Gomekli is a drug owned by Springworks Therapeutics Inc. It is protected by 14 US drug patents filed in 2025 out of which none have expired yet. Gomekli's patents will be open to challenges from 11 February, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 15, 2044. Details of Gomekli's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US11084780 | Door construction |
Feb, 2041
(15 years from now) | Active |
| US11066358 | 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 |
Feb, 2041
(15 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12029711 | Dosage forms of mirdametinib |
Mar, 2044
(18 years from now) | Active |
| US11883375 | Mirdametinib treatment |
Mar, 2043
(17 years from now) | Active |
| US12220390 | Mirdametinib treatment |
Mar, 2043
(17 years from now) | Active |
| US11806322 | Mirdametinib treatment |
Mar, 2043
(17 years from now) | Active |
| US11839595 | Mirdametinib treatment |
Mar, 2043
(17 years from now) | Active |
| US11571402 | Dispersible formulations of N-((R)-2,3-dihydroxypropoly)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof |
Feb, 2041
(15 years from now) | Active |
| US12011424 | Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib |
Feb, 2041
(15 years from now) | Active |
| US11819487 | Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib |
Feb, 2041
(15 years from now) | Active |
| US11806321 | Non-linear dosing of mirdametinib |
Feb, 2041
(15 years from now) | Active |
| US11453641 | Methods of treating neurofibromatosis with N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide |
Feb, 2041
(15 years from now) | Active |
| US12090128 | Dispersible formulations of n-((r)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benazmide and uses thereof |
Feb, 2041
(15 years from now) | Active |
| US12037306 | Methods of treating neurofibromatosis type 1 with N-((R))-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide |
Feb, 2041
(15 years from now) | Active |
FDA has granted several exclusivities to Gomekli. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Gomekli, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Gomekli.
Exclusivity Information
Gomekli holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2032. Details of Gomekli's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 11, 2030 |
| Orphan Drug Exclusivity(ODE-488) | Feb 11, 2032 |
US patents provide insights into the exclusivity only within the United States, but Gomekli is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Gomekli's family patents as well as insights into ongoing legal events on those patents.
Gomekli's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Gomekli's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 15, 2044 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gomekli Generics:
There are no approved generic versions for Gomekli as of now.
About Gomekli
Gomekli is a drug owned by Springworks Therapeutics Inc. Gomekli uses Mirdametinib as an active ingredient. Gomekli was launched by Springworks in 2025.
Approval Date:
Gomekli was approved by FDA for market use on 11 February, 2025.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Gomekli is 11 February, 2025, its NCE-1 date is estimated to be 11 February, 2029.
Active Ingredient:
Gomekli uses Mirdametinib as the active ingredient. Check out other Drugs and Companies using Mirdametinib ingredient
Dosage:
Gomekli is available in the following dosage forms - capsule form for oral use, tablet, for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG | TABLET, FOR SUSPENSION | Prescription | ORAL |
| 2MG | CAPSULE | Prescription | ORAL |