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Last Updated: April 30, 2025

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 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.

Recent Clinical Trials for midostaurin

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

SponsorPhase
Acute Leukemia French AssociationPhase 2
French Innovative Leukemia OrganisationPhase 2
Shaare Zedek Medical CenterPhase 2

See all midostaurin clinical trials

Generic filers with tentative approvals for MIDOSTAURIN
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for Free25MGCAPSULE;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 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novartis RYDAPT midostaurin CAPSULE;ORAL 207997-001 Apr 28, 2017 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Lupin MIDOSTAURIN midostaurin CAPSULE;ORAL 216015-001 May 10, 2024 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Teva Pharms MIDOSTAURIN midostaurin CAPSULE;ORAL 216076-001 Apr 29, 2024 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>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

Supplementary Protection Certificates for midostaurin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1638574 C201730062 Spain ⤷  Try for Free 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 ⤷  Try for Free PRODUCT NAME: MIDOSTAURIN ELLER ET SALT DERAF; REG. NO/DATE: EU/1/17/1218 20170920
1638574 122018000016 Germany ⤷  Try for Free PRODUCT NAME: MIDOSTAURIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1218 20170918
1638574 17C1063 France ⤷  Try for Free PRODUCT NAME: MIDOSTAURINE OU L'UN DE SES SELS; REGISTRATION NO/DATE: EU/1/17/1218 20170920
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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.

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