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FINTEPLA Drug Patent Profile

Which patents cover Fintepla, and when can generic versions of Fintepla launch?

Fintepla is a drug marketed by Ucb Inc and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventeen patent family members in twenty-seven countries.

The generic ingredient in FINTEPLA is fenfluramine hydrochloride. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fenfluramine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Fintepla

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 29, 2038. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for FINTEPLA

International Patents:	117
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	1
Patent Applications:	4,497
Drug Prices:	Drug price information for FINTEPLA
What excipients (inactive ingredients) are in FINTEPLA?	FINTEPLA excipients list
DailyMed Link:	FINTEPLA at DailyMed

See drug prices for FINTEPLA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FINTEPLA

NDA:

212102

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 FINTEPLA

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

Sponsor	Phase
Zogenix, Inc.	Phase 3
University Health Network, Toronto	Phase 3

See all FINTEPLA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for FINTEPLA

A08AA	Centrally acting antiobesity products
A08A	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A08	ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
A	Alimentary tract and metabolism

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for FINTEPLA

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 FINTEPLA

FINTEPLA is protected by thirteen US patents and six FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting FINTEPLA

FDA Regulatory Exclusivity protecting FINTEPLA

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					Y
Ucb Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102-001	Jun 25, 2020		RX	Yes	Yes
Ucb Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102-001	Jun 25, 2020		RX	Yes	Yes					Y
Ucb Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102-001	Jun 25, 2020		RX	Yes	Yes					Y
Ucb Inc	FINTEPLA	fenfluramine hydrochloride	SOLUTION;ORAL	212102-001	Jun 25, 2020		RX	Yes	Yes					Y

International Patents for FINTEPLA

When does loss-of-exclusivity occur for FINTEPLA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

New Zealand

Russian Federation

Saudi Arabia

Singapore

South Africa

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FINTEPLA around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	E054577
South Africa	201900766	FORMULATION FOR INHIBITING FORMATION OF 5¿HT 2B AGONISTS AND METHODS OF USING SAME
Australia	2022279469	Formulation for inhibiting formation of 5-HT 2b agonists and methods of using same
European Patent Office	4293009	COMPOSITIONS DE FENFLURAMINE ET LEURS PROCÉDÉS DE PRÉPARATION (FENFLURAMINE COMPOSITIONS AND METHODS OF PREPARING THE SAME)
Japan	2022133279	フェンフルラミン組成物およびその調製法