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Last Updated: December 6, 2022

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 three 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:3
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated 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:See Plans and PricingPatent Expiration:Aug 8, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent 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
Patent:See Plans and PricingPatent Expiration:Jun 27, 2022Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 022405

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 See Plans and Pricing See Plans and Pricing
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-001 Apr 6, 2011 See Plans and Pricing See Plans and Pricing
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 See Plans and Pricing See Plans and Pricing
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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