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Last Updated: September 25, 2022

FINTEPLA Drug Patent Profile


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

Fintepla is a drug marketed by Zogenix 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 four 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

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Summary for FINTEPLA
International Patents:104
US Patents:11
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 27
Patent Applications: 3,784
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
Drug Prices for FINTEPLA

See drug prices for FINTEPLA

DrugPatentWatch® Estimated Generic Entry Opportunity 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.

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 six FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FINTEPLA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for the treatment of Dravet syndrome
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for the treatment of Dravet Syndrome
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulation for inhibiting formation of 5-HT.sub.2B agonists and methods of using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Fenfluramine compositions and methods of preparing the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Control system for control of distribution of medication
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulation for inhibiting formation of 5-HT2B agonists and methods of using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for the treatment of dravet syndrome
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for the treatment of Dravet syndrome
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for the treatment of Dravet syndrome
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method for the treatment of Dravet Syndrome
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

INDICATION FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (LGS) IN PATIENTS WHO ARE 2 YEARS OF AGE AND OLDER
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: 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
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 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 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: See Plans and Pricing

Patent: 20202655
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2017006219
Estimated Expiration: See Plans and Pricing

Canada

Patent: 62367
Estimated Expiration: See Plans and Pricing

China

Patent: 7111673
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 01808
Estimated Expiration: See Plans and Pricing

Patent: 61640
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1360
Estimated Expiration: See Plans and Pricing

Patent: 7505
Estimated Expiration: See Plans and Pricing

Japan

Patent: 74402
Estimated Expiration: See Plans and Pricing

Patent: 17528849
Estimated Expiration: See Plans and Pricing

Patent: 21007038
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 17004065
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0560
Estimated Expiration: See Plans and Pricing

Patent: 2886
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 04749
Estimated Expiration: See Plans and Pricing

Patent: 17110222
Estimated Expiration: See Plans and Pricing

Saudi Arabia

Patent: 7381207
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201702494U
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1705078
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2245345
Estimated Expiration: See Plans and Pricing

Patent: 170063851
Estimated Expiration: See Plans and Pricing

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
South Africa 201900766 FORMULATION FOR INHIBITING FORMATION OF 5¿HT 2B AGONISTS AND METHODS OF USING SAME See Plans and Pricing
Portugal 3329909 See Plans and Pricing
China 109689103 用于抑制5-HT激动剂的形成的制剂及其使用方法 (FORMULATION FOR INHIBITING FORMATION OF 5-HT 2B AGONISTS AND METHODS OF USING SAME) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Dow
AstraZeneca
Merck
Harvard Business School

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.