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Last Updated: November 4, 2024

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE - Generic Drug Details


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

Nitrofurantoin; nitrofurantoin, macrocrystalline is the generic ingredient in two branded drugs marketed by Almatica, Alvogen, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Inventia, Mankind Pharma, Micro Labs, Ranbaxy Labs Ltd, Sandoz, Sunny, and Watson Labs Inc, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-five suppliers are listed for this compound.

Summary for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Recent Clinical Trials for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

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

SponsorPhase
SaltroPhase 3
MJM BontenPhase 3
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 3

See all NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE clinical trials

Pharmacology for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Anatomical Therapeutic Chemical (ATC) Classes for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

US Patents and Regulatory Information for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mankind Pharma NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 217357-001 Jul 11, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Almatica MACROBID nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 020064-001 Dec 24, 1991 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sunny NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 208516-001 May 24, 2018 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

Expired US Patents for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Almatica MACROBID nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 020064-001 Dec 24, 1991 ⤷  Sign Up ⤷  Sign Up
Almatica MACROBID nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 020064-001 Dec 24, 1991 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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