NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE - Generic Drug Details

What are the generic 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
MJM Bonten	Phase 3
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 3
Saltro	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
Sandoz	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	077066-001	Apr 5, 2005	AB	RX	No	No
Ranbaxy Labs Ltd	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	076951-001	Mar 30, 2005		DISCN	No	No
Inventia	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	211013-001	Feb 18, 2022	AB	RX	No	No
Micro Labs	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	217073-001	Nov 3, 2023	AB	RX	No	No
Alvogen	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	215002-001	Jul 20, 2022		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