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Last Updated: January 17, 2021

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Midostaurin - Generic Drug Details

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What are the generic drug sources for midostaurin and what is the scope of freedom to operate?

Midostaurin is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Midostaurin has sixty-one patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for midostaurin
Recent Clinical Trials for midostaurin

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

SponsorPhase
University Hospital Inselspital, BernePhase 1
Technische Universität DresdenPhase 1/Phase 2
PfizerPhase 1/Phase 2

See all midostaurin clinical trials

Pharmacology for midostaurin

US Patents and Regulatory Information for midostaurin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes   Start Trial   Start Trial   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 midostaurin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1441737 C01441737/01 Switzerland   Start Trial PRODUCT NAME: MIDOSTAURIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66310 04.05.2017
1638574 300917 Netherlands   Start Trial PRODUCT NAME: MIDOSTAURINE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574 17C1063 France   Start Trial PRODUCT NAME: MIDOSTAURINE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574 2017/061 Ireland   Start Trial PRODUCT NAME: MIDOSTAURIN OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574 CR 2018 00001 Denmark   Start Trial PRODUCT NAME: MIDOSTAURIN ELLER ET SALT DERAF; REG. NO/DATE: EU/1/17/1218 20170920
1638574 1890003-5 Sweden   Start Trial PRODUCT NAME: MIDOSTAURIN OR A SALT THEREOF; REG. NO/DATE: EU/1/17/1218 20170920
1638574 C20170046 00256 Estonia   Start Trial PRODUCT NAME: MIDOSTAURIIN;REG NO/DATE: EU/1/17/1218 20.09.2017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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