Generic Gomekli Availability
Last updated on May 7, 2025.
Gomekli is a brand name of mirdametinib, approved by the FDA in the following formulation(s):
GOMEKLI (mirdametinib - capsule;oral)
GOMEKLI (mirdametinib - tablet, for suspension;oral)
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Manufacturer: SPRINGWORKS
Approval date: February 11, 2025
Strength(s): 1MG [RLD]
Is there a generic version of Gomekli available?
No. There is currently no therapeutically equivalent version of Gomekli available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Gomekli. 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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Compositions of essentially pure form IV of N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof
Patent 11,066,358
Issued: July 20, 2021
Inventor(s): Irdam; Erwin
Assignee(s): WARNER-LAMBERT COMPANY LLC (New York, NY)The present disclosure relates to: a) a crystalline composition of essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide; b) pharmaceutical compositions comprising the crystalline composition of essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide, and, optionally, a pharmaceutically acceptable carrier; and c) methods of treating a tumor, a cancer, or a Rasopathy disorder by administering the crystalline composition of essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide to a subject in need thereof.
Patent expiration dates:
- February 17, 2041✓
- February 17, 2041
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Crystalline solids of MEK inhibitor N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof
Patent 11,084,780
Issued: August 10, 2021
Inventor(s): Patterson; Kristin et al.
Assignee(s): SpringWorks Therapeutics, Inc. (Stamford, CT)The present disclosure relates to a) crystalline forms of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide; b) pharmaceutical compositions comprising one or more crystalline forms of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide, and, optionally, one or more pharmaceutically acceptable carriers; c) methods of treating a tumor a cancer, or a Rasopathy disorder by administering one or more crystalline forms of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide to a subject in need thereof, and methods of producing essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide.
Patent expiration dates:
- February 17, 2041✓
- February 17, 2041
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Methods of treating neurofibromatosis with N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide
Patent 11,453,641
Issued: September 27, 2022
Inventor(s): Irdam; Erwin
Assignee(s): Warner-Lambert Company LLC (New York, NY)The present disclosure relates to: a) a crystalline composition of essentially pure Form IV of N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide; b) pharmaceutical compositions comprising the crystalline composition of essentially pure Form IV of N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide, and, optionally, a pharmaceutically acceptable carrier; and c) methods of treating a tumor, a cancer, or a Rasopathy disorder by administering the crystalline composition of essentially pure Form IV of N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide to a subject in need thereof.
Patent expiration dates:
- February 17, 2041✓
- February 17, 2041
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Dispersible formulations of N-((R)-2,3-dihydroxypropoly)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof
Patent 11,571,402
Issued: February 7, 2023
Inventor(s): Patterson; Kristin et al.
Assignee(s): SpringWorks Therapeutics, Inc. (Stamford, CT)The present disclosure relates to dispersible pharmaceutical compositions comprising N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide, and, optionally, a pharmaceutically acceptable carrier.
Patent expiration dates:
- February 17, 2041✓
- February 17, 2041
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Non-linear dosing of mirdametinib
Patent 11,806,321
Issued: November 7, 2023
Inventor(s): Iloeje; Uchenna H et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)The present disclosure relates to methods for treating certain types of tumors or cancers, such as plexiform neurofibromas (PN), plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), by administering to a patient in need thereof mirdametinib or a pharmaceutically acceptable salt thereof, such as by a certain dosing scheme.
Patent expiration dates:
- February 17, 2041✓
- February 17, 2041
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Mirdametinib treatment
Patent 11,806,322
Issued: November 7, 2023
Inventor(s): Iloeje; Uchenna H et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)The present disclosure relates to a method for treating certain types of tumors or cancers, such as plexiform neurofibromas (PN), plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), by orally administering an effective amount of mirdametinib to the patient, where an amount of mirdametinib is administered on the first day of treatment to provide (i) an AUC.sub.0-tau less than 400 ng.Math.h/mL, (ii) a C.sub.max no more than 40 ng/mL, or (iii) both.
Patent expiration dates:
- March 16, 2043✓
- March 16, 2043
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Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib
Patent 11,819,487
Issued: November 21, 2023
Inventor(s): Iloeje; Uchenna H et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)The present disclosure relates to methods for treating plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), comprising administering to a pediatric patient (e.g., 2 to 15 years of age) in need thereof mirdametinib or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- February 17, 2041✓
- February 17, 2041
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Mirdametinib treatment
Patent 11,839,595
Issued: December 12, 2023
Inventor(s): Iloeje; Uchenna H et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)The present disclosure relates to a method for treating certain types of tumors or cancers, such as plexiform neurofibromas (PN), plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), by orally administering an effective amount of mirdametinib to the patient, where an amount of mirdametinib is administered on the first day of treatment to provide (i) an AUC.sub.0-tau less than 400 ng.Math.h/mL, (ii) a C.sub.max no more than 40 ng/mL, or (iii) both.
Patent expiration dates:
- March 16, 2043✓
- March 16, 2043
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Mirdametinib treatment
Patent 11,883,375
Issued: January 30, 2024
Inventor(s): Iloeje; Uchenna H et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)The present disclosure relates to a method for treating certain types of tumors or cancers, such as plexiform neurofibromas (PN), plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), by orally administering an effective amount of mirdametinib to the patient, where an amount of mirdametinib is administered on the first day of treatment to provide (i) an AUC.sub.0-tau less than 400 ng h/mL, (ii) a C.sub.max no more than 40 ng/mL, or (iii) both.
Patent expiration dates:
- March 16, 2043✓
- March 16, 2043
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Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib
Patent 12,011,424
Issued: June 18, 2024
Inventor(s): Iloeje; Uchenna H et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)The present disclosure relates to methods for treating plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), comprising administering to a pediatric patient (e.g., 2 to 15 years of age) in need thereof mirdametinib or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- February 17, 2041✓
- February 17, 2041
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Dosage forms of mirdametinib
Patent 12,029,711
Issued: July 9, 2024
Inventor(s): Ruggiero; Piero L. et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)The present disclosure relates to an oral dosage form, such as a capsule, comprising (a) mirdametinib having a d90 no more than 250 microns, a d50 no more than 50 microns, or both, and (b) one or more pharmaceutically acceptable excipients. These dosage forms are useful in the treatment of tumors and cancers, such as plexiform neurofibromas (PN), plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), high grade glioma (HGG), low grade ovarian cancer, Langerhans cell histiocytosis (LCH), brain cancer, and a cancer that has metastasized to a patient's brain. The disclosure also related to improved dosage regimens for mirdametinib treatments.
Patent expiration dates:
- March 15, 2044✓✓
- March 15, 2044
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Methods of treating neurofibromatosis type 1 with N-((R))-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide
Patent 12,037,306
Issued: July 16, 2024
Inventor(s): Irdam; Erwin
Assignee(s): WARNER-LAMBERT COMPANY LLC (New York, NY)The present disclosure relates to: a) a crystalline composition of essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide; b) pharmaceutical compositions comprising the crystalline composition of essentially pure Form IV of N—((R)-2,3-dihvdroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide, and, optionally, a pharmaceutically acceptable carrier; and c) methods of treating a tumor, a cancer, or a Rasopathy disorder by administering the crystalline composition of essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide to a subject in need thereof.
Patent expiration dates:
- February 17, 2041✓
- February 17, 2041
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Dispersible formulations of n-((r)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benazmide and uses thereof
Patent 12,090,128
Issued: September 17, 2024
Inventor(s): Patterson; Kristin et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)The present disclosure relates to dispersible pharmaceutical compositions comprising N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide, and, optionally, a pharmaceutically acceptable carrier.
Patent expiration dates:
- February 17, 2041✓✓
- February 17, 2041
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Mirdametinib treatment
Patent 12,220,390
Issued: February 11, 2025
Inventor(s): Iloeje; Uchenna H. et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)The present disclosure relates to a method for treating certain types of tumors or cancers, such as plexiform neurofibromas (PN), plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), by orally administering an effective amount of mirdametinib to the patient, where an amount of mirdametinib is administered on the first day of treatment to provide (i) an AUC.sub.0-tau less than 400 ng.Math.h/mL, (ii) a C.sub.max no more than 40 ng/mL, or (iii) both.
Patent expiration dates:
- March 16, 2043✓
- March 16, 2043
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Mirdametinib treatment
Patent 12,257,215
Issued: March 25, 2025
Inventor(s): Iloeje; Uchenna H. et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)The present disclosure relates to a method for treating certain types of tumors or cancers, such as plexiform neurofibromas (PN), plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), by orally administering an effective amount of mirdametinib to the patient, where an amount of mirdametinib is administered on the first day of treatment to provide (i) an AUC.sub.0-tau less than 400 ng.Math.h/mL, (ii) a C.sub.max no more than 40 ng/mL, or (iii) both.
Patent expiration dates:
- March 16, 2043✓
- March 16, 2043
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Non-linear dosing of mirdametinib
Patent 12,263,146
Issued: April 1, 2025
Inventor(s): Iloeje; Uchenna H. et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)The present disclosure relates to methods for treating certain types of tumors or cancers, such as plexiform neurofibromas (PN), plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), by administering to a patient in need thereof mirdametinib or a pharmaceutically acceptable salt thereof, such as by a certain dosing scheme.
Patent expiration dates:
- February 17, 2041✓
- February 17, 2041
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Crystalline solids of MEK inhibitor N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof
Patent 12,275,688
Issued: April 15, 2025
Inventor(s): Patterson; Kristin et al.
Assignee(s): SPRINGWORKS THERAPEUTICS, INC. (Stamford, CT)The present disclosure relates to: a) crystalline forms of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide; b) pharmaceutical compositions comprising one or more crystalline forms of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide, and, optionally, one or more pharmaceutically acceptable carriers; c) methods of treating a tumor a cancer, or a Rasopathy disorder by administering one or more crystalline forms of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide to a subject in need thereof; and methods of producing essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide.
Patent expiration dates:
- February 17, 2041✓✓
- February 17, 2041
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:
- February 11, 2030 - NEW CHEMICAL ENTITY
- February 11, 2032 - TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC PLEXIFORM NEUROFIBROMAS (PN) NOT AMENABLE TO COMPLETE RESECTION
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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.
