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Last Updated: November 14, 2019

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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 patent protection?

Midostaurin is the generic ingredient in one branded drug marketed by Novartis Pharms Corp 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 Pharms Corp RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis Pharms Corp RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis Pharms Corp RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis Pharms Corp 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 122018000038 Germany   Start Trial PRODUCT NAME: MIDOSTAURIN / RYDAPT; REGISTRATION NO/DATE: EU/1/17/1218 20170918
1638574 CA 2018 00001 Denmark   Start Trial PRODUCT NAME: MIDOSTAURIN ELLER ET SALT DERAF; REG. NO/DATE: EU/1/17/1218 20170920
1638574 LUC00055 Luxembourg   Start Trial PRODUCT NAME: MIDOSTAURINE OU UN SEL DE CELLE-CI; AUTHORISATION NUMBER AND 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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