Details for New Drug Application (NDA): 212801
NDA 212801 describes ISTURISA, which is a drug marketed by Recordati Rare and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ISTURISA profile page.
The generic ingredient in ISTURISA is osilodrostat phosphate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the osilodrostat phosphate profile page.
The generic ingredient in ISTURISA is osilodrostat phosphate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the osilodrostat phosphate profile page.
Summary for 212801
| Tradename: | ISTURISA |
| Applicant: | Recordati Rare |
| Ingredient: | osilodrostat phosphate |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212801
Generic Entry Date for 212801*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 212801
Suppliers and Packaging for NDA: 212801
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ISTURISA | osilodrostat phosphate | TABLET;ORAL | 212801 | NDA | Recordati Rare Diseases, Inc. | 55292-320 | 55292-320-20 | 20 TABLET, COATED in 1 BLISTER PACK (55292-320-20) |
| ISTURISA | osilodrostat phosphate | TABLET;ORAL | 212801 | NDA | Recordati Rare Diseases, Inc. | 55292-320 | 55292-320-60 | 60 TABLET, COATED in 1 BLISTER PACK (55292-320-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Mar 6, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 6, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CUSHING’S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE | ||||||||
| Regulatory Exclusivity Expiration: | Apr 15, 2032 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULTS WITH CUSHING'S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE, EXCLUDING PATIENTS WITH CUSHING'S DISEASE | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 6, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 212801
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Recordati Rare | ISTURISA | osilodrostat phosphate | TABLET;ORAL | 212801-001 | Mar 6, 2020 | ⤷ Start Trial | ⤷ Start Trial |
| Recordati Rare | ISTURISA | osilodrostat phosphate | TABLET;ORAL | 212801-002 | Mar 6, 2020 | ⤷ Start Trial | ⤷ Start Trial |
| Recordati Rare | ISTURISA | osilodrostat phosphate | TABLET;ORAL | 212801-003 | Mar 6, 2020 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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