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Generated: September 22, 2017

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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 NDA: 021938

Tradename:
1
Applicant:
1
Ingredient:
1
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)

Summary 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 500+ biopharmaceutical companies globally:

Mallinckrodt
Farmers Insurance
Dow
Chubb
Fish and Richardson
Boehringer Ingelheim
Chinese Patent Office
US Department of Justice
Harvard Business School
Queensland Health

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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