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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.

Summary for RYDAPT

International Patents:	56
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	30
Clinical Trials:	1
Patent Applications:	57
Drug Prices:	Drug price information for RYDAPT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RYDAPT
DailyMed Link:	RYDAPT at DailyMed

Generic Entry Opportunity 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:

207997

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

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

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
Novartis Pharms Corp	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017		RX	Yes	Yes
Novartis Pharms Corp	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017		RX	Yes	Yes
Novartis Pharms Corp	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017		RX	Yes	Yes
Novartis Pharms Corp	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017		RX	Yes	Yes

International Patents for RYDAPT

Country	Document Number	Estimated Expiration
China	100457111
Slovenia	1441737
Poland	211461
Taiwan	200512213
Hungary	0401642

Supplementary Protection Certificates for RYDAPT

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