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Last Updated: March 29, 2024

Midostaurin - Generic Drug Details


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What are the generic sources for midostaurin and what is the scope of freedom to operate?

Midostaurin is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Midostaurin has sixty-two patent family members in twenty-seven countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for midostaurin
Generic Entry Date for midostaurin*:
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)
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 midostaurin

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

SponsorPhase
Shaare Zedek Medical CenterPhase 2
Jazz PharmaceuticalsPhase 1/Phase 2
Baptist Health South FloridaPhase 1/Phase 2

See all midostaurin clinical trials

Generic filers with tentative approvals for MIDOSTAURIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial25MGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

US Patents and Regulatory Information for midostaurin

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 midostaurin

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 midostaurin

Country Patent Number Title Estimated Expiration
Denmark 1441737 ⤷  Try a Trial
Poland 211461 ⤷  Try a Trial
Hungary 0401642 ⤷  Try a Trial
South Korea 20050040842 ⤷  Try a Trial
Canada 2527703 NOUVELLE UTILISATION DE DERIVES DE STAUROSPORINE (NEW PHARMACEUTICAL USES OF STAUROSPORINE DERIVATIVES) ⤷  Try a Trial
Taiwan 200301127 ⤷  Try a Trial
Portugal 1638574 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for midostaurin

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
1638574 CR 2018 00001 Denmark ⤷  Try a Trial PRODUCT NAME: MIDOSTAURIN ELLER ET SALT DERAF; REG. NO/DATE: EU/1/17/1218 20170920
1638574 300917 Netherlands ⤷  Try a Trial PRODUCT NAME: MIDOSTAURINE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1441737 C01441737/01 Switzerland ⤷  Try a Trial PRODUCT NAME: MIDOSTAURIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66310 04.05.2017
1638574 C201730062 Spain ⤷  Try a Trial PRODUCT NAME: MIDOSTAURINA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1218; DATE OF AUTHORISATION: 20170918; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1218; DATE OF FIRST AUTHORISATION IN EEA: 20170918
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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