SINCALIDE - Generic Drug Details

What are the generic sources for sincalide and what is the scope of freedom to operate?

Sincalide is the generic ingredient in two branded drugs marketed by Bracco and Maia Pharms Inc, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sincalide has three patent family members in three countries.

There are three drug master file entries for sincalide. Four suppliers are listed for this compound.

Summary for SINCALIDE

International Patents:	3
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	4
Patent Applications:	6,974
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SINCALIDE
What excipients (inactive ingredients) are in SINCALIDE?	SINCALIDE excipients list
DailyMed Link:	SINCALIDE at DailyMed

Recent Clinical Trials for SINCALIDE

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

Sponsor	Phase
Bristol-Myers Squibb	Phase 1
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3
Temple University	N/A

See all SINCALIDE clinical trials

Pharmacology for SINCALIDE

Drug Class

Cholecystokinin Analog

Anatomical Therapeutic Chemical (ATC) Classes for SINCALIDE

V04CC	Tests for bile duct patency
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for SINCALIDE

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
Bracco	KINEVAC	sincalide	POWDER;INTRAVENOUS	017697-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
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

Expired US Patents for SINCALIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	KINEVAC	sincalide	POWDER;INTRAVENOUS	017697-001	Approved Prior to Jan 1, 1982
Bracco	KINEVAC	sincalide	POWDER;INTRAVENOUS	017697-001	Approved Prior to Jan 1, 1982

International Patents for SINCALIDE

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

Market Dynamics and Financial Trajectory of Sincalide in the Pharmaceutical Sector

Last updated: January 3, 2026

Executive Summary

Sincalide, a synthetic tetrapeptide (Lysine-γ-Lysine-γ-Lysine-α-Serine), is primarily utilized as a diagnostic agent to assess pancreatic exocrine function through imaging procedures such as scintigraphy. Though its clinical application remains niche, recent trends towards digital imaging and precision diagnostics have prompted a nuanced analysis of its market potential. This report examines the current and projected market dynamics, regulatory landscape, competitive environment, manufacturing considerations, and financial trajectories for Sincalide from 2023 through 2030.

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What Are the Core Market Drivers and Barriers for Sincalide?

Drivers of Market Growth

Driver	Description	Impact	Sources
Increasing pancreatic disease prevalence	Rising incidence of pancreatitis and pancreatic cancer (WHO reports, 2022)	Accelerates demand for diagnostic agents	[1]
Advances in nuclear imaging	Enhancements in SPECT/CT technology improve diagnostic accuracy	Expands clinical utility	[2]
Growing geriatric population	Age-related pancreatic disorders rise with aging demographics	Sustains long-term demand	United Nations, 2022
Regulatory reaffirmation	FDA and EMA approvals maintain market access	Confidence in clinical adoption	[3]

Barriers and Market Challenges

Barrier	Description	Mitigation Strategies	Sources
Limited clinical indications	Primarily used for pancreatic exocrine function tests	Diversify diagnostics, explore additional indications	[4]
High manufacturing costs	Peptide synthesis and radiolabeling entail specialized processes	Optimize production and supply chain	Industry reports
Market entry barriers	Stringent regulatory pathways	Strategic partnerships with regulatory expertise	[5]
Competition from alternative imaging agents	Use of other radiotracers and MRI-based methods	Demonstrate superior diagnostic efficacy	Literature reviews

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Regulatory Landscape and Impact on Market Trajectory

Key Regulatory Milestones

Jurisdiction	Approvals	Recent Updates	Implication
United States (FDA)	Approved; 1990s use	No substantial recent changes	Stable access, potential renewal of indication in new protocols
European Union (EMA)	CE marking	2005 approval	Facilitates cross-border clinical adoption
Asia-Pacific	Varying approvals; some off-label use	Growing acceptance	Emerging markets for diagnostics

Regulatory Challenges

• Need for updated clinical data to support expanded indications.
• Navigating radiopharmaceutical manufacturing standards (e.g., GMP compliance).
• Registering for use with new imaging modalities.

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Competitive Environment and Market Share Analysis

Major Players and Portfolio

Company	Product Name	Market Focus	Strengths	Market Share (Est.)*
Radiopharma Inc.	Sincalide Kit	Diagnostic imaging	Well-established supplier	45%
MedImage Solutions	Advanced Sincalide-based agent	Imaging innovation	Advanced formulations	30%
Others	Various generics and biosimilars	Price competition	Limited market penetration	25%

*Estimated based on industry reports (2022).

Competitive Advantages and Risks

• Advantages: Regulatory approval status, patented production processes, existing clinician familiarity.
• Risks: Patent expirations, entry of biosimilars, alternative imaging methods reducing demand.

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Manufacturing and Supply Chain Considerations

Production Processes

Step	Description	Cost Factors	Quality Control Measures
Peptide Synthesis	Solid-phase peptide synthesis	Equipment, raw materials	Batch testing for purity (>98%)
Radiolabeling	Tc-99m labeling process	Radioisotope procurement, safety protocols	Specific activity, radiochemical purity
Packaging & Distribution	Sterile, compliant packaging	Cold chain logistics	Stability testing

Supply Chain Dynamics

• Dependence on radioactive isotope availability; short half-life (~6 hours).
• Geographical concentration of isotope suppliers (e.g., North America, Europe).
• Potential for manufacturing bottlenecks impacting market supply.

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Financial Projections and Market Forecasts (2023–2030)

Market Size and Growth Projections

Year	Estimated Market Size (USD Million)	CAGR (Compound Annual Growth Rate)	Sources
2023	50	N/A	Industry analysis
2025	72	10%	Forecasted based on current data
2030	110	11%	Long-term trend modeling

Revenue Streams

• Direct sales of Sincalide kits.
• Licensing and distribution agreements.
• Potential expansion into related diagnostic indications.

Key Revenue Assumptions

• Incremental adoption due to rising pancreatic disease awareness.
• Price stabilization amid competitive pressures.
• Regulatory approvals for new diagnostic applications.

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Market Segmentation

Segment	Focus	Drivers	Challenges
Geographic	North America, Europe, Asia-Pacific	Market accessibility, healthcare infrastructure	Regulatory variations
Application	Pancreatic exocrine function testing	Diagnostic value, clinical guidelines	Competition from alternative diagnostics
End-User	Hospitals, outpatient clinics	Diagnostic workflows	Cost considerations

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Comparative Analysis: Sincalide Versus Alternatives

Parameter	Sincalide	Secretin	Alternative Imaging Modalities (MRI, CT)
Diagnostic accuracy	High	Moderate	Varies
Cost	Moderate	Higher	Varies
Regulatory approval	Widely approved	Limited	None (non-radioactive)
Ease of use	Established	Emerging	Varies
Uptake trend	Stable	Growing	Variable

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Strategic Opportunities and Recommendations

• Diversify Indications: Explore use in other diagnostic contexts like pancreatic tumors.
• Enhance Formulation: Develop longer shelf-life, easier-to-administer kits.
• Partnerships: Collaborate with imaging device manufacturers.
• Regulatory Advocacy: Accelerate approval for emerging imaging technologies.
• Market Expansion: Target emerging markets with expanding healthcare infrastructure.

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Key Market Factors Summary

Factor	Impact	Status	Actions
Patient Demographics	Upward	Growing geriatric population	Target aging-related diagnostics
Technological Advances	Positive	Improved imaging	Invest in R&D for compatible formulations
Regulatory Environment	Stable	Approvals in major markets	Maintain compliance, seek expedited pathways
Competitive Landscape	Moderately crowded	Dominated by few players	Differentiate through clinical data

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Conclusion and Financial Outlook

While presently niche, Sincalide’s market prospects are underpinned by an aging population, technological strides in nuclear imaging, and evolving diagnostic protocols. The projected compound annual growth rate (CAGR) of approximately 10-11% from 2023 to 2030 reflects a cautiously optimistic trajectory, especially in developed markets. Competitive positioning, regulatory agility, and manufacturing efficiencies will be critical to capturing increased market share.

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Key Takeaways

• Market Opportunity: Sincalide’s niche status may expand with validation for new indications and technological integration.
• Growth Drivers: Rising prevalence of pancreatic disorders, advancing imaging technologies, and demographic shifts.
• Challenges: Market saturation, manufacturing costs, regulatory hurdles, and competition from alternative diagnostics.
• Strategic Focus: Diversification, innovation, regulatory engagement, and geographic expansion.
• Financial Outlook: Steady revenue growth driven by increased clinical adoption and strategic collaborations.

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FAQs

1. What are the primary clinical indications for Sincalide?
   Primarily used in hepatobiliary and pancreatic imaging to assess pancreatic exocrine function via scintigraphy.

2. How does Sincalide compare cost-wise to alternative diagnostic agents?
   Its production costs are moderate but depend heavily on peptide synthesis and radiolabeling complexities, often making it competitive against MRI or CT alternatives.

3. What regulatory challenges exist for expanding Sincalide’s indications?
   Challenges include generating sufficient clinical evidence, navigating radiopharmaceutical standards, and aligning with international approval pathways.

4. What is the patent landscape for Sincalide-based formulations?
   Patents on production methods and specific formulations have historically provided exclusivity; patent expiration may open opportunities for generics.

5. Is there potential for Sincalide to be used in non-diagnostic therapeutic applications?
   Currently, its use remains diagnostic; therapeutic applications would require significant research, particularly exploring radiolabeling for targeted treatments.

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References

[1] WHO. (2022). Global Pancreatic Disease Statistics.
[2] Smith, J. et al. (2021). Advances in Nuclear Imaging for Pancreatic Diagnostics. J Nucl Med.
[3] FDA. (2020). Radiopharmaceutical Approvals and Policy Updates.
[4] ClinicalTrials.gov. (2022). Studies on Sincalide Indications.
[5] European Medicines Agency. (2021). Radiopharmaceutical Regulatory Guidelines.