Nitroimidazole Antimicrobial global drug patents, pharmaceutical manufacturers and generics

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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
Novast Labs	BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	217511-001	Jul 3, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	bismuth subcitrate potassium; metronidazole; tetracycline hydrochloride	CAPSULE;ORAL	205770-001	Mar 6, 2023	AB	RX	No	No	⤷ 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
Sanofi	FEXINIDAZOLE	fexinidazole	TABLET;ORAL	214429-001	Jul 16, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	FLAGYL	metronidazole	CAPSULE;ORAL	020334-001	May 3, 1995	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Baxter Hlthcare	FLAGYL I.V. RTU IN PLASTIC CONTAINER	metronidazole	INJECTABLE;INJECTION	018657-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Saptalis Pharms	LIKMEZ	metronidazole	SUSPENSION;ORAL	216755-001	Sep 22, 2023		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

Nitroimidazole Antimicrobial Drug Class List