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	212801-003	Mar 6, 2020		DISCN	Yes	No	9,434,754			Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	No	8,314,097		Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No	8,835,646		Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No	10,709,691
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No

International Patents for osilodrostat phosphate

Country	Patent Number	Title	Estimated Expiration
Lithuania	C2523731
Brazil	112016030243	FORMAS DE DOSAGEM FARMACÊUTICAS, SEU PROCESSO DE PREPARAÇÃO, E USOS DE CELULOSE MICROCRISTALINA
Brazil	112012017458
Croatia	P20181406
European Patent Office	1919916	DERIVES IMIDAZOLO CONDENSES UTILISES POUR INHIBER L'ALDOSTERONE SYNTHASE ET L'AROMATASE (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	CR 2020 00025	Denmark		PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113
2523731	24/2020	Austria		PRODUCT NAME: OSILODROSTAT ODER PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, EINSCHLIESSLICH OSILODROSTATDIHYDROGENPHOSPHAT; REGISTRATION NO/DATE: EU/1/19/1407 (MITTEILUNG) 20200113
2523731	301043	Netherlands		PRODUCT NAME: OSILODROSTAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, MET INBEGRIP VAN OSILODROSTATDIWATERSTOFFOSFAAT; REGISTRATION NO/DATE: 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
2523731	2090024-7	Sweden		PRODUCT NAME: OSILODROSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING OSILODROSTAT DIHYDROGEN PHOSPHATE; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/19/1407, 2020-01-13; DEN 9 MAJ 2025 MEDDELADE PRV BESLUT OM RAETTAD SKYDDSTID FOER FOELJANDE TILLAEGGSSKYDD. 2090024-7 1090021-5 1590035-0 1890009-2 1790067-1 2090007-2 SKYDDSTIDEN FOER SAMTLIGA DESSA TILLAEGGSSKYDD AER FOERLAENGD MED EN DAG, I ENLIGHET MED PATENT- OCH MARKNADSDOMSTOLENS BESLUT I PMAE 7804-24. DEN BESLUTADE SKYDDSTIDEN FRAMGAR AV SVENSK PATENTDATABAS.

Market Dynamics and Financial Trajectory for Osilodrostat Phosphate

Last updated: March 5, 2026

What is the current commercial status of Osilodrostat phosphate?

Osilodrostat phosphate, marketed as Isturisa by Recordati, is approved for the treatment of endogenous Cushing’s syndrome. The drug received FDA approval in October 2020 and EMA approval in July 2021. Sales commenced shortly after approval, primarily driven by its indication in Cushing's syndrome, a rare endocrine disorder characterized by excess cortisol production.

How does Osilodrostat phosphate generate revenue?

Revenue streams are primarily from sales within developed markets. As of 2022, company reports indicated sales of approximately €85 million ($92 million). Growth drivers include expanding indications and geographic expansion, notably into Japan and additional European countries.

What are the key market drivers for Osilodrostat phosphate?

• Rare Disease Market: Cushing’s syndrome affects fewer than 40 per million individuals, classifying Osilodrostat as a niche drug with high unmet needs.
• Limited Competition: Few approved pharmacologic options exist. Metyrapone and ketoconazole are off-label treatments, with no approved alternatives in the U.S.
• Expanding Indications: Trials exploring use in primary aldosteronism and benign adrenal tumors could extend market potential.
• Market Access and Pricing: List prices hover around $24,000 per month, with negotiated discounts lowering effective treatment costs.

What is the competitive landscape?

• Metyrapone: Off-label use; less predictable regulatory pathways.
• Ketoconazole: Off-label use, with risks of hepatotoxicity limiting prescribing.
• Osilodrostat Phosphate: First approved drug with a dedicated label for Cushing’s syndrome, with ongoing efforts for broader labeling.

What are the growth projections and financial outlook?

Analysts project Osilodrostat sales will reach approximately €250 million (~$270 million) by 2027, driven by:

• Market penetration: Expected expansion into 25+ countries.
• Indication extension: Additional approvals in related adrenal disorders.
• Pricing strategy: Maintains premium pricing due to orphan status.

Recordati estimates annual revenue growth of approximately 20-25% through 2025, approaching €150-180 million ($160-190 million). Gross margins are high, around 80%, supported by patent protections expiring no earlier than 2035.

What regulatory and reimbursement factors influence its trajectory?

• Pricing and Reimbursement: Negotiations with payers are critical for broader access. European countries adopt varied reimbursement policies, impacting revenue.
• Regulatory Approvals: New indications or combination therapies could be pursued, contingent on trial outcomes.
• Patent Status: Patent exclusivity runs until 2035, providing pricing leverage.

How does the pipeline enhancement influence financial prospects?

Phase II and III trials are assessing Osilodrostat in indications like primary aldosteronism and non-adrenal hypercortisolism. Positive results could:

• Extend product life cycle.
• Increase market size.
• Elevate revenue surpassing current forecasts.

What are the risks to market and financial prospects?

• Market penetration delays: Due to pricing negotiations or competing therapies.
• Regulatory hurdles: Slower approval pathways or label restrictions.
• Manufacturing or supply chain disruptions: Impact sales continuity.
• Pricing pressure: Payers may favor generic or off-label treatments, limiting revenue.

Summary table: Osilodrostat Market & Financial Data

Metric	Data	Source
2022 global sales	€85 million (~$92 million)	Recordati reports
Projected 2027 sales	€250 million (~$270 million)	Analyst estimates
Price per month	~$24,000	Pricing disclosures
Patent expiration	2035	Patent filings
Approved indications	Cushing’s syndrome	FDA, EMA approvals
Key competitors	Off-label uses of metyrapone, ketoconazole	Market reports

Key Takeaways

• Osilodrostat phosphate is a niche therapy with strong growth potential driven by limited competition.
• Sales are expected to increase significantly through geographic and indication expansion.
• Pricing strategies and reimbursement negotiations are critical to revenue realization.
• Ongoing clinical trials could broaden its market, extending product lifecycle and revenue streams.
• Risks include regulatory delays and market access barriers.

FAQs

1. When did Osilodrostat phosphate receive regulatory approval?
FDA approved in October 2020; EMA approval achieved in July 2021.

2. What is the main indication for Osilodrostat?
Treatment of endogenous Cushing’s syndrome.

3. What is the estimated market size for Osilodrostat?
Expected global sales of €250–€300 million by 2027.

4. Are there any significant competitors?
No direct FDA-approved competitors; off-label use of metyrapone and ketoconazole are alternatives.

5. What factors could impact future revenue growth?
Pricing negotiations, regulatory hurdles, trial outcomes for additional indications, and manufacturing issues.

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References

[1] Recordati. (2022). Annual Financial Report.
[2] FDA. (2020). Approval of Osilodrostat for Cushing's syndrome.
[3] EMA. (2021). Marketing authorization for Isturisa.
[4] MarketLine. (2022). Pharmaceutical Market Analysis.
[5] EvaluatePharma. (2022). World Market Perspectives.