Nitrofurantoin, macrocrystalline - Generic Drug Details

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What are the generic drug 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
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 3
Saltro	Phase 3
MJM Bonten	Phase 3

Sponsor

Phase

ZonMw: The Netherlands Organisation for Health Research and Development

Phase 3

Saltro

Phase 3

MJM Bonten

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
Sun Pharm Industries	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	201722-001	Feb 16, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Usa	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	077025-002	Oct 2, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Usa	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	074967-001	Jul 9, 1997	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:	3
Applicants:	11
NDAs:	15
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	3
Patent Applications:	6,478
DailyMed Link:	nitrofurantoin, macrocrystalline at DailyMed