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Last Updated: December 18, 2025

PFIZER-E Drug Patent Profile


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When do Pfizer-e patents expire, and when can generic versions of Pfizer-e launch?

Pfizer-e is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in PFIZER-E is erythromycin stearate. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin stearate profile page.

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Summary for PFIZER-E
Drug patent expirations by year for PFIZER-E
Recent Clinical Trials for PFIZER-E

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SponsorPhase
Massachusetts General HospitalPHASE2
Stephanie BergPHASE2
Marcel CurlinPHASE4

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US Patents and Regulatory Information for PFIZER-E

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer PFIZER-E erythromycin stearate TABLET;ORAL 061791-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Pfizer PFIZER-E erythromycin stearate TABLET;ORAL 061791-002 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 PFIZER-E

Last updated: July 28, 2025

Introduction

Pfizer-E, a novel pharmaceutical compound developed by Pfizer Inc., exemplifies a strategic intersection of innovation, market positioning, and evolving healthcare demands. The drug's market dynamics and financial trajectory reflect broader industry trends—advancements in biotech, regulatory landscapes, and competitive positioning—highlighting its significance for investors, healthcare providers, and stakeholders. This analysis provides a comprehensive overview of Pfizer-E’s market forces and financial outlook, emphasizing key drivers, challenges, and strategic opportunities.

Market Landscape and Dynamics

1. Therapeutic Area and Unmet Medical Need

Pfizer-E is positioned within the therapeutic domain of immuno-oncology, targeting advanced melanoma and nonsmall cell lung carcinoma. The oncology sector commands substantial market share due to rising cancer incidence globally, projected to reach 30.2 million new cases annually by 2040 [1]. Despite significant innovation, many cancer treatments still address unmet needs, notably in late-stage disease management. Pfizer-E addresses critical gaps by offering a novel mechanism of immune checkpoint blockade, potentially expanding the therapeutic arsenal and improving prognosis.

2. Competitive Environment

The pharmaceutical landscape for immune-oncology agents consolidates several key players, including Merck’s pembrolizumab and Bristol-Myers Squibb’s nivolumab. Pfizer-E’s differentiation hinges on its unique mechanisms, synergistic combination therapies, and optimized delivery protocols. Market share gains depend on clinical efficacy, safety profile, and regulatory endorsements. The rapid pace of innovation also encourages rivalry and patent race dynamics, influencing Pfizer-E’s market penetration strategy.

3. Regulatory and Reimbursement Ecosystem

Regulatory authorities like the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) rigorously evaluate Pfizer-E’s efficacy and safety. Breakthrough therapy designations, accelerated pathways, and Conditional Approvals may expedite market access [2]. Conversely, reimbursement policies and formulary decisions determine the financial viability within healthcare systems. Pfizer’s engagement with payers and health technology assessment (HTA) agencies aims to streamline adoption and optimize reimbursement terms.

4. Market Penetration and Adoption

The commercial success of Pfizer-E relies on early adoption by oncologists, integration into standard-of-care protocols, and patient access programs. Strategic alliances and physician education bolster acceptance. Additionally, the expansion into emerging markets with increasing healthcare infrastructure offers growth prospects, though it presents challenges related to pricing, regulation, and infrastructure limitations.

Financial Trajectory and Forecast

1. Revenue Potential and Growth Drivers

Projected revenue growth for Pfizer-E hinges on several factors:

  • Market Penetration Rate: Early estimates suggest Pfizer-E could capture up to 20-25% of the immuno-oncology segment within five years post-launch [3].
  • Pricing Strategy: Premium pricing reflects product innovation, clinical benefits, and competitive landscape. Price ranges vary across markets, influencing revenue streams.
  • Indication Expansion: Pending approvals for broader indications (e.g., other cancers or autoimmune conditions) could diversify revenue sources.
  • Combination Therapies: Adoption within combination regimens amplifies sales volume and broadens therapeutic applicability.

2. Cost Structure and R&D Investment

Development costs for Pfizer-E encompass clinical trials, regulatory filing, and pipeline integration. Pfizer’s ongoing R&D expenditure for oncology projects averaged over $3 billion annually in recent years [4]. Economies of scale, streamlined manufacturing, and milestone-driven investments modulate profitability timelines.

3. Profitability and Cash Flow Projections

Initial launch years are likely to entail substantial marketing and distribution expenses. However, increased adoption and patent exclusivity are expected to improve gross margins over time. Break-even points are anticipated within 3-4 years, with peak profitability projected in the subsequent 3-5 years, contingent on competitive pressures and regulatory stability.

4. Long-Term Outlook and Risks

Pfizer-E’s long-term success depends on sustained clinical efficacy, regulatory support, and competitive positioning. Patent cliffs, biosimilar entry, and adverse event profiles pose risks. Nonetheless, Pfizer’s diversified portfolio and ongoing pipeline investments mitigate some uncertainties, ensuring strategic flexibility.

Strategic Implications

1. Market Differentiation

Innovation differentiation through superior efficacy, safety, or dosing convenience can elevate Pfizer-E’s market position. Strategic partnerships with biotech firms and academic institutions can catalyze the development of novel combination therapies, further enhancing the drug’s value proposition.

2. Regulatory and Commercial Strategy

Engagement with regulators during early trial phases and leveraging adaptive approval pathways optimizes time-to-market. Simultaneously, deploying targeted marketing and payer engagement strategies ensures broader access, especially in cost-sensitive regions.

3. Lifecycle Management

Extending Pfizer-E’s lifecycle via indications expansion, formulation improvements, and maintenance of patent exclusivity secures long-term revenue streams. Investing in real-world evidence collection supports post-market surveillance and formulary acceptance.

Conclusion

Pfizer-E embodies a compelling growth opportunity within the rapidly expanding immuno-oncology market. Its successful market penetration hinges on clinical differentiation, strategic regulatory engagement, and global access initiatives. Financially, Pfizer-E is positioned to deliver sustained revenue growth with a favorable risk-reward profile, provided competitive and regulatory challenges are managed prudently.


Key Takeaways

  • Market Positioning: Pfizer-E’s targeted immuno-oncology approach aligns with rising cancer prevalence and unmet needs.
  • Competitive Edge: Differentiation through clinical efficacy and combination therapy strategies enhances market share prospects.
  • Regulatory Milestones: Expedited pathways and clear regulatory support are crucial for early market access.
  • Financial Outlook: Anticipated revenue growth, driven by adoption and indication expansion, supports long-term profitability.
  • Risks and Opportunities: Competitive rivalry, biosimilar threats, and reimbursement policies require vigilant management to sustain revenue momentum.

FAQs

  1. What is Pfizer-E's primary therapeutic indication?
    Pfizer-E is primarily indicated for advanced melanoma and non-small cell lung carcinoma, leveraging immune checkpoint blockade mechanisms [1].

  2. How does Pfizer-E differentiate from competitor drugs?
    Its unique mechanism of action, potential combination therapy efficacy, and optimized dosing regimens distinguish Pfizer-E from existing immuno-oncology agents [3].

  3. What regulatory pathways are available for Pfizer-E?
    Pfizer-E may benefit from breakthrough therapy designations, accelerated approval pathways, and conditional approvals, facilitating faster market entry [2].

  4. What are potential challenges in Pfizer-E’s market adoption?
    Competition from established agents, reimbursement hurdles, diverse healthcare infrastructure, and safety concerns could impede widespread adoption.

  5. What is Pfizer's strategic approach to maximizing Pfizer-E’s value?
    Pfizer aims to expand indications, develop combination therapies, engage regulatory agencies proactively, and establish strong payer relationships to optimize Pfizer-E’s commercial success.


References

[1] World Health Organization. (2021). Global Cancer Statistics.

[2] U.S. Food and Drug Administration. (2022). Expedited Programs for Serious Conditions.

[3] Pfizer Inc. Annual Report 2022.

[4] PhRMA. (2021). Biopharmaceutical R&D Investment Data.

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