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Generated: April 26, 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
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 N 0310-7820-30
CAPRELSA vandetanib TABLET;ORAL 022405 NDA AstraZeneca Pharmaceuticals LP 0310-7840 N 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:➤ Sign UpPatent Expiration:Aug 14, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Aug 8, 2028Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Baxter
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Federal Trade Commission
Healthtrust
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Cipla
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