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 is one patent 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:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022405

Generic Entry Date for 022405^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Pharmacology for NDA: 022405

Mechanism of Action	Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors Protein Kinase Inhibitors

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:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Apr 6, 2011	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Aug 8, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Apr 6, 2011	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Aug 8, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022405

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

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