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Generated: November 21, 2018

DrugPatentWatch Database Preview

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 two suppliers. There are four patents protecting this drug. Additional details are available on the CAPRELSA profile page.

The generic ingredient in CAPRELSA is vandetanib. Two suppliers are 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 AstraZeneca Pharmaceuticals LP 0310-7820 0310-7820-30 30 TABLET in 1 BOTTLE, PLASTIC (0310-7820-30)
CAPRELSA vandetanib TABLET;ORAL 022405 NDA AstraZeneca Pharmaceuticals LP 0310-7840 0310-7840-30 30 TABLET in 1 BOTTLE, PLASTIC (0310-7840-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Apr 6, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 6, 2018
Regulatory Exclusivity Use:TREATMENT OF ASYMPTOMATIC OR PROGRESSIVE MEDULLARY THYROID CANCER IN PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC DISEASE
Patent:➤ Try a Free TrialPatent Expiration:Aug 14, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Aug 8, 2028Product Flag?YSubstance Flag?Delist 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 022405-001 Apr 6, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Genzyme Corp CAPRELSA vandetanib TABLET;ORAL 022405-002 Apr 6, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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