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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 and is included in one NDA. There are three patents protecting this drug.

This drug has sixty patent family members in twenty-seven countries.

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

US ANDA Litigation and Generic Entry Outlook for Rydapt

Rydapt will be eligible for patent challenges on April 28, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 28, 2024. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for RYDAPT

International Patents:	60
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	34
Clinical Trials:	6
Patent Applications:	65
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

See drug prices for RYDAPT

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.

Recent Clinical Trials for RYDAPT

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

Sponsor	Phase
Jazz Pharmaceuticals	Phase 1
Swiss Group for Clinical Cancer Research	Phase 2
Stichting Hemato-Oncologie voor Volwassenen Nederland	Phase 2

See all RYDAPT clinical trials

Recent Litigation for RYDAPT

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Novartis AG v. Lee	2013-01-14
NOVARTIS AG v. KAPPOS	2010-07-06

See all RYDAPT litigation

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

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

Midostaurin

Midostaurin (PKC412)

Midostaurin (USAN/INN)

Midostaurin [USAN:INN]

midostaurin-pkc412

Midostaurin(PKC412)

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

NCGC00484987-03

NVP-PKC412

PKC 412

PKC-412

PKC412

Q6842945

Rydapt (TN)

s8064

SB16639

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

International Patents for RYDAPT

Country	Patent Number	Estimated Expiration
Hungary	0401642
Spain	2269793
Hungary	230798
European Patent Office	1638574
South Korea	20090087139
Russian Federation	2337692

Supplementary Protection Certificates for RYDAPT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1638574	132018000000001	Italy		PRODUCT NAME: MIDOSTAURINA O UN SUO SALE(RYDAPT ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1218, 20170920
1441737	C01441737/01	Switzerland		PRODUCT NAME: MIDOSTAURIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66310 04.05.2017
1638574	LUC00055	Luxembourg		PRODUCT NAME: MIDOSTAURINE OU UN SEL DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1218 20170920
1638574	CR 2018 00001	Denmark		PRODUCT NAME: MIDOSTAURIN ELLER ET SALT DERAF; REG. NO/DATE: EU/1/17/1218 20170920
1638574	300917	Netherlands		PRODUCT NAME: MIDOSTAURINE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574	CA 2018 00001	Denmark		PRODUCT NAME: MIDOSTAURIN ELLER ET SALT DERAF; REG. NO/DATE: EU/1/17/1218 20170920