FEXINIDAZOLE - Generic Drug Details

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What are the generic sources for fexinidazole and what is the scope of patent protection?

Fexinidazole is the generic ingredient in one branded drug marketed by Sanofi and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for FEXINIDAZOLE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	14
Patent Applications:	126
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

See all FEXINIDAZOLE clinical trials

Pharmacology for FEXINIDAZOLE

Drug Class	Nitroimidazole Antimicrobial
Mechanism of Action	Cytochrome P450 1A2 Inducers Cytochrome P450 1A2 Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2B6 Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FEXINIDAZOLE

P01CA	Nitroimidazole derivatives
P01C	AGENTS AGAINST LEISHMANIASIS AND TRYPANOSOMIASIS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for FEXINIDAZOLE

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Glossary

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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

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