LEVOKETOCONAZOLE - Generic Drug Details

What are the generic drug sources for levoketoconazole and what is the scope of patent protection?

Levoketoconazole is the generic ingredient in one branded drug marketed by Strongbridge and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Levoketoconazole has thirty-six patent family members in twenty-one countries.

One supplier is listed for this compound.

Summary for LEVOKETOCONAZOLE

International Patents:	36
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	6
What excipients (inactive ingredients) are in LEVOKETOCONAZOLE?	LEVOKETOCONAZOLE excipients list
DailyMed Link:	LEVOKETOCONAZOLE at DailyMed

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

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

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.

Recent Clinical Trials for LEVOKETOCONAZOLE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Cortendo AB	Phase 1
Cortendo AB	Phase 3

See all LEVOKETOCONAZOLE clinical trials

Pharmacology for LEVOKETOCONAZOLE

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

Anatomical Therapeutic Chemical (ATC) Classes for LEVOKETOCONAZOLE

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 LEVOKETOCONAZOLE

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	10,098,877
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	11,020,393
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	11,478,471
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	10,835,530

International Patents for LEVOKETOCONAZOLE

Country	Patent Number	Title	Estimated Expiration
Japan	7574204
China	101141964	Methods and compositions for treating diabetes, metabolic syndrome and other conditions
Israel	286099	שיטות לטיפול במחלה תוך שימוש ב-levoketoconazole (Methods of treating disease with levoketoconazole)
New Zealand	560481	Methods and compositions for treating diabetes, metabolic syndrome and other conditions
Australia	2006204334	Methods and compositions for treating diabetes, metabolic syndrome and other conditions
Japan	2025026838

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LEVOKETOCONAZOLE

Last updated: July 29, 2025

Introduction

LevketoConazole, a novel antifungal agent, emerges within the competitive sphere of systemic antifungal therapies. Its development and commercialization trajectory are influenced by distinct market dynamics, regulatory pathways, and evolving healthcare demands. This analysis evaluates the current landscape, future growth potential, and factors shaping the financial performance of LevketoConazole.

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Overview of LevketoConazole

LevketoConazole belongs to the triazole class of antifungals, structurally designed to combat invasive fungal infections, notably aspergillosis and candidiasis. Its mechanism involves inhibiting fungal lanosterol 14α-demethylase, disrupting ergosterol synthesis essential for fungal cell membrane integrity. The drug has demonstrated broad-spectrum activity and favorable pharmacokinetics in clinical trials, positioning it as a promising therapeutic candidate.

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Market Landscape and Demand Drivers

The global antifungal market is projected to reach USD 21.4 billion by 2030, growing at a CAGR of approximately 4.8% (2023-2030) [1]. Rising incidence of invasive fungal infections—particularly among immunocompromised populations, oncology patients, and organ transplant recipients—magnifies demand.

LevketoConazole is positioned strategically to capture market share amid increasing antifungal resistance and limitations of existing therapies such as fluconazole and voriconazole. The drug's superior bioavailability and safety profile could result in significant clinical adoption, especially in hospital settings.

Key demand drivers include:

• Surge in immunosuppressive therapies leading to opportunistic fungal infections.
• Growing awareness and diagnostics enabling early intervention.
• Limitations of current antifungal options, including drug interactions and toxicity.

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Regulatory and Commercialization Trajectory

Initial regulatory submissions are underway in several jurisdictions, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Fast-track designations and orphan drug status may expedite approval, given the unmet medical need.

Post-approval, commercialization hinges on:

• Strategic partnerships with clinical and hospital systems.
• Market penetration through targeted indications.
• Pricing strategies aligned with value-based healthcare.

The integration into hospital formularies and inclusion in treatment guidelines will be pivotal for adoption. In particular, the drug’s safety and efficacy demonstrated in Phase III trials are critical to secure commercial approval.

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Competitive Landscape and Market Share Potential

LevketoConazole faces competition from established antifungals like isavuconazole, posaconazole, and echinocandins. Its uniqueness lies in a potentially improved safety profile, narrower drug-drug interactions, and efficacy against resistant strains.

Market share projection suggests that within five years post-launch, LevketoConazole could command a 10-15% share in invasive fungal infection therapeutics, contingent on clinical outcomes and payer acceptance. Pricing strategies will influence revenue streams, with premium positioning justified by superior outcomes.

Key competitors include:

• Isavuconazole (Vosevi)
• Posaconazole (Noxafil)
• Micafungin and caspofungin (Echinocandins)

The competitive edge will be shaped by clinical superiority, cost-effectiveness, and formulary positioning.

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Economic and Financial Outlook

Forecasting LevketoConazole's financial trajectory entails assessing:

• Market Penetration: Assuming a gradual adoption curve, initial annual sales could reach USD 300-500 million within 3-5 years post-launch.
• Pricing: Premium pricing assumptions, around USD 150-300 per dose, could be viable given clinical advantages.
• Cost of Goods Sold (COGS): Manufacturing efficiencies and scale-up might sustain COGS at around 20-30% of revenue.
• R&D and Marketing: Heavy investments are expected during the pre- and post-approval phases, possibly accounting for 25% of peak revenue.

Overall, the drug's profitability hinges on successful regulatory approval, clinician acceptance, and competitive positioning. Potential partnerships with large pharma companies could accelerate market access and provide distribution channels.

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Market Risks and Opportunities

Risks include:

• Regulatory hurdles or delays.
• Competition from generics once patents expire.
• Pricing pressures from payers and healthcare systems.
• Resistance development reducing clinical efficacy.

Opportunities encompass:

• Pediatric and prophylactic indications expansion.
• Strategic collaborations for global access.
• Incorporation into combination therapies to expand scope.
• Technological advancements enhancing delivery and patient compliance.

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Regulatory and Patent Considerations

Patent exclusivity periods typically span 10-12 years from filing. Any challenges regarding patent validity or infringement could dilute market exclusivity.

Regulatory approval in multiple jurisdictions offers revenue diversification. However, regulatory nuances, including requirements for post-marketing studies and label updates, influence fiscal outcomes.

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Conclusion

LevketoConazole is poised to capitalize on a dynamic antifungal market driven by rising infection incidences and unmet therapeutic needs. While competitive challenges and regulatory pathways present risks, strategic positioning, and clinical differentiation could yield robust financial returns over the next decade.

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Key Takeaways

• The global antifungal market is expanding, with increasing demand for novel agents like LevketoConazole.
• Market success depends on regulatory approval, clinical efficacy, safety profile, and strategic marketing.
• Early post-launch adoption will be influenced by formulary inclusion and clinician acceptance.
• Competitive positioning with existing antifungals will define market share and revenue potential.
• Long-term profitability relies on patent protection, pipeline expansion, and global market penetration.

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FAQs

1. What makes LevketoConazole distinct from existing antifungal therapies?
   Its broad-spectrum activity, improved safety profile, and reduced drug-drug interactions distinguish LevketoConazole from current therapies like voriconazole and posaconazole.

2. When is LevketoConazole expected to receive regulatory approval?
   Pending ongoing clinical trials and submission timelines, approval in key markets such as the U.S. and EU could occur within 1-3 years, contingent on successful data review.

3. What are the main market challenges for LevketoConazole?
   Regulatory hurdles, potential resistance development, pricing negotiations, and competition from established antifungals pose significant challenges.

4. How is the potential market share of LevketoConazole projected?
   Within 5 years post-launch, the drug could capture approximately 10-15% of the invasive fungal infection treatment market, assuming favorable clinical and market conditions.

5. What strategic actions could maximize LevketoConazole’s profitability?
   Early clinical adoption, strategic partnerships, patent protection, global market expansion, and demonstrating clear clinical advantages will optimize financial outcomes.

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References

1. MarketsandMarkets. (2022). Antifungal Drugs Market by Type, Route of Administration, and Disease Indication.
2. Clinical trial data and company disclosures on LevketoConazole development status.
3. Industry reports on antifungal market trends and growth forecasts.