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Last Updated: December 22, 2024

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, Taro, 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
Glenmark Pharms Ltd HYDROCORTISONE VALERATE hydrocortisone valerate CREAM;TOPICAL 211129-001 Oct 12, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm Inds Inc WESTCORT hydrocortisone valerate OINTMENT;TOPICAL 018726-001 Aug 8, 1983 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lupin Ltd HYDROCORTISONE VALERATE hydrocortisone valerate CREAM;TOPICAL 210307-001 Aug 15, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cosette HYDROCORTISONE VALERATE hydrocortisone valerate CREAM;TOPICAL 074489-001 Aug 12, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

HYDROCORTISONE VALERATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydrocortisone Valerate

Introduction

Hydrocortisone valerate, a topical corticosteroid, is widely used to treat various skin conditions, including inflammatory and pruritic dermatoses. This article delves into the market dynamics and financial trajectory of hydrocortisone valerate, highlighting key trends, drivers, and projections.

Global Market Size and Growth

The global hydrocortisone market, which includes hydrocortisone valerate, is anticipated to experience significant growth. As of 2024, the global hydrocortisone cream market size is estimated to be USD 1352.2 million, with a projected compound annual growth rate (CAGR) of 6.50% from 2024 to 2031, reaching USD 2101.3 million by 2031[1].

Regional Market Breakdown

The market for hydrocortisone valerate is distributed across various regions, each with its own growth trajectory:

  • North America: This region holds the largest market share, with an estimated market size of USD 540.88 million in 2024. It is expected to grow at a CAGR of 4.7% from 2024 to 2031[1].
  • Europe: Europe accounts for more than 30% of the global revenue, with a market size of USD 405.66 million in 2024 and a CAGR of 5.0% from 2024 to 2031[1].
  • Asia Pacific: This region is expected to show the highest growth rate, with a market size of USD 311.01 million in 2024 and a CAGR of 8.5% from 2024 to 2031[1].
  • Latin America: The Latin American market is smaller but still significant, with a market size of USD 67.61 million in 2024 and a CAGR of 5.9% from 2024 to 2031[1].
  • Middle East and Africa: This region has the smallest market share, with a market size of USD 27.04 million in 2024 and a CAGR of 6.2% from 2024 to 2031[1].

Market Drivers

Several factors are driving the growth of the hydrocortisone valerate market:

  • Increasing Incidence of Skin Conditions: The rising prevalence of cutaneous conditions such as eczema, psoriasis, and dermatitis is a significant driver. These conditions require effective treatments, and hydrocortisone valerate is a preferred option due to its efficacy[1][3].
  • Research and Development: Increased investment in research and development is leading to the creation of more effective and safer formulations of hydrocortisone valerate. This innovation is attracting more patients and healthcare providers to the market[3].
  • Growing Awareness and Healthcare Spending: As healthcare awareness and spending increase globally, more people are seeking medical treatments for skin conditions, contributing to the market's growth[3].

Market Restraints

Despite the positive trends, there are several restraints that could impact the market:

  • Side Effects and Safety Concerns: Hydrocortisone valerate, like other corticosteroids, can have side effects such as inhibition of bone formation, suppression of calcium absorption, and delayed wound healing. These concerns can limit its use, especially in pediatric and geriatric populations[4][5].
  • Regulatory Challenges: The pharmaceutical industry is heavily regulated, and changes in regulations or stringent approval processes can slow down the market growth[2].

Market Trends

Several trends are shaping the hydrocortisone valerate market:

  • Generic and Branded Products: The market includes both generic and branded products. Branded products like Westcort and Hydroval maintain a strong presence, while generic versions offer cost-effective alternatives, contributing to market growth[4][5].
  • Topical Formulations: The preference for topical formulations over oral or injectable corticosteroids is increasing due to their localized action and reduced systemic side effects[4][5].

Distribution Channels

The distribution of hydrocortisone valerate involves various channels:

  • Pharmacies and Supermarkets: These are the primary distribution channels, providing easy access to both prescription and over-the-counter (OTC) versions of the drug[2].
  • Online Retailers: The rise of online pharmacies and retailers is also contributing to the market's growth by offering convenience and sometimes lower prices[2].

End-User Analysis

The end-users of hydrocortisone valerate include:

  • Individual Consumers: Patients suffering from skin conditions are the primary end-users. The ease of use and effectiveness of hydrocortisone valerate make it a popular choice among consumers[5].
  • Healthcare Providers: Dermatologists and other healthcare providers prescribe hydrocortisone valerate, influencing the market through their recommendations[5].

Competitive Landscape

The market for hydrocortisone valerate is competitive, with several key players:

  • Taro Pharmaceuticals: Known for their branded and generic formulations of hydrocortisone valerate[4].
  • A-S Medication Solutions: Offers generic versions of hydrocortisone valerate[4].
  • Cosette Pharmaceuticals: Provides both cream and ointment formulations[4].

Financial Projections

The financial trajectory of the hydrocortisone valerate market is promising:

  • Revenue Growth: The market is expected to grow significantly, with the global hydrocortisone cream market projected to reach USD 2101.3 million by 2031[1].
  • Regional Contributions: North America, Europe, and Asia Pacific will continue to be major contributors to the market revenue, driven by increasing demand and growing healthcare spending[1].

Key Takeaways

  • The global hydrocortisone valerate market is driven by the increasing incidence of skin conditions and investments in research and development.
  • Regional markets, particularly in North America, Europe, and Asia Pacific, are expected to show significant growth.
  • Despite side effects and regulatory challenges, the market is poised for substantial expansion.
  • Topical formulations and both generic and branded products are key trends shaping the market.

FAQs

What is the current market size of the global hydrocortisone cream market?

The global hydrocortisone cream market size is estimated to be USD 1352.2 million in 2024[1].

What is the projected CAGR for the global hydrocortisone cream market from 2024 to 2031?

The projected CAGR is 6.50% from 2024 to 2031[1].

Which region holds the largest market share for hydrocortisone valerate?

North America holds the largest market share, with an estimated market size of USD 540.88 million in 2024[1].

What are the common side effects of hydrocortisone valerate?

Common side effects include inhibition of bone formation, suppression of calcium absorption, and delayed wound healing[4][5].

Is hydrocortisone valerate safe for pediatric and geriatric populations?

Hydrocortisone valerate should be used with caution in pediatric and geriatric populations due to potential side effects and the lack of comprehensive safety studies[5].

Sources

  1. Cognitive Market Research: Hydrocortisone Cream Market Report 2024 (Global Edition)
  2. Supreme Court of the United States: PDF - Gordon app
  3. Biospace: Hydrocortisone Market to Reach a Value of US$2 Bn by 2028
  4. DrugBank: Hydrocortisone valerate
  5. Mayo Clinic: Hydrocortisone valerate (topical application route) - Mayo Clinic

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