.

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): 022575

« Back to Dashboard
NDA 022575 describes VPRIV, which is a drug marketed by Shire Human Genetic and is included in one NDA. It is available from one supplier. Additional details are available on the VPRIV profile page.

The generic ingredient in VPRIV is velaglucerase alfa. One supplier is listed for this compound. Additional details are available on the velaglucerase alfa profile page.

Summary for NDA: 022575

Tradename:
VPRIV
Applicant:
Shire Human Genetic
Ingredient:
velaglucerase alfa
Patents:0

Pharmacology for NDA: 022575

Suppliers and Packaging for NDA: 022575

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VPRIV
velaglucerase alfa
INJECTABLE;IV (INFUSION) 022575 NDA Shire US Manufacturing Inc. 54092-701 54092-701-04 1 VIAL, GLASS in 1 BOX (54092-701-04) > 4 mL in 1 VIAL, GLASS
VPRIV
velaglucerase alfa
POWDER;IV (INFUSION) 022575 NDA Shire US Manufacturing Inc. 54092-701 54092-701-04 1 VIAL, GLASS in 1 BOX (54092-701-04) > 4 mL in 1 VIAL, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength400 UNITS/VIAL
Approval Date:Feb 26, 2010TE:RLD:No
Regulatory Exclusivity Expiration:Nov 21, 2016
Regulatory Exclusivity Use:ADDITION OF INFORMATION ON LONG-TERM TREATMENT WITH VPRIV IN THE CLINICAL TRIALS SECTION OF THE PACKAGE INSERT

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:POWDER;IV (INFUSION)Strength200 UNITS/VIAL
Approval Date:Feb 26, 2010TE:RLD:No
Regulatory Exclusivity Expiration:Nov 21, 2016
Regulatory Exclusivity Use:ADDITION OF INFORMATION ON LONG-TERM TREATMENT WITH VPRIV IN THE CLINICAL TRIALS SECTION OF THE PACKAGE INSERT


Complete Access Available with Subscription
« Back to Dashboard

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

How are People Using DrugPatentWatch?

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