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Last Updated: June 5, 2020

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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

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Drug patent expirations by year for RYDAPT
Drug Prices for RYDAPT

See drug prices 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.

Recent Clinical Trials for RYDAPT

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 RYDAPT clinical trials

Recent Litigation for RYDAPT

Identify potential future generic entrants

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

See all RYDAPT litigation

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
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   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 RYDAPT

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Dow
Harvard Business School
Moodys
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.