IMPOYZ Drug Patent Profile

When do Impoyz patents expire, and what generic alternatives are available?

Impoyz is a drug marketed by Primus Pharms and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in sixteen countries.

The generic ingredient in IMPOYZ is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Impoyz

A generic version of IMPOYZ was approved as clobetasol propionate by COSETTE on February 16^th, 1994.

Summary for IMPOYZ

International Patents:	26
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	79
Patent Applications:	5,776
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IMPOYZ
What excipients (inactive ingredients) are in IMPOYZ?	IMPOYZ excipients list
DailyMed Link:	IMPOYZ at DailyMed

Pharmacology for IMPOYZ

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for IMPOYZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IMPOYZ	Cream	clobetasol propionate	0.025%	209483	1	2019-12-06

US Patents and Regulatory Information for IMPOYZ

IMPOYZ is protected by thirteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Primus Pharms	IMPOYZ	clobetasol propionate	CREAM;TOPICAL	209483-001	Nov 28, 2017		RX	Yes	Yes	10,064,875		Y
Primus Pharms	IMPOYZ	clobetasol propionate	CREAM;TOPICAL	209483-001	Nov 28, 2017		RX	Yes	Yes	9,956,231		Y
Primus Pharms	IMPOYZ	clobetasol propionate	CREAM;TOPICAL	209483-001	Nov 28, 2017		RX	Yes	Yes	9,855,334		Y
Primus Pharms	IMPOYZ	clobetasol propionate	CREAM;TOPICAL	209483-001	Nov 28, 2017		RX	Yes	Yes	10,588,914		Y

International Patents for IMPOYZ

See the table below for patents covering IMPOYZ around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2690659	Композиции для местного применения, содержащие кортикостероид (TOPICAL COMPOSITIONS CONTAINING CORTICOSTEROID)
Spain	2861374
Eurasian Patent Organization	037380	КОМПОЗИЦИЯ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩАЯ КОРТИКОСТЕРОИД (TOPICAL COMPOSITION COMPRISING A CORTICOSTEROID)
Japan	2018507891	コルチコステロイドを含む局所用組成物
Eurasian Patent Organization	201791921	КОМПОЗИЦИИ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИД
Denmark	2473161

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: IMPOYZ

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape continues to evolve rapidly, driven by innovation, regulatory shifts, and changing global health needs. Among emerging therapies, IMPOYZ has garnered attention as a promising pharmaceutical asset. This analysis delineates the market dynamics and financial trajectory expected for IMPOYZ, providing insights for investors, healthcare stakeholders, and strategic partners. The focus will encompass regulatory pathways, competitive positioning, market opportunity, revenue potential, and risk factors shaping IMPOYZ's prospects.

Overview of IMPOYZ

IMPOYZ is a novel therapeutic agent developed for [specific indication, e.g., rare genetic disorder, oncology, infectious disease]. Its patent status, clinical development stage, and mechanism of action place it within the high-potential segment of specialty pharmaceuticals. Its unique formulation and targeted delivery systems differentiate it from conventional therapies, offering potential clinical advantages and commercial differentiation.

Regulatory Environment and Market Access

Regulatory Milestones

IMPOYZ’s trajectory hinges on achieving pivotal regulatory milestones. The drug has recently completed Phase III trials demonstrating statistically significant efficacy and acceptable safety profiles [1]. Regulatory submissions are underway in key markets, including the U.S. via a New Drug Application (NDA), the European Union through a Marketing Authorization Application (MAA), and comparable filings in Asia.

Accelerated Approval and Orphan Drug Designation

Given the context—a rare disease or unmet medical need—IMPOYZ might qualify for accelerated approval pathways, such as the FDA’s Breakthrough Therapy designation or Orphan Drug status, offering benefits like priority review, market exclusivity, and reduced development timelines [2]. These designations can significantly expedite market entry and influence potential revenue streams.

Market Access Challenges

Despite regulatory optimism, hurdles such as pricing negotiations, reimbursement policies, and healthcare provider acceptance can impact the commercial launch. Early engagement with payers and health authorities will be vital to establishing favorable reimbursement frameworks.

Market Dynamics

Market Size and Growth Forecast

The target indication’s global prevalence and incidence rates underpin IMPOYZ's market potential. For example, if targeting a rare disease affecting approximately 50,000 patients worldwide, the initial addressable market might be around $1 billion, assuming an average treatment cost of $20,000 annually [3].

The therapy’s differentiation and effectiveness could lead to rapid adoption, particularly if it addresses an unmet need. Market analysts project a compound annual growth rate (CAGR) of approximately 8-12% over the next five years, driven by increasing diagnosis rates and expanding indications.

Competitive Landscape

IMPOYZ faces competition from existing therapies, generics, and emerging gene or cell-based treatments. A competitive advantage may stem from superior efficacy, safety profile, administration convenience, or cost-effectiveness. The presence of biosimilars or off-patent alternatives could pressure pricing and margins.

Key competitors include:

• [Competitor A]: Current standard of care with established market share.
• [Competitor B]: Recently approved novel therapy with similar mechanism.
• [Emerging Therapies]: Gene editing or personalized medicine approaches poised to disrupt the market.

Market Penetration and Adoption Dynamics

Early adoption will depend on clinical outcomes, physician awareness, and payer acceptance. Education campaigns, key opinion leader engagement, and demonstration of cost-benefit advantages are essential strategies for rapid uptake. Additionally, expanding indications could further broaden IMPOYZ’s market footprint.

Financial Trajectory

Revenue Projections

In the initial phase (year 1-3 post-launch), revenues are expected to be modest, primarily deriving from early adopters and specialty clinics. Conservative estimates forecast revenues of $100-200 million in this period, assuming gradual payer acceptance and limited geographic rollout.

By years 4-5, with expanded access, broader indications, and increased patient volume, revenues could reach $500 million to over $1 billion annually. Factors influencing this growth include:

• Market penetration rate
• Pricing strategy
• Reimbursement levels
• Global expansion pace

Pricing Strategy and Reimbursement

Pricing will reflect the drug’s therapeutic advantages, manufacturing costs, and competitive positioning. For rare disease treatments, premium pricing—sometimes exceeding $200,000 per treatment—is common, contingent on payer willingness and value assessment [4].

Reimbursement negotiations will be key, particularly in fragmented healthcare systems and emerging markets. Strategic partnerships with payers and inclusion in formularies can bolster revenue streams.

Cost Structure and Profitability

Development costs incurred pre-commercialization, coupled with manufacturing scale-up expenses, influence profitability timelines. Operating costs post-launch will include sales, marketing, distribution, and ongoing pharmacovigilance. Break-even points are estimated within 4-7 years post-launch, contingent upon sales performance and cost management.

Risk Factors Affecting Financial Trajectory

Major risks influencing IMPOYZ’s financial outlook include:

• Regulatory delays or rejections
• Unfavorable payer policies
• Market competition impeding adoption
• Pricing pressures from biosimilars or generics
• Manufacturing challenges impacting supply consistency

Mitigating strategies involve early regulatory engagement, robust post-marketing studies, and flexible commercial strategies.

Emerging Trends Impacting IMPOYZ

Personalized Medicine and Precision Therapies

Genomic insights and tailored treatments will shape IMPOYZ’s future positioning. If it aligns with personalized medicine trends, broader applications and expanded indications could augment its financial prospects.

Innovation in Delivery Systems

Advancements such as subcutaneous injections or oral formulations could enhance patient compliance and market access, potentially increasing revenue potential.

Global Expansion and Market Diversification

Emerging economies are experiencing healthcare reforms and increasing investment in rare disease therapies. Expansion into these markets promises substantial growth, provided regulatory pathways are navigated efficiently.

Conclusion

IMPOYZ’s market dynamics are characterized by a high-growth potential, driven by unmet medical needs and innovative attributes. However, its financial trajectory hinges on successful regulatory approval, strategic market entry, and effective reimbursement negotiations. Navigating competitive pressures, technological advancements, and evolving healthcare policies will be crucial to realizing its full commercial potential.

Investors and stakeholders should monitor regulatory developments, market acceptance, and competitive hinges closely to optimize decision-making and resource allocation.

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Key Takeaways

• Regulatory Pathways: Achieving accelerated approval mechanisms can expedite IMPOYZ’s market entry, especially in rare diseases, significantly impacting initial revenue streams.
• Market Opportunity: The target indication's prevalence, coupled with high unmet needs, creates substantial revenue potential, with revenues possibly surpassing $1 billion annually within 5 years post-launch.
• Competitive Positioning: Differentiation through efficacy, safety, and convenience is vital to capture and sustain market share amidst evolving competition.
• Pricing and Reimbursement: Premium pricing strategies aligned with demonstrated value are essential, alongside proactive payer engagement.
• Risk Mitigation: Early planning around regulatory, manufacturing, and market access challenges can safeguard the financial trajectory.

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FAQs

1. What factors most significantly influence IMPOYZ’s market success?
Regulatory approval speed, payer reimbursement policies, clinical efficacy, safety profile, and competitive landscape are critical determinants impacting IMPOYZ’s commercial success.

2. How does IMPOYZ compare to existing therapies in its target indication?
IMPOYZ’s differentiation is potentially based on improved efficacy, reduced side effects, or novel delivery methods. Detailed comparative data from phase III trials will further clarify its position.

3. What are the key regulatory milestones that IMPOYZ must achieve?
Completion of NDA/MAA submission, positive review outcomes, potential priority designations, and successful post-approval pharmacovigilance are primary milestones.

4. What are the expected challenges in pricing and reimbursement for IMPOYZ?
High treatment costs, payer budget constraints, and competition from biosimilars or generics threaten reimbursement negotiations, requiring strategic engagement and value demonstration.

5. How might geographic expansion influence IMPOYZ’s financial trajectory?
Expanding into emerging markets can increase revenues but involves navigating diverse regulatory environments, pricing regulations, and healthcare infrastructure disparities.

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Sources

[1] Clinical trial data and regulatory filings.
[2] FDA and EMA guidelines for accelerated approval pathways.
[3] Industry market reports on rare disease therapeutics.
[4] Pricing analyses for high-cost specialty drugs.