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Last Updated: April 19, 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, Aurobindo Pharma Usa, Inventia, Mankind Pharma, Omsav Pharma, 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
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 3
SaltroPhase 3
MJM BontenPhase 3

See all NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE clinical trials

Pharmacology 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
Sunny NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 208516-001 May 24, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Usa NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 076648-001 Mar 22, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs Inc NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 202250-001 Jul 8, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Almatica MACROBID nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 020064-001 Dec 24, 1991 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal Pharms NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 207372-001 May 15, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ranbaxy Labs Ltd NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 076951-001 Mar 30, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Almatica MACROBID nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 020064-001 Dec 24, 1991 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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