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Last Updated: October 3, 2023

AZEDRA Drug Patent Profile


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Which patents cover Azedra, and what generic alternatives are available?

Azedra is a drug marketed by Progenics Pharms Inc and is included in one NDA.

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 AZEDRA
Drug patent expirations by year for AZEDRA
Drug Prices for AZEDRA

See drug prices for AZEDRA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AZEDRA
Generic Entry Date for AZEDRA*:
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
NDA:
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.

Recent Clinical Trials for AZEDRA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institutes of Health (NIH)Phase 1/Phase 2
David BushnellPhase 1/Phase 2
National Cancer Institute (NCI)Phase 1/Phase 2

See all AZEDRA clinical trials

Pharmacology for AZEDRA

US Patents and Regulatory Information for AZEDRA

AZEDRA is protected by zero US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AZEDRA is ⤷  Try a Trial.

This potential generic entry date is based on 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.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

FDA Regulatory Exclusivity protecting AZEDRA

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
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Progenics Pharms Inc AZEDRA iobenguane i-131 SOLUTION;INTRAVENOUS 209607-001 Jul 30, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Merck
Baxter
Colorcon
McKesson

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