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Fenfluramine hydrochloride - Generic Drug Details
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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fenfluramine hydrochloride has eighty-nine patent family members in twenty-five countries.
There are six drug master file entries for fenfluramine hydrochloride. One supplier is listed for this compound.
Summary for fenfluramine hydrochloride
| International Patents: | 89 |
| US Patents: | 11 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 6 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 37 |
| Clinical Trials: | 18 |
| Patent Applications: | 5,530 |
| DailyMed Link: | fenfluramine hydrochloride at DailyMed |
Recent Clinical Trials for fenfluramine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. | Phase 4 |
| University of Oxford | Phase 4 |
| National Institute for Health Research, United Kingdom | Phase 4 |
Paragraph IV (Patent) Challenges for FENFLURAMINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FINTEPLA | SOLUTION;ORAL | fenfluramine hydrochloride | 212102 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zogenix Inc | FINTEPLA | fenfluramine hydrochloride | SOLUTION;ORAL | 212102-001 | Jun 25, 2020 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Zogenix Inc | FINTEPLA | fenfluramine hydrochloride | SOLUTION;ORAL | 212102-001 | Jun 25, 2020 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Zogenix Inc | FINTEPLA | fenfluramine hydrochloride | SOLUTION;ORAL | 212102-001 | Jun 25, 2020 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Zogenix Inc | FINTEPLA | fenfluramine hydrochloride | SOLUTION;ORAL | 212102-001 | Jun 25, 2020 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Zogenix Inc | FINTEPLA | fenfluramine hydrochloride | SOLUTION;ORAL | 212102-001 | Jun 25, 2020 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| >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 | Estimated Expiration |
|---|---|---|
| Russian Federation | 2018121633 | ⤷ Try it Free |
| Japan | 2019501173 | ⤷ Try it Free |
| Hungary | E053114 | ⤷ Try it Free |
| Australia | 2020202655 | ⤷ Try it Free |
| Poland | 3393655 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
