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Last Updated: March 24, 2023

Midostaurin - Generic Drug Details


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What are the generic drug 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 three 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.

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
See Plans and PricingSee Plans and Pricing25MGCAPSULE;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 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

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
Russian Federation 2337692 ПРОИЗВОДНЫЕ СТАУРОСПОРИНА В КАЧЕСТВЕ ИНГИБИТОРОВ АКТИВНОСТИ РЕЦЕПТОРНОЙ ТИРОЗИНКИНАЗЫ FLT3 (STAUFOSPORINE DERIVATIVES AS INHIBITORS OF RECEPTOR TYROSINE KINASE FLT3 ACTIVITY) See Plans and Pricing
Spain 2344700 See Plans and Pricing
Canada 2462657 DERIVES DE STAUROSPORINE INHIBITEURS DE L'ACTIVITE TYROSINE KINASE DU RECEPTEUR FLT3 (STAUROSPORINE DERIVATIVES AS INHIBITORS OF FLT3 RECEPTOR TYROSINE KINASE ACTIVITY) See Plans and Pricing
Norway 335685 See Plans and Pricing
Poland 368322 See Plans and Pricing
Mexico PA05013722 NUEVOS USOS FARMACEUTICOS DE DERIVADOS DE ESTAUROSPORINA. (NEW PHARMACEUTICAL USES OF STAUROSPORINE DERIVATIVES.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for midostaurin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1638574 1890003-5 Sweden See Plans and Pricing PRODUCT NAME: MIDOSTAURIN OR A SALT THEREOF; REG. NO/DATE: EU/1/17/1218 20170920
1441737 122018000038 Germany See Plans and Pricing PRODUCT NAME: MIDOSTAURIN / RYDAPT; REGISTRATION NO/DATE: EU/1/17/1218 20170918
1638574 6/2018 Austria See Plans and Pricing PRODUCT NAME: MIDOSTAURIN ODER EIN SALZ DAVON; REGISTRATION 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 C 2017 049 Romania See Plans and Pricing PRODUCT NAME: MIDOSTAURINA SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1218; DATE OF NATIONAL AUTHORISATION: 20170918; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1218; DATE OF FIRST AUTHORISATION IN EEA: 20170918
1638574 C201730062 Spain See Plans and Pricing 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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