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FINTEPLA Drug Patent Profile

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Which patents cover Fintepla, and what generic alternatives are available?

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

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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:	2
Patent Applications:	4,605
Drug Prices:	Drug price information for FINTEPLA
What excipients (inactive ingredients) are in FINTEPLA?	FINTEPLA excipients list
DailyMed Link:	FINTEPLA at DailyMed

Drug patent expirations by year for FINTEPLA

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

Generic Entry Date for FINTEPLA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
UCB BIOSCIENCES, Inc.	Phase 3
Zogenix, Inc.	Phase 3
University Health Network, Toronto	Phase 3

See all FINTEPLA clinical trials

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FINTEPLA is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Control system for control of distribution of medication
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Method for the treatment of Dravet syndrome
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Method for the treatment of Dravet Syndrome
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Formulation for inhibiting formation of 5-HT.sub.2B agonists and methods of using same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Fenfluramine compositions and methods of preparing the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Formulation for inhibiting formation of 5-HT2B agonists and methods of using same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Method for the treatment of dravet syndrome
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Method for the treatment of Dravet syndrome
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Method for the treatment of Dravet Syndrome
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting FINTEPLA

INDICATED FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH DRAVET SYNDROME IN PATIENTS 2 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Sign Up

INDICATION FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS WHO ARE 2 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Sign Up

TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS 2 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up

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

Patent: 15326472
Patent: Control system for control of distribution of medication
Estimated Expiration: ⤷ Sign Up

Patent: 20202655
Patent: Control system for control of distribution of medication
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2017006219
Patent: sistema de controle para controle de distribuição de medicamentos
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 62367
Patent: SYSTEME DE COMMANDE DESTINE A COMMANDER LA DISTRIBUTION D'UN MEDICAMENT (CONTROL SYSTEM FOR CONTROL OF DISTRIBUTION OF MEDICATION)
Estimated Expiration: ⤷ Sign Up

China

Patent: 7111673
Patent: 控制药物分配的控制系统 (Control system for control of distribution of medication)
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 01808
Patent: SYSTÈME DE COMMANDE DESTINÉ À COMMANDER LA DISTRIBUTION D'UN MÉDICAMENT (CONTROL SYSTEM FOR CONTROL OF DISTRIBUTION OF MEDICATION)
Estimated Expiration: ⤷ Sign Up

Patent: 61640
Patent: SYSTÈME DE CONTRÔLE D'ADMINISTRATION DE MÉDICAMENTS (CONTROL SYSTEM FOR CONTROL OF DISTRIBUTION OF MEDICATION)
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 1360
Patent: מערכת בקרה לבקרת חלוקת תקופות (Control system for control of distribution of medication)
Estimated Expiration: ⤷ Sign Up

Patent: 7505
Patent: מערכת בקרה לבקרת חלוקת תקופות (Control system for control of distribution of medication)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 74402
Estimated Expiration: ⤷ Sign Up

Patent: 17528849
Patent: 薬物供給管理用の管理システム
Estimated Expiration: ⤷ Sign Up

Patent: 21007038
Patent: 薬物供給管理用の管理システム (CONTROL SYSTEM FOR CONTROLLING MEDICATION DISTRIBUTION)
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 17004065
Patent: SISTEMA DE CONTROL PARA EL CONTROL DE DISTRIBUCION DE MEDICACION. (CONTROL SYSTEM FOR CONTROL OF DISTRIBUTION OF MEDICATION.)
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 0560
Patent: Control system for control of distribution of medication
Estimated Expiration: ⤷ Sign Up

Patent: 2886
Patent: Control system for control of distribution of medication
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 04749
Patent: СИСТЕМА УПРАВЛЕНИЯ ДЛЯ УПРАВЛЕНИЯ РАСПРЕДЕЛЕНИЕМ ЛЕКАРСТВЕННЫХ ПРОДУКТОВ (CONTROL SYSTEM FOR MANAGING DISTRIBUTION OF MEDICINAL PRODUCTS)
Estimated Expiration: ⤷ Sign Up

Patent: 17110222
Patent: СИСТЕМА УПРАВЛЕНИЯ ДЛЯ УПРАВЛЕНИЯ РАСПРЕДЕЛЕНИЕМ ЛЕКАРСТВЕННЫХ ПРОДУКТОВ
Estimated Expiration: ⤷ Sign Up

Saudi Arabia

Patent: 7381207
Patent: نظام تحكم للتحكم بتوزيع دواء (CONTROL SYSTEM FOR CONTROL OF DISTRIBUTION OF MEDICATION)
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 201702494U
Patent: CONTROL SYSTEM FOR CONTROL OF DISTRIBUTION OF MEDICATION
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 1705078
Patent: CONTROL SYSTEM FOR CONTROL OF DISTRIBUTION OF MEDICATION
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 2245345
Estimated Expiration: ⤷ Sign Up

Patent: 170063851
Patent: 의약품 배포 제어를 위한 제어 시스템 (CONTROL SYSTEM FOR CONTROL OF DISTRIBUTION OF MEDICATION)
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Portugal	3393655		⤷ Sign Up
European Patent Office	4293009	COMPOSITIONS DE FENFLURAMINE ET LEURS PROCÉDÉS DE PRÉPARATION (FENFLURAMINE COMPOSITIONS AND METHODS OF PREPARING THE SAME)	⤷ Sign Up
Hungary	E054577		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2016051271		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration