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

International Patents:	106
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	20
Patent Applications:	5,657
DailyMed Link:	fenfluramine hydrochloride at DailyMed

Recent Clinical Trials for fenfluramine hydrochloride

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Sponsor	Phase
University Health Network, Toronto	Phase 3
Zogenix, Inc.	Phase 4
Hospital Ruber Internacional	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

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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	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

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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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