Last Updated: June 17, 2026

NITROFURANTOIN (MONOHYDRATE Drug Patent Profile

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When do Nitrofurantoin (monohydrate patents expire, and what generic alternatives are available?

Nitrofurantoin (monohydrate is a drug marketed by Alvogen, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Creekwood Pharms, Inventia, Mankind Pharma, Omsav Pharma, Ranbaxy Labs Ltd, Sandoz, Sunny, and Watson Labs Inc. and is included in twelve NDAs.

The generic ingredient in NITROFURANTOIN (MONOHYDRATE is nitrofurantoin; nitrofurantoin, macrocrystalline. There are twenty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.

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Summary for NITROFURANTOIN (MONOHYDRATE

US Patents:	0
Applicants:	12
NDAs:	12

US Patents and Regulatory Information for NITROFURANTOIN (MONOHYDRATE

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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
Alvogen	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	215002-001	Jul 20, 2022		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Mankind Pharma	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	217357-001	Jul 11, 2023	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Chartwell Rx	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	076648-001	Mar 22, 2004		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Watson Labs Inc	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	202250-001	Jul 8, 2015	AB	RX	No	No	⤷ 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

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