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Last Updated: June 14, 2024

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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 two 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® Litigation and Generic Entry Outlook for Rydapt

A generic version of RYDAPT was approved as midostaurin by TEVA PHARMS on April 29th, 2024.

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Drug patent expirations by year for RYDAPT
Drug Prices for RYDAPT

See drug prices for RYDAPT

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 Universität DresdenPhase 1/Phase 2

See all RYDAPT clinical trials

Pharmacology for RYDAPT
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 two US patents and two FDA Regulatory Exclusivities.

Patents protecting RYDAPT

Staurosporine derivatives as inhibitors of FLT3 receptor tyrosine kinase activity
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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

TREATMENT OF ADULT PATIENTS WITH AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM), SYSTEMIC MASTOCYTOSIS WITH ASSOCIATED HEMATOLOGICAL NEOPLASM (SM-AHN), OR MAST CELL LEUKEMIA (MCL)
Exclusivity Expiration: ⤷  Sign Up

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: ⤷  Sign Up

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

EU/EMA Drug Approvals for RYDAPT

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Novartis Europharm Ltd Rydapt midostaurin EMEA/H/C/004095
Rydapt is indicated:in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive (see section 4.2);as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM AHN), or mast cell leukaemia (MCL).
Authorised no no yes 2017-09-18
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for RYDAPT

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

Country Patent Number Title Estimated Expiration
China 100457111 ⤷  Sign Up
China 101703509 ⤷  Sign Up
Germany 60213842 ⤷  Sign Up
Australia 2004248909 New pharmaceutical uses of staurosporine derivatives ⤷  Sign Up
Portugal 1638574 ⤷  Sign Up
Brazil PI0411563 uso para derivados de estaurosporina ⤷  Sign Up
Poland 368322 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RYDAPT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1638574 CR 2018 00001 Denmark ⤷  Sign Up PRODUCT NAME: MIDOSTAURIN ELLER ET SALT DERAF; REG. NO/DATE: EU/1/17/1218 20170920
1638574 293 1-2018 Slovakia ⤷  Sign Up PRODUCT NAME: MIDOSTAURIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574 C20170046 00256 Estonia ⤷  Sign Up PRODUCT NAME: MIDOSTAURIIN;REG NO/DATE: EU/1/17/1218 20.09.2017
1638574 1890003-5 Sweden ⤷  Sign Up PRODUCT NAME: MIDOSTAURIN OR A SALT THEREOF; REG. NO/DATE: EU/1/17/1218 20170920
1638574 17C1063 France ⤷  Sign Up PRODUCT NAME: MIDOSTAURINE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574 6/2018 Austria ⤷  Sign Up PRODUCT NAME: MIDOSTAURIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574 SPC/GB18/001 United Kingdom ⤷  Sign Up PRODUCT NAME: MIDOSTAURIN OR A SALT THEREOF; REGISTERED: UK EU/1/17/1218(FOR NI) 20170920; UK PLGB 00101/1130 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.