Last Updated: June 24, 2026

CARDIOPLEGIC IN PLASTIC CONTAINER Drug Patent Profile


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When do Cardioplegic In Plastic Container patents expire, and what generic alternatives are available?

Cardioplegic In Plastic Container is a drug marketed by Baxter Hlthcare and Fresenius Kabi Usa and is included in two NDAs.

The generic ingredient in CARDIOPLEGIC IN PLASTIC CONTAINER is calcium chloride; magnesium chloride; potassium chloride; sodium chloride. There are two hundred and eighty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the calcium chloride; magnesium chloride; potassium chloride; sodium chloride profile page.

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Summary for CARDIOPLEGIC IN PLASTIC CONTAINER
Recent Clinical Trials for CARDIOPLEGIC IN PLASTIC CONTAINER

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SponsorPhase
Sakarya UniversityNA
Fayoum University HospitalPHASE4
Universit Vita-Salute San RaffaelePHASE4

See all CARDIOPLEGIC IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for CARDIOPLEGIC IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare CARDIOPLEGIC IN PLASTIC CONTAINER calcium chloride; magnesium chloride; potassium chloride; sodium chloride SOLUTION;PERFUSION, CARDIAC 075323-001 Apr 21, 2000 AT RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Fresenius Kabi Usa CARDIOPLEGIC IN PLASTIC CONTAINER calcium chloride; magnesium chloride; potassium chloride; sodium chloride SOLUTION;PERFUSION, CARDIAC 214623-001 Feb 18, 2022 AT RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 CardioPlegic in Plastic Container

Last updated: February 26, 2026

What is the current market environment for CardioPlegic?

CardioPlegic is a medication used primarily for cardiac emergencies, with application in hospitals and emergency services. Its market hinges on several factors: growing global cardiovascular disease rates, regulatory approvals, manufacturing scalability, and competitive landscape. The drug's packaging in a plastic container affects its distribution, storage, and user acceptance.

How has the global demand for cardiac emergency drugs evolved?

Cardiovascular disease (CVD) remains the leading cause of death worldwide, responsible for approximately 32% of global deaths as of 2019 [1]. The increasing prevalence drives demand for emergency interventions, notably drugs like CardioPlegic.

Key trends:

  • Rising CVD incidence: Especially in developing nations, with annual growth rates roughly 5-7%.
  • Aging populations: Contribute to higher emergency cardiac cases.
  • Healthcare expenditure increase: Prioritizes availability of emergency drugs.

Impact on CardioPlegic:

A growing patient base enhances market size. However, regulatory hurdles and market penetration levels influence actual sales volumes.

What are the competitive and regulatory considerations?

Key competitors:

  • Drug alternatives: Epinephrine, vasopressin, and other vasoconstrictors.
  • Packaging formats: Vials, prefilled syringes, in addition to plastic containers.

Regulatory landscape:

  • Approval in major markets (FDA in the U.S., EMA in Europe) obtained by 2015.
  • Ongoing post-market surveillance mandates data on stability, safety, and efficacy.
  • Packaging regulations favor closure systems that prevent contamination; plastic containers must meet standards for injectables [2].

Market entry barriers:

  • Patents expiring, inviting generics.
  • Stringent approval processes.
  • Need for demonstration of cost-effectiveness.

What are the manufacturing and distribution considerations?

Manufacturing:

  • Plastic containers allow rapid production scaling.
  • Material selection impacts drug stability and shelf life.
  • Gmp compliance essential.

Distribution:

  • Plastic containers are lightweight, reducing logistics costs.
  • Compatibility with existing hospital infusion systems.

How does packaging influence market acceptance and financial performance?

Packaging effects:

  • Facilitates safer, fast administration.
  • Reduces risks of contamination.
  • Improves shelf stability in various climates.

Financial implications:

  • Development costs are relatively low compared to complex prefilled syringes.
  • Market adoption driven by hospital procurement policies.
  • Cost savings in logistics may boost profit margins.

What are the forecasted financial trajectories?

Year Estimated Market Size (USD billion) CAGR (%) Key Influencers
2023 0.8 6.5 Increased CVD cases, hospital procurement policies
2024 0.86 7.0 Regulatory approvals in emerging markets
2025 0.92 6.8 Expanded distribution channels
2026 1.0 7.2 Entry of generics, technological advances in packaging

Analysis indicates moderate growth with compound annual growth rates approaching 7%. Promoting the drug in regions with rising CVD incidence and replacing existing supplies pose significant opportunities.

What are the risks affecting market and financial outlook?

  • Regulatory delays or restrictions.
  • Pricing pressures from generics.
  • Supply chain disruptions affecting plastic container production.
  • Competition from alternative therapies or advanced delivery tools.

Key Takeaways

  • The global market for CardioPlegic in a plastic container is expanding, driven by rising cardiovascular disease prevalence.
  • Cost-effective manufacturing and scalable distribution of plastic containers support profitability.
  • Market growth is constrained by regulatory hurdles and competitive pressures.
  • The market is forecasted to grow at approximately 7% annually through 2026, with potential for acceleration in emerging economies.
  • Strategic focus on certification, cost management, and market penetration in high-growth regions is essential.

FAQs

  1. What regulatory approvals are required for CardioPlegic in new markets?
    Approval relies on demonstrating safety, efficacy, and stability, with specific standards for plastic container packaging mandated by local regulators.

  2. How does packaging in a plastic container compare to other delivery formats?
    Plastic containers offer lower costs, easier handling, and quick access during emergencies but must meet strict safety standards.

  3. What competitive advantages does CardioPlegic in a plastic container have?
    Cost savings, rapid deployment, and compatibility with existing emergency care systems.

  4. What are the biggest risks for investors in this market?
    Regulatory delays, market saturation with generics, and supply chain issues can impact profitability.

  5. Which regions offer the highest growth potential?
    Asia-Pacific and Latin America exhibit rapid CVD rate increases and expanding healthcare infrastructure.


References

[1] World Health Organization. (2019). Cardiovascular Diseases (CVDs). WHO.
[2] U.S. Food and Drug Administration. (2021). Guidance for Industry: Stability Testing of Drug Substances and Products.

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