FENFLURAMINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug 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 Zogenix Inc and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fenfluramine hydrochloride has forty-nine patent family members in twenty countries.

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

Summary for FENFLURAMINE HYDROCHLORIDE

International Patents:	49
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	6
Suppliers / Packagers:	1
Bulk Api Vendors:	31
Clinical Trials:	17
Patent Applications:	5,318
DailyMed Link:	FENFLURAMINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for FENFLURAMINE HYDROCHLORIDE

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Sponsor	Phase
University of California, Los Angeles	Phase 2
Zogenix, Inc.	Phase 3
New York University School of Medicine	Phase 2

See all FENFLURAMINE HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for FENFLURAMINE HYDROCHLORIDE

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Glossary

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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	Start Trial	Start Trial				Start Trial
Zogenix Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102-001	Jun 25, 2020		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Zogenix Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102-001	Jun 25, 2020		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Zogenix Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102-001	Jun 25, 2020		RX	Yes	Yes	Start Trial	Start Trial				Start 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

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Country	Patent Number	Estimated Expiration
South Africa	201900766	Start Trial
Singapore	11201702494U	Start Trial
Japan	2017528849	Start Trial
Poland	2991637	Start Trial
>Country	>Patent Number	>Estimated Expiration

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