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Generated: December 13, 2017

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NALIDIXIC ACID - Generic Drug Details

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What are the generic drug sources for nalidixic acid and what is the scope of nalidixic acid 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.

Medical Subject Heading (MeSH) Categories for NALIDIXIC ACID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Watson LabsNALIDIXIC ACIDnalidixic acidTABLET;ORAL072061-001Jun 29, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Watson LabsNALIDIXIC ACIDnalidixic acidTABLET;ORAL071919-001Jun 29, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Watson LabsNALIDIXIC ACIDnalidixic acidTABLET;ORAL071936-001Jun 29, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharm IndustriesNALIDIXIC ACIDnalidixic acidTABLET;ORAL070272-001Jun 29, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsNEGGRAMnalidixic acidTABLET;ORAL014214-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsNEGGRAMnalidixic acidTABLET;ORAL014214-004Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharm IndustriesNALIDIXIC ACIDnalidixic acidTABLET;ORAL070271-001Jun 29, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsNEGGRAMnalidixic acidTABLET;ORAL014214-005Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharm IndustriesNALIDIXIC ACIDnalidixic acidTABLET;ORAL070270-001Jun 29, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sanofi Aventis UsNEGGRAMnalidixic acidSUSPENSION;ORAL017430-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: nalidixic acid

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis UsNEGGRAMnalidixic acidSUSPENSION;ORAL017430-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Sanofi Aventis UsNEGGRAMnalidixic acidTABLET;ORAL014214-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Sanofi Aventis UsNEGGRAMnalidixic acidTABLET;ORAL014214-004Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Sanofi Aventis UsNEGGRAMnalidixic acidTABLET;ORAL014214-005Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Sanofi Aventis UsNEGGRAMnalidixic acidSUSPENSION;ORAL017430-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Chubb
Daiichi Sankyo
Cerilliant
Cantor Fitzgerald
Fuji
Medtronic
Colorcon
UBS
Federal Trade Commission
Farmers Insurance

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 verifification 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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