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Generated: December 18, 2017

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Sodium phenylbutyrate - Generic Drug Details

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

Sodium phenylbutyrate
is the generic ingredient in two branded drugs marketed by Horizon Pharma Inc, Par Pharm, Sigmapharm Labs Llc, and Alvogen Malta, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are one thousand four hundred drug master file entries for sodium phenylbutyrate. Four suppliers are listed for this compound.

Pharmacology for sodium phenylbutyrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sigmapharm Labs LlcSODIUM PHENYLBUTYRATEsodium phenylbutyratePOWDER;ORAL202819-001Mar 22, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Horizon Pharma IncBUPHENYLsodium phenylbutyrateTABLET;ORAL020572-001May 13, 1996ABRXYesYes► Subscribe► Subscribe► Subscribe
Par PharmSODIUM PHENYLBUTYRATEsodium phenylbutyrateTABLET;ORAL204395-001Apr 15, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Par PharmSODIUM PHENYLBUTYRATEsodium phenylbutyratePOWDER;ORAL203918-001Jun 15, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Alvogen MaltaSODIUM PHENYLBUTYRATEsodium phenylbutyrateTABLET;ORAL090910-001Nov 18, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Horizon Pharma IncBUPHENYLsodium phenylbutyratePOWDER;ORAL020573-001Apr 30, 1996ABRXYesYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: sodium phenylbutyrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Horizon Pharma IncBUPHENYLsodium phenylbutyratePOWDER;ORAL020573-001Apr 30, 1996► Subscribe► Subscribe
Horizon Pharma IncBUPHENYLsodium phenylbutyrateTABLET;ORAL020572-001May 13, 1996► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Fish and Richardson
Cipla
Deloitte
Healthtrust
Citi
Cantor Fitzgerald
US Department of Justice
AstraZeneca
Colorcon

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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