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Last Updated: May 27, 2022

RYDAPT Drug Patent 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 and one Paragraph IV challenge.

This drug has sixty-two 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.

DrugPatentWatch® Generic Entry Outlook for Rydapt

Rydapt was eligible for patent challenges on April 28, 2021.

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 has been one patent litigation case 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

DrugPatentWatch® Estimated 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
Baptist Health South FloridaPhase 1/Phase 2
Jazz PharmaceuticalsPhase 1/Phase 2
Technische Universit├Ąt DresdenPhase 1/Phase 2

See all RYDAPT clinical trials

Paragraph IV (Patent) Challenges for RYDAPT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RYDAPT Capsules midostaurin 25 mg 207997 4 2021-04-28

US Patents and Regulatory Information for RYDAPT

RYDAPT is protected by three US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RYDAPT is See Plans and Pricing.

This potential generic entry date is based on TREATMENT OF ADULT PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), OR MAST CELL LEUKEMIA (MCL).

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting RYDAPT

Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) WHO ARE FLT3 MUTATION-POSITIVE, IN COMBINATION WITH STANDARD CYTARABINE AND DAUNORUBICIN INDUCTION AND CYTARABINE CONSOLIDATION CHEMOTHERAPY

Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) WHO ARE FLT3 MUTATION-POSITIVE, IN COMBINATION WITH STANDARD CYTARABINE AND DAUNORUBICIN INDUCTION AND CYTARABINE CONSOLIDATION CHEMOTHERAPY

Pharmaceutical uses of staurosporine derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), OR MAST CELL LEUKEMIA (MCL)

FDA Regulatory Exclusivity protecting RYDAPT

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), OR MAST CELL LEUKEMIA (MCL)
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) THAT IS FLT3 MUTATION-POSITIVE AS DETECTED BY AN FDA APPROVED TEST, IN COMBINATION WITH STANDARD CYTARABINE AND DAUNORUBICIN INDUCTION AND CYTARABINE CONSOLIDATION
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for RYDAPT

See the table below for patents covering RYDAPT around the world.

Country Patent Number Title Estimated Expiration
Poland 211461 See Plans and Pricing
Canada 2785950 NOUVELLE UTILISATION DE DERIVES DE STAUROSPORINE (NEW USE OF STAUROSPORINE DERIVATIVES) See Plans and Pricing
Japan 2005507412 See Plans and Pricing
Norway 20042123 See Plans and Pricing
Taiwan I324604 See Plans and Pricing
Hungary S1700053 See Plans and Pricing
China 101703509 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RYDAPT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1638574 659 Finland See Plans and Pricing
1638574 C01638574/01 Switzerland See Plans and Pricing PRODUCT NAME: MIDOSTAURIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66310 04.05.2017
1638574 LUC00055 Luxembourg See Plans and Pricing PRODUCT NAME: MIDOSTAURINE OU UN SEL DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/17/1218 20170920
1638574 CR 2018 00001 Denmark See Plans and Pricing PRODUCT NAME: MIDOSTAURIN ELLER ET SALT DERAF; REG. NO/DATE: EU/1/17/1218 20170920
1441737 18C1012 France See Plans and Pricing PRODUCT NAME: MIDOSTAURINE; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574 1890003-5 Sweden See Plans and Pricing PRODUCT NAME: MIDOSTAURIN OR A SALT THEREOF; REG. NO/DATE: EU/1/17/1218 20170920
1638574 293 1-2018 Slovakia See Plans and Pricing PRODUCT NAME: MIDOSTAURIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1218 20170920
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.