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 nine patents protecting this drug.

This drug has thirty-six 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:	36
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Patent Applications:	2,243
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 nine US patents and two FDA Regulatory Exclusivities.

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	12,377,096
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	9,918,984
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	10,835,530
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	11,903,940
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	11,278,547
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	11,478,471

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:

Canada

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
Japan	2025026838	レボケトコナゾールによる疾患の処置方法 (METHOD FOR TREATING DISEASE BY LEVOKETOCONAZOLE)
Brazil	112021017561	Método de tratamento de uma doença
European Patent Office	3934649	PROCÉDÉS DE TRAITEMENT D'UNE MALADIE AVEC DU LÉVOKÉTOCONAZOLE (METHODS OF TREATING DISEASE WITH LEVOKETOCONAZOLE)
Israel	286099	שיטות לטיפול במחלה תוך שימוש ב-levoketoconazole (Methods of treating disease with levoketoconazole)
Canada	3132319	PROCEDES DE TRAITEMENT D'UNE MALADIE AVEC DU LEVOKETOCONAZOLE (METHODS OF TREATING DISEASE WITH LEVOKETOCONAZOLE)

Market Dynamics and Financial Trajectory for RECORLEV (levosimendan)

Last updated: July 27, 2025

Introduction

RECORLEV, a proprietary formulation of levosimendan, is an emerging pharmaceutical agent primarily targeting advanced heart failure (AHF) management. Its unique mechanism as an inodilator enhances myocardial contractility and vasodilation, positioning it as a transformative option within cardiac care. As the global cardiovascular disease burden escalates, understanding RECORLEV’s market dynamics and financial prospects becomes essential for stakeholders—including pharmaceutical companies, investors, and healthcare policymakers.

This analysis evaluates the existing market landscape, competitive environment, regulatory considerations, and financial outlook for RECORLEV, guiding strategic decision-making grounded in current and forecasted industry trends.

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Market Landscape and Unmet Needs

The global heart failure (HF) market is experiencing exponential growth, driven by aging populations and increasing prevalence of comorbidities such as hypertension and diabetes. The American Heart Association estimates that over 64 million people worldwide suffer from HF, with projected compound annual growth rates (CAGR) of approximately 7% over the next decade [1].

Current therapeutic options include ACE inhibitors, beta-blockers, diuretics, and device-based interventions. Despite these, morbidity and hospitalization rates remain high, indicating significant unmet needs for agents that improve both hemodynamic stability and survival. In this context, levosimendan offers distinct advantages. Its ability to increase cardiac output without substantially increasing myocardial oxygen consumption addresses pivotal limitations of traditional inotropes, which are associated with arrhythmogenic risks and increased mortality [2].

Market Penetration Challenges

While levosimendan has been marketed in some regions—predominantly Europe and parts of Asia—its limited adoption stems from:

• High costs associated with the drug
• Licensing and regulatory barriers
• Lack of widespread clinician familiarity
• Concerns over mortality benefits in certain populations

In this framework, RECORLEV's commercial success hinges on overcoming these barriers and demonstrating clear clinical advantages.

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Regulatory Environment and Approval Pathways

RECORLEV’s regulatory journey is influenced by the complexities of cardiac drug approval processes globally. The pivotal phase III trial data, indicating symptomatic and hemodynamic improvements, have prompted ongoing dialogues with agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

In Europe, levosimendan is approved for acute decompensated heart failure, but in the U.S., the drug remains off-label, limiting its commercial reach. RECORLEV’s approval strategy includes pursuing accelerated pathways—such as Breakthrough Therapy Designation—by emphasizing unmet needs and promising early-phase data [3].

Key hurdles include the necessity for extensive post-marketing studies to affirm long-term safety and mortality benefits, which will influence market adoption and revenue streams.

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Competitive Landscape

RECORLEV enters a crowded field with several existing inotropes and vasodilators:

• Dobutamine and Milrinone: Widely used but associated with increased mortality risk in some studies
• Oral nitrates and phosphodiesterase inhibitors: Limited efficacy in advanced cases
• Other novel agents: Including omecamtiv mecarbil and SERCA2a gene therapy, targeting different pathophysiological pathways

Levosimendan’s differentiated profile, especially its calcium sensitization mechanism and longer half-life, may provide a competitive edge if supported by robust clinical outcomes. Furthermore, the potential for RECORLEV to expand into chronic heart failure management represents a significant market expansion opportunity.

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Financial Trajectory and Revenue Projections

Current Revenue Outlook

RECORLEV's initial revenue generation is expected from regions with existing regulatory approvals or those with expedited pathways. Early-phase sales predominantly originate from:

• Pilot programs
• Compassionate use scenarios
• Clinical trial collaborations

Assuming a phased commercialization strategy, initial sales could be modest—ranging between $50-100 million in the first 2-3 years—before scaling with broader regulatory approvals.

Growth Drivers

1. Expanded Indications: Demonstrating efficacy in chronic HF and other cardiac conditions can open new markets, doubling or tripling revenues over a 5-7 year horizon.
2. Geographic Expansion: Entry into key markets—U.S., Europe, China—once approvals are secured, could exponentially increase sales.
3. Market Penetration Strategies: Building clinician awareness through key opinion leader engagement and evidence from phase IV studies will accelerate adoption.

Risks and Cost Considerations

• Pricing pressures: Payer negotiations and competitive pricing could suppress margins.
• Development costs: High R&D investments, including clinical trials and regulatory filings, will initially consume cash flow.
• Market acceptance: Slow uptake due to clinician conservatism or competition could hamper financial growth.

Long-Term Financial Outlook

Assuming successful commercialization and market expansion, RECORLEV could generate annual revenues approaching $500 million-1 billion within 7-10 years, contingent on approval timelines, clinical trial outcomes, and competitive dynamics.

Operational margins may stabilize around 30-40%, considering manufacturing scalability, patent protections, and market access costs. Strategic partnerships and licensing agreements with regional healthcare providers will be instrumental in maximizing financial trajectory.

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Market Dynamics Influencers

Technological Advancements
Emergence of personalized medicine, biomarkers, and telemonitoring can enhance patient stratification and adherence, improving outcomes and revenues.

Healthcare Policy and Reimbursement
Government policies emphasizing value-based care—particularly in the U.S.—will influence drug pricing and adoption rates of RECORLEV.

Pandemic Impact
The COVID-19 pandemic underscored the importance of hospital-based therapies and shifted priorities toward expanding outpatient and home-based management, potentially benefiting drugs like RECORLEV that could support stability outside intensive care settings.

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Conclusion

RECORLEV’s market and financial trajectory are promising but complex. Its potential hinges on successful regulatory approvals, demonstration of long-term safety and mortality benefits, overcoming pricing and clinician adoption barriers, and strategic regional expansion. Given the escalating burden of heart failure worldwide, RECORLEV is positioned to become a pivotal player in cardiovascular therapeutics if these strategic objectives align.

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Key Takeaways

• The global heart failure market is expanding rapidly, with significant unmet needs that RECORLEV can address through its unique pharmacology.
• Regulatory pathways and clinical evidence demonstrating mortality benefits are critical determinants of RECORLEV’s commercial success.
• Competing therapies and market hesitancy pose challenges; differentiation through clinical efficacy and cost-effectiveness will be vital.
• Revenue prospects are optimistic with phased expansion, contingent on approval and payer acceptance, potentially reaching over $1 billion annually.
• Strategic collaborations, regional expansion, and emphasis on value-based healthcare models will shape RECORLEV’s long-term financial trajectory.

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FAQs

1. What is RECORLEV, and how does it differ from existing heart failure treatments?
   RECORLEV is a formulation of levosimendan, an inodilator that enhances myocardial contractility via calcium sensitization, providing hemodynamic benefits without substantial oxygen consumption—distinguishing it from traditional inotropes.

2. What are the primary regulatory challenges facing RECORLEV?
   Securing approval involves demonstrating long-term safety and mortality benefits, navigating differing regional regulatory processes, and potentially gaining expedited status through clear unmet need evidence.

3. How competitive is the landscape for RECORLEV?
   The field includes established inotropes like dobutamine, emerging agents, and gene therapies. RECORLEV's differentiation depends on clinical efficacy, safety profile, and cost-effectiveness.

4. What factors will most influence RECORLEV’s sales growth?
   Key drivers include obtaining broad regulatory approvals, expanding indications, payer reimbursement strategies, clinician acceptance, and regional market penetration.

5. What is the expected timeline for RECORLEV’s financial growth?
   Assuming favorable approvals and market acceptance, revenues could scale from tens of millions in initial years to over a billion annually within a decade, driven by indication expansion and geographic reach.

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References

1. American Heart Association. Heart Failure Facts and Statistics. 2022.
2. Packer M. Levosimendan: review of pharmacology and clinical experience. Circulation. 2020.
3. U.S. Food and Drug Administration. Breakthrough Therapy Designation Criteria. 2023.