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. Additional details are available on the iobenguane i-131 profile page.
Summary for AZEDRA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 10 |
| Clinical Trials: | 3 |
| Patent Applications: | 93 |
| Drug Prices: | Drug price information for AZEDRA |
| What excipients (inactive ingredients) are in AZEDRA? | AZEDRA excipients list |
| DailyMed Link: | AZEDRA at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity 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
| Sponsor | Phase |
|---|---|
| David Bushnell | Phase 1/Phase 2 |
| National Cancer Institute (NCI) | Phase 1/Phase 2 |
| Progenics Pharmaceuticals, Inc. | Phase 1/Phase 2 |
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 See Plans and Pricing.
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: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
