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Sodium phenylbutyrate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for sodium phenylbutyrate?

Sodium phenylbutyrate is the generic ingredient in two branded drugs marketed by Fera Pharms Llc, Par Pharm, Sigmapharm Labs Llc, and Horizon Pharma Inc, and is included in six NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: sodium phenylbutyrate

Tradenames:2
Patents:1
Applicants:4
NDAs:6
Drug Master File Entries: see list1360
Suppliers / Packagers: see list4
Bulk Api Vendors: see list46
Clinical Trials: see list929
Patent Applications: see list1,032
Therapeutic Class:Enzyme Replacements/Modifiers
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:sodium phenylbutyrate at DailyMed

Pharmacology for Ingredient: sodium phenylbutyrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Pharm
SODIUM PHENYLBUTYRATE
sodium phenylbutyrate
TABLET;ORAL204395-001Apr 15, 2016RXNoNo► Subscribe► Subscribe
Sigmapharm Labs Llc
SODIUM PHENYLBUTYRATE
sodium phenylbutyrate
POWDER;ORAL202819-001Mar 22, 2013RXNoNo► Subscribe► Subscribe
Par Pharm
SODIUM PHENYLBUTYRATE
sodium phenylbutyrate
POWDER;ORAL203918-001Jun 15, 2016RXNoNo► Subscribe► Subscribe
Horizon Pharma Inc
BUPHENYL
sodium phenylbutyrate
POWDER;ORAL020573-001Apr 30, 1996RXYesYes► Subscribe► Subscribe
Horizon Pharma Inc
BUPHENYL
sodium phenylbutyrate
TABLET;ORAL020572-001May 13, 1996RXYesYes► 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 Inc
BUPHENYL
sodium phenylbutyrate
TABLET;ORAL020572-001May 13, 19964,457,942► Subscribe
Horizon Pharma Inc
BUPHENYL
sodium phenylbutyrate
POWDER;ORAL020573-001Apr 30, 19964,457,942► Subscribe
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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. 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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