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Last Updated: March 28, 2024

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 fifteen 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
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

SponsorPhase
University Health Network, TorontoPhase 3
Hospital Ruber InternacionalPhase 4
Zogenix, Inc.Phase 4

See all FENFLURAMINE HYDROCHLORIDE clinical trials

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 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
Australia 2014261329 Fenfluramine for use in the treatment of dravet syndrome ⤷  Try a Trial
South Africa 201803583 FENFLURAMINE COMPOSITIONS AND METHODS OF PREPARING THE SAME ⤷  Try a Trial
Saudi Arabia 517381207 نظام تحكم للتحكم بتوزيع دواء (CONTROL SYSTEM FOR CONTROL OF DISTRIBUTION OF MEDICATION) ⤷  Try a Trial
Japan 2016518387 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 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.