FENFLURAMINE HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for fenfluramine hydrochloride and what is the scope of freedom to operate?
Fenfluramine hydrochloride
is the generic ingredient in one branded drug marketed by Ucb Inc and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fenfluramine hydrochloride has one hundred and seventeen patent family members in twenty-seven countries.
There are five drug master file entries for fenfluramine hydrochloride. One supplier is listed for this compound.
Summary for FENFLURAMINE HYDROCHLORIDE
International Patents: | 117 |
US Patents: | 13 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 45 |
Clinical Trials: | 20 |
Patent Applications: | 5,952 |
DailyMed Link: | FENFLURAMINE HYDROCHLORIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FENFLURAMINE HYDROCHLORIDE
Generic Entry Date for FENFLURAMINE HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;ORAL |
*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 FENFLURAMINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University Health Network, Toronto | Phase 3 |
Hospital Ruber Internacional | Phase 4 |
Zogenix, Inc. | Phase 4 |
Paragraph IV (Patent) Challenges for FENFLURAMINE HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FINTEPLA | Oral Solution | fenfluramine hydrochloride | 2.2 mg/mL | 212102 | 1 | 2021-06-21 |
US Patents and Regulatory Information for FENFLURAMINE HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Ucb Inc | FINTEPLA | fenfluramine hydrochloride | SOLUTION;ORAL | 212102-001 | Jun 25, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Ucb Inc | FINTEPLA | fenfluramine hydrochloride | SOLUTION;ORAL | 212102-001 | Jun 25, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Ucb Inc | FINTEPLA | fenfluramine hydrochloride | SOLUTION;ORAL | 212102-001 | Jun 25, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Ucb Inc | FINTEPLA | fenfluramine hydrochloride | SOLUTION;ORAL | 212102-001 | Jun 25, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ucb Inc | FINTEPLA | fenfluramine hydrochloride | SOLUTION;ORAL | 212102-001 | Jun 25, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
International Patents for FENFLURAMINE HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2018037306 | ⤷ Try a Trial | |
European Patent Office | 3329909 | FENFLURAMINE POUR SON UTILISATION DANS LE TRAITEMENT DU SYNDROME DE DRAVET (FENFLURAMINE FOR USE IN THE TREATMENT OF DRAVET SYNDROME) | ⤷ Try a Trial |
Japan | 2020063309 | ドラベ症候群の処置における使用のためのフェンフルラミン (FENFLURAMINE FOR USE IN THE TREATMENT OF DRAVET SYNDROME) | ⤷ Try a Trial |
Canada | 2909335 | FENFLURAMINE DESTINEE A ETRE UTILISEE POUR LE TRAITEMENT DU SYNDROME DE DRAVET (FENFLURAMINE FOR USE IN THE TREATMENT OF DRAVET SYNDROME) | ⤷ Try a Trial |
Japan | 6441313 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |