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Last Updated: December 13, 2019

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Midostaurin - Generic Drug Details

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What are the generic 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 fifty-nine 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
Jazz PharmaceuticalsPhase 1
Swiss Group for Clinical Cancer ResearchPhase 2
Stichting Hemato-Oncologie voor Volwassenen NederlandPhase 2

See all midostaurin clinical trials

Recent Litigation for midostaurin

Identify potential future generic entrants

District Court Litigation
Case NameDate
Novartis AG v. Lee2013-01-14
NOVARTIS AG v. KAPPOS2010-07-06

See all midostaurin litigation

Pharmacology for midostaurin
Synonyms for midostaurin
[9S-(9?,10?,11?,13?)]-N-(2,3,10,11,12,13-Hexahydro-10-methoxy-9-methyl-1-oxo-9,13-epoxy-1H,9H-diindolo[1,2,3-gh:3',2',1'-lm]pyrrolo[3,4-j][1,7]benzodiazonin-11-yl)-N-methylbenzamide
120685-11-2
4-N-benzoylstaurosporine
4'-N-Benzoylstaurosporine
ACN-036840
AKOS024457372
AN-5669
BDBM50326053
Benzoylstaurosporine
BRD-K13646352-001-01-2
CCG-101288
Cgp 41 251
CGP 41231
Cgp 41251
CGP-41251
CGP-41521
CHEBI:63452
CHEMBL608533
CS-3331
D05029
DB06595
EX-A1741
GTPL5702
HMS3229K17
HY-10230
ID912S5VON
J-004379
KB-75409
Midostaurin (PKC412)
Midostaurin (USAN/INN)
Midostaurin [USAN:INN]
Midostaurin(PKC412)
MolPort-023-276-626
N-[(2S,3R,4R,6R)-3-methoxy-2-methyl-16-oxo-29-oxa-1,7,17-triazaoctacyclo[12.12.2.1^{2,6}.0^{7,28}.0^{8,13}.0^{15,19}.0^{20,27}.0^{21,26}]nonacosa-8,10,12,14(28),15(19),20(27),21,23,25-nonaen-4-yl]-N-methylbenzamide
N-[(5S,6R,7R,9R)-6-methoxy-5-methyl-14-oxo-6,7,8,9,15,16-hexahydro-5H,14H-5,9-epoxy-4b,9a,15-triazadibenzo[b,h]cyclonona[1,2,3,4-jkl]cyclopenta[e]-as-indacen-7-yl]-N-methylbenzamide
N-Benzoylstaurosporine
NCGC00241102-01
NCGC00241102-02
NVP-PKC412
PKC 412
PKC-412
PKC-412(Midostaurin)
PKC412
RYDAPT
Rydapt (TN)
s8064
SB16639
SCHEMBL8295379
UNII-ID912S5VON
Z-3116
ZINC100013130

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
1638574 1890003-5 Sweden   Start Trial PRODUCT NAME: MIDOSTAURIN OR A SALT THEREOF; REG. NO/DATE: EU/1/17/1218 20170920
1638574 2017C/067 Belgium   Start Trial PRODUCT NAME: MIDOSTAURIN OU UN DE SES SELS (RYDAPT); AUTHORISATION NUMBER AND DATE: EU/1/17/1218 20170920
1638574 293 1-2018 Slovakia   Start Trial PRODUCT NAME: MIDOSTAURIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; 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
1441737 C01441737/01 Switzerland   Start Trial PRODUCT NAME: MIDOSTAURIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66310 04.05.2017
1638574 CA 2018 00001 Denmark   Start Trial PRODUCT NAME: MIDOSTAURIN ELLER ET SALT DERAF; REG. NO/DATE: EU/1/17/1218 20170920
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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