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Last Updated: November 9, 2025

Betamethasone benzoate - Generic Drug Details


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What are the generic sources for betamethasone benzoate and what is the scope of freedom to operate?

Betamethasone benzoate is the generic ingredient in one branded drug marketed by Parke Davis and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for betamethasone benzoate.

Summary for betamethasone benzoate
US Patents:0
Tradenames:1
Applicants:1
NDAs:4
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 22
DailyMed Link:betamethasone benzoate at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for betamethasone benzoate
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AC Corticosteroids, potent (group III)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XC Corticosteroids, potent, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
R03BA Glucocorticoids
R03B OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03 DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R Respiratory system
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

US Patents and Regulatory Information for betamethasone benzoate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis UTICORT betamethasone benzoate CREAM;TOPICAL 016998-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Parke Davis UTICORT betamethasone benzoate OINTMENT;TOPICAL 018089-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Parke Davis UTICORT betamethasone benzoate LOTION;TOPICAL 017528-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Parke Davis UTICORT betamethasone benzoate GEL;TOPICAL 017244-001 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 Betamethasone Benzoate

Last updated: July 30, 2025


Introduction

Betamethasone benzoate is a topical corticosteroid used predominantly to treat inflammatory skin conditions such as eczema, psoriasis, dermatitis, and allergic reactions. Its pharmacological profile offers potent anti-inflammatory and immunosuppressive effects, making it valuable in dermatological therapeutics. Despite its longstanding presence, the drug’s market trajectory and financial prospects are influenced by diverse factors, including regulatory pathways, competitive landscapes, and evolving healthcare trends.


Pharmacological and Therapeutic Context

Betamethasone benzoate belongs to the corticosteroid class, exerting its effects by modulating gene expression to suppress inflammatory cytokines. Its topical application minimizes systemic exposure, reducing the risk of adverse effects compared to oral or injectable corticosteroids. The drug’s efficacy in managing inflammatory dermatoses positions it as an important component within dermatological treatment regimens globally.

The global burden of skin conditions affecting millions underscores sustained demand for corticosteroid therapies. The prevalence of dermatological conditions, especially in aging populations and urban centers with increasing pollution levels, bolsters the need for effective topical corticosteroids such as betamethasone benzoate.


Market Dynamics

Regulatory Landscape

Regulatory approvals significantly influence the market trajectory of betamethasone benzoate. While it remains an essential medicine in many countries, its status varies across regions. For instance, in the United States, the drug exists primarily as a compounded product or as a component of combination therapies, with limited standalone formulations approved by the FDA. Conversely, in regions like Europe, India, and parts of Asia, betamethasone benzoate is available as a marketed pharmaceutical, often in multiple generic formulations.

Regulatory hurdles, including stringent safety and efficacy evaluations, can delay new market entrants or restrict formulations. Moreover, regulations surrounding corticosteroid use—particularly concerning long-term safety—may influence prescribing patterns and manufacturer investments.

Market Competition

The corticosteroid market is highly competitive, with numerous generics and branded products vying for dominance. Betamethasone derivatives like dipropionate and valerate often serve as competitors, sometimes offering enhanced potency or better formulation stability. Additionally, alternative topical agents, including non-steroidal immunomodulators such as calcineurin inhibitors, are increasingly competing for a share of the dermatology market.

Generic manufacturers leverage cost advantages, contributing to price erosion and narrowing profit margins for branded formulations. Patents concerning specific formulations or delivery mechanisms, where applicable, create opportunities for exclusivity and strategic pricing.

Demand Drivers

Key drivers include:

  • Prevalence of Skin Conditions: Rising incidence of atopic dermatitis, psoriasis, and other inflammatory skin diseases—especially in urbanized and aging populations—sustains demand.
  • Healthcare Access and Awareness: Improving healthcare infrastructure and dermatology awareness campaigns promote early diagnosis and treatment, supporting drug sales.
  • Physician Prescribing Patterns: Preference for potent corticosteroids for severe conditions sustains usage, although safety concerns prompt cautious prescribing.

Emerging Trends

  • Formulation Innovations: Development of non-greasy, easy-to-apply formulations, such as foams and lotions, enhances patient compliance.
  • Combination Products: Incorporating betamethasone benzoate with antimicrobial agents addresses multiple facets of skin infections and inflammation, opening new market segments.
  • Safety and Tolerance Research: Ongoing studies into minimal effective dosing and long-term safety aim to expand off-label use and guide prescribing.

Financial Trajectory Analysis

Market Size and Growth Projections

The global dermatological corticosteroids market, including betamethasone benzoate, is projected to grow at a CAGR of approximately 4–6% over the next five years (2023–2028), driven by increasing dermatological disease burden and expanding healthcare expenditure [1].

The Asia-Pacific region offers significant growth potential, fueled by rising healthcare infrastructure and population size. India, China, and Southeast Asian countries increasingly adopt corticosteroid formulations, with local manufacturers expanding their portfolio to meet demand.

Revenue and Profitability Trends

In mature markets like Europe and North America, the revenue from betamethasone benzoate products stabilizes, primarily supported by existing formulations and prescribers’ familiarity. Profit margins face pressure due to generic competition, prompting companies to innovate through formulation improvements and strategic licensing.

In emerging markets, revenues are expanding rapidly as access barriers diminish. Local pharmaceutical companies often produce cost-effective generic versions, enabling widespread usage but suppressing higher-margin sales for branded products.

Patent and Intellectual Property Impact

The expiration of patents or exclusivity periods influences the financial trajectory significantly. Generic competitors entering the market after patent expiry lead to price reductions, typically by 50% or more within the first year. To counteract erosion, pharmaceutical companies focus on product differentiation through novel formulations or combination therapies.

Regulatory and Reimbursement Factors

Reimbursement policies substantively affect market growth. Countries with comprehensive health coverage for dermatological treatments foster increased utilization. Conversely, limited coverage or high out-of-pocket costs restrict access and sales volume.

In jurisdictions with stringent regulatory controls over corticosteroid prescriptions due to safety concerns, the volume growth may slow, impacting revenue projections.


Strategic Outlook

Innovation and Formulation Development

Investments in novel delivery systems—such as liposomal encapsulation or bioadhesive patches—offer avenues for premium pricing and market share expansion. Developing formulations with reduced potency or alternative action profiles can address safety concerns and facilitate broader prescriber acceptance.

Partnerships and Licensing

Strategic collaborations with regional and local manufacturers enable rapid market penetration, especially in emerging economies. Licensing agreements for distribution and manufacturing reduce costs and accelerate revenue streams.

Regulatory Navigation

Proactive engagement with regulatory authorities and adherence to safety guidelines ensure smoother approval pathways. Monitoring evolving safety concerns allows companies to adapt formulations proactively.

Market Diversification

Extending indications beyond dermatology, including off-label uses such as topical treatments for certain autoimmune conditions, can diversify revenue streams—though such strategies require rigorous evidence and regulatory consideration.


Key Takeaways

  • Sustained Demand in Dermatology: The prevalence of inflammatory skin conditions supports ongoing demand for betamethasone benzoate, especially in emerging markets.
  • Price Erosion Challenges: Generic competition and patent expirations pressure profit margins, necessitating innovation and strategic differentiation.
  • Regional Market Opportunities: Asia-Pacific and Latin American markets offer high-growth potential, driven by improving healthcare infrastructure and increasing dermatology funding.
  • Regulatory and Safety Considerations: Growing awareness of corticosteroid safety limits long-term usage; companies must focus on safe formulation development.
  • Innovation as a Market Differentiator: Formulation advancements and combination therapies position companies for premium pricing and expanded adoption.

FAQs

1. What are the main therapeutic uses of betamethasone benzoate?
Betamethasone benzoate is primarily used topically to treat inflammatory dermatological conditions such as eczema, psoriasis, and dermatitis due to its anti-inflammatory and immunosuppressive properties.

2. How does the market for betamethasone benzoate compare globally?
The market varies regionally, with Europe and Asia leading in availability. The Asia-Pacific region shows rapid growth potential driven by increasing dermatological needs, while North America’s mature market faces plateauing demand due to patent expirations and safety considerations.

3. What factors influence the profitability of betamethasone benzoate products?
Patent status, generic competition, formulation innovation, regulatory hurdles, and reimbursement policies significantly influence profitability. Post-patent expiry, profit margins typically decline unless complemented by new formulations or combination products.

4. Are there significant safety concerns with betamethasone benzoate?
Long-term or improper use of topical corticosteroids, including betamethasone benzoate, can cause skin thinning, hormonal suppression, and other adverse effects. Safety concerns influence prescribing patterns and regulatory scrutiny.

5. What strategic approaches can companies adopt to expand betamethasone benzoate’s market share?
Innovating formulations, pursuing regional licensing agreements, expanding indications, and focusing on safety profile improvements can help companies maintain or grow their market share.


References

[1] MarketWatch, Dermatological Corticosteroids Market Forecast 2023-2028, 2023.

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