Last Updated: September 24, 2026

NALIDIXIC ACID - Generic Drug Details

Name: NALIDIXIC ACID Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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

Nalidixic acid is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Sun Pharm Industries, and Watson Labs, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Summary for NALIDIXIC ACID

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	8
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Patent Applications:	7,097
DailyMed Link:	NALIDIXIC ACID at DailyMed

Recent Clinical Trials for NALIDIXIC ACID

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

Sponsor	Phase
Albany Medical College	N/A
Alexandra Hospital, Athens, Greece	Phase 4
Hellenic Society of Gastroenterology	Phase 4

See all NALIDIXIC ACID clinical trials

Medical Subject Heading (MeSH) Categories for NALIDIXIC ACID

Anti-Bacterial Agents
Topoisomerase II Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for NALIDIXIC ACID

J01MB	Other quinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for NALIDIXIC ACID

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	NEGGRAM	nalidixic acid	TABLET;ORAL	014214-004	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sanofi Aventis Us	NEGGRAM	nalidixic acid	TABLET;ORAL	014214-005	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Sun Pharm Industries	NALIDIXIC ACID	nalidixic acid	TABLET;ORAL	070272-001	Jun 29, 1988		DISCN	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 NALIDIXIC ACID

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	NEGGRAM	nalidixic acid	SUSPENSION;ORAL	017430-001	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Sanofi Aventis Us	NEGGRAM	nalidixic acid	TABLET;ORAL	014214-002	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Sanofi Aventis Us	NEGGRAM	nalidixic acid	TABLET;ORAL	014214-005	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent 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.