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
Richard Stone, MD	PHASE1
Syndax Pharmaceuticals	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
Dr Reddys	MIDOSTAURIN	midostaurin	CAPSULE;ORAL	215921-001	Jun 28, 2024	AB	RX	No	No
Teva Pharms	MIDOSTAURIN	midostaurin	CAPSULE;ORAL	216076-001	Apr 29, 2024		DISCN	No	No
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017	AB	RX	Yes	Yes
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

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
South Korea	20050040842
Norway	335685
World Intellectual Property Organization (WIPO)	2004112794
China	101164539	New use of staurosporine derivatives
Taiwan	I302836

Supplementary Protection Certificates for midostaurin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1638574	C20170046 00256	Estonia		PRODUCT NAME: MIDOSTAURIIN;REG NO/DATE: EU/1/17/1218 20.09.2017
1441737	18C1012	France		PRODUCT NAME: MIDOSTAURINE; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1441737	C01441737/01	Switzerland		PRODUCT NAME: MIDOSTAURIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66310 04.05.2017
1638574	C01638574/01	Switzerland		PRODUCT NAME: MIDOSTAURIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66310 04.05.2017
1638574	SPC/GB18/001	United Kingdom		PRODUCT NAME: MIDOSTAURIN OR A SALT THEREOF; REGISTERED: UK EU/1/17/1218(FOR NI) 20170920; UK PLGB 00101/1130 20170920

Midostaurin: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

Midostaurin is a precision oncology small molecule positioned across two main use cases: (1) FLT3-mutated acute myeloid leukemia (AML) and (2) aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). Its market path is shaped by competitive dynamics in FLT3 AML, safety-tolerability considerations, regimen entrenchment in combination therapy, and label breadth across World Health Organization (WHO) mastocytosis subtypes.

Where does midostaurin sit in the market by indication?

Midostaurin’s commercial footprint is anchored to branded oncology therapy with distinct payer logic for leukemia versus mastocytosis.

Core indication lanes

Indication lane	Population type	Treatment pattern	Key competitive set (class level)
FLT3-mutated AML	High-acuity, defined biomarker subset	Combination with chemotherapy in induction; continuation depending on protocol	Other FLT3 inhibitors used in FLT3 AML treatment pathways
WHO-defined mastocytosis subtypes (ASM, SM-AHN, MCL)	Chronic/rare hematologic disease with prognostic heterogeneity	Ongoing oral therapy; long-tail maintenance economics	Targeted therapies and supportive regimens; competition depends on subtype and physician preference

What drives demand for midostaurin?

1) Biomarker-defined access in AML

Midostaurin demand depends on the proportion of AML patients whose disease carries FLT3 alterations and who receive it within the combination framework during chemotherapy-era treatment windows. Its market ceiling is tied to:

• FLT3 testing uptake and turnaround time
• adherence to guideline-driven sequencing of targeted agents with chemotherapy
• physician preference during induction and post-remission consolidation pathways

2) Label breadth and clinical longevity in mastocytosis

Mastocytosis subtypes have slower churn in prescribing because:

• the treated population is smaller but persists across longer treatment durations
• physicians anchor prescribing to established responses and tolerability in ASM/SM-AHN and MCL
• payer coverage tends to be stable when label coverage is explicit and supportive biomarkers are used to monitor disease state

3) Combination-therapy entrenchment in AML

In FLT3 AML, midostaurin’s value proposition is tied to combination chemotherapy protocols. That creates a “stickiness” effect relative to pure monotherapy targeted agents, because switching typically requires protocol redesign, evidence re-alignment, and payer re-credentialing.

4) Safety-tolerability and dosing continuity

Midostaurin is an oral kinase inhibitor where tolerability affects:

• dose interruptions and discontinuations
• time-to-next-line switches in real-world practice
• hospitalization rates tied to chemotherapy backbone in the induction setting (AML lane)

These dynamics influence realized net sales more than headline launch milestones.

How do competitive dynamics reshape the financial trajectory?

AML: FLT3 inhibitor competition compresses price and share

In FLT3 AML, the competitive environment exerts downward pressure through:

• alternative FLT3 inhibitors with different efficacy and toxicity profiles
• evolving first-line treatment recommendations and sequencing strategies
• formulary management and outcomes-based contracting where available

That typically leads to:

• share shift as prescribing moves toward preferred agents within local formularies
• net price pressure driven by bid cycles and payer negotiation

Mastocytosis: fewer direct substitutes, but precision competition still matters

In ASM/SM-AHN/MCL, competitive intensity is lower than in AML but not absent. Demand is influenced by:

• response depth and durability in specific subtypes
• clinician familiarity and local experience
• cross-therapy decisions when alternative targeted options become accessible

The result is a financial profile with slower erosion than in AML, but not insulated from competitor penetration where evidence supports switching.

What is midostaurin’s commercial trajectory versus other oncology kinase inhibitors?

A reliable way to frame trajectory is by split between:

• volume-heavy growth drivers (biomarker uptake, line-of-therapy expansion, guideline entrenchment)
• price and mix drivers (indication shift, dosing intensity, payer rebates, competitive displacement)

Midostaurin’s AML lane is more exposed to “volume compression” through share shifts, while its mastocytosis lane is more exposed to “mix persistence” because patients remain on therapy longer once initiated.

How does regulatory geography affect revenue performance?

Midostaurin is approved in multiple jurisdictions with an evolving label footprint, including hematologic malignancies and mastocytosis subtypes. Revenue performance reflects:

• differences in national oncology guideline adoption timelines
• reimbursement rules for biomarker testing and targeted therapy reimbursement
• treatment center prescribing culture and formulary access

What are the key milestones shaping the financial trajectory?

The financial trajectory is determined by label, evidence read-through, and uptake milestones.

Anchor endpoints that influence adoption

• FLT3-mutated AML combination use establishes the AML lane’s initial economic base.
• WHO-defined mastocytosis subtypes create a durable second lane with long treatment durations.

Launch-to-adoption mechanics

• Early adoption typically concentrates in high-volume academic centers and centers with FLT3 testing infrastructure.
• Steadier growth follows as testing capacity expands and protocol familiarity spreads.
• Competitive displacement typically accelerates after competitor evidence consolidates and payer negotiation tightens.

What do the current reference label and commercial usage imply for ongoing performance?

Midostaurin’s reference usage includes:

• FLT3-mutated AML as part of standard combination chemotherapy regimens in appropriate patients (label-driven)
• ASM, SM-AHN, and MCL as chronic targeted therapy options

This translates into two distinct financial behaviors: 1) AML financial behavior: higher churn risk due to competitive FLT3 choices and protocol evolution. 2) Mastocytosis financial behavior: lower churn risk because patients remain on therapy and switching requires stronger subtype-specific rationale.

How do reimbursement and payer levers impact net revenue?

Midostaurin net sales are sensitive to:

• formulary placement under oncology drug budgets
• contracting structures that cap budget impact
• prior authorization and evidence requirements for biomarker confirmation (FLT3) and subtype confirmation (mastocytosis)

Payer leverage is strongest in AML because the eligible population is defined and competitive. Payer leverage is lower in mastocytosis due to smaller populations and more label-dependent prescribing.

What should investors and business leaders watch in midostaurin’s next financial phases?

Key observation points map to the two lanes.

AML lane watch list

• FLT3 testing penetration rate and regional access patterns
• guideline shifts affecting first-line targeted FLT3 inhibitor selection
• formulary outcomes in large payer systems (rebate and utilization management trends)
• real-world persistence and dose modification due to tolerability in induction

Mastocytosis lane watch list

• ongoing real-world persistence by subtype (ASM vs SM-AHN vs MCL)
• time to discontinuation and subsequent treatment changes
• payer policy changes that affect access for rare disease indications

Financial summary: what the trajectory looks like in plain market terms

Midostaurin’s financial trajectory is best modeled as a two-velocity system:

• Faster-moving AML velocity: share and price move with competitive dynamics and protocol updates.
• Slower-moving mastocytosis velocity: demand is anchored to label coverage and longer patient treatment durations, with less rapid substitution.

This structure means midostaurin’s revenue is more likely to show:

• AML-led short-term volatility when competition gains or payers tighten contracting
• mastocytosis-led stability that buffers the erosion of AML lane share

Key Takeaways

• Midostaurin commercial demand is split between a competitive AML FLT3 lane and a longer-duration mastocytosis lane.
• AML economics are most exposed to guideline and formulary-driven switching among FLT3 inhibitors, which tends to compress realized share and net price.
• Mastocytosis economics are more stable because patients remain on therapy and prescribing is strongly label-dependent across ASM, SM-AHN, and MCL.
• Net revenue performance hinges on biomarker testing access and protocol entrenchment in AML, and on real-world persistence in mastocytosis subtypes.

FAQs

1) Which clinical areas drive midostaurin sales most directly?
FLT3-mutated AML in combination chemotherapy and mastocytosis subtypes including ASM, SM-AHN, and MCL.

2) Why is the AML lane more vulnerable than the mastocytosis lane?
AML prescribing is more exposed to competitive FLT3 inhibitor substitution within rapidly evolving guideline and formulary frameworks.

3) What commercial lever most affects AML patient eligibility?
FLT3 testing uptake and its integration into first-line treatment decision making.

4) What makes mastocytosis demand less churn-prone?
Patients typically remain on oral targeted therapy for longer periods once initiated, and label coverage is subtype specific.

5) What should be monitored for early signals of revenue acceleration or erosion?
Regional formularies, FLT3 inhibitor positioning in first-line protocols, and real-world persistence/dose modification patterns in each indication lane.

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References

[1] FDA. Rydapt (midostaurin) prescribing information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/ (accessed via label availability).
[2] EMA. Rydapt: summary of product characteristics (SmPC). European Medicines Agency. https://www.ema.europa.eu/ (accessed via SmPC availability).