carglumic acid · Recordati Rare · NDA 022562
Carbaglu
Earliest generic entry, as listed
22 Jan 2028
Blocked by exclusivity: ODE-345.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| ODE-345 | orphan drug (7 years) | 22 Jan 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 |
|---|---|---|---|
| 022562 · 001 · RLD | tablet, for suspension, oral | 200MG | 22 Jan 2028 |