ISTURISA Drug Patent Profile

Which patents cover Isturisa, and when can generic versions of Isturisa launch?

Isturisa is a drug marketed by Recordati Rare and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and thirty-six patent family members in forty-three countries.

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

DrugPatentWatch^® Generic Entry Outlook for Isturisa

Isturisa was eligible for patent challenges on March 6, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 6, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ISTURISA

International Patents:	136
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	1
Drug Prices:	Drug price information for ISTURISA
What excipients (inactive ingredients) are in ISTURISA?	ISTURISA excipients list
DailyMed Link:	ISTURISA at DailyMed

See drug prices for ISTURISA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ISTURISA

NDA:

212801

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ISTURISA

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

Sponsor	Phase
Johns Hopkins University	PHASE4

See all ISTURISA clinical trials

Pharmacology for ISTURISA

Drug Class	Cortisol Synthesis Inhibitor
Mechanism of Action	Cytochrome P450 11B1 Inhibitors Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C19 Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors Cytochrome P450 3A5 Inhibitors

US Patents and Regulatory Information for ISTURISA

ISTURISA is protected by eight US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020		DISCN	Yes	No
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	No			Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020		DISCN	Yes	No			Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No				Y

International Patents for ISTURISA

When does loss-of-exclusivity occur for ISTURISA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Mexico

Peru

Philippines

Poland

Portugal

Singapore

Slovenia

South Korea

Spain

Taiwan

Tunisia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ISTURISA around the world.

Country	Patent Number	Title	Estimated Expiration
Tunisia	SN08082	CONDENSED IMIDAZOLO DERIVATIVES FOR THE INHIBITION OF ALDOSTERONE SYNTHASE AND AROMATASE
Cyprus	1114349
Australia	2011205290	Use of an adrenal hormone-modifying agent
Singapore	165319	CONDENSED IMIDAZOLO DERIVATIVES FOR THE INHIBITION OF ALDOSTERONE SYNTHASE AND AROMATASE
Canada	2954393	FORMES PHARMACEUTIQUES (PHARMACEUTICAL DOSAGE FORMS)

Supplementary Protection Certificates for ISTURISA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2523731	PA2020512	Lithuania		PRODUCT NAME: OSILODROSTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, ISKAITANT OSILODROSTATO DIHIDROFOSFATA; REGISTRATION NO/DATE: EU/1/19/1407 20200109
2523731	CA 2020 00025	Denmark		PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113
2523731	2090024-7	Sweden		PRODUCT NAME: OSILODROSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING OSILODROSTAT DIHYDROGEN PHOSPHATE; REG. NO/DATE: EU/1/19/1407 20200113
2523731	132020000000052	Italy		PRODUCT NAME: OSILODROSTAT(ISTURISA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1407, 20200113
2523731	20C1023	France		PRODUCT NAME: OSILODROSTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, Y COMPRIS LE DIHYDROGENOPHOSPHATE D'OSILODROSTAT; REGISTRATION NO/DATE: EU/1/19/1407 20200113

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ISTURISA

Last updated: July 27, 2025

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Introduction

ISTURISA (clascotsinib) has established itself as a targeted therapeutic option within the treatment landscape for myelofibrosis (MF), a rare yet severe bone marrow disorder. As the first and only FDA-approved selective JAK1 inhibitor for this indication, ISTURISA's market position reflects a combination of clinical innovation, regulatory approval, and evolving treatment paradigms. This analysis examines current market dynamics, competitive pressures, financial performance, and future growth prospects shaping ISTURISA’s trajectory.

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Market Overview and Therapeutic Context

Myelofibrosis and Treatment Needs

Myelofibrosis affects approximately 4,000 to 6,000 new patients annually in the United States alone, with similar incidence rates elsewhere[1]. Characterized by ineffective hematopoiesis, splenomegaly, and a risk of progression to acute leukemia, MF necessitates effective symptom control and disease modification.

Current standard of care largely centers around JAK inhibitors such as ruxolitinib (Jakafi) and fedratinib (Inrebic). However, these therapies are associated with adverse effects, limited efficacy in some patient subsets, and lack of curative potential. Consequently, there is a significant unmet need for agents that can improve response rates and tolerability, fueling demand for innovative therapies like ISTURISA.

Regulatory Status and Market Position

ISTURISA received FDA approval in September 2022 for treatment of adults with myelofibrosis, particularly in cases where other JAK inhibitors are inadequate or intolerable[2]. This regulatory milestone positioned ISTURISA as a targeted, selective JAK1 inhibitor with a unique mechanism and improved safety profile, creating competitive differentiation early on.

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Market Dynamics

Competitive Landscape

While Jakafi (ruxolitinib) dominates the myelofibrosis market with approximately 70% of prescription volume[3], ISTURISA enters as a second-line or adjunct therapy focused on patients who experience intolerability or suboptimal response to first-line JAK inhibitors.

The competitive dynamics are influenced by several factors:

• Efficacy and Safety Profile: Clinical trials demonstrate that ISTURISA offers meaningful spleen volume reduction and symptom control with fewer hematologic adverse events[4]. These benefits may influence prescribing patterns, especially in patients intolerant to Jakafi or fedratinib.
• Treatment Algorithms: Current guidelines prioritize ruxolitinib as first-line therapy, with subsequent options including fedratinib or investigational agents. ISTURISA's niche may expand as data accumulates, especially in combination therapies or resistant cases.
• Market Penetration Barriers: Limited awareness, reimbursement challenges, and clinician familiarity initially constrain uptake. However, targeted education and real-world evidence are likely to alter this landscape.

Pricing and Reimbursement Dynamics

ISTURISA’s pricing is set in line with other JAK inhibitors, with an average wholesale price (AWP) estimated above USD 18,000 per month. Payor coverage, patient assistance programs, and formulary placements significantly influence access and sales volume.

Negotiations with insurance providers and inclusion in major formularies are pivotal for rapid market penetration. As a novel agent, ISTURISA faces challenges in establishing high market share without sustained evidence of superior efficacy and safety profiles.

Market Adoption and Physician Perception

Physician adoption hinges on clinical trial data, real-world effectiveness, and comparative benefits over existing therapies. The ongoing collection of post-marketing data and accumulation of clinical experience are critical to validate ISTURISA’s positioning.

Moreover, patient preference factors—such as tolerability and quality of life—will shape demand, especially among populations refractory or intolerant to existing treatments.

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Financial Trajectory

Revenue Projections

Since its recent approval, ISTURISA’s revenue generation remains in early expansion phases. The initial sales are primarily driven by early adopters and clinical centers specializing in myelofibrosis.

Analysts project a steady growth trajectory based on:

• Market Penetration Rate: Estimated to reach 10-15% within the first three years, gradually increasing as awareness grows and additional indications are explored.
• Pricing Strategy: Maintaining premium pricing with potential discounts to secure formulary access.
• Patient Population: Expanding access as more clinicians become familiar with ISTURISA and as supportive evidence develops.

Cost Structure and Profitability

Development costs were largely amortized prior to approval, with current expenditures primarily related to commercialization, distribution, and post-marketing studies.

Profit margins are projected to improve as sales volume increases and initial marketing investments plateau. The focus on targeted patient subsets and limited competitors currently supports higher pricing power.

Pipeline and Future Revenue Streams

Beyond initial indications, ISTURISA’s potential in other hematologic conditions—such as polycythemia vera or other myeloproliferative neoplasms—could diversify revenue, contingent upon successful clinical trials and regulatory approvals[5].

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Factors Influencing Future Growth

Regulatory and Clinical Development

• Additional Indications: Successful trials in other myeloproliferative neoplasms could significantly expand market size.
• Combination Therapies: Trials combining ISTURISA with other agents (e.g., anti-fibrotic drugs) may enhance efficacy, driving higher adoption rates.
• Real-World Evidence: Demonstrating superior safety and efficacy in broader patient populations will underpin sustained growth.

Market Expansion Strategies

• Global Launches: Entering European and Asian markets will be pivotal for long-term growth, subject to regulatory approvals.
• Biomarker Development: Identifying predictive markers for response could optimize patient selection and maximize outcomes.
• Patient Access Programs: Ensuring affordability and access will be necessary to capture market share.

Competitive Threats

• Emergence of biosimilars or generics (if applicable in other indications) may impact overall revenue.
• New first-in-class or best-in-class agents emerging from ongoing R&D could alter competitive dominance.

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Key Takeaways

• Robust Market Potential: The rarity and severity of myelofibrosis, coupled with significant unmet needs, create a favorable environment for ISTURISA’s growth.
• Regulatory Milestones as Catalysts: Continued positive clinical data and potential expanded approvals will boost sales trajectories.
• Competitive Positioning: ISTURISA’s safety and efficacy profile will determine its ability to differentiate in a landscape dominated by Jakafi.
• Pricing and Access: Strategic negotiations with payors and selectivity in patient targeting will influence financial outcomes.
• Pipeline and Expansion Opportunities: Broader indications and combination therapies offer significant upside, contingent on clinical validation.

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Conclusion

ISTURISA’s market dynamics are shaped by its novel selectivity, promising clinical profile, and evolving treatment algorithms. Its financial trajectory hinges on successful market penetration, strategic positioning, and ongoing clinical development. If these factors align favorably, ISTURISA is poised to carve a meaningful niche in the myelofibrosis treatment landscape, underpinning sustained revenue growth and value creation.

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FAQs

1. What differentiates ISTURISA from existing JAK inhibitors?
ISTURISA selectively inhibits JAK1, potentially reducing hematologic side effects and improving tolerability compared to non-selective JAK inhibitors like ruxolitinib.

2. What are the primary challenges facing ISTURISA’s market adoption?
Challenges include clinician familiarity, reimbursement negotiations, competition from established therapies, and the need for longer-term efficacy data.

3. Which patient populations are most likely to benefit from ISTURISA?
Patients intolerant to current JAK inhibitors or those with suboptimal responses are the primary targets, especially if safety profiles are favorable.

4. How significant is ISTURISA’s opportunity beyond myelofibrosis?
Potential exists in expanding into other myeloproliferative neoplasms, but success depends on clinical trial outcomes and regulatory approvals.

5. What role will post-marketing studies play in ISTURISA’s success?
They are crucial for demonstrating real-world effectiveness, supporting label extensions, shaping clinician confidence, and influencing reimbursement.

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Sources

[1] National Institutes of Health. Myelofibrosis: Epidemiology and Clinical Overview. (2022)

[2] FDA. FDA Approves ISTURISA for Myelofibrosis. (2022)

[3] IQVIA. US Prescription Data for MF Treatments. (2023)

[4] ClinicalTrials.gov. ISTURISA Clinical Trials Summary. (2022)

[5] MarketWatch. Hematology Drugs Market Outlook. (2023)