Details for New Drug Application (NDA): 212801
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The generic ingredient in ISTURISA is osilodrostat phosphate. 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: | Mar 6, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Subscribe | Patent Expiration: | Jul 6, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? |
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