Mirdametinib Patent Expiration
Mirdametinib was first introduced by Springworks Therapeutics Inc
Mirdametinib Patents
Given below is the list of patents protecting Mirdametinib, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Gomekli | US12390430 | Oct 10, 2044 | Springworks | |
| Gomekli | US12029711 | Dosage forms of mirdametinib | Mar 15, 2044 | Springworks |
| Gomekli | US12383517 | Dosage Forms Of Mirdametinib | Mar 15, 2044 | Springworks |
| Gomekli | US12661330 | Mirdametinib Treatment | Feb 05, 2044 | Springworks |
| Gomekli | US11806322 | Mirdametinib treatment | Apr 09, 2043 | Springworks |
| Gomekli | US11839595 | Mirdametinib treatment | Mar 16, 2043 | Springworks |
| Gomekli | US11883375 | Mirdametinib treatment | Mar 16, 2043 | Springworks |
| Gomekli | US12220390 | Mirdametinib treatment | Mar 16, 2043 | Springworks |
| Gomekli | US12257215 | Mirdametinib treatment | Mar 16, 2043 | Springworks |
| Gomekli | US12324791 | Mirdametinib treatment | Mar 16, 2043 | Springworks |
| Gomekli | 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 17, 2041 | Springworks |
| Gomekli | US11084780 | Door construction | Feb 17, 2041 | Springworks |
| Gomekli | US11453641 | Methods of treating neurofibromatosis with N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide | Feb 17, 2041 | Springworks |
| Gomekli | US11571402 | Dispersible formulations of N-((R)-2,3-dihydroxypropoly)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof | Feb 17, 2041 | Springworks |
| Gomekli | US11806321 | Non-linear dosing of mirdametinib | Feb 17, 2041 | Springworks |
| Gomekli | US11819487 | Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib | Feb 17, 2041 | Springworks |
| Gomekli | US12011424 | Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib | Feb 17, 2041 | Springworks |
| Gomekli | US12037306 | Methods of treating neurofibromatosis type 1 with N-((R))-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide | Feb 17, 2041 | Springworks |
| Gomekli | US12090128 | Dispersible formulations of n-((r)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benazmide and uses thereof | Feb 17, 2041 | Springworks |
| Gomekli | US12263146 | Non-linear dosing of mirdametinib | Feb 17, 2041 | Springworks |
| Gomekli | 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 17, 2041 | Springworks |
| Gomekli | US12295925 | Treatment of neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) in pediatric patients with mirdametinib | Feb 17, 2041 | Springworks |
| Gomekli | US12357597 | Dispersible Formulations Of N-((R)-2,3-Dihydroxypropoxy)-3,4-Difluoro-2-(2-Fluoro-4-Iodo-Phenylamino)-Benazmide And Uses Thereof | Feb 17, 2041 | Springworks |
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Clinical Trials
Recent Clinical Trials on Mirdametinib:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma | St. Jude Children's Research Hospital | NA |
RECRUITING
(Sep 1, 2026)
| PHASE1, PHASE2 |
| Mirdametinib in Histiocytic Disorders | Children's Hospital Medical Center, Cincinnati | NA |
RECRUITING
(Sep 1, 2026)
| PHASE2 |
| Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | NA |
RECRUITING
(Sep 1, 2026)
| PHASE1 |
| A Study of Mirdametinib in People With Central Nervous System Tumors | Memorial Sloan Kettering Cancer Center | NA |
RECRUITING
(Sep 1, 2026)
| PHASE1, PHASE2 |
| Combination Therapy (Mirdametinib and Sirolimus) for RAS Mutated Relapsed Refractory Multiple Myeloma | National Cancer Institute (NCI) | NA |
SUSPENDED
(Aug 26, 2026)
| PHASE1, PHASE2 |
| Mirdametinib + BGB-3245 in Advanced Solid Tumors | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | NA |
TERMINATED
(Aug 1, 2026)
| PHASE1, PHASE2 |
| Phase 1/2 Study of Mirdametinib + Vinblastine for Newly Diagnosed/Previously Untreated PLGG + Activation of MAPK | St. Justine's Hospital | NA |
RECRUITING
(Aug 1, 2026)
| PHASE1, PHASE2 |
| MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | NA |
ACTIVE NOT RECRUITING
(Jun 1, 2026)
| PHASE2 |
| Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia | National Cancer Institute (NCI) | NA |
RECRUITING
(May 1, 2026)
| PHASE2 |
| Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF). | Johns Hopkins University | NA |
RECRUITING
(Apr 1, 2026)
| PHASE1, PHASE2 |