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Last Updated: July 3, 2020

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SUNITINIB MALATE - Generic Drug Details

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What are the generic drug sources for sunitinib malate and what is the scope of patent protection?

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 eighty patent family members in forty-two countries.

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

Recent Clinical Trials for SUNITINIB MALATE

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

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

See all SUNITINIB MALATE clinical trials

Generic filers with tentative approvals for SUNITINIB MALATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 50MG BASECAPSULE;ORAL
  Start Trial  Start TrialEQ 37.5MG BASECAPSULE;ORAL
  Start Trial  Start TrialEQ 25MG BASECAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for SUNITINIB MALATE
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for SUNITINIB MALATE
Tradename Dosage Ingredient NDA Submissiondate
SUTENT CAPSULE;ORAL sunitinib malate 021938 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
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-002 Jan 26, 2006 RX Yes No   Start Trial   Start Trial Y   Start Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-003 Jan 26, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-002 Jan 26, 2006 RX Yes No   Start Trial   Start Trial Y   Start Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-001 Jan 26, 2006 RX Yes No   Start Trial   Start Trial Y   Start Trial
Cppi Cv SUTENT sunitinib malate CAPSULE;ORAL 021938-001 Jan 26, 2006 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for SUNITINIB MALATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1255752 PA2008002,C1255752 Lithuania   Start Trial PRODUCT NAME: SUNITINIBUM; REGISTRATION NO/DATE: EU/1/06/347/001, EU/1/06/347/002, EU/1/06/347/003 20060719
1255752 C01255752/02 Switzerland   Start Trial PRODUCT NAME: TOCERANIB; REGISTRATION NO/DATE: SWISSMEDIC 60121 09.07.2010
1255752 SPC/GB08/007 United Kingdom   Start Trial PRODUCT NAME: SUNITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE L-MALATE SALT.; REGISTERED: UK EU/1/06/347/001 20060724; UK EU/1/06/347/002 20060724; UK EU/1/06/347/003 20060724
1255752 91407 Luxembourg   Start Trial PRODUCT NAME: SUNITINIB, OPTIONNELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE SEL L-MALATE (SUTENT ); AUTHORISATION NUMBER AND DATE: EU/1/06/347/001-003 - SUTENT-SUNITINIB 20060724
1255752 300332 Netherlands   Start Trial PRODUCT NAME: SUNITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET L-MALAATZOUT; REGISTRATION NO/DATE: EU/1/06/347/001-003 20060724
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Express Scripts
Harvard Business School
McKesson
Baxter
AstraZeneca

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