Nitrofurantoin - Generic Drug Details

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What are the generic sources for nitrofurantoin and what is the scope of patent protection?

Sponsor	Phase
University of Minnesota	Early Phase 1
Walter Reed National Military Medical Center	Phase 2
Goodlife Pharma B.V.	Phase 4

Sponsor

Phase

University of Minnesota

Early Phase 1

Walter Reed National Military Medical Center

Phase 2

Goodlife Pharma B.V.

Phase 4

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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
Athem	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	074336-002	Jan 25, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sunny	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	208516-001	May 24, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	NITROFURANTOIN MACROCRYSTALLINE	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	070248-001	Jun 24, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novel Labs Inc	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	203233-001	Jul 9, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	NITROFURANTOIN	nitrofurantoin	TABLET;ORAL	085796-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	209225-001	Mar 30, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	8
Applicants:	30
NDAs:	45
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	54
Patent Applications:	6,479
Drug Prices:	Drug price trends for nitrofurantoin
What excipients (inactive ingredients) are in nitrofurantoin?	nitrofurantoin excipients list
DailyMed Link:	nitrofurantoin at DailyMed