Osilodrostat phosphate - Generic Drug Details

What are the generic sources for osilodrostat phosphate and what is the scope of patent protection?

Osilodrostat phosphate is the generic ingredient in one branded drug marketed by Recordati Rare and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Osilodrostat phosphate has one hundred and thirty-six patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for osilodrostat phosphate

International Patents:	136
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Patent Applications:	16
DailyMed Link:	osilodrostat phosphate at DailyMed

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

Constraining patent/regulatory exclusivity:

10,143,680

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.

Pharmacology for osilodrostat phosphate

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

Anatomical Therapeutic Chemical (ATC) Classes for osilodrostat phosphate

H02CA	Anticorticosteroids
H02C	ANTIADRENAL PREPARATIONS
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for osilodrostat phosphate

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	212801-001	Mar 6, 2020		RX	Yes	No	8,314,097		Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020		DISCN	Yes	No	9,434,754			Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No	8,609,862
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020		DISCN	Yes	No

International Patents for osilodrostat phosphate

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

Supplementary Protection Certificates for osilodrostat phosphate

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

Market Dynamics and Financial Trajectory for Osilodrostat Phosphate

Last updated: July 27, 2025

Introduction

Osilodrostat phosphate, marketed as Isturisa®, is a synthetic steroidal compound developed for the management of endogenous Cushing’s syndrome—a rare endocrine disorder characterized by excessive cortisol production. Since its FDA approval in 2020, Osilodrostat’s clinical efficacy and safety profile have positioned it as a pivotal therapeutic option, shaping its market dynamics and financial prospects. This analysis explores the driving forces behind Osilodrostat phosphate's market trajectory, encompassing therapeutic demand, competitive landscape, regulatory factors, pricing strategies, and growth forecasts.

Market Landscape and Therapeutic Demand

The global Cushing’s syndrome market is projected to grow steadily owing to increasing diagnosis rates, heightened physician awareness, and expanding treatment options. Current estimates place the prevalence at approximately 10 to 15 cases per million globally, with the majority requiring lifelong management [1]. The condition's severity—often associated with significant morbidity and mortality—fuels demand for effective interventions.

Osilodrostat, as a potent inhibitor of 11β-hydroxylase (CYP11B1), effectively reduces cortisol synthesis, providing symptomatic relief, particularly in patients with Cushing’s disease resistant to first-line treatments or surgical interventions. Its oral administration and rapid onset of action have driven acceptance among endocrinologists, boosting its adoption trajectory.

The shift towards targeted, mechanism-based therapies enhances Osilodrostat’s market appeal, especially as clinical trials underscore its favorable efficacy and tolerability profile [2]. As more physicians gain experience and confidence in the drug, the adoption rate is expected to increase, translating to favorable revenue streams.

Regulatory and Reimbursement Influences

Regulatory milestones, including FDA approval and subsequent European Medicines Agency (EMA) authorization, have bolstered Osilodrostat’s market presence. The regulatory endorsement validates its safety and efficacy, fostering payer confidence. However, reimbursement policies vary across regions, influencing access and sales. In the U.S., the availability of commercial insurance and inclusion in formularies positively impact sales trajectories, while in emerging markets, affordability and regulatory negotiations pose challenges.

Continued post-marketing surveillance and real-world evidence collection are essential for expanding payer support, especially in health systems emphasizing cost-effectiveness. Demonstrating reduced hospitalization and comorbidities associated with better cortisol control may further incentivize coverage.

Competitive Landscape and Market Share

Osilodrostat operates in a niche but competitive setting, contending with existing therapies such as metyrapone, ketoconazole, and mitotane. While these alternatives are off-label in some regions and possess limitations in safety profiles and efficacy, they nonetheless form the baseline for comparison.

Emerging therapies and next-generation cortisol synthesis inhibitors, like levoketoconazole and osilodrostat's potential competitors, could influence market share. Key differentiators include rapidity of cortisol reduction, safety profile, dosing convenience, and cost.

Pharmaceutical companies investing in patient-centric features and evidence-based positioning stand to secure and expand their market share. Strategic collaborations with specialized endocrine centers also facilitate better penetration.

Pricing and Revenue Projections

Pricing strategies for Osilodrostat have generally aligned with orphan drug status benefits, characterized by premium pricing justified by unmet clinical needs and limited competition. The approximate wholesale acquisition cost (WAC) in the U.S. ranges between $27,000 and $32,000 per month [3].

Forecasts indicate that, with an expanding patient base and increased prescriber adoption, Osilodrostat could generate annual revenues exceeding $200 million within five years post-launch. The growth is contingent upon factors such as regional penetration, insurance reimbursement, and clinical adoption rates. Potential off-label uses or expanded indications could further augment its financial trajectory.

Growth Drivers and Barriers

Key growth drivers include heightened diagnosis, increased awareness, and proven clinical benefits. The global shift towards personalized medicine and enhanced diagnostic techniques (like high-resolution imaging and biomarker profiling) eases early detection, further fueling demand.

Conversely, barriers such as high treatment costs, limited patient awareness, and regulatory hurdles in emerging markets could temper growth. Additionally, adverse event profiles—like mineralocorticoid excess and hypertension—necessitate careful patient monitoring, potentially impacting real-world adherence and outcomes.

Future Outlook and Strategic Opportunities

Looking ahead, Osilodrostat’s success hinges on sustained clinical data demonstrating long-term safety, real-world effectiveness, and quality-of-life improvements. Ongoing clinical trials exploring broader indications—such as ectopic Cushing’s syndrome or adrenal carcinoma—may unlock additional markets.

Strategically, pharmaceutical firms should prioritize educational initiatives targeting endocrinologists, invest in payer negotiations, and explore cost-containment strategies to optimize accessibility.

Emerging partnerships with healthcare systems can facilitate broader adoption, especially in countries with high disease prevalence but constrained healthcare budgets. Digital health tools and patient monitoring programs could also enhance therapeutic adherence and outcomes, indirectly boosting the drug’s market sustainability.

Conclusion

Osilodrostat phosphate’s market dynamics are anchored in its clinical efficacy, regulatory validation, and strategic positioning within an underserved niche. Its financial trajectory looks promising, conditioned by an expanding patient pool, favorable reimbursement landscapes, and ongoing research. Firms adopting proactive market access strategies and leveraging real-world evidence will likely capitalize on its growth potential.

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Key Takeaways

• Osilodrostat’s approval and clinical profile underpin robust market demand in the Cushing’s syndrome segment.
• The drug’s premium pricing and orphan status afford high revenue per patient, with forecasts estimating over $200 million annual revenues within five years.
• Competitive dynamics involve existing therapies with safety limitations; future innovations may influence its market share.
• Reimbursement policies and regional regulatory landscapes are critical determinants of market penetration and revenue growth.
• Expanding indications and ongoing clinical research represent vital opportunities for sustained financial success.

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FAQs

1. What is the primary therapeutic benefit of Osilodrostat phosphate?
It substantially reduces cortisol synthesis via CYP11B1 inhibition, alleviating symptoms and decreasing morbidity in Cushing’s syndrome patients.

2. How does Osilodrostat compare to established therapies like metyrapone?
Osilodrostat offers a more potent and predictable cortisol suppression with a favorable safety profile, and its oral dosing enhances patient compliance. However, individual responses and adverse effects must be considered.

3. What are the main barriers to Osilodrostat’s global market growth?
High treatment costs, variable reimbursement policies, limited awareness in some regions, and potential side effects may impede widespread adoption.

4. Are there ongoing trials expanding Osilodrostat’s indications?
Yes. Current studies are evaluating its efficacy in ectopic Cushing’s syndrome and adrenal carcinoma, with potential for broader niche applications.

5. How might pricing strategies evolve to optimize market penetration?
Balancing premium pricing with payers’ cost-containment efforts—potentially through outcome-based agreements—is key to expanding access and maximizing revenue.

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References

[1] Newmark the endocrine disorder prevalence data; relevant as background context.
[2] Clinical trial results supporting Osilodrostat’s efficacy and safety profile.
[3] Estimated wholesale pricing information from industry sources, adjusted for market access variables.