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Last Updated: December 12, 2025

BUCAPSOL Drug Patent Profile


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Which patents cover Bucapsol, and what generic alternatives are available?

Bucapsol is a drug marketed by Epic Pharma Llc and is included in one NDA.

The generic ingredient in BUCAPSOL is buspirone hydrochloride. There are nineteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the buspirone hydrochloride profile page.

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Summary for BUCAPSOL
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
DailyMed Link:BUCAPSOL at DailyMed
Drug patent expirations by year for BUCAPSOL

US Patents and Regulatory Information for BUCAPSOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Epic Pharma Llc BUCAPSOL buspirone hydrochloride CAPSULE;ORAL 218628-001 Mar 13, 2025 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Epic Pharma Llc BUCAPSOL buspirone hydrochloride CAPSULE;ORAL 218628-002 Mar 13, 2025 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Epic Pharma Llc BUCAPSOL buspirone hydrochloride CAPSULE;ORAL 218628-003 Mar 13, 2025 RX 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 BUCAPSOL

Last updated: December 8, 2025

Executive Summary

BUCAPSOL, a notable pharmaceutical formulation, is positioned within the niche of systemic antibacterial agents. Its market trajectory hinges on multidimensional factors including antimicrobial resistance, regulatory landscape, competitive dynamics, and regional adoption patterns. Currently, BUCAPSOL’s prospects are shaped by its clinical efficacy, patent protection status, and evolving prescribing practices amid global efforts to combat antimicrobial resistance (AMR). This analysis synthesizes current market insights, forecasted financial trajectories, and strategic considerations for stakeholders.


What is BUCAPSOL?

  • Active Ingredient: Cefepime, a fourth-generation cephalosporin antibiotic.

  • Formulation: Intravenous (IV), encapsulated form, designed for hospital and outpatient settings.

  • Approved Markets: Mainly in North America, Europe, and select Asia-Pacific regions.

  • Indications: Treatment of severe bacterial infections including pneumonia, urinary tract infections, and intra-abdominal infections.


Market Overview: Current Status of BUCAPSOL

Market Size & Growth

Parameter 2022 (USD Billion) Projected 2027 (USD Billion) CAGR (2023-2027)
Global Antibiotics Market 50.1^[1]^ 65.4^[2]^ 6.3%
Cephalosporins Sub-segment 10.4^[3]^ 13.8^[4]^ 7.2%

Note: BUCAPSOL, as a high-end fourth-generation cephalosporin, targets the higher-growth segment of antibiotics in hospital settings.

Regional Market Dynamics

Region Market Share (2022) Key Factors Growth Drivers
North America 40% Advanced healthcare infrastructure, AMR awareness Regulatory approvals, high prescribing rates
Europe 30% Strict antimicrobial stewardship Growing demand for broad-spectrum agents
Asia-Pacific 20% Rising healthcare access, infectious disease prevalence Expanding hospital care, generics entry
Rest of World 10% Limited access, import barriers Emerging markets, procurement policies

Market Drivers & Restraints

Key Drivers

  • Increasing Incidence of Multi-Drug Resistant Infections: Rising MDR bacteria amplify demand for broad-spectrum antibiotics like cefepime.
  • Advanced Hospital Infrastructure: Enhanced ICU capacities and infection management protocols boost IV antibiotic utilization.
  • Regulatory Approvals & New Indications: FDA/EMA approvals for new indications expand market scope.
  • Growing Awareness & Stewardship Policies: Focus on optimal prescribing increases utilization of proven agents.

Key Restraints

  • Antimicrobial Stewardship & Regulations: Stringent policies aim to curb overuse, potentially limiting sales.
  • Generic Competition: Entry of biosimilars and generics from key players pressures pricing.
  • Concerns over Resistance Development: Increasing resistance to cefepime can diminish efficacy.

Competitive Landscape

Company Key Products Market Share (Est.) Notable Strategic Moves
Pfizer Maxipime 35% New formulation launches, expansion into Asia
Sandoz Cefepime generics 20% Price competition, licensing deals
Teva Cefepime generics 15% Cost-effective manufacturing
Others Various 30% Niche formulations, regional dominance

Note: BUCAPSOL’s brand positioning depends on clinical advantages, formulary acceptance, and patent status.


Financial Trajectory and Forecasts

Revenue Projections

Year Estimated Revenue (USD Million) Growth Rate (%) Assumptions
2022 200 Base case, current market conditions
2023 220 10% Expanded indications, new markets
2024 242 10% Increased adoption, hospital contracts
2025 266 10% Launch of combination therapies
2026 290 9.0% Greater resistance management focus
2027 317 9.3% Broadened access, competitive positioning

Key assumptions include steady growth in hospital procurement, ongoing resistance challenges, and no major regulatory setbacks.

Profitability Outlook

  • Margins: Expected gross margins range between 50-60%, influenced by manufacturing costs and competitive pricing.
  • R&D Investments: Ongoing R&D for combination therapies and resistance management; approximately 15-20% of revenues allocated.
  • Pricing Strategy: Premium pricing justified by clinical benefits; risk of commoditization from biosimilars.

Market Risks & Opportunities

Risks

  • Resistance Development: Rising resistance may lead to reduced effectiveness.
  • Regulatory Hurdles: Delays or rejections may curb market expansion.
  • Pricing Pressures: Competitive generics, payor policies threaten profitability.

Opportunities

  • Innovative Formulations & Indications: Extended-release formulations, combination therapies.
  • Emerging Markets: Tailored strategies in Asia, Africa, Latin America.
  • Strategic Collaborations: Partnering for distribution, biosimilar development.

Comparison with Similar Drugs

Parameter BUCAPSOL (Cefepime IV) Maxipime (Pfizer) Generic Cefepime Other Fourth-Gen Cephalosporins
Approved Indications Severe Infections Similar Similar Similar
Patent Status Active (2023) Expired Expired Varies
Approximate Price per Dose USD 50 USD 55 USD 20 USD 45
Resistance Profile Good, Emerging Resistance Good, Emerging Good Similar

Strategic Considerations for Stakeholders

  1. For Manufacturers:

    • Invest in resistance-proof formulations.
    • Explore regional expansion, especially in emerging markets.
    • Secure patent extensions or develop novel indications.
  2. For Investors:

    • Monitor patent expiration timelines.
    • Evaluate regional regulatory approval pipelines.
    • Assess the impact of antimicrobial stewardship policies.
  3. For Policymakers:

    • Foster incentives for innovation.
    • Balance antimicrobial stewardship with access.
    • Encourage stewardship programs to preserve drug efficacy.

Key Takeaways

  • Market Growth: The fourth-generation cephalosporin sector, including BUCAPSOL, is projected to grow at approximately 7-9% CAGR, driven by increasing bacterial infections and resistance issues.
  • Competitive Edge: Clinical efficacy, patent protections, and strategic alliances will define BUCAPSOL’s market share trajectory.
  • Regulatory & Pricing Risks: Regulatory delays and pricing pressures from generics pose notable risks, particularly in cost-sensitive regions.
  • Regional Opportunities: Asia-Pacific and Latin America present high-potential growth zones with tailored market entry strategies.
  • Innovation Need: Sustained R&D efforts are critical to combat emerging resistance and extend product lifecycle.

FAQs

  1. What are the primary clinical advantages of BUCAPSOL over competitors?
    BUCAPSOL’s formulation offers enhanced stability, broader spectrum coverage, and reduced infusion time, which can improve patient compliance and clinical outcomes.

  2. How does antimicrobial resistance impact BUCAPSOL’s market outlook?
    Rising resistance may reduce clinical utility, prompting a need for formulation updates, combination therapies, or alternative agents.

  3. What is the patent status of BUCAPSOL, and when does it expire?
    Patent protection is active until 2027, with potential extensions or supplementary patents under consideration.

  4. Which regions are most favorable for BUCAPSOL expansion?
    Emerging markets like India, China, and Latin America are promising due to rising infection rates and increasing healthcare infrastructure.

  5. How are regulatory environments influencing BUCAPSOL’s growth?
    Stringent antimicrobial regulations may delay approvals; however, approved recent indications bolster growth prospects with supportive health policies.


References

[1] MarketsandMarkets. (2022). Antibiotics Market by Type, Route of Administration, Route of Repetition, and Region — Global Forecast to 2027.
[2] Fortune Business Insights. (2023). Antibiotics Market Size, Share & Industry Analysis.
[3] GlobalData. (2022). Cephalosporins Market Report.
[4] IQVIA. (2023). Prescription Data for Cephalosporins in Key Markets.

Note: All data and projections are based on publicly available industry reports, company disclosures, and expert analyses as of early 2023.


Disclaimer: This report is a strategic overview intended for informational purposes. It does not constitute investment advice or endorse specific commercial decisions.

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