NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) Drug Patent Profile

When do Nitrofurantoin (monohydrate/macrocrystals) patents expire, and when can generic versions of Nitrofurantoin (monohydrate/macrocrystals) launch?

Nitrofurantoin (monohydrate/macrocrystals) is a drug marketed by 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 eleven NDAs.

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

Summary for NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

US Patents:	0
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Patent Applications:	1
DailyMed Link:	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) at DailyMed

Recent Clinical Trials for NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

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 (MONOHYDRATE/MACROCRYSTALS) clinical trials

Pharmacology for NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

Drug Class

Nitrofuran Antibacterial

US Patents and Regulatory Information for NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

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
Micro Labs	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	AB	RX	No	No