Nitrofurantoin, macrocrystalline - Generic Drug Details

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

Nitrofurantoin, macrocrystalline is the generic ingredient in three branded drugs marketed by Almatica, Actavis Labs Fl Inc, Alembic, Athem, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Novel Labs Inc, Sun Pharm Industries, Watson Labs, and Zydus Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-eight suppliers are listed for this compound.

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

Sponsor

Phase

Saltro

Phase 3

MJM Bonten

Phase 3

ZonMw: The Netherlands Organisation for Health Research and Development

Phase 3

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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
Alembic	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	211935-002	Jun 25, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Industries	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	201722-003	Feb 16, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Almatica	MACRODANTIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	016620-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novel Labs Inc	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	203233-001	Jul 9, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma Usa	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	077025-001	Aug 18, 2004	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alembic	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	211935-001	Jun 25, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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:	3
Applicants:	11
NDAs:	15
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	3
Patent Applications:	6,478
Formulation / Manufacturing:	see details
DailyMed Link:	nitrofurantoin, macrocrystalline at DailyMed