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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-five 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:	135
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Patent Applications:	125
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.

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 six 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	212801-001	Mar 6, 2020		RX	Yes	No
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020		DISCN	Yes	No
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020		DISCN	Yes	No

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
Malaysia	151601	CONDENSED IMIDAZOLO DERIVATIVES FOR THE INHIBITION OF ALDOSTERONE SYNTHASE AND AROMATASE
Japan	5602250
Eurasian Patent Organization	201991359	ФАРМАЦЕВТИЧЕСКИЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ

Supplementary Protection Certificates for ISTURISA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2523731	400 50015-2020	Slovakia		PRODUCT NAME: OSILODROSTAT VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; 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	122020000026	Germany		PRODUCT NAME: OSILODROSTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, EINSCHLIESSLICH OSILODROSTATDIHYDROGENPHOSPHAT; REGISTRATION NO/DATE: EU/1/19/1407 20200109

ISTURISA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ISTURISA

Introduction to ISTURISA

ISTURISA, also known as osilodrostat, is a cortisol synthesis inhibitor developed by Recordati Rare Diseases for the treatment of Cushing’s syndrome, a rare endocrine disorder characterized by excessive cortisol levels.

Market Size and Growth

The Cushing’s syndrome market, in which ISTURISA is a key player, 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 launch of new and more efficacious therapeutic options like ISTURISA[1].

Key Drivers of Market Growth

Launch of New Therapies

The introduction of ISTURISA, along with other new treatments such as Recorlev and Relacorilant, is a significant driver of market growth. These therapies offer improved efficacy and safety profiles compared to traditional treatments like ketoconazole and metyrapone, thereby increasing patient access and treatment adherence[1].

Increasing Patient Access

The approval and availability of ISTURISA in key markets, particularly in the EU and the US, have expanded patient access to this novel therapy. For instance, the approval of ISTURISA by the China National Medical Products Administration (NMPA) in September 2024 further broadens its global reach[2].

Clinical Efficacy and Safety

Phase III LINC 4 Study

The Phase III LINC 4 study presented at The Endocrine Society’s Annual Meeting demonstrated the efficacy and safety of ISTURISA. The study showed that ISTURISA rapidly and sustainably normalized mean urinary free cortisol (mUFC) levels in the majority of patients. At week 12, 77% of patients achieved normal mUFC levels compared to 8% on placebo, and by week 36, 81% of patients maintained normal mUFC levels[3][4].

Improvements in Clinical Parameters

The study also highlighted improvements in cardiovascular and metabolic parameters, including systolic and diastolic blood pressure and glycated hemoglobin (HbA1c), which are critical for reducing morbidity and improving the quality of life for patients with Cushing’s disease[3][4].

Safety Profile

ISTURISA has been found to be well tolerated, with common adverse events including arthralgia, decreased appetite, fatigue, nausea, and headache. Hypocortisolism-related adverse events were manageable with dose adjustments and did not typically require treatment discontinuation[4].

Financial Performance of Recordati

Revenue Growth

Recordati, the company behind ISTURISA, has reported strong financial performance. In the first nine months of 2024, Recordati saw a 12% increase in net revenue, reaching €1.743 billion, and a 14.9% increase in operating income compared to the same period in 2023[2].

EBITDA and Net Income

The company's EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortization) increased by 11.8% to €665.7 million, with a margin of 38.2% of net revenue. Adjusted net income rose by 9.5% to €445.4 million, reflecting higher operating income partially offset by increased financial expenses and a higher tax rate[2].

Free Cash Flow and Debt

Recordati's free cash flow increased by €42.5 million to €434.3 million in the first nine months of 2024, driven by higher EBITDA. The company's net debt as of September 2024 was €1.317 billion, representing a leverage of just below 1.6x EBITDA[2].

Regulatory Approvals and Expansion

Global Approvals

The approval of ISTURISA by regulatory bodies in key markets, including the US and China, has been instrumental in its market success. These approvals have expanded the drug's reach and contributed to the overall growth of the Cushing’s syndrome market[2][3].

Pipeline and Corporate Development

Recordati's agreement with Sanofi to acquire the global rights to Enjaymo®, another rare disease treatment, further strengthens the company's pipeline and positions it for continued growth in the rare diseases segment[2].

Key Takeaways

• Market Growth: The Cushing’s syndrome market is expected to grow at a CAGR of more than 10% from 2020 to 2030, driven by new therapies like ISTURISA.
• Clinical Efficacy: ISTURISA has demonstrated rapid and sustained normalization of mUFC levels, improving clinical parameters and quality of life for patients.
• Financial Performance: Recordati has reported strong revenue and EBITDA growth, with increasing free cash flow and manageable debt levels.
• Regulatory Approvals: ISTURISA has received approvals in key markets, including the US and China, expanding its global reach.

FAQs

What is the current market size of Cushing’s syndrome therapies?

The Cushing’s syndrome market was valued at 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].

What are the key benefits of ISTURISA in treating Cushing’s disease?

ISTURISA rapidly and sustainably normalizes mUFC levels, improves cardiovascular and metabolic parameters, and is well tolerated[3][4].

Which company developed ISTURISA?

ISTURISA was developed by Recordati Rare Diseases[3].

What are the common adverse events associated with ISTURISA?

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

How has Recordati's financial performance been impacted by ISTURISA?

Recordati has seen significant revenue and EBITDA growth, along with increased free cash flow, partly due to the success of ISTURISA[2].

Sources

1. GlobalData: Cushing's Syndrome - Opportunity Assessment and Forecast to 2030
2. GlobeNewswire: RECORDATI: CONTINUED DOUBLE-DIGIT GROWTH IN THE FIRST NINE MONTHS OF 2024
3. via.tt.se: Recordati Rare Diseases: Positive Results From the Phase III LINC 4 Study
4. European Pharmaceutical Review: Isturisa continues to show promise in Cushing's disease
5. Missouri Department of Social Services: Isturisa NDFB (PDF)