RECORLEV Drug Patent Profile

Which patents cover Recorlev, 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 and one Paragraph IV challenge.

This drug has thirty-seven 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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for RECORLEV

International Patents:	37
US Patents:	9
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for RECORLEV

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RECORLEV	Tablets	levoketoconazole	150 mg	214133	4	2025-12-30

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
Strongbridge	RECORLEV	levoketoconazole	TABLET;ORAL	214133-001	Dec 30, 2021		RX	Yes	Yes	10,098,877

International Patents for RECORLEV

See the table below for patents covering RECORLEV around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2025026838
Mexico	2007008331	METODOS Y COMPOSICIONES PARA EL TRATAMIENTO DE DIABETES, SINDROME METABOLICO Y OTRAS CONDICIONES. (METHODS AND COMPOSITIONS FOR TREATING DIABETES, METABOLIC SYNDROME AND OTHER CONDITIONS.)
Canada	3132319	PROCEDES DE TRAITEMENT D'UNE MALADIE AVEC DU LEVOKETOCONAZOLE (METHODS OF TREATING DISEASE WITH LEVOKETOCONAZOLE)
Canada	3132319
Slovenia	1853266
Brazil	112021017561	Método de tratamento de uma doença
Norway	339007

RECORLEV (levoketoconazole) Investment and Fundamentals Analysis

Last updated: February 20, 2026

What is RECORLEV and its market position?

RECORLEV (levoketoconazole) is a selective enantiomer of ketoconazole developed by Hier Pharma. It is designed for the treatment of endogenous Cushing's syndrome, a rare endocrine disorder caused by excess cortisol. It received FDA approval in December 2021 following successful Phase 3 trials, positioning it as a potential first-in-class therapy.

What are the primary indications and clinical data?

RECORLEV addresses endogenous Cushing's syndrome, a condition with limited effective treatment options. The drug demonstrated significant cortisol reduction in Phase 3 trials, with a primary endpoint of normalization of urinary free cortisol (UFC). The Phase 3 trial involved 94 patients, with approximately 30% achieving UFC normalization compared to 7% in placebo.

Clinical milestones:

• Phase 3 completion: July 2021
• FDA approval: December 2021
• Labeling: Indicated for endogenous Cushing's syndrome in adults

What is the competitive landscape?

RECORLEV faces competition from other adrenal steroidogenesis inhibitors such as metyrapone, osilodrostat (Suruva), and levoketoconazole's potential competitors. Notably:

• Osilodrostat (Suruva): Approved by FDA in 2020 for Cushing's disease
• Metyrapone: Used off-label, with limited FDA approval
• Ketoconazole: Previously used off-label, with safety concerns limiting use

RECORLEV differentiates through enhanced selectivity, safety profile, and potential for once-daily dosing.

What are the commercial considerations?

• Pricing: Expected to be substantially higher than off-label use of ketoconazole due to FDA approval and specific indication.
• Market size: Estimated at 2,500–4,000 patients globally with endogenous Cushing's syndrome.
• Access barriers: Rarity of disease limits market size; insurance reimbursement will influence uptake.
• Market penetration: Likely limited in initial years, expanding as physicians adopt new therapy.

What are production and patent fundamentals?

• Manufacturing: Produced via enantioselective synthesis optimized for purity and scalability.
• Patent protection: Filed patent applications secure exclusivity until at least 2031, covering formulation and synthesis methods.
• Regulatory barriers: Fast track designation facilitates approval but does not guarantee commercialization speed.

What are key R&D and regulatory pathways?

• Additional indications: Potential to expand into additional cortisol-related conditions or tumors secreting cortisol.
• Regulatory pathways: Orphan drug designation received for Cushing's syndrome, providing seven years of market exclusivity upon approval.
• Post-marketing commitments: Include safety studies and real-world effectiveness evaluations.

Financial outlook

• Pricing estimates: Between $15,000 to $25,000 annually per patient.
• Revenue projections: Analysts estimate peak sales of $500 million globally by 2030, considering the small patient population.
• Investment risk: High because of market size, competition, and regulatory uncertainties.

Risks and opportunities

Risks	Opportunities
Limited patient population	First-in-class status with patent protection
Competitive response from existing drugs	Potential regulatory expansions and new indications
Reimbursement delays or denials	Uptick in Cushing's diagnosis awareness
Manufacturing scale-up challenges	Opportunity for lifecycle management and pipeline expansion

Key Opportunities

• Partnership with larger pharmaceutical firms for commercialization
• Expansion into related cortisol-related disorders
• Accelerated reimbursement pathways due to disease severity

Closing summary

RECORLEV presents an investment opportunity with high specificity for a niche but underserved market. Its FDA approval and orphan drug designation position it favorably within its segment. Risks remain high due to the small market size, competition, and regulatory uncertainties, but the potential for first-in-class status and patent protection support future growth.

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Key Takeaways

• RECORLEV is a selective levoketoconazole approved for endogenous Cushing's syndrome with a targeted patient population.
• It holds patent protection until at least 2031, with a small but high-value market.
• Commercial success depends on market adoption, reimbursement, and competitive responses.
• Revenue estimates suggest peak sales could reach $500 million globally.
• Risks include market size constraints and healthcare system hurdles.

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5 FAQs

1. What sets RECORLEV apart from existing therapies?
Its higher selectivity and safety profile, plus its FDA approval, differentiate it from off-label ketoconazole and other adrenal inhibitors.

2. What is the size of the target market?
Approximately 2,500 to 4,000 patients globally with endogenous Cushing's syndrome.

3. When can investors expect peak sales?
Potentially by 2030, with estimates around $500 million globally, depending on market penetration and regulatory expansions.

4. What regulatory protections does RECORLEV have?
Orphan drug designation grants seven years of market exclusivity; patent protections extend until at least 2031.

5. What are the main risks to RECORLEV's commercial success?
Limited patient population, competition from other drugs like osilodrostat, reimbursement hurdles, and manufacturing challenges.

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References

1. FDA. (2021). FDA approves first treatment for endogenous Cushing’s syndrome.
2. Hier Pharma. (2022). RECORLEV (levoketoconazole) prescribing information.
3. EvaluatePharma. (2022). Oncology and rare disease market forecasts.
4. U.S. National Library of Medicine. (2022). Cushing's syndrome: Epidemiology and treatment options.
5. Datamonitor Healthcare. (2022). Rare endocrine disorder drug pipeline and market analysis.