drug
mirdametinib ODT
Marketedupdated 3mo agoby SpringWorks Therapeutics Inc
Approvedcommunity read0 votes
Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 3 investigational indications.
indications
investigational
NSCLC
all catalysts(0)
nothing on the calendar yet
Trials studying mirdametinib ODT
- phase2MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas
- phase2Mirdametinib + BGB-3245 in Advanced Solid Tumors
- phase2A Study of Mirdametinib in People With Central Nervous System Tumors
- phase2Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF).
- phase1Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib
- phase1To Assess the Enzyme Inducing Effects of Carbamazepine on the PK of Mirdametinib in Healthy Participants
- —Individual Patient Compassionate Use of Mirdametinib
- phase2A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma
Patent cliff
source: FDA Orange Bookfirst barrier falls
Feb 11, 2030
~3.5 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (57)
- Oct 10, 2044method-of-use (U-4130)US 12390430
- Oct 10, 2044method-of-use (U-4130)US 12390430
- Oct 10, 2044method-of-use (U-4130)US 12390430
- Mar 15, 2044formulationUS 12029711
- Mar 15, 2044formulationUS 12029711
- Mar 15, 2044formulationUS 12029711
- Mar 15, 2044formulationUS 12383517
- Mar 15, 2044formulationUS 12383517
- Apr 9, 2043method-of-use (U-4130)US 11806322
- Apr 9, 2043method-of-use (U-4130)US 11806322
- Apr 9, 2043method-of-use (U-4130)US 11806322
- Mar 16, 2043method-of-use (U-4130)US 11839595
- Mar 16, 2043method-of-use (U-4130)US 11839595
- Mar 16, 2043method-of-use (U-4130)US 11839595
- Mar 16, 2043method-of-use (U-4130)US 11883375
- Mar 16, 2043method-of-use (U-4130)US 11883375
- Mar 16, 2043method-of-use (U-4130)US 11883375
- Mar 16, 2043method-of-use (U-4130)US 12220390
- Mar 16, 2043method-of-use (U-4130)US 12220390
- Mar 16, 2043method-of-use (U-4130)US 12220390
- Mar 16, 2043method-of-use (U-4130)US 12257215
- Mar 16, 2043method-of-use (U-4130)US 12257215
- Mar 16, 2043method-of-use (U-4130)US 12257215
- Mar 16, 2043method-of-use (U-4130)US 12324791
- Mar 16, 2043method-of-use (U-4130)US 12324791
- Mar 16, 2043method-of-use (U-4130)US 12324791
- Feb 17, 2041compositionUS 11066358
- Feb 17, 2041compositionUS 11066358
- Feb 17, 2041compositionUS 11066358
- Feb 17, 2041compositionUS 11084780
- Feb 17, 2041compositionUS 11084780
- Feb 17, 2041compositionUS 11084780
- Feb 17, 2041method-of-use (U-4130)US 11453641
- Feb 17, 2041method-of-use (U-4130)US 11453641
- Feb 17, 2041method-of-use (U-4130)US 11453641
- Feb 17, 2041formulationUS 11571402
- Feb 17, 2041method-of-use (U-4130)US 11806321
- Feb 17, 2041method-of-use (U-4130)US 11806321
- Feb 17, 2041method-of-use (U-4130)US 11806321
- Feb 17, 2041method-of-use (U-4130)US 11819487
- Feb 17, 2041method-of-use (U-4130)US 11819487
- Feb 17, 2041method-of-use (U-4130)US 11819487
- Feb 17, 2041method-of-use (U-4130)US 12011424
- Feb 17, 2041method-of-use (U-4130)US 12011424
- Feb 17, 2041method-of-use (U-4130)US 12037306
- Feb 17, 2041method-of-use (U-4130)US 12037306
- Feb 17, 2041method-of-use (U-4130)US 12037306
- Feb 17, 2041formulationUS 12090128
- Feb 17, 2041method-of-use (U-4130)US 12263146
- Feb 17, 2041method-of-use (U-4130)US 12263146
- Feb 17, 2041method-of-use (U-4130)US 12263146
- Feb 17, 2041formulationUS 12275688
- Feb 17, 2041formulationUS 12275688
- Feb 17, 2041method-of-use (U-4130)US 12295925
- Feb 17, 2041method-of-use (U-4130)US 12295925
- Feb 17, 2041method-of-use (U-4130)US 12295925
- Feb 17, 2041method-of-use (U-4130)US 12357597
FDA exclusivities (6)
- Feb 11, 2032ODE-488Orphan Drug (7y)
- Feb 11, 2032ODE-488Orphan Drug (7y)
- Feb 11, 2032ODE-488Orphan Drug (7y)
- Feb 11, 2030NCENew Chemical Entity (5y)3.5y
- Feb 11, 2030NCENew Chemical Entity (5y)3.5y
- Feb 11, 2030NCENew Chemical Entity (5y)3.5y
News(0)
no news has mentioned this drug yet
Data sources
last refreshed 26m ago
Found something off?
comments(0)
5-min edit window · permanent after that