chenodiol · Mirum · NDA 219488
Ctexli
Earliest generic entry, as listed
21 Feb 2032
Blocked by exclusivity: ODE-523.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 2 unexpired
| ODE-523 | orphan drug (7 years) | 21 Feb 2032 |
| NP | new product | 21 Feb 2028 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 219488 · 001 · RLD | tablet, oral | 250MG | 21 Feb 2032 |