OSILODROSTAT PHOSPHATE - Generic Drug Details

What are the generic drug sources for osilodrostat phosphate and what is the scope of freedom to operate?

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-five patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for OSILODROSTAT PHOSPHATE

International Patents:	135
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	8
Patent Applications:	7
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	8,835,646		Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	No	10,143,680		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	212801-002	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	8,609,862

International Patents for OSILODROSTAT PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
Denmark	1919916
Canada	2954393	FORMES PHARMACEUTIQUES (PHARMACEUTICAL DOSAGE FORMS)
Japan	2018150326	副腎ホルモン修飾剤の使用 (USE OF ADRENAL HORMONE-MODIFYING AGENT)
Taiwan	201305175	Organic compounds
Spain	2527209

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	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	2020012	Norway		PRODUCT NAME: OSILODROSTAT ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV, INKLUDERT OSILODROSTAT DIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200203
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	132020000000052	Italy		PRODUCT NAME: OSILODROSTAT(ISTURISA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1407, 20200113

OSILODROSTAT PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Osilodrostat Phosphate

Introduction

Osilodrostat phosphate, a small molecule drug, has emerged as a significant treatment option for Cushing's disease, a rare endocrine disorder characterized by excessive cortisol production. Here, we delve into the market dynamics and financial trajectory of osilodrostat phosphate, highlighting its impact, growth prospects, and key factors influencing its market position.

Market Size and Growth

The market for Cushing's syndrome therapies, which includes osilodrostat phosphate, was valued at approximately $121.4 million in 2020. This market is expected to grow at a Compound Annual Growth Rate (CAGR) of more than 10% from 2020 to 2030, driven by the introduction of new and more efficacious treatments[1].

Key Drivers of Growth

Launch of New Treatments

The launch of osilodrostat phosphate, along with other new treatments such as Recorlev and Relacorilant, is a significant driver of market growth. These drugs offer improved therapeutic options for patients, enhancing treatment outcomes and patient access, particularly in the EU and the US[1].

Increasing Patient Access

The approval and availability of osilodrostat phosphate in key markets, such as the EU and the US, have expanded patient access to this treatment. In the EU, specifically in Germany, the increasing availability of novel steroidogenesis inhibitors like Isturisa is expected to drive market growth and reduce the market share of traditional, less effective therapies[1].

Clinical Efficacy and Safety

Osilodrostat phosphate has demonstrated strong clinical efficacy in reducing urinary free cortisol (mUFC) levels in patients with Cushing's disease. In a pivotal Phase III study, 86.1% of patients treated with osilodrostat maintained normal mUFC levels without dose changes, compared to 29.4% in the placebo group[2][5].

Long-Term Effectiveness

Long-term studies have shown that osilodrostat phosphate maintains its effectiveness over extended periods. A study over 156 weeks indicated significant reductions in mUFC levels, with a median reduction of -92.99% from baseline at week 156[3].

Safety Profile

Osilodrostat phosphate has been generally well-tolerated, with a safety profile consistent with previous reports. Common adverse events include decreased appetite, arthralgia, fatigue, nausea, headache, and dizziness. However, these can be managed through appropriate dose titration and monitoring[4][5].

Regulatory Landscape

Approvals and Designations

Osilodrostat phosphate has received regulatory approvals in several regions, including the EU (approved on January 9, 2020) and has been designated as an Orphan Drug in the US, EU, and Australia. These designations and approvals facilitate faster market entry and enhanced market access[4].

Market Competition

The market for Cushing's disease treatments is competitive, with several key players including Corcept Therapeutics Inc., Recordati SpA, Laboratorie HRA Pharma SAS, Strongbridge Biopharma PLC, and Sparrow Pharmaceuticals. Osilodrostat phosphate competes with other therapies such as Signifor/Signifor LAR, Korlym, Isturisa, Metopirone, Lysodren, and Ketoconazole[1].

Financial Projections

Given the strong clinical data and increasing market access, osilodrostat phosphate is expected to contribute significantly to the growth of the Cushing's syndrome market. The market's projected CAGR of over 10% from 2020 to 2030 indicates a robust financial trajectory for osilodrostat phosphate and other new treatments entering the market[1].

Key Takeaways

• Market Growth: The Cushing's syndrome market is expected to grow at a CAGR of more than 10% from 2020 to 2030.
• Clinical Efficacy: Osilodrostat phosphate has shown strong efficacy in reducing mUFC levels and improving patient outcomes.
• Regulatory Approvals: The drug has received key regulatory approvals and designations, enhancing its market access.
• Safety Profile: Osilodrostat phosphate is generally well-tolerated, with manageable adverse events.
• Market Competition: The market is competitive, but osilodrostat phosphate's efficacy and safety profile position it favorably.

FAQs

What is the current market size for Cushing's syndrome therapies?

The current market size for Cushing's syndrome therapies was approximately $121.4 million in 2020[1].

What is the expected growth rate of the Cushing's syndrome market?

The market is expected to grow at a CAGR of more than 10% from 2020 to 2030[1].

How effective is osilodrostat phosphate in treating Cushing's disease?

Osilodrostat phosphate has been shown to be highly effective, with 86.1% of patients maintaining normal mUFC levels without dose changes in a pivotal Phase III study[2][5].

What are the common adverse events associated with osilodrostat phosphate?

Common adverse events include decreased appetite, arthralgia, fatigue, nausea, headache, and dizziness[4].

Has osilodrostat phosphate received any regulatory approvals?

Yes, it has been approved in the EU and designated as an Orphan Drug in several regions, including the US, EU, and Australia[4].

Who are the key players in the Cushing's disease treatment market?

Key players include Corcept Therapeutics Inc., Recordati SpA, Laboratorie HRA Pharma SAS, Strongbridge Biopharma PLC, and Sparrow Pharmaceuticals[1].