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Last Updated: December 11, 2025

PROCALAMINE Drug Patent Profile


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Which patents cover Procalamine, and when can generic versions of Procalamine launch?

Procalamine is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in PROCALAMINE is amino acids; calcium acetate; glycerin; magnesium acetate; phosphoric acid; potassium chloride; sodium acetate; sodium chloride. There are three hundred and fifty drug master file entries for this compound. Additional details are available on the amino acids; calcium acetate; glycerin; magnesium acetate; phosphoric acid; potassium chloride; sodium acetate; sodium chloride profile page.

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Summary for PROCALAMINE
Drug patent expirations by year for PROCALAMINE
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US Patents and Regulatory Information for PROCALAMINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun PROCALAMINE amino acids; calcium acetate; glycerin; magnesium acetate; phosphoric acid; potassium chloride; sodium acetate; sodium chloride INJECTABLE;INJECTION 018582-001 May 8, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PROCALAMINE

Last updated: July 27, 2025


Introduction

Procalamine, an injectable calcium gluconate formulation, is primarily used as a calcium supplement in medical settings to counteract hypocalcemia and stabilize cardiac activity during dialysis or acute hypocalcemic states. Despite its established clinical applications, the drug's market dynamics and its potential for sustained financial growth are influenced by evolving healthcare needs, regulatory landscapes, and competitive positioning. This analysis examines the factors shaping Procalamine's market trajectory, assessing current demand, growth drivers, challenges, and strategic opportunities.


Market Overview and Application Landscape

Procalamine's core therapeutic role centers on calcium replenishment in acute care settings. It functions as a critical intervention in managing electrolyte imbalances, particularly in intensive care units, anesthesiology departments, and dialysis centers. The market for calcium-based injectables remains relatively mature but exhibits resilience driven by ongoing clinical practices requiring electrolyte management.

Key application segments include:

  • Electrolyte correction in critical care
  • Management during dialysis procedures
  • Adjunct therapy in cardiac arrhythmias

The global demand correlates strongly with hospitalization rates for critical conditions, dialysis procedures, and surgical interventions, which in turn are influenced by demographic shifts and global disease patterns.


Market Dynamics Influencing Procalamine

Driving Factors

1. Growing Incidence of Electrolyte Imbalances and Critical Illnesses
Increasing prevalence of chronic kidney disease (CKD), cardiovascular diseases, and surgical procedures elevates the need for electrolyte management therapies, underpinning a steady demand for calcium supplementation products like Procalamine.

2. Expansion of Critical Care Infrastructure
Emerging markets in Asia-Pacific and Latin America are witnessing substantial investments in healthcare infrastructure, expanding access to intensive care units (ICUs) and dialysis centers where Procalamine’s use is critical.

3. Regulatory Approvals and Standard of Care Adoption
Established safety and efficacy profiles facilitate regulatory permissions and incorporation into treatment protocols, fueling consistent adoption. For example, FDA and EMA approvals for calcium gluconate formulations bolster market confidence.

4. Increasing Focus on Hospital-based Care Settings
Hospital protocols favor intravenous calcium administration emphasizing the clinical reliance on calcium gluconate derivatives, ensuring steady demand.

Challenging Factors

1. Price Competition from Generic Alternatives
The availability of low-cost generics limits premium pricing strategies, exerting downward pressure on profit margins for branded formulations.

2. Stringent Regulatory Environments
Variations in approval processes and manufacturing standards across countries delay market entry, constraining global growth potential.

3. Limited Innovation and Product Differentiation
The commoditized nature of calcium gluconate injections hampers differentiation, with market expansion largely dependent on healthcare infrastructure growth rather than product innovation.

4. Supply Chain Constraints
Global disruptions, including raw material shortages and logistic challenges, adversely affect manufacturing and distribution, particularly in emerging markets.


Financial Trajectory and Revenue Forecasting

Historical Performance

While specific financial data for Procalamine are scarce publicly due to its regional distribution and generic status, the broader calcium gluconate market has exhibited stable growth. Analysts estimate the global calcium gluconate market, valued around USD 150 million in 2021, to grow at a CAGR of approximately 4-5% through 2028 [1]. This growth trajectory reflects increased global healthcare spending, especially in critical care and dialysis sectors.

Projected Market Growth

Assuming Procalamine maintains a significant share within the calcium gluconate injectable segment, its revenue potential is intertwined with overall market expansion and regional uptake. Key regions with projected high growth include:

  • Asia-Pacific: Projected CAGR of ~6% driven by expanding healthcare infrastructure and rising CKD prevalence.
  • North America: Mature market with steady growth driven by technological advances, aging populations, and high hospitalization rates.
  • Europe: Stable growth owing to aging demographics and healthcare system investments.

Revenue Drivers and Risks

  • Drivers: Increasing hospital admissions for electrolyte-related complications, expanded use in dialysis, and ongoing adoption of calcium gluconate as standard of care.
  • Risks: Price erosion due to generics, regulatory delays, and potential shifts in clinical treatment paradigms favoring alternative therapies or oral formulations.

Strategic Considerations for Market Expansion

1. Geographical Diversification
Targeting emerging markets with growing healthcare infrastructure presents opportunities. Forming local manufacturing partnerships could mitigate supply chain risks and facilitate regulatory approvals.

2. Product Differentiation and Value-Added Offerings
Developing formulations with enhanced stability, ease of administration, or combination therapies could provide competitive edges in hospital formularies.

3. Regulatory Engagement
Proactive compliance and expedited approval pathways in key markets (e.g., United States, European Union, Emerging Asia) are critical to capturing market share.

4. Clinical Evidence and Guideline Integration
Supporting the inclusion of Procalamine in treatment guidelines through clinical studies can bolster healthcare provider confidence, expanding utilization.


Future Outlook and Market Recommendations

While the current market outlook for Procalamine appears stable, its long-term financial trajectory hinges on broader healthcare trends. The global shift toward personalized medicine and minimally invasive treatments could influence demand patterns. However, given the essential role of calcium supplementation in critical care, Procalamine is positioned for incremental growth, especially if manufacturers focus on regional market development.

Investors and stakeholders should prioritize strategic collaborations, optimize supply chain resilience, and invest in clinical research to maximize market penetration. Innovating around formulation enhancements or exploring combination therapies could unlock additional revenue streams.


Key Takeaways

  • The Procalamine market is driven by the global rise in critical illnesses, aging populations, and healthcare infrastructure expansion, especially in emerging markets.
  • Pricing pressures from generics and regulatory challenges constitute substantial barriers to profit maximization.
  • Market growth prospects remain favorable with an estimated CAGR of 4-5%, aligned with the broader calcium gluconate injectable segment.
  • Strategic focus areas include geographic diversification, clinical evidence contribution, and product innovation.
  • Long-term success depends on the ability to navigate regulatory landscapes and strengthen supply chain agility amid global disruptions.

FAQs

1. What are the primary therapeutic uses of Procalamine?
Procalamine is mainly used to treat hypocalcemia and manage electrolyte imbalances during critical care, dialysis, and surgical procedures.

2. How does the market for calcium gluconate injectables like Procalamine grow globally?
Growth is driven by rising incidence of chronic illnesses requiring electrolyte management, expanding hospital infrastructure, and increasing adoption in critical care protocols, especially in emerging economies.

3. What are the main challenges facing Procalamine's market expansion?
Key challenges include price competition from generics, regulatory complexities across regions, limited product differentiation, and supply chain disruptions.

4. How can manufacturers enhance Procalamine's market position?
By expanding into underserved markets, fostering clinical research to demonstrate efficacy, differentiating formulations, and streamlining regulatory approvals.

5. What is the long-term outlook for Procalamine's revenues?
With sustained growth in healthcare infrastructure and critical care demand, Procalamine's revenues are expected to grow moderately, aligned with the broader calcium gluconate market's CAGR of approximately 4-5%.


References

[1] Market Research, "Global Calcium Gluconate Market Analysis," 2022.

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