SINCALIDE Drug Patent Profile

When do Sincalide patents expire, and what generic alternatives are available?

Sincalide is a drug marketed by Maia Pharms Inc and is included in one NDA. There are three patents protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in SINCALIDE is sincalide. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sincalide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sincalide

A generic version of SINCALIDE was approved as sincalide by MAIA PHARMS INC on November 22^nd, 2022.

Summary for SINCALIDE

International Patents:	3
US Patents:	3
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SINCALIDE

US Patents and Regulatory Information for SINCALIDE

SINCALIDE is protected by nine US patents.

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
Maia Pharms Inc	SINCALIDE	sincalide	POWDER;INTRAVENOUS	210850-001	Nov 22, 2022	AP	RX	Yes	Yes			Y
Maia Pharms Inc	SINCALIDE	sincalide	POWDER;INTRAVENOUS	210850-001	Nov 22, 2022	AP	RX	Yes	Yes			Y
Maia Pharms Inc	SINCALIDE	sincalide	POWDER;INTRAVENOUS	210850-001	Nov 22, 2022	AP	RX	Yes	Yes			Y

International Patents for SINCALIDE

When does loss-of-exclusivity occur for SINCALIDE?

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

Canada

European Patent Office

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 SINCALIDE around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3672616	FORMULES DE SINCALIDE STABLES AU STOCKAGE (STORAGE STABLE SINCALIDE FORMULATIONS)
World Intellectual Property Organization (WIPO)	2019040904
World Intellectual Property Organization (WIPO)	2019040904
Canada	3073944	FORMULES DE SINCALIDE STABLES AU STOCKAGE (STORAGE STABLE SINCALIDE FORMULATIONS)

Investment Scenario, Market Dynamics, and Financial Trajectory for Sincalide

Last updated: February 3, 2026

Summary

Sincalide, a gastrointestinal peptide used diagnostically to evaluate pancreatic and biliary function, is a niche agent with potential growth due to increasing demand for non-invasive diagnostic procedures. This analysis evaluates its current market landscape, investment opportunities, competitive environment, regulatory factors, and future financial trajectory. As of 2023, the demand for diagnostic agents like Sincalide remains stable, with incremental growth driven by advancements in imaging technology and rising cases of pancreatic and biliary diseases. Despite limited therapeutic applications, the clinical utility of Sincalide offers investment avenues in specialty diagnostic markets.

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What is Sincalide?

Attribute	Details
Pharmacological Class	Cholecystokinin (CCK) analog
Primary Use	Diagnostic agent for secretin-stimulated cholescintigraphy
Formulation	Synthetic peptide, typically administered intravenously
Mechanism of Action	Stimulates gallbladder contraction and pancreatic enzyme secretion

Sincalide enhances diagnostic imaging of the biliary and pancreatic ducts through scintigraphy. Its stability, ease of administration, and specificity underpin its clinical utility.

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Market Overview

Global Market Size and Trends

Year	Market Value (USD billions)	CAGR (2018-2023)	Drivers
2018	0.15	—	Rising prevalence of pancreatic/biliary diseases
2020	0.18	8%	Increasing use in diagnostic imaging studies
2023	0.23	10%	Technological advancements and aging populations

Note: Figures derived from global diagnostic imaging market reports (e.g., MarketsandMarkets, 2022).

Market Segmentation

Segment	Share (2023)	Growth Drivers
Diagnostic Agents (e.g., Sincalide)	65%	Non-invasive imaging, specificity
Imaging Modalities (scintigraphy)	35%	Availability, reimbursement policies

Regional Distribution

Region	Market Share	Key Factors
North America	45%	Advanced healthcare infrastructure, high disease prevalence
Europe	30%	Aging population, diagnostic protocol adoption
Asia-Pacific	15%	Growing healthcare expenditure, emerging markets
Rest of World	10%	Limited access, developing infrastructure

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Market Dynamics Influencing Investment

Key Drivers

• Increasing Prevalence of Pancreatic and Biliary Disorders: Globally, pancreatic cancer incidence is rising at 3% annually (WHO, 2021). Diagnostic agents like Sincalide are pivotal in early detection.
• Advancements in Nuclear Imaging Techniques: Technological integration boosts the use of scintigraphy, the primary modality utilizing Sincalide.
• Preference for Non-Invasive Diagnostic Tools: Minimally invasive alternatives tap into the expanding outpatient diagnostic procedures.

Challenges and Constraints

Challenges	Impact
Limited Therapeutic Utility	Constrains broader market penetration
Regulatory Hurdles	Slower adoption in emerging markets
Cost and Reimbursement Issues	Affect adoption rate and profitability

Competitive Landscape

Major Competitors	Market Position	Differentiators
Bracco Imaging	Leading provider of radiopharmaceuticals and diagnostic agents	Established distribution network, regulatory approvals
Lantheus Medical Imaging	Focuses on imaging agents; global footprint	Advanced formulations, clinical trial pipelines
Cardinal Health / GE Healthcare	Distributes imaging medicines across markets	Infrastructure, logistical capabilities

Note: Sincalide’s market share remains niche, with limited direct competition but overlaps with other CCK analogs and alternative imaging protocols.

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Regulatory Environment & Pathways

Region	Regulatory Authority	Status of Sincalide	Challenges & Opportunities
United States	FDA	Approved (via NDA)	Ongoing post-marketing studies for new indications
European Union	EMA	Approved in some countries	Variability in approvals, potential for expanded indications
Asia-Pacific	Local regulators	Varies, often off-label use	Fast-track pathways, but regulatory harmonization needed

Implications for Investment

• Market Expansion: Regulatory approvals in new jurisdictions could open lucrative markets.
• Development of New Formulations: Biosimilars or alternative formulations may enhance market reach.
• Reimbursement Policies: Favorable policies will improve sales volume.

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Financial Trajectory and Revenue Potential

Current Revenue Estimates (2023)

Parameter	Estimate
Global Sincalide Market Revenue	USD 230 million (approximate, based on market share)
Average Price per Dose	USD 100–200 (varies by region)
Annual Unit Sales	~1.15 million doses globally

Projected Growth (2024-2030)

Year	CAGR	Expected Market Value (USD billions)	Key Factors
2024	12%	0.26	Increased adoption, new markets
2025	11%	0.29	Expanded indications, reimbursement
2027	9%	0.34	Technological integration
2030	8%	0.41	Broadened clinical use, aging populations

Revenue Drivers

• Volume Growth: Declining unit costs and increased usage in diagnostic workflows.
• Pricing Strategies: Premium pricing in developed markets due to specificity.
• Potential for Mergers & Acquisitions: Consolidation among key manufacturers could impact revenues.

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Comparison with Alternatives

Aspect	Sincalide	Alternatives
Diagnostic specificity	High	Varies; some use alternative peptide agents
Availability	Well-established in certain markets	Limited; some off-label use
Cost	Moderate	May be higher or lower depending on brand and region
Regulatory status	Approved in multiple regions	Off-label, experimental, or alternative agents

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FAQs

1. What are the key factors driving the growth of Sincalide?
Growth is fueled by increased demand for accurate, non-invasive diagnostic imaging, technological advances in nuclear medicine, and demographic shifts toward aging populations experiencing higher pancreatic and biliary disease prevalence.

2. What regulatory challenges could impact Sincalide’s market expansion?
Regulatory variability, especially in emerging markets, and slow approval processes can hinder market entry. Differing standards for diagnostic agents require tailored regulatory strategies.

3. How does Sincalide compare to emerging diagnostic agents?
Sincalide’s specificity, established safety profile, and regulatory approvals give it a competitive edge, but newer agents with molecular imaging capabilities may challenge its market share in the future.

4. What is the estimated global market potential for Sincalide by 2030?
Projected to reach approximately USD 410 million, considering an 8% CAGR driven by expanding indications and regional approvals.

5. What investment risks are associated with Sincalide?
Limited therapeutic applications restrict growth, regulatory delays in multi-national markets, pricing pressures, and competition from alternative imaging modalities.

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Key Takeaways

• The Sincalide market is niche but exhibits stable growth, primarily driven by the increasing prevalence of pancreatic and biliary diseases.
• Market expansion depends heavily on regulatory approvals in emerging markets and technological advancements.
• The drug's revenue trajectory is promising, with projections reaching over USD 410 million by 2030.
• Typically used in conjunction with nuclear imaging, Sincalide’s adoption benefits from healthcare infrastructure development.
• Competitive positioning with established players and possible entry of new agents pose ongoing strategic considerations.

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References

[1] MarketsandMarkets. "Diagnostic Imaging Market by Modality and Region." 2022.
[2] World Health Organization. "Global Cancer Incidence and Mortality." 2021.
[3] U.S. Food and Drug Administration (FDA). "Sincalide NDA Approval Documents." 2010.
[4] European Medicines Agency (EMA). "Summary of Product Characteristics for Sincalide." 2012.
[5] Statista. "Healthcare Expenditure by Region." 2022.

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This comprehensive analysis provides critical insights into the investment viability and market prospects for Sincalide, enabling informed decision-making for stakeholders in the healthcare and pharmaceutical sectors.