Gomekli is a drug owned by Springworks Therapeutics Inc. It is protected by 22 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 Oct 10, 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. | |||
| 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
(14 years from now) | Active |
| US11084780 | Door construction |
Feb, 2041
(14 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). | |||
| US12390430 | NA |
Oct, 2044
(18 years from now) | Active |
| US12383517 | Dosage Forms Of Mirdametinib |
Mar, 2044
(18 years from now) | Active |
| US12029711 | Dosage forms of mirdametinib |
Mar, 2044
(18 years from now) | Active |
| US11806322 | Mirdametinib treatment |
Apr, 2043
(17 years from now) | Active |
| US12220390 | Mirdametinib treatment |
Mar, 2043
(17 years from now) | Active |
| US12324791 | Mirdametinib treatment |
Mar, 2043
(17 years from now) | Active |
| US11839595 | Mirdametinib treatment |
Mar, 2043
(17 years from now) | Active |
| US12257215 | Mirdametinib treatment |
Mar, 2043
(17 years from now) | Active |
| US11883375 | 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
(14 years from now) | Active |
| US12357597 | Dispersible Formulations Of N-((R)-2,3-Dihydroxypropoxy)-3,4-Difluoro-2-(2-Fluoro-4-Iodo-Phenylamino)-Benazmide And Uses Thereof |
Feb, 2041
(14 years from now) | Active |
| US12295925 | Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib |
Feb, 2041
(14 years from now) | Active |
| US11819487 | Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib |
Feb, 2041
(14 years from now) | Active |
| US11806321 | Non-linear dosing of mirdametinib |
Feb, 2041
(14 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
(14 years from now) | Active |
| US12263146 | Non-linear dosing of mirdametinib |
Feb, 2041
(14 years from now) | Active |
| US12275688 | Crystalline solids of MEK inhibitor N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof |
Feb, 2041
(14 years from now) | Active |
| US12011424 | Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib |
Feb, 2041
(14 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
(14 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
(14 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Gomekli's patents.
Latest Legal Activities on Gomekli's Patents
Given below is the list of recent legal activities going on the following patents of Gomekli.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed | 26 Aug, 2025 | US12390430 |
| Email Notification | 19 Aug, 2025 | US12390430 |
| Recordation of Patent Grant Mailed | 19 Aug, 2025 | US12383517 |
| Recordation of Patent eGrant | 19 Aug, 2025 | US12390430 |
| Patent eGrant Notification | 19 Aug, 2025 | US12390430 |
| Mail Patent eGrant Notification | 19 Aug, 2025 | US12390430 |
| Patent Issue Date Used in PTA Calculation | 19 Aug, 2025 | US12390430 |
| Recordation of Patent eGrant | 12 Aug, 2025 | US12383517 |
| Email Notification | 12 Aug, 2025 | US12383517 |
| Mail Patent eGrant Notification | 12 Aug, 2025 | US12383517 |
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 Oct 10, 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 capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2MG | CAPSULE | Prescription | ORAL |
| 1MG | CAPSULE | Prescription | ORAL |