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Last Updated: November 22, 2024

SUNITINIB MALATE Drug Patent Profile


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When do Sunitinib Malate patents expire, and when can generic versions of Sunitinib Malate launch?

Sunitinib Malate is a drug marketed by Dr Reddys, Eugia Pharma, Mylan, Natco Pharma, Sun Pharm, Teva Pharms Usa, and Wanbang Biopharms. and is included in seven NDAs.

The generic ingredient in SUNITINIB MALATE is sunitinib malate. There are eight drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sunitinib malate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sunitinib Malate

A generic version of SUNITINIB MALATE was approved as sunitinib malate by SUN PHARM on August 16th, 2021.

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Drug patent expirations by year for SUNITINIB MALATE
Drug Prices for SUNITINIB MALATE

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Recent Clinical Trials for SUNITINIB MALATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ExelixisPhase 3
VU University Medical CenterPhase 2/Phase 3
Graybug VisionPhase 2

See all SUNITINIB MALATE clinical trials

Pharmacology for SUNITINIB MALATE
Drug ClassKinase Inhibitor
Mechanism of ActionProtein 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
Wanbang Biopharms SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 218012-004 Aug 21, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 215843-001 Apr 11, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 213914-002 Aug 16, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 213803-004 Nov 30, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma SUNITINIB MALATE sunitinib malate CAPSULE;ORAL 218615-003 Mar 14, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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