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 eleven patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and twelve patent family members in twenty-six 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: | 112 |
US Patents: | 11 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 30 |
Clinical Trials: | 1 |
Patent Applications: | 4,604 |
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
Generic Entry Date for FINTEPLA*:
Constraining patent/regulatory exclusivity:
NDA:
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 |
Anatomical Therapeutic Chemical (ATC) Classes for FINTEPLA
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 eleven US patents and eight FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of FINTEPLA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method for the treatment of Dravet syndrome
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method for the treatment of Dravet Syndrome
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Formulation for inhibiting formation of 5-HT.sub.2B agonists and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Fenfluramine compositions and methods of preparing the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Formulation for inhibiting formation of 5-HT2B agonists and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Formulation for inhibiting formation of 5-HT2B agonists and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method for the treatment of dravet syndrome
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method for the treatment of Dravet syndrome
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method for the treatment of Dravet syndrome
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method for the treatment of Dravet Syndrome
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial
INDICATION FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS WHO ARE 2 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS 2 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
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
Estimated Expiration: ⤷ Try a Trial
Patent: 20202655
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2017006219
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 62367
Estimated Expiration: ⤷ Try a Trial
China
Patent: 7111673
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 01808
Estimated Expiration: ⤷ Try a Trial
Patent: 61640
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 1360
Estimated Expiration: ⤷ Try a Trial
Patent: 7505
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 74402
Estimated Expiration: ⤷ Try a Trial
Patent: 17528849
Estimated Expiration: ⤷ Try a Trial
Patent: 21007038
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 17004065
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 0560
Estimated Expiration: ⤷ Try a Trial
Patent: 2886
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 04749
Estimated Expiration: ⤷ Try a Trial
Patent: 17110222
Estimated Expiration: ⤷ Try a Trial
Saudi Arabia
Patent: 7381207
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201702494U
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1705078
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2245345
Estimated Expiration: ⤷ Try a Trial
Patent: 170063851
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Saudi Arabia | 517381207 | نظام تحكم للتحكم بتوزيع دواء (CONTROL SYSTEM FOR CONTROL OF DISTRIBUTION OF MEDICATION) | ⤷ Try a Trial |
Portugal | 3393655 | ⤷ Try a Trial | |
South Korea | 20230021172 | 5-HT2B 작용물질의 형성을 억제하기 위한 제제 및 그것의 사용 방법 (5-HT2B FORMULATION FOR INHIBITING FORMATION OF 5-HT2B AGONISTS AND METHODS OF USING SAME) | ⤷ Try a Trial |
Lithuania | 3393655 | ⤷ Try a Trial | |
European Patent Office | 3961640 | SYSTÈME DE CONTRÔLE D'ADMINISTRATION DE MÉDICAMENTS (CONTROL SYSTEM FOR CONTROL OF DISTRIBUTION OF MEDICATION) | ⤷ Try a Trial |
Singapore | 11201900975X | FORMULATION FOR INHIBITING FORMATION OF 5-HT 2B AGONISTS AND METHODS OF USING SAME | ⤷ Try a Trial |
South Korea | 20190040237 | 5-HT2B 작용물질의 형성을 억제하기 위한 제제 및 그것의 사용 방법 | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |