Fluorodopa f-18 - Generic Drug Details
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What are the generic sources for fluorodopa f-18 and what is the scope of patent protection?
Fluorodopa f-18
is the generic ingredient in one branded drug marketed by Feinstein and is included in one NDA. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for fluorodopa f-18
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 11 |
| Clinical Trials: | 12 |
| Patent Applications: | 407 |
| DailyMed Link: | fluorodopa f-18 at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for fluorodopa f-18
Generic Entry Date for fluorodopa f-18*:
Constraining patent/regulatory exclusivity:
EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY 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 fluorodopa f-18
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Andrew Newberg | Phase 2 |
| Thomas Jefferson University | Phase 2 |
| Washington University School of Medicine | Phase 1 |
US Patents and Regulatory Information for fluorodopa f-18
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Feinstein | FLUORODOPA F18 | fluorodopa f-18 | SOLUTION;INTRAVENOUS | 200655-001 | Oct 10, 2019 | 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 |
