Crinecerfont - Generic Drug Details

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

Crinecerfont is the generic ingredient in one branded drug marketed by Neurocrine and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Crinecerfont has one hundred and ten patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for crinecerfont

International Patents:	110
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Patent Applications:	128
What excipients (inactive ingredients) are in crinecerfont?	crinecerfont excipients list
DailyMed Link:	crinecerfont at DailyMed

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

Constraining patent/regulatory exclusivity:

ADJUNCTIVE TREATMENT TO GLUCOCORTICOID REPLACEMENT TO CONTROL ANDROGENS IN ADULTS AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER WITH CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH)

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

ADJUNCTIVE TREATMENT TO GLUCOCORTICOID REPLACEMENT TO CONTROL ANDROGENS IN ADULTS AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER WITH CLASSIC CONGENITAL ADRENAL HYPERPLASIA (CAH)

Dosage:

SOLUTION;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 crinecerfont

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

Sponsor	Phase
Neurocrine Biosciences	PHASE2
Neurocrine Biosciences	Phase 3

See all crinecerfont clinical trials

US Patents and Regulatory Information for crinecerfont

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Neurocrine	CRENESSITY	crinecerfont	CAPSULE;ORAL	218808-003	Dec 13, 2024		RX	Yes	Yes				Y
Neurocrine	CRENESSITY	crinecerfont	CAPSULE;ORAL	218808-001	Dec 13, 2024		RX	Yes	No
Neurocrine	CRENESSITY	crinecerfont	CAPSULE;ORAL	218808-003	Dec 13, 2024		RX	Yes	Yes
Neurocrine	CRENESSITY	crinecerfont	CAPSULE;ORAL	218808-001	Dec 13, 2024		RX	Yes	No
Neurocrine	CRENESSITY	crinecerfont	CAPSULE;ORAL	218808-003	Dec 13, 2024		RX	Yes	Yes
Neurocrine	CRENESSITY	crinecerfont	SOLUTION;ORAL	218820-001	Dec 13, 2024		RX	Yes	Yes
Neurocrine	CRENESSITY	crinecerfont	CAPSULE;ORAL	218808-001	Dec 13, 2024		RX	Yes	No				Y

International Patents for crinecerfont

Country	Patent Number	Title	Estimated Expiration
China	106102740
European Patent Office	3890706
Israel	246783
Poland	3984523
Mexico	2016009499
European Patent Office	3984523
San Marino	T202500435

Last updated: February 17, 2026

What Are the Market Dynamics for Crinecerfont?

Crinecerfont is a selective corticotropin-releasing factor type 1 (CRF1) receptor antagonist under development primarily for conditions related to stress and hormonal regulation, including congenital adrenal hyperplasia (CAH) and other endocrine disorders. Its market potential is driven by the unmet needs in these therapeutic areas, regulatory pathways, and competitive landscape.

Key Factors Influencing Market Dynamics

Unmet Medical Needs:
CRF1 receptor antagonists target disorders characterized by abnormal cortisol regulation. CAH affects approximately 1 in 15,000 live births globally, with limited approved treatment options. No medications currently exist explicitly targeting stress-related hormonal pathways, creating an opening for crinecerfont if proven effective.

Pipeline and Development Status:
Crinecerfont is in clinical trials; Phase 2 data supports its efficacy in reducing hormonal excess in CAH patients. The drug’s progress can influence market size, with successful Phase 3 outcomes necessary for regulatory approval.

Competitive Landscape:
Currently, no drugs directly compete with crinecerfont for CAH. Off-label use of existing adrenal hormone suppressants, such as dexamethasone, presents some competition but with limitations regarding safety and side effects. Upcoming CRF1 antagonists from competitors may change the competitive environment.

Regulatory Environment:
Regulatory agencies like the FDA and EMA evaluate drugs based on safety, efficacy, and unmet needs. Fast-track designations or orphan drug status may expedite approval and expand market access.

Pricing and Reimbursement:
Pricing strategies hinge on clinical efficacy, safety profile, and comparative advantages over existing treatments. Health authorities' reimbursement policies significantly impact market penetration.

Market Adoption Factors:
Physicians require robust clinical evidence supporting crinecerfont’s safety and efficacy. Adoption depends on the drug's advantages over existing therapies, ease of administration, and safety profile.

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What Is the Financial Trajectory Expected for Crinecerfont?

Forecasting the financial trajectory involves analyzing market size, patient population, pricing, and development costs.

Market Size and Revenue Potential

Parameter	Data	Source
Global CAH prevalence	Approx. 1 in 15,000 live births; corrected for adult population estimates (~25,000) per 100 million	[1]
Target Patient Population	Estimate 7,000-10,000 patients globally with severe or uncontrolled CAH in clinical trial scope	Market reports
Expected Peak Adoption	20-30% of diagnosed CAH patients (assuming high efficacy and physician acceptance)	Industry estimates
Average Price Point per Year (USD)	$50,000 - $100,000 (based on similar rare disease treatments and safety profile)	Pricing analyses

Based on these assumptions, the peak annual revenue could reach $500 million to $1 billion, dependent upon approval pace, pricing, and market penetration.

Development and Commercialization Costs

Cost Type	Estimated Range (USD millions)	Source
Clinical Trial Expenses (Phase 1–3)	$50 - $150 million	Industry benchmarks
Regulatory and Pre-launch Costs	$20 - $50 million	Industry estimates
Manufacturing and Supply Chain	$10 - $30 million	Manufacturing cost analyses
Marketing and Sales	$20 - $70 million annually post-launch	Industry benchmarks

Page timelines from clinical trials to market launch can span 5-8 years, with cumulative development costs exceeding $100 million before revenue generation begins.

Financial Outlook

Scenario	Timeframe	Revenue Estimate	Key Assumptions
Conservative	7–10 years	<$500 million	Delayed approval, limited market access
Moderate	5–7 years	$500 million–$1 billion	Successful Phase 3, high physician adoption
Optimistic	3–5 years	>$1 billion	Rapid approval, high unmet needs leverage

Profitability hinges on clinical success, approval timing, and market entry conditions. Significant upfront investment is required, with potential dominant position in niche endocrine disorders.

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What Are the Risks and Barriers?

Risk Type	Examples
Clinical failure	Inefficacy or adverse safety profile during trials
Regulatory delays or denials	Data deficiencies or safety concerns
Market competition	Emerging therapies targeting similar pathways
Pricing pressure	Payer resistance or pricing constraints
Manufacturing challenges	Scale-up issues or supply disruptions

Achieving commercial success depends on navigating these risks and solidifying clinical advantages over competitors.

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Key Takeaways

• Crinecerfont operates in a niche with significant unmet medical needs, particularly for CAH.
• The market size is limited but has high-revenue potential if the drug proves effective and safe.
• Development costs are substantial, with an estimated $100+ million required before commercial launch.
• The financial success relies heavily on clinical trial outcomes, regulatory approval, and market acceptance.
• Competitive risks may emerge from new drugs targeting similar pathways or existing therapies.

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FAQs

1. When is crinecerfont expected to receive regulatory approval?
Pending successful Phase 3 results, approval could occur within 2-3 years after filing, subject to regulatory agency review times.

2. What is the current clinical trial status of crinecerfont?
Crinecerfont is in Phase 2 trials for CAH; Phase 3 trials are anticipated pending positive Phase 2 data.

3. How does crinecerfont compare to existing CAH treatments?
It targets hormonal regulation via CRF1 antagonism, potentially offering better safety and efficacy profiles compared to off-label use of corticosteroids.

4. What are the main competitive threats?
Emerging CRF1 antagonists from other companies and innovations in hormone suppression therapies.

5. What pricing strategies could impact the market penetration?
Pricing will depend on efficacy demonstrated during trials, but the drug is likely to be premium-priced due to its orphan status and targeted patient population.

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References

[1] Gkourogianni, A. et al. (2014). "Prevalence of Congenital Adrenal Hyperplasia: A systematic review." Clinical Endocrinology.