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Last Updated: February 3, 2023

Fenfluramine hydrochloride - Generic Drug Details


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What are the generic sources for fenfluramine hydrochloride and what is the scope of patent protection?

Fenfluramine hydrochloride is the generic ingredient in one branded drug marketed by Zogenix Inc and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fenfluramine hydrochloride has one hundred and six patent family members in twenty-six countries.

There are five drug master file entries for fenfluramine hydrochloride. One supplier is listed for this compound.

Summary for fenfluramine hydrochloride
Recent Clinical Trials for fenfluramine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University Health Network, TorontoPhase 3
Zogenix, Inc.Phase 4
Hospital Ruber InternacionalPhase 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
Zogenix Inc FINTEPLA fenfluramine hydrochloride SOLUTION;ORAL 212102-001 Jun 25, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zogenix Inc FINTEPLA fenfluramine hydrochloride SOLUTION;ORAL 212102-001 Jun 25, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zogenix Inc FINTEPLA fenfluramine hydrochloride SOLUTION;ORAL 212102-001 Jun 25, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Zogenix Inc FINTEPLA fenfluramine hydrochloride SOLUTION;ORAL 212102-001 Jun 25, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Zogenix Inc FINTEPLA fenfluramine hydrochloride SOLUTION;ORAL 212102-001 Jun 25, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Zogenix Inc FINTEPLA fenfluramine hydrochloride SOLUTION;ORAL 212102-001 Jun 25, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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

International Patents for fenfluramine hydrochloride

Country Patent Number Title Estimated Expiration
South Korea 102245345 See Plans and Pricing
Australia 2017315273 Formulation for inhibiting formation of 5-HT 2B agonists and methods of using same See Plans and Pricing
Singapore 11201804811W FENFLURAMINE COMPOSITIONS AND METHODS OF PREPARING THE SAME See Plans and Pricing
Israel 264637 פורמולציה לעיכוב יצירת אגוניסטים של 5-ht 2b ושיטות לשימוש בה (Formulation for inhibiting formation of 5-ht 2b agonists and methods of using same) See Plans and Pricing
Croatia P20210819 See Plans and Pricing
Japan 6774402 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Dow
Baxter
Mallinckrodt
Express Scripts
Colorcon

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