Fenfluramine hydrochloride - Generic Drug Details
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What are the generic sources for fenfluramine hydrochloride and what is the scope of freedom to operate?
Fenfluramine hydrochloride
is the generic ingredient in one branded drug marketed by Ucb Inc and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fenfluramine hydrochloride has one hundred and seventeen patent family members in twenty-seven countries.
There are five drug master file entries for fenfluramine hydrochloride. One supplier is listed for this compound.
Summary for fenfluramine hydrochloride
International Patents: | 117 |
US Patents: | 13 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 45 |
Clinical Trials: | 20 |
Patent Applications: | 5,952 |
DailyMed Link: | fenfluramine hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for fenfluramine hydrochloride
Generic Entry Date for fenfluramine hydrochloride*:
Constraining patent/regulatory exclusivity:
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 fenfluramine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University Health Network, Toronto | Phase 3 |
Hospital Ruber Internacional | Phase 4 |
Zogenix, Inc. | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for fenfluramine hydrochloride
Paragraph IV (Patent) Challenges for FENFLURAMINE HYDROCHLORIDE
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 fenfluramine hydrochloride
International Patents for fenfluramine hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20190040237 | 5-HT2B 작용물질의 형성을 억제하기 위한 제제 및 그것의 사용 방법 | ⤷ Try a Trial |
Russian Federation | 2020128323 | ФЕНФЛУРАМИНОВЫЕ КОМПОЗИЦИИ И СПОСОБЫ ИХ ПОЛУЧЕНИЯ | ⤷ 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 |
Australia | 2016379346 | Fenfluramine compositions and methods of preparing the same | ⤷ Try a Trial |
Lithuania | 3329909 | ⤷ Try a Trial | |
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) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |