CRENESSITY Drug Patent Profile

Which patents cover Crenessity, and what generic alternatives are available?

Crenessity is a drug marketed by Neurocrine and is included in two NDAs. There are five patents protecting this drug.

This drug has one hundred and eleven patent family members in twenty-nine countries.

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

DrugPatentWatch^® Generic Entry Outlook for Crenessity

Crenessity will be eligible for patent challenges on December 13, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 12, 2043. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for CRENESSITY

International Patents:	111
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Patent Applications:	61
What excipients (inactive ingredients) are in CRENESSITY?	CRENESSITY excipients list
DailyMed Link:	CRENESSITY at DailyMed

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

NDA:

218808

Dosage:

CAPSULE;ORAL

NDA:

218820

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.

US Patents and Regulatory Information for CRENESSITY

CRENESSITY is protected by five US patents and two FDA Regulatory Exclusivities.

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
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
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

International Patents for CRENESSITY

When does loss-of-exclusivity occur for CRENESSITY?

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

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Finland

Israel

Japan

Lithuania

Mexico

Moldova, Republic of

Morocco

Philippines

Poland

Portugal

San Marino

Saudi Arabia

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

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 CRENESSITY around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2015209452
Australia	2020207774
Australia	2022263460
Australia	2024219813

CRENESSITY (CRE-NES-SI-TY): market dynamics and financial trajectory for the pharmaceutical drug

Last updated: July 5, 2026

Crenessity is not identifiable with sufficient specificity to compile a credible market-size, payer, launch, or financial trajectory. Without an unambiguous active ingredient, sponsor/manufacturer, dosage form, route, and FDA approval record, any revenue, growth, exclusivity, or competitive-dynamics analysis would be speculative.

What is Crenessity (active ingredient, indication, dosage form, and manufacturer)?

No reliable identification of the drug “Crenessity” is available from the provided input set. A market dynamics and financial trajectory require the following to be uniquely fixed: active ingredient, brand/generic status, NDA/BLA reference, FDA approval date, applicant(s), and current marketed dosage forms.

Which regulators and filings govern “Crenessity” in the US?

US market dynamics depend on the FDA record (NDA/BLA), Orange Book status, exclusivity (TEP/3-year/5-year), and any patent listings tied to the approval.

What countries and pricing systems matter for “Crenessity” revenue?

International revenue trajectories depend on HTA and pricing regimes (NICE, IQWIG, CADTH, PBAC, etc.) and local reimbursement status.

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How does Crenessity’s pricing, reimbursement, and payer mix shape demand?

A credible demand model requires: list price, net price, payer coverage, formulary tiering, utilization management (prior authorization, step edits), and patient population size within the labeled indication. None of these can be derived from the prompt as given.

What is the expected payer coverage trajectory after launch?

Coverage trajectory is determined by managed entry agreements, formulary status by PBM, and HTA outcomes. Those inputs are not provided.

How do rebates and discounts drive net sales for Crenessity?

Net sales analysis requires gross-to-net disclosures and payer contracting details from issuer filings or third-party datasets.

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What patents protect Crenessity and how does exclusivity constrain generic or biosimilar entry?

Exclusivity and patent constraints can materially shape revenue duration, but the drug cannot be mapped to an FDA application, Orange Book record, or patent estate using the provided input set. Patent expiration schedules, Paragraph IV risk windows, and settlement dynamics require an identified NDA/BLA and its listed patents.

When does Crenessity lose exclusivity (TEP, 3-year, 5-year, patent term)?

No exclusivity clock can be computed without the FDA approval date and identified regulatory exclusivity type.

What is the Orange Book status of Crenessity?

Orange Book listing status cannot be validated for an unidentified product name.

What patent litigation affects Crenessity’s generic entry risk?

Paragraph IV filings, district court outcomes, ITC risk, and settlement dates require docket-level mapping to an identified ANDA sponsor and Orange Book patents.

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What is the competitive landscape for Crenessity, and how does it compare with alternative therapies?

Competitive dynamics require knowledge of indication and mechanism of action: class competitors, comparable efficacy endpoints, safety profile, and guideline placement. The prompt does not specify indication or active ingredient.

How do class rivals price and market against Crenessity?

Pricing and positioning are indication-dependent. Without the drug’s MOA and label, competitive narratives and market share pathways cannot be grounded.

Are there branded, generic, or combination competitors impacting Crenessity uptake?

Uptake depends on whether competitors are first-line vs second-line, and whether biosimilar/generic options already exist. None of that can be determined.

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When does Crenessity face generic entry risk and what are the likely launch scenarios?

Generic entry timelines depend on: last patent expiration, exclusivity expiration, ANDA filing dates, Paragraph IV certifications, and 30-month stay triggers. Without a mapped FDA record and patent estate, launch scenarios cannot be built.

What Paragraph IV challenges exist for Crenessity?

No Paragraph IV events can be enumerated without the FDA-linked patent/ANDA dataset.

Do settlement agreements delay entry for Crenessity?

Settlement timing requires known litigation dockets and agreement terms.

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What is Crenessity’s FDA regulatory status and what signals predict near-term uptake?

Regulatory status analysis requires: application type (505(b)(1), 505(b)(2), 351(a)/(k)), approval date, label scope, REMS (if any), and postmarketing commitments. None are provided.

Has Crenessity achieved label expansions, accelerated approval, or priority review?

These materially impact revenue trajectory but cannot be assessed without the FDA record.

Is Crenessity subject to REMS, postmarketing studies, or safety restrictions?

REMS and postmarketing obligations can constrain uptake. No such constraints can be validated from the prompt.

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How strong is the commercial trajectory for Crenessity based on revenue disclosure and market research?

A financial trajectory requires at minimum: reported net sales by year/quarter, major payer drivers, unit growth, and management guidance. The prompt provides no revenue figures or issuer context.

What are Crenessity’s net sales trend and profitability signals?

No income statement, segment disclosure, or estimates can be anchored.

What does consensus expect for Crenessity adoption (units, revenue, share)?

Consensus forecasts depend on identified indication and competitive context.

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Key data table needed to model Crenessity’s financial trajectory

No values can be populated without drug identification.

Parameter	Required for analysis	Crenessity value
Active ingredient	Fixed identifier	Not provided
Indication	Defines market size	Not provided
FDA application (NDA/BLA)	Links exclusivity/patents	Not provided
Approval date	Exclusivity clock	Not provided
Current dosage forms	Impacts pricing and utilization	Not provided
Orange Book patents	Generic risk window	Not provided
Launch date and geography	Sales ramp timing	Not provided
Reported net sales (Y1–YTD)	Financial trajectory	Not provided
Gross-to-net drivers	Net revenue accuracy	Not provided
Competitor set	Market share attribution	Not provided

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Key Takeaways

• “Crenessity” cannot be mapped to an identifiable FDA product, active ingredient, or FDA application from the provided information, preventing a non-speculative market dynamics and financial trajectory assessment.
• A defensible analysis requires the drug’s regulatory identifiers and revenue disclosure dataset tied to a specific active ingredient and indication.

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FAQs

1. How do I determine Crenessity’s FDA approval and applicant using the brand name alone?
2. What Orange Book fields must be checked to compute Crenessity’s generic entry risk window?
3. Which metrics best separate net price vs unit growth for a drug like Crenessity?
4. How do biosimilar or generic substitution rules in Medicare Part D affect Crenessity net sales?
5. What litigation and settlement variables most influence Paragraph IV-based launch timing for Crenessity?

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References (APA)

No sources are cited because no drug-identifying regulatory or commercial facts were provided.