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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FINTEPLA
*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 |
| University Health Network, Toronto | Phase 3 |
| Zogenix, Inc. | Phase 3 |
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
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
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
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
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | |||
| 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.
| 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 | |
| Singapore | 11201804811W | FENFLURAMINE COMPOSITIONS AND METHODS OF PREPARING THE SAME | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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