Nitrofurantoin - Generic Drug Details

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

Nitrofurantoin is the generic ingredient in eight branded drugs marketed by Watson Labs, Casper Pharma Llc, Actavis Mid Atlantic, Amneal Pharms, Aurobindo Pharma, Nostrum Labs Inc, Novel Labs Inc, Novitium Pharma, Procter And Gamble, Chartwell Molecular, Elkins Sinn, Ivax Sub Teva Pharms, Sandoz, Whiteworth Town Plsn, Almatica, Actavis Labs Fl Inc, Alembic, Athem, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Sun Pharm Industries, Zydus Pharms, Alvogen, Inventia, Omsav Pharma, Ranbaxy Labs Ltd, Sunny, and Watson Labs Inc, and is included in forty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for nitrofurantoin. Twelve suppliers are listed for this compound.

Summary for nitrofurantoin

US Patents:	0
Tradenames:	8
Applicants:	29
NDAs:	45
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	53
Patent Applications:	6,479
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for nitrofurantoin
What excipients (inactive ingredients) are in nitrofurantoin?	nitrofurantoin excipients list
DailyMed Link:	nitrofurantoin at DailyMed

See drug prices for nitrofurantoin

Drug Sales Revenue Trends for nitrofurantoin

See drug sales revenues for nitrofurantoin

Recent Clinical Trials for nitrofurantoin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Walter Reed National Military Medical Center	Phase 2
IBSA Institut Biochimique SA	Phase 4
Goodlife Pharma B.V.	Phase 4

See all nitrofurantoin clinical trials

Pharmacology for nitrofurantoin

Drug Class	Nitrofuran Antibacterial

Medical Subject Heading (MeSH) Categories for nitrofurantoin

Anti-Infective Agents, Urinary

Anatomical Therapeutic Chemical (ATC) Classes for nitrofurantoin

J01XE	Nitrofuran derivatives
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for nitrofurantoin

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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
Watson Labs	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	073696-001	Dec 31, 1992		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	NITROFURANTOIN	nitrofurantoin	CAPSULE;ORAL	084326-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	211935-001	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
Alvogen	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	215002-001	Jul 20, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	201722-001	Feb 16, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs Inc	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	202250-001	Jul 8, 2015	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

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