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Last Updated: December 5, 2022

Sunitinib malate - Generic Drug Details


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

Sunitinib malate is the generic ingredient in two branded drugs marketed by Dr Reddys, Mylan, Sun Pharm, Teva Pharms Usa, and Cppi Cv, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for sunitinib malate. Seven suppliers are listed for this compound.

Summary for sunitinib malate
Recent Clinical Trials for sunitinib malate

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SponsorPhase
VU University Medical CenterPhase 2/Phase 3
Graybug VisionPhase 2
University of Colorado, DenverPhase 1

See all sunitinib malate clinical trials

Pharmacology for sunitinib malate
Drug ClassKinase Inhibitor
Mechanism of Action Protein Kinase Inhibitors
Paragraph IV (Patent) Challenges for SUNITINIB MALATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SUTENT Capsules sunitinib malate 12.5 mg, 25 mg, 37.5 mg and 50 mg 021938 1 2010-01-26

US Patents and Regulatory Information for sunitinib malate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 213914-002 Aug 16, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 213914-003 Aug 16, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 201275-002 Dec 6, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 215843-004 Apr 11, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms Usa SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 213803-002 Nov 30, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 215843-002 Apr 11, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-001 Jan 26, 2006 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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