NITROFURANTOIN (MONOHYDRATE Drug Patent Profile

Which patents cover Nitrofurantoin (monohydrate, and what generic alternatives are available?

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

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

Summary for NITROFURANTOIN (MONOHYDRATE

US Patents:	0
Applicants:	11
NDAs:	11

US Patents and Regulatory Information for NITROFURANTOIN (MONOHYDRATE

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
Omsav Pharma	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	217073-001	Nov 3, 2023	AB	RX	No	No
Chartwell Rx	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	076648-001	Mar 22, 2004		DISCN	No	No
Ranbaxy Labs Ltd	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	076951-001	Mar 30, 2005		DISCN	No	No
Amneal Pharms	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	207372-001	May 15, 2017		DISCN	No	No
Aurobindo Pharma	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	209225-001	Mar 30, 2023	AB	RX	No	No