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Last Updated: March 18, 2024

NALIDIXIC ACID - Generic Drug Details


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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.

There are two drug master file entries for nalidixic acid.

Recent Clinical Trials for NALIDIXIC ACID

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

SponsorPhase
Albany Medical CollegeN/A
Hellenic Society of GastroenterologyPhase 4
Alexandra Hospital, Athens, GreecePhase 4

See all NALIDIXIC ACID clinical trials

Medical Subject Heading (MeSH) Categories for NALIDIXIC ACID

US Patents and Regulatory Information for NALIDIXIC ACID

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 NALIDIXIC ACID nalidixic acid TABLET;ORAL 070271-001 Jun 29, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us NEGGRAM nalidixic acid TABLET;ORAL 014214-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Industries NALIDIXIC ACID nalidixic acid TABLET;ORAL 070270-001 Jun 29, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs NALIDIXIC ACID nalidixic acid TABLET;ORAL 071919-001 Jun 29, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us NEGGRAM nalidixic acid SUSPENSION;ORAL 017430-001 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

Expired US Patents for NALIDIXIC ACID

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 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us NEGGRAM nalidixic acid TABLET;ORAL 014214-004 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us NEGGRAM nalidixic acid TABLET;ORAL 014214-002 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us NEGGRAM nalidixic acid SUSPENSION;ORAL 017430-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us NEGGRAM nalidixic acid TABLET;ORAL 014214-005 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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