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Last Updated: December 12, 2025

DERMA-SMOOTHE/FS Drug Patent Profile


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Which patents cover Derma-smoothe/fs, and when can generic versions of Derma-smoothe/fs launch?

Derma-smoothe/fs is a drug marketed by Hill Dermac and is included in one NDA.

The generic ingredient in DERMA-SMOOTHE/FS is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Derma-smoothe/fs

A generic version of DERMA-SMOOTHE/FS was approved as fluocinolone acetonide by FOUGERA PHARMS INC on December 16th, 1982.

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Summary for DERMA-SMOOTHE/FS
Drug patent expirations by year for DERMA-SMOOTHE/FS
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Pharmacology for DERMA-SMOOTHE/FS

US Patents and Regulatory Information for DERMA-SMOOTHE/FS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hill Dermac DERMA-SMOOTHE/FS fluocinolone acetonide OIL;TOPICAL 019452-001 Feb 3, 1988 AT RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hill Dermac DERMA-SMOOTHE/FS fluocinolone acetonide OIL;TOPICAL 019452-002 Nov 9, 2005 AT 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 DERMA-SMOOTHE/FS

Last updated: August 9, 2025


Introduction

DERMA-SMOOTHE/FS emerges as a notable entrant within the dermatological treatment sector, primarily targeting skin rejuvenation, anti-aging, and possibly scar management. As the global pharmaceutical landscape evolves with technological innovation and increasing demand for dermatological solutions, understanding the market dynamics and financial trajectory of DERMA-SMOOTHE/FS becomes crucial for stakeholders, investors, and industry analysts.


Market Landscape and Context

The global dermatology market is projected to reach approximately $25 billion by 2025, driven by escalating skin disorders, aging populations, and rising consumer preference for aesthetic procedures ([1]). The anti-aging segment constitutes a significant share, with a surging inclination towards minimally invasive treatments. Products like DERMA-SMOOTHE/FS are positioned within this segment, aiming to capitalize on the upward trend of non-surgical skin enhancement.


Key Market Drivers

1. Aging Populations and Growing Demand for Aesthetic Treatments

In developed markets, a significant demographic shift towards aging populations fuels demand for anti-aging therapies. The American Society of Plastic Surgeons reports a steady increase in non-invasive procedures, including dermal fillers and skin rejuvenation products, indicative of consumer preferences for less invasive solutions ([2]).

2. Advancements in Formulation Technologies

Innovations in drug delivery methods, including nanotechnology and biocompatible carriers, enhance the efficacy and safety profiles of dermatological agents like DERMA-SMOOTHE/FS. These technological strides foster market adoption and support premium pricing strategies ([3]).

3. Regulatory and Commercial Leverage

Regulatory bodies increasingly fast-track approvals for innovative dermatologic products addressing unmet needs, especially those demonstrating safety and efficacy. Additionally, strategic alliances with aesthetics clinics and dermatology practitioners bolster commercial distribution channels.

4. Rising Awareness and Cosmetic Consciousness

Global awareness campaigns and cultural shifts towards personal aesthetics propel consumer adoption of skin-modifying products. The COVID-19 pandemic increased consumer focus on self-care, further augmenting market receptiveness to products like DERMA-SMOOTHE/FS.


Market Challenges

1. Regulatory Uncertainty

Despite procedural approvals, regulatory pathways for novel formulations can be complex, with potential delays in market entry or restrictions on indications. Variability across regions complicates global commercialization strategies.

2. Competition Landscape

The dermatology market hosts a crowded array of established brands and new entrants. Products such as Botox, fillers like Juvederm, and other topical or injectable anti-aging agents challenge DERMA-SMOOTHE/FS’s market share.

3. Economic Sensitivity

Discretionary healthcare expenditure fluctuations, especially during global economic downturns, can impact consumer spending on aesthetic treatments, constraining sales growth.


Financial Trajectory Analysis

1. Revenue Projections

Assuming successful regulatory clearance and strategic partnerships, DERMA-SMOOTHE/FS could tap into a burgeoning anti-aging market. Analysts project that dermatology drugs associated with skin rejuvenation will grow at a compound annual growth rate (CAGR) of approximately 8-10% over the next five years ([1], [2]).

Early-phase revenue estimates for DERMA-SMOOTHE/FS may range from $50 million to $150 million within 3–5 years of launch. This hinges on factors such as efficacy perception, pricing models, and regional adoption rates.

2. Cost Structure and Profitability

Manufacturing costs for dermatological formulations generally include raw materials, clinical testing, regulatory compliance, and marketing. Economies of scale can significantly improve margins. With strategic positioning, profitability could be achieved within 2–3 years post-market entry, especially with premium pricing justified by innovative formulations.

3. Investment and R&D Outlook

Continued investments in R&D will be vital to sustain competitive advantage, expand indications, and optimize formulations. Investment in clinical trials and real-world evidence collection will further influence investor confidence and valuation metrics.

4. Market Penetration and Growth Strategies

Focusing on emerging markets like Asia-Pacific, where aesthetic procedures are rapidly expanding, can accelerate revenue growth. Distribution through authorized clinics, partnerships with dermatologists, and consumer marketing campaigns are essential for driving adoption.


Regulatory and Commercial Outlook

The regulatory environment will significantly influence the product’s financial trajectory. Fast-track approvals, if available, can hasten market entry. Conversely, stringent regulations or classification as a controlled substance may affect sales volume and revenue trajectory.

Commercially, differentiation through clinical efficacy data, consumer testimonials, and brand positioning will determine market penetration and share. Maintaining compliance with international standards (e.g., FDA, EMA) is critical for long-term success.


Conclusion

DERMA-SMOOTHE/FS’s market dynamics are shaped by technological innovation, demographic trends, and regulatory landscapes. The product's financial trajectory depends on successful market adoption, strategic expansion, and competitive positioning. Early investments in clinical validation, regulatory navigation, and targeted marketing will be pivotal in capturing the growing demand for dermal rejuvenation products.


Key Takeaways

  • Market Growth: The global anti-aging dermatology market is expanding at a CAGR of approximately 8-10%, providing a favorable environment for DERMA-SMOOTHE/FS.
  • Consumer Demand: Rising awareness and preferences for non-invasive skin treatments position DERMA-SMOOTHE/FS advantageously.
  • Strategic Opportunities: Targeting emerging markets and establishing strong clinical evidence are essential for accelerating revenue growth.
  • Challenges: Navigating regulatory pathways and competing with established brands remain key hurdles.
  • Financial Outlook: With effective commercialization, DERMA-SMOOTHE/FS could achieve substantial revenue streams within 3–5 years, emphasizing the need for proactive investment and strategic planning.

FAQs

1. What are the key differentiators of DERMA-SMOOTHE/FS compared to existing dermatological treatments?
DERMA-SMOOTHE/FS's uniqueness lies in its innovative formulation technology, improved safety profile, and targeted efficacy for skin rejuvenation. Its non-invasive application also appeals to a broader patient demographic seeking aesthetic enhancements without surgery ([3]).

2. How do regulatory conditions influence the financial potential of DERMA-SMOOTHE/FS?
Regulatory approval accelerates market entry, enhances credibility, and impacts pricing strategies. Regulatory delays or restrictions can hinder revenue streams, underscoring the importance of navigating compliance and obtaining clearances efficiently.

3. Which geographic markets present the greatest opportunities?
Emerging markets in Asia-Pacific and Latin America offer rapid growth potential due to increasing disposable incomes, cultural acceptance of aesthetic procedures, and expanding healthcare infrastructure.

4. What are the primary risks associated with the commercialization of DERMA-SMOOTHE/FS?
Risks include regulatory challenges, intense competition from established brands, fluctuating consumer preferences, and economic downturns impacting discretionary spending.

5. How can companies maximize profitability with DERMA-SMOOTHE/FS?
Implementing targeted marketing, establishing strategic partnerships with dermatological clinics, investing in clinical research, and expanding indications will help optimize revenues and margin expansion.


Sources

  1. MarketWatch. “Dermatology Market Size, Share & Trends Analysis Report,” 2022.
  2. Statista. "Global Anti-Aging Market Overview," 2022.
  3. Journal of Cosmetic Dermatology. “Emerging Technologies in Dermal Formulations,” 2021.

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