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RECORLEV Drug Patent Profile

When do Recorlev patents expire, and when can generic versions of Recorlev launch?

Recorlev is a drug marketed by Strongbridge and is included in one NDA. There are eight patents protecting this drug.

This drug has thirty-three patent family members in twenty-one countries.

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

DrugPatentWatch^® Generic Entry Outlook for Recorlev

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 30, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RECORLEV

International Patents:	33
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Patent Applications:	1,576
Drug Prices:	Drug price information for RECORLEV
What excipients (inactive ingredients) are in RECORLEV?	RECORLEV excipients list
DailyMed Link:	RECORLEV at DailyMed

See drug prices for RECORLEV

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

Constraining patent/regulatory exclusivity:

FOR TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULT PATIENTS WITH CUSHING'S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE

NDA:

214133

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 RECORLEV

Drug Class	Cortisol Synthesis Inhibitor
Mechanism of Action	Cytochrome P450 11A1 Inhibitors Cytochrome P450 11B1 Inhibitors Cytochrome P450 17A1 Inhibitors Cytochrome P450 2B6 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for RECORLEV

RECORLEV is protected by eight US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on FOR TREATMENT OF ENDOGENOUS HYPERCORTISOLEMIA IN ADULT PATIENTS WITH CUSHING'S SYNDROME FOR WHOM SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE.

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
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes

International Patents for RECORLEV

When does loss-of-exclusivity occur for RECORLEV?

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

Australia

Austria

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Slovenia

South Africa

South Korea

Spain

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 RECORLEV around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006072881
New Zealand	560481	Methods and compositions for treating diabetes, metabolic syndrome and other conditions
China	101141964	Methods and compositions for treating diabetes, metabolic syndrome and other conditions
China	113710250	用左旋酮康唑治疗疾病的方法 (Methods of treating disease with levoketoconazole)
Israel	286099	שיטות לטיפול במחלה תוך שימוש ב-levoketoconazole (Methods of treating disease with levoketoconazole)
South Korea	20210135278	레보케토코나졸로 질환을 치료하는 방법
European Patent Office	3934649	PROCÉDÉS DE TRAITEMENT D'UNE MALADIE AVEC DU LÉVOKÉTOCONAZOLE (METHODS OF TREATING DISEASE WITH LEVOKETOCONAZOLE)

RECORLEV Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Recorlev®

Introduction

Recorlev®, developed by Xeris Biopharma, is a significant addition to the treatment landscape for endogenous hypercortisolemia in adult patients with Cushing’s syndrome. This article delves into the market dynamics and financial trajectory of Recorlev, highlighting its approval, clinical efficacy, market performance, and future outlook.

FDA Approval and Clinical Efficacy

Recorlev (levoketoconazole) received U.S. FDA approval on December 30, 2021, based on positive results from two pivotal Phase 3 studies: SONICS and LOGICS. These studies demonstrated the safety and efficacy of Recorlev in normalizing and maintaining therapeutic response in patients with Cushing’s syndrome[1].

SONICS and LOGICS Studies

• The SONICS study met its primary and key secondary endpoints, significantly reducing and normalizing mean urinary free cortisol concentrations without a dose increase.
• The LOGICS study, a double-blind, placebo-controlled randomized-withdrawal study, confirmed the efficacy and safety of Recorlev in maintaining therapeutic response compared with placebo[1].

Market Performance

Since its approval, Recorlev has shown impressive market performance.

Revenue Growth

In Q3 2024, Recorlev generated nearly $18 million in revenue, representing a 119% increase from Q3 2023. This growth was driven by a 125% increase in the number of patients on therapy[2][5].

Patient Adoption

The significant increase in patients on therapy indicates strong adoption and acceptance of Recorlev by both clinicians and patients. This trend is expected to continue as more patients seek effective treatments for Cushing’s syndrome.

Financial Trajectory

Xeris Biopharma's financial performance has been positively impacted by Recorlev's success.

Revenue Guidance

The company raised its total revenue guidance for 2024 to $198 million to $202 million, reflecting the strong performance of Recorlev and other products like Gvoke[2][5].

Cash Position

Xeris Biopharma ended Q3 2024 with a strong cash position of over $69 million, which is crucial for further growth investments and pipeline advancements without the need for dilutive financing[2].

Commercial Expansion

The commercial success of Recorlev is supported by Xeris Biopharma's strategic initiatives.

Commercial Organization

The company is focusing on expanding the Recorlev commercial organization to further penetrate the market and maintain strong margin profiles while managing expenses[2].

Pipeline Advancements

In addition to Recorlev, Xeris Biopharma is advancing other pipeline products, such as XP8121, with plans for a Phase 3 program following positive Phase 2 data and FDA discussions[2].

Adverse Reactions and Drug Interactions

While Recorlev has shown significant efficacy, it is not without potential side effects and interactions.

Common Adverse Reactions

The most common adverse reactions include nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, and others[1].

Potential Clinical Manifestations

Recorlev may lower serum testosterone levels, leading to clinical manifestations such as gynecomastia, impotence, and oligospermia in men, and decreased libido and mood changes in women[1].

Market Dynamics and Competition

The market for Cushing’s syndrome treatments is niche but growing, with Recorlev positioning itself as a key player.

Rare Disease Market

Cushing’s syndrome is a rare and potentially life-threatening disease if not appropriately treated. The limited effective treatment options make Recorlev a welcome addition to the therapeutic landscape[1].

Competitive Landscape

While Recorlev faces competition from other treatments, its unique profile and strong clinical data set it apart. The absence of other FDA-approved treatments specifically for endogenous hypercortisolemia in Cushing’s syndrome patients gives Recorlev a significant market advantage[1].

Future Outlook

The future looks promising for Recorlev and Xeris Biopharma.

Financial Guidance for 2025

The company plans to provide detailed financial guidance for 2025 when it releases its year-end results in March, indicating confidence in its financial trajectory[2].

Continued Growth

With a strong cash position and a robust revenue growth trajectory, Xeris Biopharma is well-positioned to continue investing in its pipeline and commercial expansion, ensuring sustained growth for Recorlev and other products[2].

Key Takeaways

• FDA Approval: Recorlev was approved based on positive Phase 3 studies, demonstrating its safety and efficacy in treating Cushing’s syndrome.
• Revenue Growth: Recorlev generated $17.7 million in Q3 2024, a 119% increase from Q3 2023, driven by a significant increase in patients on therapy.
• Financial Trajectory: Xeris Biopharma raised its revenue guidance to $198-$202 million for 2024 and maintains a strong cash position.
• Commercial Expansion: The company is expanding its commercial organization to support Recorlev’s market penetration.
• Pipeline Advancements: Xeris Biopharma is advancing other pipeline products, including XP8121.

FAQs

What is Recorlev used for?

Recorlev (levoketoconazole) is used for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative[1].

What were the key findings of the SONICS and LOGICS studies?

The SONICS study significantly reduced and normalized mean urinary free cortisol concentrations without a dose increase. The LOGICS study confirmed the efficacy and safety of Recorlev in maintaining therapeutic response compared with placebo[1].

How has Recorlev performed financially since its approval?

Recorlev generated nearly $18 million in revenue in Q3 2024, a 119% increase from Q3 2023, driven by a 125% increase in the number of patients on therapy[2][5].

What are the common adverse reactions associated with Recorlev?

Common adverse reactions include nausea/vomiting, hypokalemia, hemorrhage/contusion, systemic hypertension, headache, hepatic injury, and others[1].

What is the future outlook for Recorlev and Xeris Biopharma?

The company plans to provide detailed financial guidance for 2025 and continues to invest in its pipeline and commercial expansion, ensuring sustained growth for Recorlev and other products[2].

Sources

1. Xeris Biopharma Announces U.S. FDA Approval of Recorlev® (levoketoconazole) for the Treatment of Endogenous Hypercortisolemia in Adult Patients With Cushing’s Syndrome. Xeris Biopharma.
2. Earnings call: Xeris Biopharma posts record revenue in Q3 2024. Investing.com.
3. MARKET PERFORMANCE ANALYSIS - Antimicrobial Drugs. NCBI.
4. Net Present Value Model: Recorlev. GlobalData.
5. Xeris Biopharma Reports Third Quarter 2024 Financial Results. TradingView.