OSILODROSTAT PHOSPHATE | N212801 | RECORDATI RARE DISEASES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Annora Pharma Private Limited FDA-2026-P-4574 Annora Pharma Private Limited filed this citizen petition under 21 CFR 314.122(a) requesting that the FDA determine whether the Reference Listed Drug ISTURSIA (osilodrostat) tablets 10 mg, Product Number 003, NDA 212801, held by Recordati Rare Diseases Inc., was voluntarily withdrawn from the commer | 505(q) | 2026-04-24 | Open | Annora Pharma Private Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| ODE-286 | Mar 6, 2027 | < 1 year |
| ODE-535 | Apr 15, 2032 | Active |
Orange Book patent listing for Isturisa (osilodrostat phosphate) updated: U.S. Patent 8,314,097 expiration date extended from Mar 2029 to May 2033.
Old: Mar 27, 2029
New: May 20, 2033
ISTURISA (osilodrostat phosphate) patent 8,314,097 expiration date extended from Mar 2029 to May 2033 in the Orange Book.
Old: Mar 27, 2029
New: May 20, 2033
New: New record
New: New record
New: New record