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Generated: December 11, 2018

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RYDAPT Drug Profile

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When do Rydapt patents expire, and what generic alternatives are available?

Rydapt is a drug marketed by Novartis Pharms Corp and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-six patent family members in twenty-six countries.

The generic ingredient in RYDAPT is midostaurin. One supplier is listed for this compound. Additional details are available on the midostaurin profile page.

Drug patent expirations by year for RYDAPT
Generic Entry Opportunity Date for RYDAPT
Generic Entry Date for RYDAPT*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), OR MAST CELL LEUKEMIA (MCL)
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for RYDAPT
Synonyms for RYDAPT
[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
CPG 41251
CS-3331
D05029
D07NVU
D0KL7G
D0V2BO
DB06595
GTPL5702
HY-10230
ID912S5VON
J-004379
KB-75409
MCL-1-specific antisense oligonucleotide + midostaurin(PKC412)
MFCD12828879
Midostaurin
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
PKC412
Rydapt (TN)
s8064
SCHEMBL8295379
UNII-ID912S5VON
Z-3116
ZINC100013130

US Patents and Regulatory Information for RYDAPT

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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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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Supplementary Protection Certificates for RYDAPT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0917 Netherlands ➤ Try a Free Trial PRODUCT NAME: MIDOSTAURINE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1218 20170920
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Federal Trade Commission
Citi
Johnson and Johnson
Medtronic
Queensland Health
US Army
Deloitte
Daiichi Sankyo

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