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:	47
Clinical Trials:	4
Patent Applications:	2,698
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
Penn State 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)

SINCALIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sincalide

Introduction

Sincalide, a synthetic peptide hormone, is widely used as a diagnostic aid for hepatobiliary and pancreatic conditions. Understanding its market dynamics and financial trajectory is crucial for pharmaceutical companies, healthcare providers, and investors.

Clinical Use and Demand

Sincalide is administered parenterally to contract the gallbladder, aiding in diagnostic imaging of hepatobiliary diseases. Its use is critical in medical diagnostics, particularly for conditions involving the gallbladder and pancreas[4][5].

Diagnostic Procedures

The drug is used in various diagnostic procedures, including the assessment of gallbladder function and pancreatic secretion. Its ability to stimulate pancreatic secretion and intestinal motility makes it an essential tool in gastroenterology and hepatology[4].

Patient Population

The demand for sincalide is driven by the prevalence of gallbladder and pancreatic disorders. With an aging population and increasing incidence of gastrointestinal diseases, the demand for diagnostic aids like sincalide is expected to rise.

Market Challenges

Despite its clinical importance, the market for sincalide faces several challenges.

Supply Chain Interruptions

Frequent shortages due to intermittent supply have been a significant issue. This instability can lead to increased costs and reduced availability, impacting both healthcare providers and patients[1].

Shelf-Life Concerns

Historically, sincalide had an estimated post-reconstitution shelf-life of 8 hours, which was updated in 2014 with limited supporting data. Recent studies, however, suggest that sincalide remains chemically stable for at least 8 days when stored in sterile water at room temperature or refrigeration[1].

Economic Impact

The stability of sincalide beyond the previously recommended 8 hours has significant economic implications.

Cost Savings

Extending the shelf-life of sincalide can reduce waste and lower costs for medical institutions. Since a significant portion of the vial is often wasted due to the short shelf-life, prolonging this period can lead to substantial cost savings[1].

Supply Chain Efficiency

Improved stability can also enhance supply chain efficiency by reducing the need for frequent reordering and minimizing the impact of supply chain disruptions.

Regulatory Environment

The regulatory landscape plays a crucial role in the market dynamics of sincalide.

FDA Guidelines

The FDA's guidelines on reconstituted medications specify that any reconstituted medication should not be used past the expiration time specified by the manufacturer. However, studies suggesting longer stability periods may prompt reevaluation of these guidelines[1].

PDUFA Performance

The Prescription Drug User Fee Act (PDUFA) performance reports indicate the FDA's efficiency in reviewing and approving drug applications. While sincalide is not a new drug, any changes in its formulation or usage guidelines would need to align with PDUFA regulations[3].

Competitive Landscape

Sincalide operates in a niche market with limited competition due to its specific use as a diagnostic aid.

Market Monopoly

Bracco Diagnostics Inc. is the primary manufacturer of sincalide (Kinevac), giving it a significant market share. The lack of direct competitors means that market dynamics are largely influenced by the supply and demand for this specific product[1][4].

Financial Trajectory

The financial performance of sincalide is influenced by several factors.

Revenue Streams

The revenue generated from sincalide sales is substantial, given its critical role in diagnostic procedures. However, the intermittent supply and short shelf-life have historically impacted revenue stability.

Cost Structure

The cost structure includes manufacturing, distribution, and storage costs. Extending the shelf-life could reduce storage and distribution costs, potentially increasing profit margins.

Market Growth

The market for sincalide is expected to grow due to increasing demand for diagnostic services and the aging population. Improved stability and reduced waste could further enhance market growth.

Industry Expert Insights

Industry experts highlight the importance of stability studies in optimizing the use of sincalide.

"The findings of this study warrant microbial testing over this storage duration before any recommendations on extended usage can be made," notes a study on the chemical stability of sincalide[1].

Statistics and Data

• Shelf-Life Extension: Studies indicate that sincalide remains chemically stable for at least 8 days after reconstitution, a significant extension from the previously recommended 8 hours[1].
• Waste Reduction: Approximately 67% of the sincalide vial is wasted when administered to an average adult due to the short shelf-life. Extending the shelf-life could reduce this waste substantially[1].
• Market Demand: The demand for diagnostic aids like sincalide is expected to rise with the increasing prevalence of gastrointestinal diseases.

Key Takeaways

• Extended Shelf-Life: Sincalide is chemically stable for at least 8 days after reconstitution, offering potential cost-saving benefits.
• Supply Chain Efficiency: Improved stability can enhance supply chain efficiency and reduce waste.
• Regulatory Considerations: Any changes in usage guidelines would need to align with FDA regulations.
• Market Growth: The market for sincalide is expected to grow due to increasing demand for diagnostic services.
• Cost Savings: Extending the shelf-life can reduce costs for medical institutions.

FAQs

What is sincalide used for?

Sincalide is used as a diagnostic aid to contract the gallbladder and assess pancreatic secretion, aiding in the diagnosis of hepatobiliary and pancreatic conditions.

How long is sincalide stable after reconstitution?

Recent studies suggest that sincalide remains chemically stable for at least 8 days after reconstitution in sterile water, whether stored at room temperature or refrigeration.

What are the common adverse reactions to sincalide?

Common adverse reactions include abdominal discomfort or pain, nausea, and transient abdominal cramping. Serious allergic reactions, such as anaphylaxis, are rare but can occur[4][5].

How does the extended shelf-life of sincalide impact its market?

The extended shelf-life can reduce waste, lower costs, and enhance supply chain efficiency, potentially increasing market growth and revenue stability.

Is sincalide available from multiple manufacturers?

Currently, Bracco Diagnostics Inc. is the primary manufacturer of sincalide (Kinevac), giving it a significant market share in this niche market[1][4].

Sources

1. Chemical Stability of Reconstituted Sincalide in Sterile Water Under Different Storage Conditions. Tech, 48(2), 174.
2. Michael Moseley - Stanford Profiles.
3. FY 2018 PDUFA Performance Report. FDA.
4. CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 017697Orig1s031. FDA.
5. Sincalide (intravenous route) - Mayo Clinic. Mayo Clinic.