RYDAPT Drug Patent Profile

When do Rydapt patents expire, and what generic alternatives are available?

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
Pfizer	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	8,575,146
Novartis	RYDAPT	midostaurin	CAPSULE;ORAL	207997-001	Apr 28, 2017	AB	RX	Yes	Yes	7,973,031

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	8,222,244

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
Brazil	PI0411563	uso para derivados de estaurosporina
Poland	1638574
Portugal	1441737
Austria	464052

Supplementary Protection Certificates for RYDAPT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1638574	122018000016	Germany		PRODUCT NAME: MIDOSTAURIN ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/17/1218 20170918
1638574	293 1-2018	Slovakia		PRODUCT NAME: MIDOSTAURIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1218 20170920
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	300917	Netherlands		PRODUCT NAME: MIDOSTAURINE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/17/1218 20170920

Market Dynamics and Financial Trajectory for RYDAPT (Midostaurin)

Last updated: July 27, 2025

Introduction

RYDAPT (midostaurin) stands as a pivotal agent in the landscape of targeted oncologic therapies. Approved by the U.S. Food and Drug Administration (FDA) in 2017 for treating newly diagnosed acute myeloid leukemia (AML) with FLT3 mutations and for systemic mastocytosis, RYDAPT has carved a niche within hematologic oncology. Its market trajectory and future financial prospects are shaped by diverse factors including clinical adoption, competitive landscape, regulatory developments, and evolving treatment paradigms.

Therapeutic Profile and Market Niche

Midostaurin functions as a multikinase inhibitor, targeting FLT3, KIT, and other kinases involved in oncogenic processes. Its primary indication in AML addresses a subset of patients harboring FLT3 mutations, which constitute roughly 30% of AML cases. This mutation significantly influences prognosis, positioning midostaurin as an essential targeted therapy for this niche. Additionally, indications in systemic mastocytosis broaden its therapeutic scope, albeit with a smaller patient population, offering opportunities for diversification.

Market Dynamics

Growing Prevalence of Targeted Therapies

The ascendancy of precision medicine underpins the demand for agents like RYDAPT. Advances in molecular diagnostics facilitate the identification of FLT3 mutations, leading to increased diagnostic testing rates. Consequently, the eligible patient pool for midostaurin expands, bolstering its market potential. The increased adoption of comprehensive genomic profiling in AML patients has been a critical driver ([1]).

Competitive Landscape and Emerging Alternatives

RYDAPT faces competition from other FLT3 inhibitors such as gilteritinib (Astellas) and quizartinib (Venclexta). Gilteritinib, approved in 2018 for relapsed/refractory FLT3-mutated AML, offers an alternative that has shown favorable efficacy. The rivalry compels RYDAPT’s manufacturer to emphasize differentiation, including its first-mover advantage and its established position in frontline therapy.

Furthermore, the introduction of combination regimens incorporating RYDAPT with chemotherapy or other targeted agents could reshape the competitive landscape. Resistance mechanisms, notably secondary mutations in FLT3, pose challenges, necessitating ongoing innovation.

Regulatory and Reimbursement Factors

Regulatory approvals in additional territories, such as the European Union, and expansion of indications could significantly influence sales. Similarly, reimbursement policies in major markets like the U.S. and Europe determine accessibility and adoption rates. Payer negotiations and formulary placements remain pivotal in translating clinical efficacy into commercial success.

Market Penetration and Adoption Barriers

Despite FDA approval, real-world adoption of RYDAPT has encountered delays due to factors including clinician familiarity with competing agents, logistical challenges of testing, and incremental evidence consolidation. Clinical practice guidelines increasingly recommend midostaurin as a standard part of AML treatment for FLT3-mutated cases (e.g., NCCN Guidelines), which favors uptake ([2]).

Patent and Exclusivity Timing

Midostaurin’s patent life and exclusivity periods influence pricing power and market share. Patent expirations or the emergence of biosimilars or generics can accelerate price erosion, impacting revenue streams.

Financial Trajectory Projections

Revenue Trends

Market analysts project the global AML drug market will grow at a compound annual growth rate (CAGR) of approximately 10-12% over the next five years, driven by increased diagnosis, broader indication approvals, and combination therapies ([3]). RYDAPT is expected to capture a significant share within this niche, with revenues potentially doubling by 2028 if adoption accelerates and market expansion continues.

Pricing Strategy and Revenue Growth

RYDAPT’s pricing, aligned with targeted oncology agents, remains premium. Current U.S. wholesale acquisition costs (WAC) approximate $17,000–$20,000 per month, reflecting its niche status and clinical value. Price adjustments will depend on competitive dynamics and negotiated discounts, influencing profit margins.

Impact of Combination Regimens

Upcoming data supporting RYDAPT in combination with chemotherapy or other targeted agents could unlock new revenue streams. Enhanced efficacy and retreatment options translate into increased utilization, favoring sustained and growing sales.

Potential Market Challenges

Resistance development, off-label use limits, and the emergence of superior or more convenient therapies threaten RYDAPT’s growth trajectory. Additionally, any regulatory restrictions or unfavorable reimbursement policies could hamper profitability.

Strategic Opportunities

• Expansion of Indications: Applying for approvals in additional hematological malignancies or solid tumors with FLT3 or KIT involvement can diversify revenue sources.

• Combination Therapies: Investing in clinical trials that demonstrate superior outcomes with multi-agent regimens can enhance market penetration.

• Global Market Penetration: Strengthening presence in emerging markets with increasing oncology spending presents growth avenues.

• Biomarker Development: Supporting companion diagnostics facilitates targeted therapy adoption, optimizing treatment selection and maximizing sales.

Risks and Uncertainties

• Competitive Innovation: The advent of next-generation FLT3 inhibitors with better safety profiles or efficacy could displace midostaurin.

• Regulatory Hurdles: Delays or rejections in new indications or geographic approvals impede revenue expansion.

• Market Saturation: Increased treatment options may limit market share in approved indications.

Conclusion

The financial trajectory of RYDAPT hinges on sustained clinical adoption, strategic expansion, and competitive positioning. While current momentum favors growth within AML treatment paradigms, potential challenges from emerging therapies and market dynamics necessitate proactive strategic planning. The drug’s future will depend on ongoing clinical data, regulatory developments, and its positioning as a cornerstone in targeted hematologic oncology.

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Key Takeaways

• Market Expansion: Increasing molecular diagnostics and treatment guidelines endorsement position RYDAPT favorably within AML, with potential expansion into other FLT3-driven malignancies.

• Competitive Landscape: While RYDAPT remains a first-line therapy for FLT3-mutated AML, disruptions from newer FLT3 inhibitors necessitate innovation and strategic differentiation.

• Pricing and Reimbursement: Premium pricing is justified by targeted efficacy, but market penetration depends on favorable reimbursement policies across regions.

• Safety and Resistance: Managing resistance through combination therapies and monitoring safety profiles are critical for maintaining clinical and commercial viability.

• Growth Drivers: Adoption of combination regimens, indication expansions, and global market penetration are pivotal to achieving robust revenue growth.

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FAQs

1. What are the primary drivers behind RYDAPT’s market growth?
Increased diagnosis of FLT3 mutations, evolving treatment guidelines endorsing midostaurin, and advancements in diagnostic testing are key drivers. Expansion into combination therapies and emerging indications further enhance growth prospects.

2. How does the competitive landscape impact RYDAPT’s financial outlook?
The emergence of newer FLT3 inhibitors like gilteritinib introduces competition, potentially constraining market share. Differentiation through clinical efficacy, safety, and combination strategies is vital to sustain revenue.

3. What regulatory factors could influence RYDAPT’s future sales?
Additional regional approvals, expanded indications, and reimbursement policies heavily influence adoption. Regulatory delays or restrictions could hamper growth.

4. How significant is the impact of resistance development on RYDAPT’s long-term viability?
Resistance mutations can diminish efficacy, necessitating combination therapies or next-generation inhibitors. Monitoring and addressing resistance are essential for maintaining treatment relevance.

5. What strategic initiatives can optimize RYDAPT’s market penetration?
Developing new indications, advancing biomarker support, engaging in combination trials, and expanding into emerging markets are vital strategies for sustained growth.

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References

[1] National Comprehensive Cancer Network (NCCN) Guidelines. Acute Myeloid Leukemia, 2023.

[2] FDA Drug Approval Database. RYDAPT (midostaurin) approval details, 2017.

[3] Global Oncology Market Reports. Hematologic Malignancies Market Forecast, 2022–2027.