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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
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Serving leading biopharmaceutical companies globally:

Queensland Health
Federal Trade Commission
Daiichi Sankyo
McKesson
McKinsey
Novartis
AstraZeneca
Johnson and Johnson
Chinese Patent Office
Fish and Richardson

Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203284

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NDA 203284 describes RAVICTI, which is a drug marketed by Horizon Theraps Inc and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the RAVICTI profile page.

The generic ingredient in RAVICTI is glycerol phenylbutyrate. There are forty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the glycerol phenylbutyrate profile page.

Summary for 203284

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:7
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 203284

Suppliers and Packaging for NDA: 203284

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAVICTI
glycerol phenylbutyrate
LIQUID;ORAL 203284 NDA Horizon Therapeutics, LLC. 75987-050 75987-050-06 1 BOTTLE in 1 CARTON (75987-050-06) > 25 mL in 1 BOTTLE
RAVICTI
glycerol phenylbutyrate
LIQUID;ORAL 203284 NDA Horizon Therapeutics, LLC. 75987-050 75987-050-07 4 BOTTLE in 1 CARTON (75987-050-07) > 25 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:LIQUID;ORALStrength1.1GM/ML
Approval Date:Feb 1, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 28, 2020
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Feb 1, 2020
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Jul 28, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF A NITROGEN METABOLISM DISORDER


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Serving leading biopharmaceutical companies globally:

Express Scripts
Chinese Patent Office
Harvard Business School
US Army
US Department of Justice
Chubb
Fuji
Federal Trade Commission
Colorcon
Baxter

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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