RYDAPT Drug Patent Profile

When do Rydapt patents expire, and when can generic versions of Rydapt launch?

Rydapt is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-two patent family members in twenty-seven countries.

The generic ingredient in RYDAPT is midostaurin. One supplier is listed for this compound. Additional details are available on the midostaurin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Rydapt

A generic version of RYDAPT was approved as midostaurin by LUPIN on May 10^th, 2024.

Summary for RYDAPT

International Patents:	62
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	12
Patent Applications:	4,991
Drug Prices:	Drug price information for RYDAPT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RYDAPT
What excipients (inactive ingredients) are in RYDAPT?	RYDAPT excipients list
DailyMed Link:	RYDAPT at DailyMed

See drug prices for RYDAPT

Recent Clinical Trials for RYDAPT

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

Sponsor	Phase
Baptist Health South Florida	Phase 1/Phase 2
Jazz Pharmaceuticals	Phase 1/Phase 2
Novartis Pharmaceuticals	Phase 1/Phase 2

See all RYDAPT clinical trials

Pharmacology for RYDAPT

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Paragraph IV (Patent) Challenges for RYDAPT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYDAPT	Capsules	midostaurin	25 mg	207997	4	2021-04-28

US Patents and Regulatory Information for RYDAPT

RYDAPT is protected by two US patents.

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

Expired US Patents for RYDAPT

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 RYDAPT

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 RYDAPT

See the table below for patents covering RYDAPT around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	230798	Staurosporine derivatives as inhibitors of flt3 receptor tyrosine kinase activity
Brazil	PI0411563	uso para derivados de estaurosporina
Hungary	0401642
Slovenia	1441737
Hong Kong	1068262

Supplementary Protection Certificates for RYDAPT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1638574	659	Finland
1441737	18C1012	France		PRODUCT NAME: MIDOSTAURINE; REGISTRATION NO/DATE: EU/1/17/1218 20170920
1638574	C 2017 049	Romania		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	CR 2018 00001	Denmark		PRODUCT NAME: MIDOSTAURIN ELLER ET SALT DERAF; REG. NO/DATE: EU/1/17/1218 20170920

Market Dynamics and Financial Trajectory for RYDAPT (Midostaurin)

Last updated: December 29, 2025

Summary

RYDAPT (midostaurin) is an oral kinase inhibitor developed by Novartis for the treatment of certain hematologic malignancies, notably including acute myeloid leukemia (AML) with FLT3 mutations and systemic mastocytosis. Since its FDA approval in April 2017, RYDAPT has carved a distinctive niche in targeted cancer therapy, driven by evolving diagnostic criteria, competing agents, and regulatory policies. This report evaluates the key market drivers, competitive landscape, financial prospects, and strategic considerations shaping RYDAPT’s commercial trajectory.

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What Are the Market Dynamics Affecting RYDAPT’s Commercial Success?

1. Target Patient Populations and Diagnostic Adoption

• Primary Indications:

  • AML with FLT3 mutation: RYDAPT is approved for adult patients with newly diagnosed FLT3-mutated AML in combination with chemotherapy.
  • Advanced systemic mastocytosis (SM): Including aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematologic neoplasm (SM-AHN), and mast cell leukemia (MCL).

• Market Potential:

  • Estimated 15-20% of AML cases possess FLT3 mutations, translating to approximately 9,000-12,000 eligible newly diagnosed patients annually in the U.S. (based on 20,000 AML cases per year; SEER data[1]).
  • Systemic mastocytosis is rare (prevalence: 1 in 10,000 to 20,000), but with high unmet medical need.

• Diagnostic Challenges:

  • Increasing utilization of FLT3 mutation testing enhances patient stratification.
  • However, variability in testing rates and diagnostic access affects market penetration.

2. Competition and Alternative Therapies

• Targeted AML Agents:

  • Gilteritinib (Xospata, Astellas) – Approved in 2018 for relapsed/refractory FLT3-mutated AML, capturing a segment outside frontline therapy.
  • Quizartinib (development halted in some regions but still notable elsewhere).

• Chemotherapy and Allogeneic Stem Cell Transplant:

  • RYDAPT is often used as an adjunct to intensive chemotherapy, with transplant being a definitive therapy.

• Other Mast Cell Disorder Treatments:

  • Menadione, cladribine, and newer agents under clinical investigation.

• Market Share:

  • RYDAPT’s initial claims were limited to specific indications; expanding its use depends on regulatory approvals and real-world evidence demonstrating superiority or added benefit.

3. Regulatory and Reimbursement Factors

• Regulatory Approvals:

  • Initially approved in U.S., EU, and Japan, with ongoing approvals expanding indications, including post-marketing studies to support label extensions.

• Pricing and Reimbursement:

  • RYDAPT’s cost (~$20,000/month in the U.S.) influences access, especially in markets with strict reimbursement policies.
  • Payer negotiations and cost-effectiveness assessments impact uptake.

4. Market Penetration and Physician Adoption

• Physician Awareness:

  • Education on FLT3 testing and tailored therapy has increased adoption.
  • Integration into treatment guidelines (e.g., NCCN) bolsters prescribing confidence.

• Patient Access Programs:

  • Novartis’ patient support initiatives mitigate barriers to access, especially for rare disease indications.

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How Is RYDAPT’s Financial Trajectory Shaped by Market Factors?

1. Revenue Streams and Sales History

Year	Approximate Global Sales (USD Million)	Notes
2017	50	Launch year, initial uptake
2018	125	Growing recognition, expanded indications
2019	180	Increased adoption, clinical data support
2020	210	Impact of COVID-19, delayed diagnosis
2021	250	Market expansion in Europe and Japan
2022	280	Steady growth, new indication studies underway

(Note: Figures approximated based on Novartis Annual Reports and industry estimates.)

2. Sales Drivers and Forecasting

• Key Drivers:

  • Expansion of frontline AML indication with ongoing clinical trials (e.g., RATIFY extension studies).
  • Increased diagnostic testing and physician education.
  • Approved use in broader SM subtypes.

• Forecast (2023–2028):

  • Compound Annual Growth Rate (CAGR): projected at 8-10%, contingent on approval of new indications and increased clinical adoption.
  • Market ceiling: Estimated global peak sales of $500-700 million by 2028.

3. Pricing and Reimbursement Impact

• Continued high-cost positioning (~$240,000 annually for full course in AML) necessitates continued payer engagement and health economic validation.

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What Are the Key Factors in RYDAPT’s Competitive Landscape?

Competitors	Indications	Strengths	Challenges
Gilteritinib (Xospata)	FLT3-mutated AML (relapsed/refractory)	Oral, approved for relapsed AML	Not indicated for frontline unless amended
Quizartinib (Vendale)	FLT3 inhibitor (development status varies)	Potent FLT3 inhibition	Marketed in some regions, regulatory hurdles
Midostaurin (RYDAPT)	FLT3-mutated AML (frontline)	First-in-class, broad indications	Competition from newer agents, diagnostics
Sabatolimab + Hypomethylating Agents	Myeloid malignancies	Emerging, early-stage trials	Limited current market share

Note: The competitive landscape is evolving; clinical trial results and regulatory decisions profoundly influence dynamics.

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How Do Regulatory Policies Influence RYDAPT’s Market Expansion?

• FDA and EMA Approvals:

  • Landmark approval in 2017 for AML with FLT3 mutation.
  • Ongoing trials aiming to expand indications: maintenance therapy, relapsed settings, and rare mastocytosis subtypes.

• Orphan Drug Designations:

  • Support for SM subtypes, facilitating market exclusivity and incentives.

• Guideline Incorporation:

  • Inclusion in NCCN guidelines (version 4.2022) as recommended therapy for FLT3-mutant AML improves clinician adoption.

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Comparative Analysis: RYDAPT vs. Gilteritinib in AML

Feature	RYDAPT	Gilteritinib (Xospata)
Year of Approval	2017	2018
Indication	Newly diagnosed FLT3-mutated AML	Relapsed/refractory FLT3-mutated AML
Administration Route	Oral	Oral
Dosage	50 mg twice daily	120 mg daily
Cost	~$240,000/year	Similar (~$230,000–$250,000)
Regulatory Status	Approved for frontline AML + SM	Approved for R/R AML

Implication:
While Gilteritinib addresses relapsed/refractory AML, RYDAPT is uniquely positioned in the frontline setting, with potential to capture a substantial market share upon further label expansion.

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Deepening Market Strategy: Opportunities and Risks

Opportunities

• Label Expansion:

  • Demonstrating efficacy as maintenance therapy post-transplant could open new revenue streams.
  • Broader systemic mastocytosis indications (e.g., pediatric use).

• Biomarker-Driven Treatment:

  • Advances in FLT3 mutation testing can improve patient stratification and adherence.

• Combination Therapies:

  • Investigating synergistic regimens with other targeted agents or immunotherapies.

Risks

• Development Delays:

  • Slow clinical trial progress can hinder label expansion.

• Market Penetration Barriers:

  • High costs and reimbursement hurdles may limit access.

• Competitive Disruption:

  • Emergence of superior agents or novel mechanisms could erode market share.

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Conclusion

RYDAPT’s market viability hinges on its role as a frontline treatment for FLT3-mutated AML and its therapeutic positioning within hematologic malignancies. Its financial trajectory is buoyed by increasing diagnostic recognition, expanding clinical evidence, and evolving treatment guidelines. Nevertheless, sustained growth requires strategic expansion into new indications, competitive differentiation, and proactive regulatory engagement.

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Key Takeaways

• Market Potential: RYDAPT targets a niche but significant subset of AML and rare mastocytosis, with a global peak sales estimate of $500–700 million by 2028.

• Strategic Drivers: Enhanced diagnostic testing, guideline inclusion, and clinical trials for label expansion are critical for commercial success.

• Competitive Landscape: Gilteritinib dominates relapsed AML, but RYDAPT’s frontline role offers a point of differentiation.

• Pricing and Reimbursement: High-cost positioning necessitates robust health economic strategies.

• Risks and Opportunities: Continuous innovation, regulatory milestones, and market access policies will shape future growth prospects.

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FAQs

Q1: How does the clinical efficacy of RYDAPT compare with other FLT3 inhibitors?
A1: RYDAPT has demonstrated significant survival benefits in frontline AML with FLT3 mutations, notably in combination with chemotherapy, whereas agents like gilteritinib are approved for relapsed/refractory settings. Head-to-head trials are limited; thus, direct comparison remains challenging.

Q2: What are the main challenges in expanding RYDAPT’s indications?
A2: Challenges include demonstrating efficacy in new settings via clinical trials, regulatory approvals, high development costs, and competition from emerging therapies.

Q3: How does reimbursement influence RYDAPT’s sales?
A3: Reimbursement policies significantly affect patient access; high drug costs require insurers to perceive sufficient clinical benefit, impacting adoption rates.

Q4: Are there ongoing clinical trials that could extend RYDAPT’s market?
A4: Yes, ongoing trials are exploring RYDAPT as maintenance therapy and in combination with other agents across various hematologic malignancies.

Q5: What role do diagnostics play in RYDAPT’s market strategy?
A5: Accurate and widespread FLT3 testing is essential for identifying eligible patients, thereby directly influencing sales and treatment outcomes.

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References

1. SEER Cancer Statistics Review, 1975–2018. National Cancer Institute.
2. Novartis Annual Reports, 2017–2022.
3. NCCN Clinical Practice Guidelines in Oncology, Hematologic Malignancies, Version 4.2022.
4. FDA and EMA approvals and regulatory documents.
5. Market research reports and industry analyses (e.g., Evaluate Pharma, 2022).