Generic Mekinist Availability
Last updated on Apr 10, 2025.
Mekinist is a brand name of trametinib, approved by the FDA in the following formulation(s):
MEKINIST (trametinib dimethyl sulfoxide - solution;oral)
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Manufacturer: NOVARTIS
Approval date: March 16, 2023
Strength(s): EQ 0.05MG BASE/ML [RLD]
MEKINIST (trametinib dimethyl sulfoxide - tablet;oral)
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Manufacturer: NOVARTIS
Approval date: May 29, 2013
Strength(s): EQ 0.5MG [RLD] [AB], EQ 1MG (discontinued) [RLD] [AB], EQ 2MG [RLD] [AB]
Is there a generic version of Mekinist available?
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: 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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Method of adjuvant cancer treatment
Patent 10,869,869
Issued: December 22, 2020
Inventor(s): Laquerre Sylvie & Lebowitz Peter F.
Assignee(s): Novartis AGThe present invention provides a method of providing adjuvant treatment to a human patient which comprises administering to such a patient therapeutically effective doses of dabrafenib and trametinib for a time period sufficient to increase relapse-free survival (RFS).
Patent expiration dates:
- August 30, 2033✓
- August 30, 2033
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Method of adjuvant cancer treatment
Patent 10869869*PE
Issued: December 22, 2020
Inventor(s): Laquerre Sylvie & Lebowitz Peter F.
Assignee(s): Novartis AGThe present invention provides a method of providing adjuvant treatment to a human patient which comprises administering to such a patient therapeutically effective doses of dabrafenib and trametinib for a time period sufficient to increase relapse-free survival (RFS).
Patent expiration dates:
- February 28, 2034
- February 28, 2034
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Pyrimidine compound and medical use thereof
Patent 7,378,423
Issued: May 27, 2008
Inventor(s): Kawasaki; Hisashi et al.
Assignee(s): Japan Tobacco Inc. (Tokyo, JP)The present invention relates to a pyrimidine compound or a pharmaceutically acceptable salt thereof represented by the following formula [I] ##STR00001## 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:
- May 29, 2027✓✓
- May 29, 2027
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Pyrimidine compound and medical use thereof
Patent 7378423*PED
Issued: May 27, 2008
Inventor(s): Kawasaki; Hisashi et al.
Assignee(s): Japan Tobacco Inc. (Tokyo, JP)The present invention relates to a pyrimidine compound or a pharmaceutically acceptable salt thereof represented by the following formula [I] ##STR00001## 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:
- November 29, 2027✓
- November 29, 2027
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Pharmaceutical composition
Patent 8,580,304
Issued: November 12, 2013
Inventor(s): DeMarini Douglas J. & Henriquez Francisco & Le Ngocdiep T. & Wang Lihong
Assignee(s): GlaxoSmithKline LLCDisclosed 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✓
- January 28, 2032
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Pharmaceutical composition
Patent 8580304*PED
Issued: November 12, 2013
Inventor(s): DeMarini Douglas J. & Henriquez Francisco & Le Ngocdiep T. & Wang Lihong
Assignee(s): GlaxoSmithKline LLCDisclosed 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:
- July 28, 2032✓
- July 28, 2032
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Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent 8,703,781
Issued: April 22, 2014
Inventor(s): Dumble Melissa & Kumar Rakesh & Laquerre Sylvie & Lebowitz Peter
Assignee(s): GlaxoSmithKline LLCA 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✓✓✓
- October 15, 2030✓✓✓
- October 15, 2030✓✓✓
- October 15, 2030✓✓✓
- October 15, 2030✓✓✓
- October 15, 2030✓✓✓
- October 15, 2030
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Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Patent 8703781*PED
Issued: April 22, 2014
Inventor(s): Dumble Melissa & Kumar Rakesh & Laquerre Sylvie & Lebowitz Peter
Assignee(s): GlaxoSmithKline LLCA 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:
- April 15, 2031✓
- April 15, 2031
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Pyrimidine compound and medical use thereof
Patent 8,835,443
Issued: September 16, 2014
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]
Patent expiration dates:
- June 10, 2025✓
- June 10, 2025✓
- June 10, 2025✓
- June 10, 2025✓
- June 10, 2025✓
- June 10, 2025✓
- June 10, 2025✓
- June 10, 2025
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Pyrimidine compound and medical use thereof
Patent 8835443*PED
Issued: September 16, 2014
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]
Patent expiration dates:
- December 10, 2025✓
- December 10, 2025
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Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Patent 8,952,018
Issued: February 10, 2015
Inventor(s): Dumble Melissa & Kumar Rakesh & Laquerre Sylvie & Lebowitz Peter
Assignee(s): GlaxosmithKline LLCA 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-fluorophenyl}-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✓
- October 15, 2030
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Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors
Patent 8952018*PED
Issued: February 10, 2015
Inventor(s): Dumble Melissa & Kumar Rakesh & Laquerre Sylvie & Lebowitz Peter
Assignee(s): GlaxosmithKline LLCA 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-fluorophenyl}-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:
- April 15, 2031✓
- April 15, 2031
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Pharmaceutical composition
Patent 9,155,706
Issued: October 13, 2015
Inventor(s): DeMarini Douglas J. & Henriquez Francisco & Le Ngocdiep T. & Wang Lihong
Assignee(s): Novartis AGDisclosed 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✓
- January 28, 2032
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Pharmaceutical composition
Patent 9155706*PED
Issued: October 13, 2015
Inventor(s): DeMarini Douglas J. & Henriquez Francisco & Le Ngocdiep T. & Wang Lihong
Assignee(s): Novartis AGDisclosed 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:
- July 28, 2032✓
- July 28, 2032
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Pharmaceutical composition
Patent 9,271,941
Issued: March 1, 2016
Inventor(s): DeMarini Douglas J. & Henriquez Francisco & Le Ngocdiep T. & Wang Lihong
Assignee(s): Novartis AGDisclosed 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✓
- January 28, 2032
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Pharmaceutical composition
Patent 9271941*PED
Issued: March 1, 2016
Inventor(s): DeMarini Douglas J. & Henriquez Francisco & Le Ngocdiep T. & Wang Lihong
Assignee(s): Novartis AGDisclosed 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:
- July 28, 2032✓
- July 28, 2032
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Pharmaceutical composition
Patent 9,399,021
Issued: July 26, 2016
Inventor(s): DeMarini Douglas J. & Henriquez Francisco & Le Ngocdiep T. & Wang Lihong
Assignee(s): Novartis AGDisclosed 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✓
- January 28, 2032
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Pharmaceutical composition
Patent 9399021*PED
Issued: July 26, 2016
Inventor(s): DeMarini Douglas J. & Henriquez Francisco & Le Ngocdiep T. & Wang Lihong
Assignee(s): Novartis AGDisclosed 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:
- July 28, 2032✓
- July 28, 2032
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:
- April 30, 2025 - TRAMETINIB IS INDICATED, IN COMBINATION WITH DABRAFENIB, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION
- May 4, 2025 - TRAMETINIB AND DABRAFENIB IN COMBINATION, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS
- June 22, 2025 - TRAMETINIB IS INDICATED IN COMBINATION WITH DABRAFENIB, FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH UNRESECTABLE OR METASTATIC SOLID TUMORS WITH BRAF V600E MUTATION WHO HAVE PROGRESSED FOLLOWING PRIOR TREATMENT AND HAVE
- October 30, 2025 - PEDIATRIC EXCLUSIVITY
- November 4, 2025 - PEDIATRIC EXCLUSIVITY
- December 22, 2025 - PEDIATRIC EXCLUSIVITY
- March 16, 2026 - TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA WITH A BRAF V600 MUTATION WHO REQUIRE SYSTEMIC THERAPY
- March 16, 2026 - NEW PRODUCT
- September 16, 2026 - PEDIATRIC EXCLUSIVITY
- March 16, 2030 - TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY
- September 16, 2030 - PEDIATRIC EXCLUSIVITY
More about Mekinist (trametinib)
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- Drug class: multikinase inhibitors
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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. |
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.