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Last Updated: August 13, 2020

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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 Alvogen, Amneal Pharms, Mylan, Ranbaxy Labs Ltd, Sandoz, Sunny Pharmtech Inc, and Watson Labs Inc, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for nitrofurantoin; nitrofurantoin, macrocrystalline. Twenty-seven 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
University of California, San DiegoN/A
University of British ColumbiaPhase 4
Duke UniversityPhase 4

See all NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE clinical trials

Pharmacology for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Paragraph IV (Patent) Challenges for NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Tradename Dosage Ingredient NDA Submissiondate
MACROBID CAPSULE;ORAL nitrofurantoin; nitrofurantoin, macrocrystalline 020064

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

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Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Dow
McKinsey
AstraZeneca
Mallinckrodt

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