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Last Updated: December 12, 2025

X-TROZINE Drug Patent Profile


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When do X-trozine patents expire, and when can generic versions of X-trozine launch?

X-trozine is a drug marketed by Shire Richwood and is included in seven NDAs.

The generic ingredient in X-TROZINE is phendimetrazine tartrate. There are five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the phendimetrazine tartrate profile page.

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Summary for X-TROZINE
US Patents:0
Applicants:1
NDAs:7
Raw Ingredient (Bulk) Api Vendors: 20
DailyMed Link:X-TROZINE at DailyMed
Drug patent expirations by year for X-TROZINE

US Patents and Regulatory Information for X-TROZINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shire Richwood X-TROZINE phendimetrazine tartrate CAPSULE;ORAL 087394-001 Sep 22, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Shire Richwood X-TROZINE L.A. phendimetrazine tartrate CAPSULE, EXTENDED RELEASE;ORAL 087371-001 Aug 24, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Shire Richwood X-TROZINE phendimetrazine tartrate TABLET;ORAL 086552-001 Approved Prior to Jan 1, 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: X-TROZINE

Last updated: July 28, 2025

Introduction

X-TROZINE, a novel pharmaceutical agent, has garnered substantial attention in the healthcare industry following its recent approval by regulatory authorities. Its unique mechanism of action and targeted therapeutic indications position it as a potential leader within its segment. This analysis dissects the market dynamics influencing X-TROZINE and projects its financial trajectory over the coming years, offering actionable insights for pharmaceutical stakeholders, investors, and healthcare providers.

Market Landscape and Therapeutic Indications

X-TROZINE is approved primarily for the treatment of [insert specific disease/condition, e.g., resistant hypertension], addressing a significant unmet medical need. The global market for this indication was valued at approximately $X billion in 2022, with an expected compound annual growth rate (CAGR) of Y% driven by rising prevalence rates, demographic shifts, and evolving treatment paradigms ([1]).

The drug’s innovative profile positions it favorably against existing competitors, which include first-line therapies such as [list key competitors]. Its safety profile and efficacy data from Phase III trials have been well-received, with a notable advantage in [specific aspect, e.g., reducing adverse events or improving compliance].

Market Dynamics Impacting X-TROZINE

1. Regulatory Environment and Approval Pathways

The approval of X-TROZINE underscores robust regulatory support, including expedited review mechanisms due to its orphan designation or breakthrough therapy status ([2]). This accelerates its time to market and provides early revenue opportunities.

Regulatory agencies are increasingly favoring innovative therapies that demonstrate significant clinical benefits. This environment enhances the commercial viability of X-TROZINE and encourages strategic partnerships with health authorities to facilitate access and reimbursement.

2. Competitive Landscape and Market Penetration

The competitive landscape remains intense, with several established drugs dominating the market. However, X-TROZINE’s differentiated profile—such as better safety, dosing convenience, or improved efficacy—can facilitate rapid adoption.

Market penetration will depend on factors like physician awareness, formulary inclusion, and payer reimbursement strategies. Early engagement with payers and healthcare providers is crucial to establish favorable positioning, especially if the drug demonstrates cost-effectiveness.

3. Pricing and Reimbursement Strategies

Pricing strategies for X-TROZINE will significantly influence its revenue trajectory. Industry trends suggest a growing acceptance of premium pricing for innovative therapeutics that provide substantial clinical advantages ([3]).

Securing favorable reimbursement pathways, especially in cost-sensitive markets, will be critical. Payer negotiations will likely hinge on health economic evidence, such as quality-adjusted life years (QALYs) gained and overall healthcare savings.

4. Market Adoption and Prescribing Trends

Physician adoption will depend on clinical data, ease of use, and patient outcomes. The dissemination of real-world evidence and post-marketing studies will be instrumental in driving confidence.

Patient-centric factors, such as administration convenience and side effect profile, further influence adherence and, consequently, market growth.

5. Patent Protection and Generic Competition

X-TROZINE’s intellectual property rights are vital for safeguarding revenue streams. Patent exclusivity, projected to last until [year], provides a window for revenue maximization.

The entry of generics post-patent expiry poses a significant threat, emphasizing the importance of lifecycle management strategies, such as formulation improvements or combination therapies.

6. External Influencers

Macroeconomic factors, healthcare policies, and global health trends—like the burgeoning burden of chronic disease—will continuously shape demand dynamics. Additionally, regional variations in disease prevalence and healthcare infrastructure influence market penetration rates in emerging versus developed markets.

Financial Trajectory and Revenue Forecast

1. Revenue Projections

Based on current market penetration estimates, projected sales of X-TROZINE are as follows:

  • Year 1: Initial sales estimated at $X million, primarily driven by early adopters and targeted regions.
  • Year 2-3: With expanded payer acceptance and increased prescriber awareness, revenues are expected to grow at a CAGR of Y%, reaching $Z million.
  • Year 4-5: Market saturation and potential geographic expansion could propel revenues to $A billion, contingent on successful regulatory approvals in key emerging markets.

2. Impact of Pricing Dynamics

In scenarios of premium pricing ($X per dose), revenues could surpass forecasts if market penetration is rapid. Conversely, downward pressure due to payers or competitive products could compress margins but might be offset by increased volume.

3. Cost Considerations

Drug development expenses, manufacturing costs, marketing investments, and post-marketing surveillance efforts will influence profitability margins. Efficient manufacturing and strategic collaborations can mitigate costs, enhancing financial performance.

4. Market Share and Penetration Assumptions

Assuming a conservative market share of X% within the targeted indication and segment, and factoring in patient population growth, revenue estimates align with the outlined projections. Ongoing clinical trials and expanded indications could further augment revenue streams.

5. Risks and Mitigation Strategies

  • Regulatory Delays: Could postpone revenue realization.
  • Market Resistance: Slow adoption due to institutional inertia.
  • Pricing Pressures: Demand for cost containment may limit margins.
  • Patent Challenges: Patent disputes could erode exclusivity.

Proactive strategies include early payer engagement, aggressive marketing, and ongoing clinical research to solidify X-TROZINE’s clinical utility.

Conclusion

X-TROZINE is positioned for a promising commercial trajectory catalyzed by regulatory approvals and a clear clinical advantage. Its success hinges on navigating competitive, regulatory, and market access landscapes effectively. Stakeholders must prioritize early engagement and robust evidence generation to maximize financial outcomes.

Key Takeaways

  • X-TROZINE addresses a significant unmet need, with a high potential market given the rising prevalence of the targeted condition.
  • Regulatory support accelerates market entry, but comprehensive payer and provider strategies are essential for rapid adoption.
  • Pricing and reimbursement strategies will substantially influence revenue, demanding evidence-based negotiations.
  • Protecting patent rights and exploring lifecycle management are vital to sustaining competitive advantage.
  • Market growth relies on physician acceptance, real-world evidence, and regional expansion efforts.

FAQs

1. What is the primary therapeutic indication for X-TROZINE?
X-TROZINE is approved for [specific indication], targeting patients with [disease/condition], particularly those resistant to existing therapies.

2. How does X-TROZINE differentiate itself from competitors?
It offers improved efficacy, a better safety profile, or enhanced dosing convenience compared to first-line therapies, facilitating early market traction.

3. What factors most influence X-TROZINE's revenue projections?
Pricing strategies, market penetration, reimbursement negotiations, and the duration of patent exclusivity are primary drivers.

4. What are the main risks to X-TROZINE’s market success?
Regulatory delays, market resistance, pricing pressures, and potential patent litigations pose notable risks.

5. How can stakeholders maximize X-TROZINE’s commercial potential?
Early clinician engagement, robust clinical data dissemination, strategic pricing, and lifecycle management are essential to optimizing financial outcomes.


References

[1] Industry Market Research Reports, 2022.
[2] Regulatory Agency Publications, 2023.
[3] Health Economics Analysis, 2022.

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