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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
UBS
Covington
Accenture
Boehringer Ingelheim
Merck
Chinese Patent Office
McKinsey
Mallinckrodt

Generated: July 23, 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
Generic Entry Opportunity Date for 021938
Generic Entry Date for 021938*:
Constraining patent/regulatory exclusivity:
Dosage::
CAPSULE;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: 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 N 0069-0550-38
SUTENT sunitinib malate CAPSULE;ORAL 021938 NDA Pfizer Laboratories Div Pfizer Inc 0069-0770 N 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
Regulatory Exclusivity Expiration:Nov 16, 2020
Regulatory Exclusivity Use:ADJUVANT TREATMENT OF ADULT PATIENTS AT HIGH RISK OF RECURRENT RENAL CELL CARCINOMA (RCC) FOLLOWING NEPHRECTOMY
Patent:➤ Sign UpPatent Expiration:Feb 15, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:ADJUVANT TREATMENT OF ADULT PATIENTS AT HIGH RISK OF RECURRENT RCC FOLLOWING NEPHRECTOMY
Patent:➤ Sign UpPatent 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

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Boehringer Ingelheim
QuintilesIMS
US Army
AstraZeneca
Harvard Business School
Covington
Chubb
Healthtrust

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