mannitol · Pharmaxis Europe · NDA 202049
Bronchitol
Earliest generic entry, as listed
30 Oct 2027
Blocked by exclusivity: ODE-327.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| ODE-327 | orphan drug (7 years) | 30 Oct 2027 |
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 |
|---|---|---|---|
| 202049 · 001 · RLD | powder, inhalation | 40MG | 30 Oct 2027 |