FEXINIDAZOLE Drug Patent Profile
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When do Fexinidazole patents expire, and when can generic versions of Fexinidazole launch?
Fexinidazole is a drug marketed by Sanofi and is included in one NDA.
The generic ingredient in FEXINIDAZOLE is fexinidazole. One supplier is listed for this compound. Additional details are available on the fexinidazole profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fexinidazole
A generic version of FEXINIDAZOLE was approved as fexinidazole by SANOFI on July 16th, 2021.
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Summary for FEXINIDAZOLE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 78 |
| Clinical Trials: | 14 |
| Patent Applications: | 78 |
| What excipients (inactive ingredients) are in FEXINIDAZOLE? | FEXINIDAZOLE excipients list |
| DailyMed Link: | FEXINIDAZOLE at DailyMed |
Recent Clinical Trials for FEXINIDAZOLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| European and Developing Countries Clinical Trials Partnership (EDCTP) | Phase 2/Phase 3 |
| Drugs for Neglected Diseases | Phase 3 |
| Sanofi | Phase 3 |
Pharmacology for FEXINIDAZOLE
Anatomical Therapeutic Chemical (ATC) Classes for FEXINIDAZOLE
US Patents and Regulatory Information for FEXINIDAZOLE
FEXINIDAZOLE is protected by zero US patents and two FDA Regulatory Exclusivities.
FDA Regulatory Exclusivity protecting FEXINIDAZOLE
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
FOR THE TREATMENT OF BOTH THE FIRST-STAGE (HEMOLYMPHATIC) AND SECOND-STAGE (MENINGOENCEPHALITIC) HUMAN AFRICAN TRYPANOSOMIASIS (HAT) DUE TO TRYPANOSOMA BRUCEI GAMBIENSE IN PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 20 KG
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi | FEXINIDAZOLE | fexinidazole | TABLET;ORAL | 214429-001 | Jul 16, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sanofi | FEXINIDAZOLE | fexinidazole | TABLET;ORAL | 214429-001 | Jul 16, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
