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: | 21 |
| Patent Applications: | 5,952 |
| DailyMed Link: | fenfluramine hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for fenfluramine hydrochloride
*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 |
|---|---|
| UCB BIOSCIENCES, Inc. | Phase 3 |
| University Health Network, Toronto | Phase 3 |
| 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
| 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 | 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 | |||
| 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 | |||
| >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 fenfluramine hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | 201821071 | Formulation for inhibiting formation of 5-HT2B agonists and methods of using same | ⤷ Sign Up |
| Croatia | P20210267 | ⤷ Sign Up | |
| Singapore | 10202005916Q | FENFLURAMINE COMPOSITIONS AND METHODS OF PREPARING THE SAME | ⤷ Sign Up |
| Taiwan | I776407 | ⤷ Sign Up | |
| Denmark | 3329909 | ⤷ Sign Up | |
| Singapore | 11201900975X | FORMULATION FOR INHIBITING FORMATION OF 5-HT 2B AGONISTS AND METHODS OF USING SAME | ⤷ Sign Up |
| Denmark | 2991637 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
