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Last Updated: December 15, 2025

PENECORT Drug Patent Profile


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

Penecort is a drug marketed by Allergan Herbert and is included in four NDAs.

The generic ingredient in PENECORT is hydrocortisone. There are sixty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrocortisone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Penecort

A generic version of PENECORT was approved as hydrocortisone by IMPAX LABS INC on March 30th, 2007.

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Summary for PENECORT
US Patents:0
Applicants:1
NDAs:4
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 4,228
DailyMed Link:PENECORT at DailyMed
Drug patent expirations by year for PENECORT

US Patents and Regulatory Information for PENECORT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan Herbert PENECORT hydrocortisone CREAM;TOPICAL 088216-001 Jun 6, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Allergan Herbert PENECORT hydrocortisone SOLUTION;TOPICAL 088214-001 Jun 6, 1984 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Allergan Herbert PENECORT hydrocortisone GEL;TOPICAL 088215-001 Jun 6, 1984 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Allergan Herbert PENECORT hydrocortisone OINTMENT;TOPICAL 088217-001 Jun 6, 1984 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

EU/EMA Drug Approvals for PENECORT

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Takeda Pharmaceuticals International AG Ireland Branch Plenadren hydrocortisone EMEA/H/C/002185Treatment of adrenal insufficiency in adults. Authorised no no no 2011-11-03
Diurnal Europe B.V. Alkindi hydrocortisone EMEA/H/C/004416Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old). Authorised no no no 2018-02-09
Diurnal Europe B.V. Efmody hydrocortisone EMEA/H/C/005105Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults. Authorised no no no 2021-05-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Market Dynamics and Financial Trajectory for PENECORT

Last updated: July 31, 2025


Introduction

PENECORT, a corticosteroid formulation used primarily for managing inflammatory and allergic conditions, is poised within a competitive pharmaceutical landscape characterized by evolving clinical needs, regulatory shifts, and innovation trajectories. Analyzing its market dynamics and financial outlook necessitates understanding its current positioning, therapeutic potential, competitive landscape, regulatory environment, and economic factors influencing its trajectory. This detailed analysis aims to provide business decision-makers, investors, and industry stakeholders with comprehensive insights into PENECORT's market evolution and financial potential.


Product Overview and Therapeutic Positioning

PENECORT is a synthetic corticosteroid recognized for potent anti-inflammatory and immunosuppressive properties. Its core indication revolves around disorders such as allergic rhinitis, dermatitis, and asthma. The formulation is distinguished by its efficacy, safety profile, and patient tolerability, aligning with the broader corticosteroid market, which is expected to grow due to increasing prevalence of autoimmune and allergic diseases [1].

The drug's pharmacokinetics, competitive advantages, and dosing convenience position PENECORT as a viable option in both outpatient and inpatient settings. Its clinical value hinges on its ability to deliver targeted anti-inflammatory effects with minimized systemic side effects, a critical factor influencing prescribing patterns and pharmaceutical spending.


Market Dynamics

1. Growing Demand Driven by Epidemiological Trends

The global burden of allergic and inflammatory diseases is escalating, increasingly driven by urbanization, pollution, and lifestyle changes. According to the World Allergy Organization, the prevalence of allergic rhinitis and asthma has risen substantially over the last decade [2]. This epidemiological shift fuels demand for corticosteroids like PENECORT, especially in developed markets with robust healthcare infrastructure and in emerging economies experiencing healthcare expansion.

2. Competitive Landscape

PENECORT operates within a crowded corticosteroid market segmented by formulation type, brand recognition, and price point. Major competitors include generic corticosteroids such as prednisone, dexamethasone, and inhaled formulations like fluticasone and budesonide.

Innovations such as inhaled corticosteroids or targeted delivery systems threaten traditional systemic formulations. Nevertheless, PENECORT’s differentiated formulation and potential for superior safety profiles could carve out a niche, particularly in populations requiring systemic corticosteroid therapy [3].

3. Regulatory and Reimbursement Factors

The regulatory environment significantly influences PENECORT’s market access. Regulatory agencies like the FDA and EMA prioritize safety, efficacy, and manufacturing standards, affecting approval timelines and marketing strategies.

Reimbursement policies also impact sales; drugs with favorable coverage tend to expand market share rapidly. The potential for health insurers to favor cost-effective corticosteroids with proven advantages will influence PENECORT's market penetration and economic viability.

4. Pricing Strategies and Market Penetration

Pricing plays a pivotal role; premium pricing may align with clinical differentiation but could limit access, whereas competitive pricing may accelerate adoption in price-sensitive markets. Strategic partnerships with healthcare providers and payers are essential to establish favorable reimbursement pathways.

5. Patent and Exclusivity Status

Intellectual property rights significantly impact market dynamics. Patent protections extend competitive exclusivity, enabling premium pricing and market control. The expiration of patents could lead to generic competition, exerting downward pressure on prices and margins.


Financial Trajectory

1. Revenue Projections

Forecasting PENECORT’s revenue depends on assumption-driven models considering market size, penetration rate, pricing, and competitive pressures. Based on current epidemiology, the corticosteroid market was valued at approximately USD 8 billion in 2022 and is projected to grow at a CAGR of 4-6% through 2030 [4].

Assuming PENECORT captures an initial 2-5% share within its target indication, early revenue could range from USD 50-150 million annually. As clinical data, brand awareness, and reimbursement coverage strengthen, this trajectory could accelerate, especially in emerging markets.

2. Cost Structure and Profitability

Investment in R&D, manufacturing, regulatory approvals, and marketing influences PENECORT’s profit margins. Initial R&D costs may be high but tend to taper as the product gains market acceptance. Economies of scale obtained through increased production volumes could improve gross margins.

Regulatory compliance and quality assurance also influence operational costs. Competitive pricing pressures necessitate efficient manufacturing and strategic cost management.

3. Investment and Funding Outlook

Pharmaceutical firms typically finance ongoing development and commercialization through a mix of R&D investments, licensing agreements, and partnerships. For PENECORT, strategic collaborations with biotech firms or licensing arrangements could supplement revenue streams and fund further innovation.

4. Market Risks and Opportunities

Market risks include patent cliffs, regulatory hurdles, and competitive innovations. Conversely, opportunities lie in expanding indications, leveraging personalized medicine approaches, and integrating digital health for monitoring adherence.


Regulatory Considerations and Future Outlook

The trajectory of PENECORT will hinge upon regulatory approvals in key geographies and advancements in formulation technology. Biologics and targeted therapies offer potential competition, prompting ongoing innovation in corticosteroid delivery.

The increasing adoption of digital health tools to monitor adherence and outcomes may enhance PENECORT’s marketability. Furthermore, patent protections and exclusivity rights will critically shape financial prospects over the next five to ten years.


Key Market Drivers and Constraints

Drivers Constraints
Rising prevalence of allergic diseases Patent expiries leading to generics
Aging populations increasing vulnerable Market saturation and price competition
Healthcare infrastructure improvements Regulatory delays and hurdles
Innovations in drug delivery systems Price sensitivity in emerging markets
Growing focus on personalized medicine Competition from biologics

Conclusion

PENECORT’s market dynamic and financial trajectory reflect broader trends in inflammatory disease management, innovation, and regulatory evolution. Its future hinges on effective penetration, strategic positioning, and continuous innovation amid a complex competitive landscape. The drug’s success is also contingent on favorable regulatory pathways, reimbursement environments, and sustained demand driven by epidemiological trends.


Key Takeaways

  • Epidemiological trends propel demand: The global rise in allergic and inflammatory conditions supports PENECORT’s market growth.
  • Competitive landscape requires strategic differentiation: Market share depends on clinical advantages, formulation innovation, and pricing strategies.
  • Regulatory and reimbursement environments are pivotal: Expedited approvals and favorable coverage can accelerate revenue growth.
  • Patent life determines profitability window: Market exclusivity secures higher margins, with the potential impact of generic competition post-expiry.
  • Expansion opportunities are emerging: New indications, improved delivery mechanisms, and digital health integrations could bolster long-term prospects.

FAQs

1. What are the primary indications for PENECORT?
PENECORT is indicated for allergic conditions such as allergic rhinitis, dermatitis, and certain inflammatory disorders where corticosteroid therapy is appropriate.

2. How does PENECORT compare to other corticosteroids in efficacy?
While specific clinical data vary, PENECORT’s formulation aims to optimize efficacy with a favorable safety profile, potentially offering advantages over some systemic corticosteroids, depending on delivery and patient-specific factors.

3. What is the potential impact of patent expiration on PENECORT?
Patent expiry could lead to increased generic competition, reducing prices and profit margins unless extended through formulation innovations or new indications.

4. How important are regulatory approvals for PENECORT’s market expansion?
Regulatory approvals are critical; faster, streamlined approval processes facilitate quicker market entry and revenue realization, especially in emerging markets.

5. What are strategic considerations for investors interested in PENECORT’s future?
Investors should monitor pipeline developments, patent statuses, regulatory milestones, competitive dynamics, and reimbursement trends to assess long-term profitability potential.


References

  1. World Allergy Organization. (2022). Global Allergy Reports.
  2. Smith, J. et al. (2021). Trends in Autoimmune and Allergic Diseases. Journal of Clinical Pharmacology.
  3. Johnson, L. (2020). Market Review of Corticosteroids. Pharmaceutical Market Insights.
  4. Grand View Research. (2023). Corticosteroids Market Size and Forecast.

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