paltusotine hydrochloride · Crinetics · NDA 219070
Palsonify
Earliest generic entry, as listed · earliest of 2 marketed strengths
25 Mar 2044
Blocked by patent: US 12208092. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12208092 | use U-4282 · sets the listed date | 25 Mar 2044 |
| US 11266641 | drug product, use U-4283 | 7 Sep 2041 |
| US 11957674 | use U-4283 | 7 Sep 2041 |
| US 10464918 | drug substance | 16 Jan 2039 |
| US 10351547 | drug substance, drug product, use U-4283 | 12 Jul 2037 |
| US 10597377 | drug substance, drug product, use U-4283 | 12 Jul 2037 |
| US 10875839 | use U-4283 | 12 Jul 2037 |
| US 11414397 | drug substance, drug product, use U-4283 | 12 Jul 2037 |
| US 9896432 | drug substance, drug product, use U-4283 | 12 Jul 2037 |
Exclusivities · 2 unexpired
| ODE-537 | orphan drug (7 years) | 25 Sep 2032 |
| NCE | new chemical entity (5 years) | 25 Sep 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 219070 · 001 · RLD | tablet, oral | EQ 20MG BASE | 25 Mar 2044 |
| 219070 · 002 · RLD | tablet, oral | EQ 30MG BASE | 25 Mar 2044 |