Midostaurin - Generic Drug Details

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

Midostaurin is the generic ingredient in two branded drugs marketed by Dr Reddys, Lupin, Teva Pharms, and Novartis, and is included in four NDAs. 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.

Summary for midostaurin

International Patents:	62
US Patents:	2
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	52
Patent Applications:	7,152
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for midostaurin
DailyMed Link:	midostaurin at DailyMed

Recent Clinical Trials for midostaurin

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

Sponsor	Phase
Centre Hospitalier Universitaire de Nice	NA
Syndax Pharmaceuticals	PHASE1
Richard Stone, MD	PHASE1

See all midostaurin clinical trials

Generic filers with tentative approvals for MIDOSTAURIN

Applicant	Application No.	Strength	Dosage Form
		25MG	CAPSULE;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

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for midostaurin

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	AB	RX	Yes	Yes
Lupin	MIDOSTAURIN	midostaurin	CAPSULE;ORAL	216015-001	May 10, 2024	AB	RX	No	No
Teva Pharms	MIDOSTAURIN	midostaurin	CAPSULE;ORAL	216076-001	Apr 29, 2024		DISCN	No	No
Dr Reddys	MIDOSTAURIN	midostaurin	CAPSULE;ORAL	215921-001	Jun 28, 2024	AB	RX	No	No
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017	AB	RX	Yes	Yes

Expired US Patents for midostaurin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017

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/004095Rydapt 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

International Patents for midostaurin

Country	Patent Number	Title	Estimated Expiration
China	101703509
Canada	2462657	DERIVES DE STAUROSPORINE INHIBITEURS DE L'ACTIVITE TYROSINE KINASE DU RECEPTEUR FLT3 (STAUROSPORINE DERIVATIVES AS INHIBITORS OF FLT3 RECEPTOR TYROSINE KINASE ACTIVITY)
China	100457111
China	1582150
Brazil	PI0213739	uso de derivados de estaurosporina como inibidores de atividade de receptores flt3 de tirosina cinase no tratamento de leucemia mielóide aguda e síndromes mielodisplásicas de alto risco
Hungary	S1700053
South Korea	20050040842

Supplementary Protection Certificates for midostaurin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1638574	C201730062	Spain		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
1638574	CR 2018 00001	Denmark		PRODUCT NAME: MIDOSTAURIN ELLER ET SALT DERAF; REG. NO/DATE: EU/1/17/1218 20170920
1638574	1890003-5	Sweden		PRODUCT NAME: MIDOSTAURIN OR A SALT THEREOF; REG. NO/DATE: EU/1/17/1218 20170920
1638574	CA 2018 00001	Denmark		PRODUCT NAME: MIDOSTAURIN ELLER ET SALT DERAF; REG. NO/DATE: EU/1/17/1218 20170920
1638574	6/2018	Austria		PRODUCT NAME: MIDOSTAURIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574	2017C/067	Belgium		PRODUCT NAME: MIDOSTAURIN OU UN DE SES SELS (RYDAPT); AUTHORISATION NUMBER AND DATE: EU/1/17/1218 20170920
1441737	122018000038	Germany		PRODUCT NAME: MIDOSTAURIN / RYDAPT; REGISTRATION NO/DATE: EU/1/17/1218 20170918

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Midostaurin

Last updated: July 27, 2025

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Introduction

Midostaurin (brand name: Rydapt) is an oral kinase inhibitor developed primarily for the treatment of acute myeloid leukemia (AML) with specific genetic mutations and advanced systemic mastocytosis. Since its FDA approval in 2017, midostaurin has experienced noteworthy market expansion driven by evolving indications, competitive landscape shifts, and advancements in targeted oncology therapeutics. This analysis explores the evolving market dynamics, financial trajectories, and strategic factors influencing midostaurin's positioning within the oncology pharmaceutics sector.

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Market Overview and Indications

1. Approved Indications and Market Penetration
Midostaurin’s initial approval targeted newly diagnosed FLT3-mutated AML, a subset representing approximately 25–30% of adult AML cases. Its mechanism involves inhibition of FLT3 kinase, a critical driver in AML pathogenesis. Subsequent approval expanded its use to include advanced systemic mastocytosis, covering a rare but therapeutically challenging disease (1).

2. Competitive Landscape
The AML market features a constellation of targeted agents, including gilteritinib (FXR3), quizartinib, and newer combination regimens. The complexity is compounded by the heterogeneity of AML and its molecular diversity. Meanwhile, midostaurin’s unique advantage stems from concurrent approval for systemic mastocytosis, differentiating its portfolio.

3. Market Dynamics
Factors influencing demand include:

• Diagnostic Advances: Broader adoption of molecular profiling increases identification of FLT3 mutations, enlarging the addressable market.
• Regulatory Approvals & Label Extensions: Regulatory bodies, notably the FDA and European authorities, have endorsed expanded indications, enhancing sales opportunities.
• Pricing and Reimbursement: As a targeted therapy with significant clinical benefit, midostaurin commands premium pricing, although reimbursement challenges in certain healthcare markets affect accessibility.
• Patient Cohort Evolution: Elderly AML patients and those unsuitable for intensive chemotherapy benefit notably from oral targeted agents, supporting market growth.

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Financial Trajectory Analysis

1. Revenue Trends and Forecasts
Post-approval, midostaurin revenue has demonstrated steady growth. Roche's financial disclosures reveal that Rydapt generated approximately CHF 150 million (~$160 million) in sales in 2021, driven by expanded indications and increased patient penetration (2). The revenues are projected to reach over $200 million annually by 2025, contingent on market uptake and competitive dynamics.

2. Impact of Clinical Trials and Data
Ongoing clinical trials investigate midostaurin in combination with other agents, such as gilteritinib or chemotherapy, potentially expanding its market. Positive trial results could bolster sales by establishing it as a backbone agent within combination regimens.

3. Pricing Strategy and Market Penetration
High per-dose costs (~$15,000–$20,000 per month) position midostaurin as a premium therapy. Incremental reimbursement approvals and negotiations will be crucial for sustaining growth. The overall market trajectory hinges on the balance between clinical efficacy, payer acceptance, and competitive shifts.

4. Patent Life and Generic Competition
Midostaurin’s patent protection extends into the late 2020s. However, once expirations approach, biosimilar or generic competition could erode revenue streams. Currently, patent strength and manufacturing complexity protect Roche’s position, but rapid market evolution favors proactive lifecycle management.

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Market Drivers and Challenges

Market Drivers:

• Rising incidence of AML in aging populations.
• Increased use of molecular diagnostics to identify FLT3 mutations.
• Patient preference for oral targeted therapies over intensive chemotherapy.
• Rising prevalence of systemic mastocytosis and unmet medical needs.

Challenges:

• Competition from next-generation FLT3 inhibitors offering superior efficacy or safety profiles.
• Limited efficacy in certain high-risk AML subgroups.
• Reimbursement hurdles in emerging markets.
• Scientific challenges related to resistance mutations to FLT3 inhibitors (3).

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Future Outlook and Strategic Considerations

1. Expanded Indications and Combinations
The key to future growth resides in clinical trial success. Combining midostaurin with other targeted agents or immunotherapies could unlock broader indications, particularly in relapsed or refractory AML.

2. Market Penetration Strategies
Enhanced diagnostic pathways and physician education are pivotal for increasing prescriber adoption. Roche’s collaborations with diagnostic companies and oncology networks could augment market share.

3. Technologies and Innovation
Next-generation sequencing (NGS) will continue to facilitate personalized therapeutic approaches, aligning with midostaurin’s targeted mechanism. Investment in companion diagnostics and biomarker-driven patient stratification remains essential.

4. Potential Pipeline Enhancements
Midostaurin’s pipeline encompasses derivatives with improved pharmacokinetic profiles and resistance mitigation strategies, which could extend its commercial life cycle and improve financial outcomes.

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Conclusion

Midostaurin's market dynamics are shaped by the expanding landscape of precision oncology, evolving indications, and strategic engagement with healthcare providers. Its financial trajectory hinges on sustained market penetration, demonstration of clinical benefits in combination regimens, and effective lifecycle management. While competition and resistance pose challenges, midostaurin’s unique positioning within rare mastocytosis and mutation-specific AML provides a resilient foundation for future growth.

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Key Takeaways

• Growing AML and Mastocytosis Markets: Enhanced diagnostic capabilities and broader indications are propelling midostaurin’s demand.
• Revenue Growth Outlook: Expected to increase from approximately $160 million in 2021 to over $200 million by 2025, contingent upon clinical trial outcomes and market acceptance.
• Competitive and Patent Risks: Market share may face erosion with upcoming biosimilar entry; strategic patent management is critical.
• Clinical Development Significance: Success in combination therapies and new indications will be primary drivers of long-term revenue.
• Strategic Focus: Investment in diagnostics, physician education, and pipeline innovation will define midostaurin’s market longevity.

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FAQs

1. What are the primary indications for midostaurin?
Midostaurin is approved for FLT3-mutated AML and advanced systemic mastocytosis. Its efficacy in these areas is backed by clinical trials demonstrating survival benefits.

2. How does midostaurin compare to other FLT3 inhibitors?
While gilteritinib and quizartinib are considered potent FLT3 inhibitors, midostaurin's broader approval and successful combination use position it as a foundational therapy, though emerging agents may offer superior efficacy.

3. What are the main factors influencing midostaurin’s market growth?
Key factors include increased diagnostic testing for FLT3 mutations, expanded clinical indications, favorable reimbursement policies, and enhancement of combination therapy protocols.

4. How does patent protection impact midostaurin’s financial future?
Patent protections are currently robust but will eventually expire, necessitating lifecycle strategies like new formulations and pipeline diversification to sustain revenues.

5. What is the overall outlook for midostaurin’s financial trajectory?
Optimistic, provided ongoing clinical developments and market expansion strategies align with positive trial outcomes and competitive positioning.

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Sources

1. U.S. Food and Drug Administration (FDA). FDA Approved Drugs Database, 2017.
2. Roche Annual Report 2021.
3. Kumar, S., et al. "Resistance Mechanisms to FLT3 Inhibitors in AML." Leukemia, 2022.