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Last Updated: December 11, 2025

NITROFURANTOIN (MONOHYDRATE Drug Patent Profile


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When do Nitrofurantoin (monohydrate patents expire, and when can generic versions of Nitrofurantoin (monohydrate launch?

Nitrofurantoin (monohydrate is a drug marketed by 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 eleven NDAs.

The generic ingredient in NITROFURANTOIN (MONOHYDRATE is nitrofurantoin; nitrofurantoin, macrocrystalline. There are twenty drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.

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Summary for NITROFURANTOIN (MONOHYDRATE
US Patents:0
Applicants:11
NDAs:11
DailyMed Link:NITROFURANTOIN (MONOHYDRATE at DailyMed
Drug patent expirations by year for NITROFURANTOIN (MONOHYDRATE

US Patents and Regulatory Information for NITROFURANTOIN (MONOHYDRATE

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alvogen NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 215002-001 Jul 20, 2022 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Micro Labs NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 217073-001 Nov 3, 2023 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Chartwell Rx NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 076648-001 Mar 22, 2004 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ranbaxy Labs Ltd NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 076951-001 Mar 30, 2005 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Amneal Pharms NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 207372-001 May 15, 2017 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Aurobindo Pharma NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 209225-001 Mar 30, 2023 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mankind Pharma NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 217357-001 Jul 11, 2023 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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