.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203284

« Back to Dashboard
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 six 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-seven 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 NDA: 203284

Tradename:
RAVICTI
Applicant:
Horizon Theraps Inc
Ingredient:
glycerol phenylbutyrate
Patents:6
Formulation / Manufacturing:see details

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
Patent:8,404,215Patent Expiration:Mar 9, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER
Patent:8,642,012Patent Expiration:Sep 22, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER
Patent:9,095,559Patent Expiration:Mar 9, 2032Product Flag?Substance Flag?Delist Request?
Patented Use:DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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.

`abc