You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 29, 2024

Nitrofurantoin - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

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

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, Inventia, Omsav Pharma, 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

US Patents:	0
Tradenames:	8
Applicants:	29
NDAs:	45
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	52
Patent Applications:	6,478
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for nitrofurantoin
What excipients (inactive ingredients) are in nitrofurantoin?	nitrofurantoin excipients list
DailyMed Link:	nitrofurantoin at DailyMed

See drug prices for nitrofurantoin

Drug Sales Revenue Trends for nitrofurantoin

See drug sales revenues for nitrofurantoin

Recent Clinical Trials for nitrofurantoin

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

Sponsor	Phase
IBSA Institut Biochimique SA	Phase 4
Goodlife Pharma B.V.	Phase 4
Radboud University Medical Center	Phase 4

See all nitrofurantoin clinical trials

Pharmacology for nitrofurantoin

Drug Class	Nitrofuran Antibacterial

Medical Subject Heading (MeSH) Categories for nitrofurantoin

Anti-Infective Agents, Urinary

Anatomical Therapeutic Chemical (ATC) Classes for nitrofurantoin

J01XE	Nitrofuran derivatives
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for nitrofurantoin

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
Sun Pharm Industries	NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	201722-003	Feb 16, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	NITROFURANTOIN MACROCRYSTALLINE	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	070248-001	Jun 24, 1988		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	nitrofurantoin; nitrofurantoin, macrocrystalline	CAPSULE;ORAL	077066-001	Apr 5, 2005	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	NITROFURANTOIN	nitrofurantoin	TABLET;ORAL	080447-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	NITROFURANTOIN	nitrofurantoin	TABLET;ORAL	085797-001	Approved Prior to Jan 1, 1982		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

Make Better Decisions: Try a trial or see plans & pricing

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. 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.