Iobenguane i-131 - Generic Drug Details
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What are the generic drug sources for iobenguane i-131 and what is the scope of freedom to operate?
Iobenguane i-131
is the generic ingredient in one branded drug marketed by Progenics Pharms Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.Summary for iobenguane i-131
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 12 |
| Clinical Trials: | 16 |
| Patent Applications: | 180 |
| What excipients (inactive ingredients) are in iobenguane i-131? | iobenguane i-131 excipients list |
| DailyMed Link: | iobenguane i-131 at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for iobenguane i-131
Generic Entry Date for iobenguane i-131*:
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.
Recent Clinical Trials for iobenguane i-131
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jubilant DraxImage Inc. | Phase 2 |
| Mayo Clinic | Early Phase 1 |
| National Cancer Institute (NCI) | Early Phase 1 |
US Patents and Regulatory Information for iobenguane i-131
| 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 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
