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Generated: November 14, 2018

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. It is available from one supplier. Additional details are available on the AZEDRA profile page.

The generic ingredient in AZEDRA is iobenguane i-131. One supplier is listed for this compound. 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.

Pharmacology for NDA: 209607
Mechanism of ActionRadiopharmaceutical Activity
Suppliers and Packaging for NDA: 209607
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZEDRA iobenguane i-131 SOLUTION;INTRAVENOUS 209607 NDA Progenics Pharmaceuticals, Inc. 71258-015 71258-015-02 1 CONTAINER in 1 BOX, UNIT-DOSE (71258-015-02) > 1 VIAL, GLASS in 1 CONTAINER > 2 mL in 1 VIAL, GLASS
AZEDRA iobenguane i-131 SOLUTION;INTRAVENOUS 209607 NDA Progenics Pharmaceuticals, Inc. 71258-015 71258-015-22 1 CONTAINER in 1 BOX, UNIT-DOSE (71258-015-22) > 1 VIAL, GLASS in 1 CONTAINER > 22.5 mL in 1 VIAL, GLASS

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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