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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Argus Health
Merck
Express Scripts
Julphar
Cerilliant
Covington
Fish and Richardson
Moodys
Fuji

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021938

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NDA 021938 describes SUTENT, which is a drug marketed by Cppi Cv and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SUTENT profile page.

The generic ingredient in SUTENT is sunitinib malate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sunitinib malate profile page.
Summary for 021938
Tradename:SUTENT
Applicant:Cppi Cv
Ingredient:sunitinib malate
Patents:3
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 021938
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 021938
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUTENT sunitinib malate CAPSULE;ORAL 021938 NDA Pfizer Laboratories Div Pfizer Inc 0069-0550 0069-0550-38 28 CAPSULE in 1 BOTTLE (0069-0550-38)
SUTENT sunitinib malate CAPSULE;ORAL 021938 NDA Pfizer Laboratories Div Pfizer Inc 0069-0770 0069-0770-38 28 CAPSULE in 1 BOTTLE (0069-0770-38)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 12.5MG BASE
Approval Date:Jan 26, 2006TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Feb 15, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL TUMORS, RENAL CELL CARCINOMA AND ADVANCED PANCREATIC NEUROENDOCRINE TUMORS, WITH SUNITINIB
Patent:➤ SubscribePatent Expiration:Feb 15, 2021Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ SubscribePatent Expiration:Dec 22, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF GASTROINTESTINAL STROMAL TUMOR WITH SUNITINIB

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Deloitte
McKinsey
UBS
Teva
Johnson and Johnson
Chubb
Merck
Harvard Business School

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 verifification 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.

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