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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 022405


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NDA 022405 describes CAPRELSA, which is a drug marketed by Genzyme Corp and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the CAPRELSA profile page.

The generic ingredient in CAPRELSA is vandetanib. One supplier is listed for this compound. Additional details are available on the vandetanib profile page.
Summary for 022405
Tradename:CAPRELSA
Applicant:Genzyme Corp
Ingredient:vandetanib
Patents:4
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022405
Generic Entry Date for 022405*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 022405
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPRELSA vandetanib TABLET;ORAL 022405 NDA Genzyme Corporation 58468-7820 58468-7820-3 1 BOTTLE, PLASTIC in 1 CARTON (58468-7820-3) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
CAPRELSA vandetanib TABLET;ORAL 022405 NDA Genzyme Corporation 58468-7840 58468-7840-3 1 BOTTLE, PLASTIC in 1 CARTON (58468-7840-3) > 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Apr 6, 2011TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 14, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Aug 8, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Feb 6, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:FOR USE IN PATIENTS HAVING SYMPTOMATIC OR PROGRESSIVE MEDULLARY THYROID CANCER, WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC DISEASE

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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 verification 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.