cliffwatch

mirdametinib · Springworks · NDA 219379, 219389

Gomekli

Earliest generic entry, as listed · earliest of 5 marketed strengths
10 Oct 2044

Blocked by patent: US 12390430. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 23 unexpired

PatentClaimsExpires
US 12390430use U-413010 Oct 2044
US 12029711product, use U-413015 Mar 2044
US 12383517product, use U-413015 Mar 2044
US 12661330use U-41305 Feb 2044
US 11806322use U-41309 Apr 2043
US 11839595use U-413016 Mar 2043
US 11883375use U-413016 Mar 2043
US 12220390use U-413016 Mar 2043
US 12257215use U-413016 Mar 2043
US 12324791use U-459116 Mar 2043
US 11066358substance, product17 Feb 2041
US 11084780substance17 Feb 2041
US 11453641use U-413017 Feb 2041
US 11571402product17 Feb 2041
US 11806321use U-413017 Feb 2041
US 11819487use U-459017 Feb 2041
US 12011424use U-459517 Feb 2041
US 12037306use U-413017 Feb 2041
US 12090128product, use U-413017 Feb 2041
US 12263146use U-413017 Feb 2041
US 12275688product, use U-413017 Feb 2041
US 12295925use U-459017 Feb 2041
US 12357597use U-413017 Feb 2041

Exclusivities · 3 unexpired

ODE-488orphan drug (7 years)11 Feb 2032
ODE*11 Feb 2032
NCEnew chemical entity (5 years)11 Feb 2030

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 5

NDA · productFormStrengthListed expiry
219379 · 001 · RLDtablet, for suspension, oral1MG10 Oct 2044
219379 · 002 · RLDtablet, for suspension, oral3MG10 Oct 2044
219379 · 003 · RLDtablet, for suspension, oral4MG10 Oct 2044
219389 · 001 · RLDcapsule, oral1MG10 Oct 2044
219389 · 002 · RLDcapsule, oral2MG10 Oct 2044