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.

Summary for nitrofurantoin, macrocrystalline

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

Recent Clinical Trials for 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, macrocrystalline clinical trials

Pharmacology for nitrofurantoin, macrocrystalline

Drug Class	Nitrofuran Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for 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, macrocrystalline

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Glossary

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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	074336-001	Jan 25, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	211935-003	Jun 25, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Fl Inc	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	091095-003	Jun 18, 2015		DISCN	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

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