FLUORODOPA F18 Drug Patent Profile
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When do Fluorodopa F18 patents expire, and what generic alternatives are available?
Fluorodopa F18 is a drug marketed by Feinstein and is included in one NDA.
The generic ingredient in FLUORODOPA F18 is fluorodopa f-18. One supplier is listed for this compound. Additional details are available on the fluorodopa f-18 profile page.
Summary for FLUORODOPA F18
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 7 |
| Clinical Trials: | 11 |
| Patent Applications: | 210 |
| DailyMed Link: | FLUORODOPA F18 at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for FLUORODOPA F18
Generic Entry Date for FLUORODOPA F18*:
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 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 FLUORODOPA F18
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 F18
FLUORODOPA F18 is protected by zero US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of FLUORODOPA F18 is See Plans and Pricing.
This potential generic entry date is based on EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY.
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 FLUORODOPA F18
EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR - SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing
NEW CHEMICAL ENTITY
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Feinstein | FLUORODOPA F18 | fluorodopa f-18 | SOLUTION;INTRAVENOUS | 200655-001 | Oct 10, 2019 | 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 |
