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Last Updated: March 29, 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® 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 have been three 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.

There is one tentative approval for the generic drug (midostaurin), which indicates the potential for near-term generic launch.

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 Loss of Exclusivity (LOE) 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
Novartis PharmaceuticalsPhase 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RYDAPT is ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial

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: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

Supplementary Protection Certificates for RYDAPT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1638574 17C1063 France ⤷  Try a Trial PRODUCT NAME: MIDOSTAURINE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1441737 18C1012 France ⤷  Try a Trial PRODUCT NAME: MIDOSTAURINE; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574 C20170046 00256 Estonia ⤷  Try a Trial PRODUCT NAME: MIDOSTAURIIN;REG NO/DATE: EU/1/17/1218 20.09.2017
>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.