Midostaurin - Generic Drug Details

What are the generic 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:	50
Clinical Trials:	49
Patent Applications:	7,195
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
Acute Leukemia French Association	Phase 2
French Innovative Leukemia Organisation	Phase 2
Shaare Zedek Medical Center	Phase 2

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
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

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/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

International Patents for midostaurin

Country	Patent Number	Title	Estimated Expiration
Germany	602004026578
Luxembourg	C00055
Israel	161156
Japan	2012144572	NEW PHARMACEUTICAL USE OF STAUROSPORINE DERIVATIVE

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	CA 2018 00001	Denmark		PRODUCT NAME: MIDOSTAURIN ELLER ET SALT DERAF; REG. NO/DATE: EU/1/17/1218 20170920
1638574	122018000016	Germany		PRODUCT NAME: MIDOSTAURIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1218 20170918
1638574	17C1063	France		PRODUCT NAME: MIDOSTAURINE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/17/1218 20170920

Market Dynamics and Financial Trajectory for Midostaurin

Introduction

Midostaurin, a tyrosine kinase inhibitor, has emerged as a crucial treatment for acute myeloid leukemia (AML), particularly in patients with FLT3 mutations. This article delves into the market dynamics and financial trajectory of midostaurin, highlighting its current market size, growth prospects, cost-effectiveness, and the factors driving its adoption.

Current Market Size and Growth Prospects

The midostaurin drugs market was valued at USD 1.2 billion in 2023 and is projected to reach USD 1.9 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 7.3% from 2024 to 2031[1].

Segmentation of the Midostaurin Market

The market is segmented based on application (midostaurin capsules, tablets, and injections) and product (treatment of AML and FLT3-mutated AML). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1].

Drivers of Market Growth

Several factors are driving the growth of the midostaurin market:

Growing Cancer Prevalence

The increasing frequency of FLT3-mutated AML and associated malignancies has created a greater need for midostaurin, contributing to market growth[1].

Regulatory Approvals

Broader approvals and indications for midostaurin have increased its market potential. Recent regulatory approvals have expanded the drug's use, making it more accessible to patients[1].

Research Advancements

Ongoing clinical trials and studies that confirm the effectiveness of midostaurin are fueling its adoption. These research advancements are crucial in establishing midostaurin as a key treatment option in oncology[1].

Better Diagnostics

Improved diagnostic techniques have made it easier to identify appropriate patients for midostaurin treatment, thereby increasing its use[1].

Cost-Effectiveness of Midostaurin

Studies have shown that midostaurin is a cost-effective treatment for FLT3-mutated AML. Here are some key findings:

Lifetime Costs and Outcomes

In the United States, patients treated with midostaurin incurred higher total direct costs over a lifetime compared to those in the placebo arm ($4,043,470 vs. $3,959,741). However, midostaurin resulted in 1.59 more life years and 1.37 more quality-adjusted life years (QALYs), leading to an incremental cost-effectiveness ratio (ICER) of $52,596 per life year or $61,167 per QALY[2].

Cost-Effectiveness in Different Regions

In Spain, the addition of midostaurin to standard chemotherapy resulted in 1.46 life years gained and 1.23 QALYs gained, with an ICER of €32,854 per life year and €38,985 per QALY. The probabilistic analysis showed that midostaurin was cost-effective in 82.3% of simulations at a threshold of €50,000/QALY[5].

Competitive Landscape

The midostaurin market is dominated by several key players, including Novartis, Bayer, Pfizer, Roche, Takeda, AbbVie, Astellas Pharma, Celgene, Amgen, and Merck & Co. These companies are profiled in market reports, which also include the year of market entry and various market-related factors[1].

Regional Market Dynamics

North America

North America is the largest market for midostaurin, driven by high acceptance rates among patients and physicians. The region is expected to grow at a CAGR of 14.41% during the forecast period, primarily due to significant investments in research and development[3].

Europe

Europe is the fastest-growing market for midostaurin, with a CAGR of 14.04% during the forecast period. Countries like Germany, France, the U.K., Italy, and Spain are actively involved in enhancing FLT3-mutated cancer treatment through extensive research and increased pharmaceutical R&D expenditure[3].

Financial Projections and Trends

Market Size Projections

The global FLT3 inhibitors market, which includes midostaurin, was valued at USD 487.53 million in 2023 and is expected to reach USD 1,234.03 million by 2032, growing at a CAGR of 10.87%[3].

Revenue and Growth

Despite some reports suggesting a decline in the midostaurin market size to USD 103.3 million by 2030 with a CAGR of -3.0%[4], the overall trend indicates significant growth driven by increasing demand for targeted therapies in AML treatment.

Key Takeaways

• Market Growth: The midostaurin market is expected to grow significantly, driven by increasing cancer prevalence, regulatory approvals, and research advancements.
• Cost-Effectiveness: Midostaurin is cost-effective in treating FLT3-mutated AML, with favorable ICERs in various regions.
• Regional Dynamics: North America and Europe are key markets, with significant growth driven by research and development activities.
• Competitive Landscape: Major pharmaceutical companies dominate the market, with Novartis being a key player.

FAQs

What is the current market size of the midostaurin drugs market?

The midostaurin drugs market was valued at USD 1.2 billion in 2023[1].

What is the projected growth rate of the midostaurin market?

The market is expected to grow at a CAGR of 7.3% from 2024 to 2031[1].

Is midostaurin cost-effective in treating FLT3-mutated AML?

Yes, midostaurin has been shown to be cost-effective in treating FLT3-mutated AML, with favorable ICERs in various studies[2][5].

Which regions are the largest markets for midostaurin?

North America and Europe are the largest and fastest-growing markets, respectively[3].

Who are the key players in the midostaurin market?

Key players include Novartis, Bayer, Pfizer, Roche, Takeda, AbbVie, Astellas Pharma, Celgene, Amgen, and Merck & Co.[1].

Sources

1. Market Research Intellect: Midostaurin Drugs Market Size, Share & Trends [2031].
2. Analysis Group: Cost Effectiveness of Midostaurin in the Treatment of Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia in the United States.
3. Straits Research: Global FLT3 Inhibitors Market Size, Top Share, Report to 2032.
4. Valuates Reports: Midostaurin Drugs - Market, Report Size, Worth, Revenue, Growth.
5. PubMed: Cost-Effectiveness Of Midostaurin In The Treatment Of Acute Myeloid Leukemia with FLT3 Mutation.