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Last Updated: December 30, 2025

LOCOID LIPOCREAM Drug Patent Profile


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Which patents cover Locoid Lipocream, and what generic alternatives are available?

Locoid Lipocream is a drug marketed by Precision Dermat and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Locoid Lipocream

A generic version of LOCOID LIPOCREAM was approved as hydrocortisone butyrate by TARO PHARM INDS on January 14th, 2004.

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Summary for LOCOID LIPOCREAM
Drug patent expirations by year for LOCOID LIPOCREAM
Drug Prices for LOCOID LIPOCREAM

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Recent Clinical Trials for LOCOID LIPOCREAM

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

SponsorPhase
Icahn School of Medicine at Mount SinaiN/A
St. Luke's-Roosevelt Hospital CenterPhase 4
GlaxoSmithKlinePhase 4

See all LOCOID LIPOCREAM clinical trials

Paragraph IV (Patent) Challenges for LOCOID LIPOCREAM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LOCOID LIPOCREAM Cream hydrocortisone butyrate 0.10% 020769 1 2010-06-28

US Patents and Regulatory Information for LOCOID LIPOCREAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Precision Dermat LOCOID LIPOCREAM hydrocortisone butyrate CREAM;TOPICAL 020769-001 Sep 8, 1997 AB2 RX Yes Yes ⤷  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 LOCOID LIPOCREAM

Last updated: July 30, 2025


Introduction

LOCOID LIPOCREAM, a topical corticosteroid formulated for inflammation, dermatitis, and other dermatological conditions, has carved a niche in the dermatology segment of pharmaceutical markets worldwide. Its significance hinges on evolving dermatological needs, regulatory landscapes, and competitive dynamics. This analysis explores the market forces shaping LOCOID LIPOCREAM’s trajectory, its financial prospects, and strategic considerations underpinning its growth.


Pharmaceutical Market Overview: Dermatology and Topical Corticosteroids

The global dermatology market is projected to reach USD 29.24 billion by 2027, expanding at a CAGR of 7.7% [1]. Topical corticosteroids, including LOCOID LIPOCREAM, represent a substantial segment, with applications spanning eczema, psoriasis, seborrheic dermatitis, and allergic reactions. The rising prevalence of dermatological disorders—driven by lifestyle factors, environmental changes, and aging populations—bolsters demand.

LOCOID LIPOCREAM, as a mid-potency corticosteroid, is favored for its efficacy and safety profile, especially in sensitive skin areas. Its formulation as a lipocream enhances skin penetration and patient adherence.


Market Dynamics Influencing LOCOID LIPOCREAM

1. Increasing Prevalence of Dermatological Diseases

The escalation of skin conditions such as atopic dermatitis, psoriasis, and contact dermatitis contributes directly to increased demand for corticosteroid treatments. The World Health Organization estimates that atopic dermatitis affects approximately 15-20% of children and 1-3% of adults globally, highlighting significant treatment needs [2].

2. Rising Aging Population and Chronic Skin Disorders

Elderly populations are more susceptible to chronic skin conditions. The aging demographic is expanding, particularly in developed nations, which sustains steady demand for corticosteroid therapies like LOCOID LIPOCREAM.

3. Advances in Derma-Pharmacology and Liposomal Formulations

Innovations in formulation science, especially liposomal delivery systems, improve drug efficacy and reduce adverse effects, thereby broadening clinical use cases and patient acceptability. Lipocream bases enhance percutaneous absorption, making LOCOID LIPOCREAM a preferred choice in many treatment protocols.

4. Regulatory and Pricing Dynamics

Stringent regulatory reviews, especially in markets like the U.S., Europe, and Japan, impact product launch timelines and profitability. Patent protections for formulations influence pricing strategies, with generics entering markets post-patent expiry, intensifying price competition.

5. Market Penetration and Physician Prescribing Behaviors

Physician awareness and comfort level with LOCOID LIPOCREAM influence its market penetration. Educational initiatives, clinical guidelines, and real-world evidence bolster prescribing patterns.

6. Competition and Brand Positioning

LOCOID LIPOCREAM faces competition from both established brands and biosimilars. Differentiation based on formulation strength, safety profile, and cost influences market share.


Financial Trajectory and Growth Drivers

1. Revenue Streams and Pricing Strategies

LOCOID LIPOCREAM’s revenue heavily depends on established OBVIOUSMDs, market penetration, and pricing strategies. As patents expire or face challenges, generic versions decrease prices, impacting margins but expanding volume sales.

2. Market Expansion and Geographic Growth

Initial strongholds in North America and Europe now extend into emerging markets such as India, Brazil, and Southeast Asia, where dermatology disease prevalence is rising, and access to affordable formulations is improving. Regulatory approvals and market entry strategies in these regions can exponentially increase revenues.

3. Product Line Extensions and New Formulations

Development of new concentrations, combined formulations (e.g., corticosteroid with emollients or anti-infectives), and alternative delivery systems (e.g., foams, gels) create additional revenue streams and mitigate competitive pressure.

4. Strategic Partnerships and Licensing Deals

Collaborations with regional pharmaceutical firms facilitate faster market penetration and local manufacturing, reducing costs and improving margins while increasing overall sales.

5. Impact of Patent and Regulatory Environment

Patent expirations represent a pivotal point, leading to increased generic competition. Conversely, new patent filings for novel formulations or delivery mechanisms can protect market share and sustain premium pricing over extended periods.


Market Challenges

  • Safety Concerns and Refinements: Long-term corticosteroid use risks, such as skin atrophy, necessitate careful prescribing, which can restrict market growth.
  • Generic Competition: The entrance of lower-cost generics post-patent expiry dilutes revenue and margin potential.
  • Regulatory Barriers: Variability in approval processes across regions delays commercialization.
  • Patient Compliance: Formulation acceptability impacts adherence, influencing pharmaceutical utilization.

Projected Financial Trajectory

Considering current growth drivers and challenges, LOCOID LIPOCREAM’s market share is poised to grow steadily over the next five years. The compound annual growth rate (CAGR) for the corticosteroid topical segment is expected to remain around 6-8%. For LOCOID specifically, early-stage expansion could see revenues increase at a CAGR of approximately 4-6%, contingent on geographic expansion, innovation, and market share capture.

In mature markets, revenue stabilization may occur due to saturation, but expansion into emerging markets and portfolio diversification could offset this plateau. The development of new formulations and combinations might create incremental revenue streams, adding resilience.


Strategic Considerations for Stakeholders

  • Accelerate Clinical Evidence Generation: Demonstrating safety and comparative efficacy can solidify LOCOID LIPOCREAM’s positioning.
  • Optimize Market Entry: Focus on regions with unmet dermatology needs and favorable regulatory environments.
  • Innovate Formulations: Invest in novel delivery systems to enhance competitive advantage.
  • Expand Product Portfolio: Develop complementary dermatological therapies for dosage flexibility and broader indications.
  • Monitor Patent Landscape: Navigate patent expiries prudently, securing new patent protections where possible.

Conclusion

LOCOID LIPOCREAM's market has a resilient growth outlook driven by escalating dermatological disorder prevalence, formulation innovations, and demographic trends. Its financial trajectory hinges on strategic market penetration, innovation, and navigating regulatory pathways effectively. While challenges such as competition and safety concerns persist, ongoing product differentiation and geographic expansion stand to bolster its revenue streams over the foreseeable horizon.


Key Takeaways

  • The global dermatology market, especially topical corticosteroids, is on a steady growth trajectory, propelling LOCOID LIPOCREAM’s demand.
  • Demographic and environmental factors are primary drivers, with aging populations amplifying chronic condition management needs.
  • Innovation in formulation, regulatory navigation, and geographic expansion are central to maximizing revenue potential.
  • Patent expirations necessitate strategic pivoting toward generics and biosimilars, emphasizing cost-efficiency and market share maintenance.
  • Stakeholders should prioritize clinical data, product differentiation, and regional strategies to sustain long-term profitability.

FAQs

1. What are the primary dermatological conditions treated with LOCOID LIPOCREAM?
LOCOID LIPOCREAM is primarily used to treat inflammatory skin conditions such as eczema, psoriasis, contact dermatitis, and seborrheic dermatitis, leveraging its corticosteroid potency for anti-inflammatory and immunosuppressive effects.

2. How does formulation innovation impact LOCOID LIPOCREAM’s market position?
Formulation advancements, particularly liposomal delivery systems, enhance drug penetration and safety, improving patient adherence and expanding therapeutic indications, thereby strengthening market position.

3. What are the major regulatory considerations affecting LOCOID LIPOCREAM’s market expansion?
Regulatory bodies like the FDA and EMA scrutinize safety and efficacy data, impacting approval timelines. Variability across regions can delay market entry; compliance with local standards is crucial.

4. How do patent expiries influence LOCOID LIPOCREAM’s revenue future?
Patent expiries open the market to generic competitors, reducing prices and margins but potentially increasing volume sales. Strategic innovation and patent filings can mitigate revenue declines.

5. What are the key strategic steps for pharmaceutical companies aiming to grow LOCOID LIPOCREAM’s market share?
Investing in clinical research, expanding into emerging markets, developing new formulations, and forming regional partnerships are vital strategies to enhance market share and ensure sustained growth.


References

[1] Research and Markets. “Dermatology Drugs Market Analysis & Trends,” 2022.
[2] World Health Organization. “Global Prevalence of Atopic Dermatitis,” 2021.

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