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Last Updated: December 11, 2025

HYDROCORTISONE VALERATE - Generic Drug Details


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What are the generic sources for hydrocortisone valerate and what is the scope of patent protection?

Hydrocortisone valerate is the generic ingredient in two branded drugs marketed by Cosette, Encube Ethicals, Glenmark Pharms Ltd, Lupin Ltd, Padagis Israel, Sun Pharma Canada, Sun Pharm Inds Inc, and Fougera Pharms, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for hydrocortisone valerate. Six suppliers are listed for this compound.

Summary for HYDROCORTISONE VALERATE
Drug Prices for HYDROCORTISONE VALERATE

See drug prices for HYDROCORTISONE VALERATE

Pharmacology for HYDROCORTISONE VALERATE
Anatomical Therapeutic Chemical (ATC) Classes for HYDROCORTISONE VALERATE
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
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
D07AA Corticosteroids, weak (group I)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XA Corticosteroids, weak, 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
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
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

US Patents and Regulatory Information for HYDROCORTISONE VALERATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cosette HYDROCORTISONE VALERATE hydrocortisone valerate CREAM;TOPICAL 074489-001 Aug 12, 1998 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fougera Pharms HYDROCORTISONE VALERATE hydrocortisone valerate OINTMENT;TOPICAL 075085-001 Jul 31, 2001 DISCN No 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 Hydrocortisone Valerate

Last updated: July 28, 2025

Introduction

Hydrocortisone Valerate is a potent synthetic glucocorticoid utilized primarily for its anti-inflammatory and immunosuppressive properties. It finds extensive application in dermatology for treating eczema, dermatitis, psoriasis, and other inflammatory skin conditions, as well as in certain allergic, autoimmune, and endocrine disorders. As the pharmaceutical landscape evolves, understanding the market dynamics and financial trajectory of Hydrocortisone Valerate is vital for manufacturers, investors, and healthcare stakeholders seeking informed strategic decisions.

Market Overview

The global corticosteroids market, which includes Hydrocortisone Valerate, is projected to grow steadily, driven by rising prevalence of chronic inflammatory and autoimmune diseases, increasing dermatological conditions, and expanding healthcare infrastructure globally. The corticosteroids segment is expected to maintain steady growth owing to increasing awareness, advancements in drug delivery systems, and ongoing research for novel corticosteroid formulations.

Therapeutic Applications and Market Penetration

Hydrocortisone Valerate primarily caters to dermatological indications, with a significant portion of prescriptions in North America and Europe. Emerging markets in Asia-Pacific, Latin America, and the Middle East are witnessing increased adoption owing to rising healthcare expenditure and improved access to dermatological treatments. The drug's efficacy, combined with a favorable safety profile when used appropriately, sustains its market presence.

Regulatory Environment and Patent Landscape

Hydrocortisone Valerate is generally off-patent in many jurisdictions, leading to highly competitive generics markets. However, patent expirations in key markets have facilitated entry of multiple generic manufacturers, exerting downward pressure on prices and margins. Regulatory approvals for new formulations or delivery systems (e.g., foam, gel, or patch) could offer differentiated value propositions, influencing market dynamics [1].

Market Drivers

  • Increasing Disease Prevalence: The rising incidence of skin conditions like eczema and psoriasis, especially in aging populations, amplifies demand for effective corticosteroids, including Hydrocortisone Valerate.
  • Expanding Dermatology Market: Growth in outpatient dermatology clinics and cosmetic dermatology boosts prescriptions.
  • Improved Drug Delivery Technologies: Innovations such as topical gels, foams, and patches enhance drug efficacy and patient adherence, expanding the drug's application scope.
  • Emerging Markets: Rising healthcare expenditure and increasing awareness elevate market penetration in developing economies.

Market Challenges

  • Price Erosion from Generics: The availability of multiple generic formulations suppresses prices, impacting revenue streams.
  • Safety Concerns: Long-term use of corticosteroids poses risks such as skin atrophy and systemic side effects, necessitating cautious prescribing and potentially limiting market size.
  • Regulatory Scrutiny: Increasing regulatory oversight for topical corticosteroids may impact market entry and formulations.

Competitive Landscape

The market is fragmented, with key competitors primarily comprising generic manufacturers. Major pharmaceutical companies and regional players compete on price, formulation differentiation, and distribution networks. Companies investing in novel delivery systems or combination therapies could gain differentiated market positioning.

Financial Trajectory and Revenue Outlook

Historical Perspective

Historically, Hydrocortisone Valerate has experienced steady revenues, primarily driven by prescriptions in dermatology. However, patent expirations and heightened generic competition in recent years have led to revenue erosion in mature markets.

Projected Trends

  • Short-term (1-3 years): Revenues may stabilize with new formulations or indications, but overall growth remains cautious due to pricing pressures.
  • Mid-term (3-5 years): Opportunities arise from strategic launches of novel delivery systems, combination products, and expansion into emerging markets.
  • Long-term (5+ years): Market growth will be influenced by innovations in corticosteroid therapy, regulatory policies, and healthcare infrastructure developments.

Impact of Innovation and Regulatory Changes

Enhanced formulations that improve safety and efficacy, such as non-steroidal or localized acting variants, could unlock new market segments. Regulatory approval pathways for such innovations represent significant financial opportunities but require substantial R&D investment.

Strategic Considerations for Stakeholders

  • For Manufacturers: Focus on formulation innovation, differentiated delivery systems, and targeted marketing to sustain revenue amid patent expirations and price pressures.
  • For Investors: Monitor regulatory developments, pipeline advancements, and emerging markets to identify growth prospects.
  • For Healthcare Providers: Emphasize safe and effective use to enhance patient outcomes, which can reinforce market stability for established drugs like Hydrocortisone Valerate.

Key Market Opportunities

  • Development of Combination Products: Integration with antibiotics or antifungals to expand clinical utility.
  • Topical Formulation Diversification: Introduction of patches, gels, or foams tailored for specific patient needs.
  • Digital Engagement: Leveraging teledermatology and digital marketing to reach underserved populations.

Risks and Uncertainties

  • Regulatory Restrictions: Stricter regulations on corticosteroid use could limit prescribing patterns.
  • Market Saturation: High availability of generic options may cap pricing and profit margins.
  • Patient Safety Concerns: Adverse effects could impact prescription rates and market growth.

Conclusion

Hydrocortisone Valerate remains a key player within the corticosteroid market, with a stable but highly competitive landscape. Its financial trajectory is characterized by moderate growth prospects, heavily influenced by innovation, regulatory environments, and market expansion into emerging economies. Stakeholders should consider strategic formulation development and targeted market entry initiatives to optimize returns.

Key Takeaways

  • Market Stability with Competitive Pressures: While demand for corticosteroids persists, generic competition continues to drive down prices, challenging revenue growth.
  • Innovation as a Differentiator: Patent expirations necessitate a focus on formulation improvements and delivery systems to maintain market share.
  • Emerging Market Potential: Expanding healthcare access in developing regions presents significant growth opportunities.
  • Regulatory and Safety Considerations: Ensuring compliance and safety profiling are essential to sustain market position.
  • Strategic Diversification: Combining Hydrocortisone Valerate with other therapies or developing novel formulations can unlock future revenue streams.

FAQs

  1. What factors influence the pricing of Hydrocortisone Valerate in the global market?
    Pricing is primarily driven by patent status, competitive pressure from generics, manufacturing costs, and regional regulatory policies.

  2. How does patent expiration impact the financial prospects of Hydrocortisone Valerate?
    Patent expiration leads to increased generic competition, typically resulting in price erosion and reduced profit margins, although it also opens opportunities for new formulations.

  3. Are there upcoming innovations that could revive the market for Hydrocortisone Valerate?
    Yes, innovations in topical delivery systems such as foams, patches, and combination therapies hold promise for expanding indications and improving safety profiles.

  4. What regions offer the most potential for growth in Hydrocortisone Valerate markets?
    Emerging economies in Asia-Pacific, Latin America, and the Middle East exhibit substantial growth potential due to increasing healthcare infrastructure and prescription rates.

  5. What are the primary safety concerns associated with Hydrocortisone Valerate, and how do they affect market dynamics?
    Long-term use can cause skin atrophy and systemic effects, prompting cautious prescribing and regulatory scrutiny, which can limit market expansion if safety profiles are not well-managed.


Sources:

[1] MarketWatch, “Global Corticosteroids Market Size, Share, Growth Analysis,” 2022.

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