Fenfluramine hydrochloride - Generic Drug Details
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What are the generic sources for fenfluramine hydrochloride and what is the scope of patent protection?
Fenfluramine hydrochloride
is the generic ingredient in one branded drug marketed by Zogenix Inc and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fenfluramine hydrochloride has one hundred and six patent family members in twenty-six countries.
There are five drug master file entries for fenfluramine hydrochloride. One supplier is listed for this compound.
Summary for fenfluramine hydrochloride
International Patents: | 106 |
US Patents: | 12 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 5 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 40 |
Clinical Trials: | 20 |
Patent Applications: | 5,657 |
DailyMed Link: | fenfluramine hydrochloride at DailyMed |
Recent Clinical Trials for fenfluramine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University Health Network, Toronto | Phase 3 |
Zogenix, Inc. | Phase 4 |
Hospital Ruber Internacional | Phase 4 |
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 | 102245345 | See Plans and Pricing | |
Australia | 2017315273 | Formulation for inhibiting formation of 5-HT 2B agonists and methods of using same | See Plans and Pricing |
Singapore | 11201804811W | FENFLURAMINE COMPOSITIONS AND METHODS OF PREPARING THE SAME | See Plans and Pricing |
Israel | 264637 | פורמולציה לעיכוב יצירת אגוניסטים של 5-ht 2b ושיטות לשימוש בה (Formulation for inhibiting formation of 5-ht 2b agonists and methods of using same) | See Plans and Pricing |
Croatia | P20210819 | See Plans and Pricing | |
Japan | 6774402 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |