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AZEDRA Drug Profile
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When do Azedra patents expire, and when can generic versions of Azedra launch?
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
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 7 |
| Clinical Trials: | 2 |
| Patent Applications: | 5 |
| Drug Prices: | Drug price information for AZEDRA |
| DailyMed Link: | AZEDRA at DailyMed |
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 |
|---|---|
| Molecular Insight Pharmaceuticals, Inc. | Phase 2 |
| Molecular Insight Pharmaceuticals, Inc. | N/A |
Pharmacology for AZEDRA
| Drug Class | Radioactive Diagnostic Agent |
| Mechanism of Action | Radiopharmaceutical Activity |
Synonyms for AZEDRA
| (m-((sup 131)I)Iodobenzyl)guanidine |
| (m-Iodo-(sup 131)I-benzyl)guanidine |
| [131]I-MIBG |
| [131I]mIBG |
| 131I-m-Iodobenzylguanidine |
| 131I-MIBG |
| 2-[(3-iodanylphenyl)methyl]guanidine |
| 2-[(3-iodophenyl)methyl]guanidine |
| 3-Iodobenzylguanidine |
| 3-Iodobenzylguanidine (131I) (JAN) |
| 77679-27-7 |
| AC1L2FP4 |
| AC1Q50E4 |
| CHEBI:135997 |
| CHEMBL1615779 |
| D03308 |
| DTXSID30228311 |
| Guanidine, ((3-(iodo-(sup 131)I)phenyl)methyl)- |
| Guanidine, ((3-iodo-131I)phenyl)methyl)- |
| I-131 meta-iodobenzyl guanidine |
| I-131 Metaiodobenzylguanidine |
| I-131 MIBG |
| Iobeguane I 131 |
| Iobeguane I 131 [USAN] |
| Iobenguane ((sup 131)I) |
| Iobenguane ((sup 131)I) [INN] |
| Iobenguane (131I) |
| Iobenguane (131I) [INN] |
| Iobenguane I 131 |
| Iobenguane I 131 (USP) |
| Iobenguane I 131 [USAN:USP] |
| Iobenguane I131 |
| Iobenguane iobenguane ((sup 131)I) |
| Iobenguane Sulfate I 123 (iobenguane (131 I)) |
| Iobenguane[131I] |
| Iobenguano (131 I) |
| Iobenguano (131 I) [Spanish] |
| Iobenguanum (131 I) |
| Iobenguanum (131 I) [Latin] |
| Iobenguanum (313 I) [Latin] |
| LS-177380 |
| m-[123I/125I/131I]MIBG |
| m-Iodobenzylguanidine |
| M131IBG |
| meta-Iodobenzylguanidine (MIBG) labeled with iodine-131 |
| MIBG-(131 I) |
| MIBG[Radioiodinated] |
| MOLI000967 |
| MyoMIBG-123I injection |
| PDWUPXJEEYOOTR-JRGAVVOBSA-N |
| Pheo MIBG-131I injection |
| PheoMIBG-I 131 (TN) |
| PheoMIBG-I(131) Injection |
| Q461L7AK4R |
| SCHEMBL13092741 |
| Ultratrace iobenguane 131I |
| Ultratrace iobenguane I131 |
| Ultratrace MIBG |
| UNII-Q461L7AK4R |
US Patents and Regulatory Information for AZEDRA
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Progenics Pharms Inc | AZEDRA | iobenguane i-131 | SOLUTION;INTRAVENOUS | 209607-001 | Jul 30, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
