Last Updated: May 9, 2026

HYDROCORTISONE VALERATE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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
Encube Ethicals HYDROCORTISONE VALERATE hydrocortisone valerate CREAM;TOPICAL 211047-001 Nov 4, 2021 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glenmark Pharms Ltd HYDROCORTISONE VALERATE hydrocortisone valerate CREAM;TOPICAL 211129-001 Oct 12, 2018 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lupin Ltd HYDROCORTISONE VALERATE hydrocortisone valerate CREAM;TOPICAL 210307-001 Aug 15, 2019 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Cosette HYDROCORTISONE VALERATE hydrocortisone valerate CREAM;TOPICAL 074489-001 Aug 12, 1998 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sun Pharma Canada HYDROCORTISONE VALERATE hydrocortisone valerate OINTMENT;TOPICAL 075043-001 Aug 25, 1998 AB RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 Dynamics and Financial Trajectory

Last updated: April 24, 2026

Hydrocortisone valerate is a topical corticosteroid marketed primarily for inflammatory dermatoses. The commercial trajectory is shaped by (1) generic penetration, (2) label breadth and prescriber familiarity across eczema and dermatitis indications, (3) formulation and vehicle differentiation (cream, ointment, lotion, and combination products), and (4) competitive intensity from alternative topical steroids and non-steroidal anti-inflammatory dermatology products.

Because hydrocortisone valerate’s core molecule is off-patent and widely generic, the financial profile in mature markets is driven less by innovation and more by pricing, distribution, reimbursement dynamics, and switchability between strengths, vehicles, and payor formularies. Growth is typically modest and volume-led, while price erosion is the primary headwind.

Where is hydrocortisone valerate positioned in the dermatology market?

Competitive set

Hydrocortisone valerate competes in the topical anti-inflammatory/corticosteroid segment, where the main substitutes are:

  • Other topical corticosteroids (different classes/potency tiers)
  • Non-steroidal dermatosis therapies (e.g., calcineurin inhibitors, topical PDE4 inhibitors, JAK inhibitors for atopic dermatitis where indicated)
  • Barrier and adjunct dermatology products that reduce reliance on steroids

In practice, prescribers choose based on potency tier, tolerability, vehicle preference, anatomic site, and payor coverage. Hydrocortisone valerate’s market access tends to be strongest where it aligns with guideline therapy steps for mild to moderate inflammatory skin disease and where generic availability keeps net prices low.

Channel dynamics

The topical steroid market skews toward:

  • Retail pharmacy distribution for branded-to-generic and generic-only SKUs
  • Dermatology and primary care prescribing patterns (often with switching among generics during dispensing)

This structure favors high-volume, low-margin products, and it compresses value capture for any new entrant unless paired with differentiated delivery, combination formulations, or payer-driven access.

What are the drivers of demand growth or decline?

Demand drivers

  1. Chronicity of dermatologic inflammation
    • Conditions such as eczema/dermatitis are recurring and generate repeat demand.
  2. Vehicle-based prescribing
    • Ointments suit dry lesions; creams suit broader use; lotions support scalp application. Hydrocortisone valerate sales track vehicle availability and form-factor convenience.
  3. Formulary inclusion for mild to moderate regimens
    • For payors, topical corticosteroids are cost-controlled options; hydrocortisone valerate stays relevant when included as a preferred generic.

Demand headwinds

  1. Generic substitution and price compression
    • Once multiple generics exist, pharmacy-level and plan-level substitution accelerates erosion.
  2. Therapy migration toward non-steroidal options
    • In atopic dermatitis, newer steroid-sparing agents reduce long-term steroid reliance for some patients, especially where payors cover them.
  3. Safety and stewardship
    • Topical steroid stewardship limits prolonged use on sensitive areas, which constrains incremental growth even when total patient demand persists.

How do pricing and reimbursement dynamics typically play out for mature generics?

Pricing trajectory (typical pattern)

  • Initial entry or reformulation cycles: pricing stabilizes briefly after a branded or semi-branded phase.
  • Post-multiplicity of generics: net pricing declines toward competitive floors, with periodic declines after new market entrants or NDC-level competition.
  • Vehicle and strength effects: higher-cost vehicles or harder-to-source strengths can hold value longer, but overall erosion remains dominant.

Because hydrocortisone valerate is largely commoditized, the financial trajectory is expected to be:

  • Volume stable to declining depending on competitive mix
  • Revenue down through net price erosion
  • Margin pressured by promotional intensity and pharmacy reimbursement mechanics

What is the financial trajectory implied by the patent and market structure?

Hydrocortisone valerate is an established corticosteroid with a mature market. Its financial trajectory follows a generic life-cycle pattern:

  • After patent expiry: rapid generic adoption
  • After broad generic coverage: sustained volume sales but declining revenue per unit
  • After market share equalization among generics: revenue tracks market size, not molecule innovation

This is consistent with the commercial reality of widely available topical steroids: companies can defend share through packaging, coverage, and distribution relationships, but they cannot defend price as effectively as novel dermatology agents.

Which product attributes most influence sales performance?

Formulation and strength

Hydrocortisone valerate competes through:

  • Vehicle (cream, ointment, lotion)
  • Strength/grade aligned to local standards and label dosing
  • Pack size that matches course duration patterns and dispensing behavior

For payors and pharmacy buyers, these parameters matter because they determine which product is lowest net cost under therapeutic interchange rules.

Combination products and local market preferences

Where combination formulations exist (e.g., steroid paired with antifungal/antibiotic in some geographies and indications), they can shift demand by expanding label utility and reducing treatment switching. The financial impact is typically:

  • Higher revenue potential per prescription than monotherapy
  • More complex payer coverage due to combination value assessments
  • Greater competition from other fixed-dose combinations

What does the competitive landscape imply for future sales?

Substitution pressure

Hydrocortisone valerate faces substitution from:

  • Other topical steroids that cover the same inflammatory use-cases with different potency tiers
  • Steroid-sparing modalities for atopic dermatitis and chronic inflammatory conditions (where covered and clinically appropriate)

Net effect: new prescriptions for hydrocortisone valerate tend to be captured from within topical steroid and OTC/OTC-adjacent pathways rather than from broad therapy expansion.

Market segmentation and regional coverage

The molecule’s performance depends on:

  • Availability of generics at sufficient scale
  • Local regulatory status and labeling specificity
  • Reimbursement formularies that set preferred agents among topical corticosteroids

The most resilient sales tend to occur where:

  • Formularies keep a generic topical steroid in first-line steps
  • There is stable patient adherence and repeat use for recurring disease flares

How could investors or strategists frame the revenue outlook?

For business professionals, hydrocortisone valerate revenue outlook is best modeled as:

  • Revenue = Unit demand x Net price
  • Unit demand: supported by chronic indication prevalence and vehicle selection
  • Net price: driven down by generic competition, promotional intensity, and plan preference

A practical expectation is:

  • Limited upside unless a company captures incremental share via distribution or coverage gains
  • Ongoing downside risk from new competitors and switching among equally effective generics

In mature categories, financial performance is usually determined by operational execution rather than clinical differentiation.

Key data points for market context

Indication framing (regulatory label category)

Hydrocortisone valerate is used as a topical corticosteroid for inflammatory dermatoses. Specific authorized indications vary by jurisdiction and product label.

Regulatory category

Hydrocortisone valerate is a topical corticosteroid with established dosing and safety considerations for dermal use.

Evidence base anchor

Hydrocortisone valerate’s clinical use is reflected in authoritative monographs and regulatory product information for topical corticosteroids.

Key Takeaways

  • Hydrocortisone valerate’s financial trajectory is driven by generic commoditization: stable volume potential with ongoing net price erosion.
  • Demand is supported by chronic dermatologic disease patterns and vehicle-based prescribing, but long-term growth is capped by substitution to other topical steroids and steroid-sparing alternatives.
  • Competitive intensity is structural: market share is contestable through coverage, pharmacy switching, and pack/vehicle availability, not through molecule innovation.
  • Revenue outlook is best treated as a mature generic model: unit-led, margin-pressured, and sensitive to plan/formulary position.

FAQs

1) What market forces most affect hydrocortisone valerate revenue?
Generic competition, formulary tier placement, pharmacy-level substitution, and net price erosion tied to the number of interchangeable products.

2) Does hydrocortisone valerate benefit from chronic skin conditions?
Yes. Recurring inflammatory dermatoses support repeat use, though conversion to other therapies can limit net growth.

3) What product characteristics matter most commercially?
Vehicle (cream/ointment/lotion), pack size, and strength, because they influence prescribing habits, course duration, and payer preference.

4) How do newer dermatology therapies change its outlook?
They can reduce steroid reliance for some patients, particularly in atopic dermatitis settings where payors cover steroid-sparing options.

5) Is the financial trajectory expected to be growth-led or price-led?
It is typically volume-led with adverse price dynamics, producing margin pressure and limited revenue upside unless share is gained.


References

[1] FDA. Drug Development and Drug Interactions: Corticosteroids (Topical). FDA Drug Safety and Labeling resources. https://www.fda.gov/
[2] European Medicines Agency (EMA). Product information and EPARs for topical corticosteroids (hydrocortisone derivatives). EMA medicine documents. https://www.ema.europa.eu/
[3] DailyMed. Hydrocortisone Valerate topical product labeling (examples by NDC/manufacturer). U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.