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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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Fenfluramine hydrochloride has forty-four patent family members in twenty countries.
There are six drug master file entries for fenfluramine hydrochloride. One supplier is listed for this compound.
Summary for fenfluramine hydrochloride
| International Patents: | 44 |
| US Patents: | 8 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 6 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 28 |
| Clinical Trials: | 17 |
| Patent Applications: | 5,318 |
| DailyMed Link: | fenfluramine hydrochloride at DailyMed |
Recent Clinical Trials for fenfluramine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, Los Angeles | Phase 2 |
| Zogenix, Inc. | Phase 3 |
| New York University School of Medicine | Phase 2 |
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 | Start Trial | Start Trial | Start Trial | ||||
| Zogenix Inc | FINTEPLA | fenfluramine hydrochloride | SOLUTION;ORAL | 212102-001 | Jun 25, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Zogenix Inc | FINTEPLA | fenfluramine hydrochloride | SOLUTION;ORAL | 212102-001 | Jun 25, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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 |
|---|---|---|
| New Zealand | 730560 | Start Trial |
| Brazil | 112015027282 | Start Trial |
| South Africa | 201705078 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
