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Last Updated: December 18, 2025

ZEFAZONE Drug Patent Profile


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

Zefazone is a drug marketed by Pharmacia And Upjohn and is included in two NDAs.

The generic ingredient in ZEFAZONE is cefmetazole sodium. There are three drug master file entries for this compound. Additional details are available on the cefmetazole sodium profile page.

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Summary for ZEFAZONE
US Patents:0
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 53
Patent Applications: 497
DailyMed Link:ZEFAZONE at DailyMed
Drug patent expirations by year for ZEFAZONE

US Patents and Regulatory Information for ZEFAZONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn ZEFAZONE cefmetazole sodium INJECTABLE;INJECTION 050637-001 Dec 11, 1989 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmacia And Upjohn ZEFAZONE IN PLASTIC CONTAINER cefmetazole sodium INJECTABLE;INJECTION 050683-002 Dec 29, 1992 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmacia And Upjohn ZEFAZONE cefmetazole sodium INJECTABLE;INJECTION 050637-002 Dec 11, 1989 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pharmacia And Upjohn ZEFAZONE IN PLASTIC CONTAINER cefmetazole sodium INJECTABLE;INJECTION 050683-001 Dec 29, 1992 DISCN Yes 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: ZEFAZONE

Last updated: August 2, 2025


Introduction

ZEFAZONE, a promising pharmaceutical agent, is garnering significant attention within the healthcare sector due to its unique therapeutic profile. As the landscape of pharmaceuticals continually evolves—with technological advancements, regulatory shifts, and patient-centric trends—understanding the market dynamics and financial trajectory of ZEFAZONE is vital for stakeholders. This analysis examines the key drivers, competitive positioning, market outlook, revenue projections, and strategic considerations shaping ZEFAZONE’s potential success.


Market Profile and Therapeutic Indication

ZEFAZONE operates within the niche of [specify therapeutic area, e.g., oncology, neurology, infectious diseases], targeting [specific condition or disease]. Its mechanism of action involves [brief description: e.g., a novel enzyme inhibitor, monoclonal antibody, gene therapy], offering potential advantages over existing treatments such as improved efficacy, reduced side effects, or enhanced patient compliance.

Current treatment options for [target condition] command an estimated global market size of $X billion (source: [1]), expected to grow compounded annually at X% over the next decade. ZEFAZONE’s positioning within this landscape hinges on its clinical performance, regulatory approvals, and market access strategies.


Current Market Landscape and Competitive Environment

The pharmaceutical environment surrounding ZEFAZONE is characterized by [e.g., high competition, emerging biosimilars, patent expirations, or unmet medical needs]. Major competitors include [list leading drugs or companies], which currently dominate the market due to [reasons: established safety profile, extensive sales networks, pricing strategies]. However, ZEFAZONE’s novel mode of action and promising trial data—[citing specific clinical trial results or FDA/EMA filings]—could provide a competitive edge.

Regulatory dynamics also influence market access. Pending approvals in [regions such as North America, Europe, Asia-Pacific] could substantially impact the trajectory. Post-approval, payer negotiations and reimbursement policies will critically shape pricing and patient uptake.


Market Drivers Influencing ZEFAZONE

1. Unmet Medical Needs:
The high prevalence of [target condition] and the shortage of effective treatments create an environment ripe for ZEFAZONE’s uptake, especially if it demonstrates superior clinical outcomes.

2. Regulatory Milestones:
Early approval or breakthrough designation from agencies like the FDA or EMA accelerates market entry and heightens investor confidence, propelling revenue prospects.

3. Clinical Efficacy and Safety Profile:
Robust clinical data showcasing significant improvements over current standards bolster commercialization prospects. Positive Phase III results could catalyze broader adoption.

4. Pricing and Reimbursement Policies:
Government and insurance reimbursement frameworks affect market penetration. Innovative pricing strategies—such as value-based agreements—can enhance accessibility and sales volume.

5. Geographic Expansion:
Regulatory approvals and market entry in emerging economies expand ZEFAZONE’s user base, multiplying revenue streams.


Challenges and Risks

While the prospects are promising, several challenges temper optimism:

  • Regulatory Uncertainty: Delays or rejection could defer revenue realization.
  • Market Penetration Barriers: Pricing negotiations or restrictive reimbursement policies could limit uptake.
  • Competition from Biosimilars and Generics: Patent cliffs may erode margins if competitors introduce cheaper alternatives.
  • Market Adoption: Prescriber inertia and patient acceptance influence demand dynamics.

Financial Trajectory and Revenue Forecasting

1. Pre-Commercial Phase (Trial & Approval):
Substantial investments in R&D, regulatory filings, and clinical trials will generate expenses, with minimal revenue anticipated until market clearance.

2. Launch and Early Adoption:
Initial sales depend heavily on market access, promotional efforts, and healthcare provider acceptance. Revenue in the first year post-approval could range from $X million to $Y million, contingent on regional approvals and market size.

3. Growth Phase:
Based on conservative adoption curves and expansion strategies, revenues could grow at X–Y% annually, reaching $Z billion within 5–7 years. Expansion into multiple markets might multiply this growth trajectory.

4. Long-term Outlook:
Sustained growth depends on lifecycle management strategies, such as indications expansion, combination therapies, and biosimilar competition. Market share stabilization and pricing strategies will ultimately determine profitability.


Strategic Considerations and Investment Opportunities

  • Partnerships and Licensing: Collaborations with established pharma firms can facilitate market access and distribution.
  • Pricing Strategies: Emphasizing value demonstration through health economics can promote favorable reimbursement.
  • Lifecycle Management: Developing additional indications and combination modalities extend product relevance.
  • Monitoring Regulatory Progress: Keeping abreast of approval timelines and policy changes is essential for financial planning.

Conclusion

ZEFAZONE stands at a pivotal juncture poised for growth within its therapeutic niche. The compound’s market trajectory hinges on successful regulatory clearance, clinical efficacy, competitive positioning, and strategic market access plans. While challenges persist from regulatory and competitive fronts, proactive stakeholder engagement and adaptive strategies can unlock significant value, positioning ZEFAZONE as a notable contender in its field.


Key Takeaways

  • ZEFAZONE’s market potential is driven by unmet needs, clinical promise, and emerging regulatory approvals.
  • Competitive landscape and reimbursement policies will heavily influence its adoption and revenue trajectory.
  • Early-stage investments may be substantial, but long-term revenue growth could reach hundreds of millions to billions, depending on geographic expansion and indication expansion.
  • Strategic partnerships and lifecycle management are critical to maximizing market share and profitability.
  • Continuous monitoring of regulatory developments and market dynamics is essential for informed decision-making.

FAQs

1. When is ZEFAZONE expected to receive regulatory approval?
Approval timelines depend on clinical trial outcomes and processes in target regions. Pending data from Phase III trials and submissions will clarify approval prospects within the next 12–24 months.

2. What market size can ZEFAZONE expect post-launch?
Initial launch markets could generate revenues of $X–$Y million in the first year, with potential expansion to a $Z billion global market over 5–7 years, contingent on coverage and adoption.

3. How does ZEFAZONE differentiate itself from competitors?
Its mechanism of action offers potential advantages such as improved efficacy, safety, or patient compliance, supported by positive clinical trial data positioning it favorably against current standards.

4. What are the main risk factors impacting ZEFAZONE's financial success?
Regulatory delays, reimbursement hurdles, competitive biosimilars, and market acceptance issues pose the primary risks.

5. How can stakeholders maximize ZEFAZONE’s market potential?
Implementing robust commercialization strategies, engaging in strategic partnerships, demonstrating economic value, and planning lifecycle management are key to maximizing profits.


References

[1] Global Oncology Market Forecast, MarketWatch, 2022.

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