmaceutically acceptable salt thereof represented by the following formula [I] wherein each symbol is as defined in the specification and a method of therapeutically or prophylactically treating an undesirable cell proliferation, comprising administering such a compound. The compound of the present invention has superior activity in suppressing undesirable cell proliferation, particularly, an antitumor activity, and is useful as an antitumor agent for the prophylaxis or treatment of cancer, rheumatism, and the like. In addition, the compound of the present invention can be a more effective antitumor agent when used in combination with other antitumor agents such as an alkylating agent or metabolism antagonist.
    Patent expiration dates:
    • September 13, 2025
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      Patent use: IN COMBINATION WITH DABRAFENIB FOR THE TREATMENT OF UNRESECTABLE OR METASTATIC MELANOMA.
    • September 13, 2025
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      Patent use: TREATMENT OF UNRESECTABLE OR METASTATIC MELANOMA
  • Pharmaceutical composition
    Patent 9,155,706
    Issued: October 13, 2015
    Assignee(s): Novartis AG
    Disclosed are novel pharmaceutical compositions containing 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 dimethyl sulfoxide solvate, methods of using the compositions in therapy and processes for preparing the same.
    Patent expiration dates:
    • January 28, 2032
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      Drug product
  • Pharmaceutical composition
    Patent 9,271,941
    Issued: March 1, 2016
    Assignee(s): Novartis AG
    Disclosed are novel pharmaceutical compositions containing 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 dimethyl sulfoxide solvate, methods of using the compositions in therapy and processes for preparing the same.
    Patent expiration dates:
    • January 28, 2032
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      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:
    • 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 8, 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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