Nitrofurantoin; nitrofurantoin, macrocrystalline - Generic Drug Details

What are the generic drug sources for nitrofurantoin; nitrofurantoin, macrocrystalline and what is the scope of patent protection?

Nitrofurantoin; nitrofurantoin, macrocrystalline is the generic ingredient in two branded drugs marketed by Almatica, Alvogen, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Inventia, Mankind Pharma, Micro Labs, Ranbaxy Labs Ltd, Sandoz, Sunny, and Watson Labs Inc, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-five suppliers are listed for this compound.

Summary for nitrofurantoin; nitrofurantoin, macrocrystalline

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Finished Product Suppliers / Packagers:	35
Clinical Trials:	3
DailyMed Link:	nitrofurantoin; nitrofurantoin, macrocrystalline at DailyMed

Recent Clinical Trials for nitrofurantoin; nitrofurantoin, macrocrystalline

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 3
Saltro	Phase 3
MJM Bonten	Phase 3

See all nitrofurantoin; nitrofurantoin, macrocrystalline clinical trials

Pharmacology for nitrofurantoin; nitrofurantoin, macrocrystalline

Drug Class

Nitrofuran Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for nitrofurantoin; nitrofurantoin, macrocrystalline

J01XE	Nitrofuran derivatives
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for nitrofurantoin; nitrofurantoin, macrocrystalline

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mankind Pharma	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	217357-001	Jul 11, 2023	AB	RX	No	No
Almatica	MACROBID	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	020064-001	Dec 24, 1991	AB	RX	Yes	Yes
Sunny	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	208516-001	May 24, 2018	AB	RX	No	No
Watson Labs Inc	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	202250-001	Jul 8, 2015	AB	RX	No	No
Chartwell Rx	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	076648-001	Mar 22, 2004		DISCN	No	No

Expired US Patents for nitrofurantoin; nitrofurantoin, macrocrystalline

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almatica	MACROBID	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	020064-001	Dec 24, 1991
Almatica	MACROBID	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	020064-001	Dec 24, 1991