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
| Patent | Claims | Expires |
|---|---|---|
| US 12390430 | use U-4130 · sets the listed date | 10 Oct 2044 |
| US 12029711 | drug product, use U-4130 | 15 Mar 2044 |
| US 12383517 | drug product, use U-4130 | 15 Mar 2044 |
| US 12661330 | use U-4130 | 5 Feb 2044 |
| US 11806322 | use U-4130 | 9 Apr 2043 |
| US 11839595 | use U-4130 | 16 Mar 2043 |
| US 11883375 | use U-4130 | 16 Mar 2043 |
| US 12220390 | use U-4130 | 16 Mar 2043 |
| US 12257215 | use U-4130 | 16 Mar 2043 |
| US 12324791 | use U-4591 | 16 Mar 2043 |
| US 11066358 | drug substance, drug product | 17 Feb 2041 |
| US 11084780 | drug substance | 17 Feb 2041 |
| US 11453641 | use U-4130 | 17 Feb 2041 |
| US 11571402 | drug product | 17 Feb 2041 |
| US 11806321 | use U-4130 | 17 Feb 2041 |
| US 11819487 | use U-4590 | 17 Feb 2041 |
| US 12011424 | use U-4595 | 17 Feb 2041 |
| US 12037306 | use U-4130 | 17 Feb 2041 |
| US 12090128 | drug product, use U-4130 | 17 Feb 2041 |
| US 12263146 | use U-4130 | 17 Feb 2041 |
| US 12275688 | drug product, use U-4130 | 17 Feb 2041 |
| US 12295925 | use U-4590 | 17 Feb 2041 |
| US 12357597 | use U-4130 | 17 Feb 2041 |
Exclusivities · 3 unexpired
| ODE-488 | orphan drug (7 years) | 11 Feb 2032 |
| ODE* | 11 Feb 2032 | |
| NCE | new 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 · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 219379 · 001 · RLD | tablet, for suspension, oral | 1MG | 10 Oct 2044 |
| 219379 · 002 · RLD | tablet, for suspension, oral | 3MG | 10 Oct 2044 |
| 219379 · 003 · RLD | tablet, for suspension, oral | 4MG | 10 Oct 2044 |
| 219389 · 001 · RLD | capsule, oral | 1MG | 10 Oct 2044 |
| 219389 · 002 · RLD | capsule, oral | 2MG | 10 Oct 2044 |