Nalidixic acid - Generic Drug Details

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What are the generic drug sources for nalidixic acid and what is the scope of freedom to operate?

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.

There are two drug master file entries for nalidixic acid.

Summary for nalidixic acid

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	8
Drug Master File Entries:	2
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	6
Patent Applications:	6,545
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
Hellenic Society of Gastroenterology	Phase 4
Alexandra Hospital, Athens, Greece	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	SUSPENSION;ORAL	017430-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	NALIDIXIC ACID	nalidixic acid	TABLET;ORAL	072061-001	Jun 29, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sanofi Aventis Us	NEGGRAM	nalidixic acid	TABLET;ORAL	014214-005	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	NEGGRAM	nalidixic acid	TABLET;ORAL	014214-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	NEGGRAM	nalidixic acid	TABLET;ORAL	014214-004	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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