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Generated: May 27, 2017

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Sunitinib malate - Generic Drug Details

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What are the generic sources for sunitinib malate and what is the scope of sunitinib malate freedom to operate?

Sunitinib malate
is the generic ingredient in one branded drug marketed by Cppi Cv and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Sunitinib malate has sixty-eight patent family members in thirty-nine countries.

There are six drug master file entries for sunitinib malate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: sunitinib malate

Drug Master File Entries: see list6
Suppliers / Packagers: see list1
Bulk Api Vendors: see list118
Clinical Trials: see list205
Patent Applications: see list11,474
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:sunitinib malate at DailyMed

Pharmacology for Ingredient: sunitinib malate

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

Tentative approvals for SUNITINIB MALATE

Applicant Application No. Strength Dosage Form
► Subscribe► SubscribeEQ 12.5MG BASECAPSULE;ORAL
► Subscribe► SubscribeEQ 50MG BASECAPSULE;ORAL
► Subscribe► SubscribeEQ 37.5MG BASECAPSULE;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cppi Cv
sunitinib malate
CAPSULE;ORAL021938-001Jan 26, 2006RXYesNo7,125,905► SubscribeYY ► Subscribe
Cppi Cv
sunitinib malate
CAPSULE;ORAL021938-004Mar 31, 2009RXYesNo7,125,905► SubscribeYY ► Subscribe
Cppi Cv
sunitinib malate
CAPSULE;ORAL021938-004Mar 31, 2009RXYesNo6,573,293► SubscribeYY ► Subscribe
Cppi Cv
sunitinib malate
CAPSULE;ORAL021938-003Jan 26, 2006RXYesYes7,125,905► SubscribeYY ► Subscribe
Cppi Cv
sunitinib malate
CAPSULE;ORAL021938-001Jan 26, 2006RXYesNo7,211,600► Subscribe ► Subscribe
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