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Last Updated: December 11, 2025

WESTCORT Drug Patent Profile


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When do Westcort patents expire, and when can generic versions of Westcort launch?

Westcort is a drug marketed by Sun Pharm Inds Inc and is included in two NDAs.

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

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Summary for WESTCORT
Drug patent expirations by year for WESTCORT
Recent Clinical Trials for WESTCORT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Stanford UniversityPhase 2
The Leukemia and Lymphoma SocietyPhase 2
National Cancer Institute (NCI)Phase 2

See all WESTCORT clinical trials

US Patents and Regulatory Information for WESTCORT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Inc WESTCORT hydrocortisone valerate CREAM;TOPICAL 017950-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sun Pharm Inds Inc WESTCORT hydrocortisone valerate OINTMENT;TOPICAL 018726-001 Aug 8, 1983 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: WESTCORT

Last updated: August 1, 2025


Introduction

WESTCORT, a topical corticosteroid formulated as a hydrocortisone valerate cream, has established itself within dermatology’s therapeutic landscape. Its core indications—primarily for inflammatory and Pruritic conditions such as eczema, dermatitis, and psoriasis—anchor its commercial positioning. As the pharmaceutical sector evolves amid regulatory shifts, technological innovations, and market demand fluctuations, understanding the dynamic forces shaping WESTCORT’s trajectory is essential for stakeholders evaluating investment, licensing, or competitive strategies.


Pharmacological Profile and Clinical Relevance

WESTCORT's active ingredient, hydrocortisone valerate, offers potent anti-inflammatory, antipruritic, and vasoconstrictive properties. Its efficacy in reducing skin inflammation makes it a preferred topical corticosteroid, particularly in moderate to severe inflammatory dermatological indications. The formulation’s safety profile—characterized by minimal systemic absorption when used appropriately—solidifies its clinical utility and supports ongoing prescription rates.


Market Dynamics Influencing WESTCORT

1. Regulatory Environment and Patent Landscape

While WESTCORT is available as a generic formulation, patent expirations for certain corticosteroids have expanded market competition. The expiration of patents on corticosteroid formulations has created opportunities for generic manufacturers, intensifying price competition and pressuring brand-name sales. Conversely, stringent regulatory pathways—such as the FDA’s ANDA (Abbreviated New Drug Application) process—pose entry barriers for new entrants but facilitate generic proliferation, impacting profit margins.

2. Competitive Landscape

The dermatology segment hosts a mature portfolio of corticosteroids, including potent options like clobetasol propionate and betamethasone dipropionate. WESTCORT competes on efficacy, safety profile, and formulary positioning. The rise of biosimilars and new topical agents targeting inflammatory pathways (e.g., calcineurin inhibitors, PDE4 inhibitors) introduces substitution threats and alternative therapies. Pharmaceutical companies leverage clinical data and formulary negotiations to maintain market share.

3. Prescriber and Patient Trends

Increasing awareness of corticosteroid adverse effects—such as skin atrophy, hypothalamic-pituitary-adrenal (HPA) axis suppression—has increased the emphasis on prescribing the lowest effective potency for the shortest duration, potentially limiting long-term sales volume. Growing preference for non-steroidal topical agents in certain patient populations influences overall demand, but corticosteroids remain central to acute management.

4. Geographic and Demographic Factors

Market penetration varies globally. Developed markets (e.g., North America, Europe) benefit from established regulatory approval, high dermatologist prescription rates, and insurance coverage, sustaining steady revenue streams. Emerging markets—such as Asia-Pacific and Latin America—offer growth potential driven by rising dermatology awareness, increasing disposable income, and expanding healthcare infrastructure, though regulatory hurdles and pricing pressures are more prominent.

5. Innovation and Formulation Advances

Advances in topical delivery systems—such as liposomal, nanotechnology-based, or novel carriers—aim to enhance drug penetration, reduce side effects, and improve patient compliance. While WESTCORT’s current formulation remains standard, innovation could impact its market longevity, either through reformulation or the evolution of combination therapies.


Financial Trajectory and Sales Forecasts

1. Historical Sales Patterns

Though specific sales figures for WESTCORT are proprietary, analyses of corticosteroid segments reveal moderate growth trajectories over recent years, attributed to continued demand in dermatology and the aging population’s skin health needs. The global topical corticosteroid market was valued at approximately USD 3 billion in 2021, with a projected CAGR of 4.3% through 2028, indicating consistent demand (Statista, 2022).

2. Revenue Drivers

  • Pricing Dynamics: Price stabilization through generic competition tends to narrow margins; however, high-value formulations with differentiated features could maintain premium pricing.
  • Prescription Trends: Increases in dermatology diagnoses, especially in aging demographics, and greater adoption of corticosteroids as first-line therapy underpin sustained sales.
  • Reimbursement Policies: Insurance coverage and formulary prioritization directly influence prescription volume and patient access.

3. Outlook and Future Trends

Given the current landscape, WESTCORT’s financial trajectory is poised for stable maintenance or slow growth, contingent on:

  • Continued formulary inclusion.
  • Strategic licensing agreements.
  • Adoption of innovative delivery systems.
  • Expansion into emerging markets with targeted regulatory strategies.

Potential decline could materialize if non-steroidal topical agents or systemic therapies replace corticosteroids in treatment algorithms or if regulatory pressures mandate cost-containment.


Strategic Implications and Opportunities

  • Diversification: Formulation improvements (e.g., combination therapies, reduced potency formulations) can expand indications and patient acceptance.
  • Market Expansion: Focused entry into high-growth geographies, especially in Asia-Pacific, can augment revenues.
  • Regulatory Push: Navigating fast-track approvals or gaining extended exclusivity rights through formulations or delivery mechanisms can prolong market dominance.
  • Innovation: Investing in evidence-based, non-steroidal alternatives could mitigate future competitive threats.

Key Takeaways

  • WESTCORT’s market stability hinges on its proven efficacy and safety profile amidst fierce generic competition.
  • Regulatory landscapes, especially patent expirations, broadly influence its pricing and market share.
  • Demographic shifts and geographic expansion, notably in emerging markets, provide growth opportunities.
  • Innovation in formulations and delivery systems may extend the brand’s relevance and commercial lifespan.
  • The overall financial trajectory is characterized by steady demand with moderate growth, subject to regulatory, competitive, and technological dynamics.

FAQs

1. What factors affect WESTCORT's market share in dermatological treatments?
Market share is influenced by regulatory approvals, formulary inclusion, competitive pricing, prescriber preferences, and the emergence of alternative therapies.

2. How do patent expirations impact WESTCORT's market prospects?
Patent expirations typically lead to increased generic competition, reducing prices and profit margins but broadening access and usage.

3. Are there upcoming innovations that could disrupt WESTCORT's market?
Yes, non-steroidal anti-inflammatory topical agents and advanced delivery systems are emerging, potentially replacing traditional corticosteroids in some indications.

4. What geographic markets offer the most growth opportunities for WESTCORT?
Emerging regions like Asia-Pacific and Latin America, driven by rising dermatology awareness and healthcare access, present significant expansion potential.

5. How important are regulatory strategies in sustaining WESTCORT's financial performance?
They are critical; timely approvals, patent protections, and compliance determine market exclusivity and revenue continuity.


References

  1. Statista. (2022). Global Topical Corticosteroids Market Size & Industry Trends.
  2. FDA. (2020). ANDA Submission and Approval Process for Generic Drugs.
  3. MarketWatch. (2023). Dermatology Drugs Market Analysis and Forecast.
  4. EvaluatePharma. (2022). Topical Corticosteroids: Market Overview & Future Outlook.
  5. IMS Health. (2021). Prescription Trends in Dermatology.

This comprehensive analysis aims to empower business professionals with strategic insights into WESTCORT’s current market position and future financial prospects, enabling informed decision-making within the dermatological pharmaceutical sector.

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