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Last Updated: November 22, 2024

NITROFURANTOIN - Generic Drug Details


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What are the generic sources for nitrofurantoin and what is the scope of freedom to operate?

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, Chartwell Rx, Inventia, Micro Labs, 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. Eleven suppliers are listed for this compound.

Summary for NITROFURANTOIN
Drug Prices for NITROFURANTOIN

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Drug Sales Revenue Trends for NITROFURANTOIN

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Recent Clinical Trials for NITROFURANTOIN

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

SponsorPhase
University of MinnesotaEarly Phase 1
Walter Reed National Military Medical CenterPhase 2
Radboud University Medical CenterPhase 4

See all NITROFURANTOIN clinical trials

Pharmacology for NITROFURANTOIN
Medical Subject Heading (MeSH) Categories for NITROFURANTOIN

US Patents and Regulatory Information for NITROFURANTOIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Procter And Gamble FURADANTIN nitrofurantoin TABLET;ORAL 008693-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mankind Pharma NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 217272-002 Mar 21, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Athem NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 074336-003 Jan 25, 1995 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ranbaxy Labs Ltd NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 076951-001 Mar 30, 2005 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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