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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209607


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NDA 209607 describes AZEDRA, which is a drug marketed by Progenics Pharms Inc and is included in one NDA. Additional details are available on the AZEDRA profile page.

The generic ingredient in AZEDRA is iobenguane i-131. Additional details are available on the iobenguane i-131 profile page.
Summary for 209607
Tradename:AZEDRA
Applicant:Progenics Pharms Inc
Ingredient:iobenguane i-131
Patents:0
Generic Entry Opportunity Date for 209607
Generic Entry Date for 209607*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH IOBENGUANE SCAN POSITIVE, UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC PHEOCHROMOCYTOMA OR PARAGANGLIOMA WHO REQUIRE SYSTEMIC ANTICANCER THERAPY
Dosage:
SOLUTION;INTRAVENOUS

*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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength15mCi/ML
Approval Date:Jul 30, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 30, 2021
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Jul 30, 2025
Regulatory Exclusivity Use:TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH IOBENGUANE SCAN POSITIVE, UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC PHEOCHROMOCYTOMA OR PARAGANGLIOMA WHO REQUIRE SYSTEMIC ANTICANCER THERAPY

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