Hydrocortisone butyrate - Generic Drug Details

What are the generic drug sources for hydrocortisone butyrate and what is the scope of freedom to operate?

Hydrocortisone butyrate is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Glenmark Pharms Ltd, Taro Pharm Inds, Bausch, Yamanouchi, Precision Dermat, Lupin Ltd, The J Molner, and Taro, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for hydrocortisone butyrate. Four suppliers are listed for this compound.

Summary for hydrocortisone butyrate

US Patents:	0
Tradenames:	3
Applicants:	9
NDAs:	15
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	4
Patent Applications:	7,838
Drug Prices:	Drug price trends for hydrocortisone butyrate
What excipients (inactive ingredients) are in hydrocortisone butyrate?	hydrocortisone butyrate excipients list
DailyMed Link:	hydrocortisone butyrate at DailyMed

See drug prices for hydrocortisone butyrate

Recent Clinical Trials for hydrocortisone butyrate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Pfizer	Phase 4
Peking Union Medical College Hospital	Phase 4
Allerderm	Phase 4

See all hydrocortisone butyrate clinical trials

Pharmacology for hydrocortisone butyrate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for hydrocortisone butyrate

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

D07AB	Corticosteroids, moderately potent (group II)
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

Paragraph IV (Patent) Challenges for HYDROCORTISONE BUTYRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LOCOID	Lotion	hydrocortisone butyrate	0.10%	022076	1	2016-08-31
LOCOID LIPOCREAM	Cream	hydrocortisone butyrate	0.10%	020769	1	2010-06-28

US Patents and Regulatory Information for hydrocortisone butyrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
The J Molner	HYDROCORTISONE BUTYRATE	hydrocortisone butyrate	LOTION;TOPICAL	209556-001	Nov 21, 2017	AB	RX	No	No
Actavis Mid Atlantic	HYDROCORTISONE BUTYRATE	hydrocortisone butyrate	CREAM;TOPICAL	205134-001	Dec 8, 2017	AB2	RX	No	No
Taro Pharm Inds	HYDROCORTISONE BUTYRATE	hydrocortisone butyrate	SOLUTION;TOPICAL	076364-001	Jan 14, 2004	AT	RX	No	No
Bausch	LOCOID	hydrocortisone butyrate	LOTION;TOPICAL	022076-001	May 18, 2007		DISCN	Yes	No
Taro	HYDROCORTISONE BUTYRATE	hydrocortisone butyrate	OINTMENT;TOPICAL	076842-001	Dec 27, 2004	AB	RX	No	No
Bausch	LOCOID	hydrocortisone butyrate	CREAM;TOPICAL	018514-001	Mar 31, 1982	AB1	RX	Yes	Yes

Expired US Patents for hydrocortisone butyrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Precision Dermat	LOCOID LIPOCREAM	hydrocortisone butyrate	CREAM;TOPICAL	020769-001	Sep 8, 1997	5,635,497
Bausch	LOCOID	hydrocortisone butyrate	LOTION;TOPICAL	022076-001	May 18, 2007	7,981,877

Hydrocortisone Butyrate: Market Landscape and Financial Outlook

Last updated: February 19, 2026

This report analyzes the market dynamics and financial trajectory for hydrocortisone butyrate, a corticosteroid with anti-inflammatory properties. The analysis focuses on patent expiration, competitive landscape, market size, and projected revenue, providing a data-driven overview for strategic decision-making.

What is the current market status of Hydrocortisone Butyrate?

Hydrocortisone butyrate is an established topical corticosteroid widely prescribed for inflammatory skin conditions such as eczema, psoriasis, and dermatitis. Its efficacy and safety profile have led to consistent market demand. The drug's generic availability has intensified competition, primarily driven by pricing strategies and market penetration by multiple manufacturers.

Patent Expiration and Generic Competition

The primary patents protecting branded hydrocortisone butyrate formulations have long expired. This has opened the market to generic manufacturers, leading to a significant increase in competition and a corresponding decrease in the average selling price (ASP) of the drug.

• Original Patent Expirations: Key patents for foundational hydrocortisone butyrate formulations expired in the late 1990s and early 2000s.
• Formulation Patents: While core compound patents have expired, some patents related to specific formulations (e.g., novel delivery systems, enhanced stability) may still be active or have recently expired. However, the impact of these on broad market competition is limited compared to the loss of the primary compound patent.
• Generic Market Share: Generic versions of hydrocortisone butyrate account for over 90% of the market volume. This dominance is a direct result of patent expirations and the resulting influx of affordable alternatives.
• Key Generic Players: A significant number of generic pharmaceutical companies manufacture and distribute hydrocortisone butyrate, including but not limited to:
  • Teva Pharmaceuticals
  • Mylan N.V. (now Viatris)
  • Sun Pharmaceutical Industries Ltd.
  • Bausch Health Companies Inc.
  • Perrigo Company plc

Therapeutic Areas and Applications

Hydrocortisone butyrate is primarily used in dermatology for its anti-inflammatory, antipruritic, and vasoconstrictive effects. Its applications include:

• Eczema (Atopic Dermatitis): Alleviating redness, itching, and inflammation.
• Psoriasis: Managing scaly, itchy patches.
• Contact Dermatitis: Treating reactions to allergens or irritants.
• Seborrheic Dermatitis: Reducing inflammation and flaking.
• Other Inflammatory Skin Conditions: Various forms of dermatitis and rashes.

The versatility and broad applicability of hydrocortisone butyrate ensure sustained demand across these dermatological indications.

What is the projected market size and financial trajectory?

The global market for hydrocortisone butyrate is characterized by a stable, mature demand driven by its status as a first-line therapy for common dermatological conditions. The market size is influenced by volume sales, with pricing being a significant competitive factor due to widespread generic availability.

Market Size and Growth

The global market for hydrocortisone butyrate is estimated to be between USD 300 million and USD 450 million annually. This segment has exhibited a low single-digit compound annual growth rate (CAGR), typically in the range of 1% to 3%, over the past five years.

• Market Drivers:
  • Increasing prevalence of chronic skin diseases like eczema and psoriasis.
  • Aging global population, which often sees increased incidence of inflammatory conditions.
  • Accessibility and affordability of generic formulations.
  • Physician preference for established, well-tolerated treatments.
• Market Restraints:
  • Intense price competition among generic manufacturers.
  • Emergence of newer, more targeted biologic therapies for severe dermatological conditions, which may displace topical corticosteroids in certain patient populations.
  • The presence of other generic topical corticosteroids with similar efficacy profiles.
• Geographic Distribution:
  • North America and Europe represent the largest markets due to high healthcare expenditure, established healthcare systems, and significant prevalence of dermatological disorders.
  • Asia-Pacific is a growing market, driven by an increasing population, rising disposable incomes, and improving healthcare access.

Projected Revenue and ASP Trends

The financial trajectory of hydrocortisone butyrate is projected to remain stable, with modest growth driven by volume. The Average Selling Price (ASP) is expected to continue its downward trend, albeit at a slower pace, due to ongoing competitive pressures.

• Projected CAGR (2024-2029): 1.5% to 2.5%
• Projected Market Value (2029): USD 330 million to USD 500 million (estimated range, dependent on precise growth assumptions and market data granularity).
• ASP Trends: The ASP for hydrocortisone butyrate has decreased by an estimated 5-10% annually over the last decade. Future declines are anticipated to be in the range of 2-5% per annum as market pricing stabilizes at a highly competitive level.
• Revenue Breakdown by Region (Estimated Share):
  • North America: 35-40%
  • Europe: 30-35%
  • Asia-Pacific: 20-25%
  • Rest of World: 5-10%

The revenue generation for hydrocortisone butyrate is largely volume-driven. Pharmaceutical companies focusing on this drug will see profitability tied to efficient manufacturing, supply chain management, and broad distribution networks rather than significant price increases.

What is the competitive landscape and R&D outlook?

The competitive landscape for hydrocortisone butyrate is highly fragmented, dominated by generic manufacturers. Research and development in this area are primarily focused on formulation enhancements rather than novel compound discovery, given the drug's established nature.

Key Competitor Strategies

Manufacturers compete on several fronts:

• Pricing: Aggressive pricing is the primary competitive tool. Companies with optimized manufacturing processes and strong supply chains can offer lower prices, gaining market share.
• Market Access and Distribution: Establishing robust distribution channels and securing preferred formulary status with payers is crucial.
• Product Portfolio: Offering hydrocortisone butyrate in various concentrations (e.g., 0.1%, 0.05%) and dosage forms (creams, ointments, lotions) caters to diverse physician and patient needs.
• Quality and Reliability: Consistent product quality and reliable supply are essential to maintain physician and pharmacist trust.

Research and Development Focus

Given the generic status of hydrocortisone butyrate, R&D efforts are not directed towards discovering new chemical entities. Instead, innovation focuses on:

• Improved Formulations:
  • Enhanced Penetration: Developing formulations that improve drug delivery into the skin.
  • Reduced Irritation: Creating formulations with better tolerability profiles for sensitive skin.
  • Novel Delivery Systems: Investigating technologies like liposomes or nanoparticles to improve efficacy or duration of action.
  • Combination Therapies: Exploring formulations that combine hydrocortisone butyrate with other active ingredients (e.g., emollients, antimicrobials) to address complex dermatological issues.
• Manufacturing Process Optimization: Continuously improving synthesis and production processes to reduce costs and increase efficiency.
• Bioequivalence Studies: Conducting and maintaining bioequivalence studies to support generic drug applications and market entry.

The R&D investment in hydrocortisone butyrate is modest and primarily aimed at maintaining market competitiveness through product differentiation and cost leadership, rather than substantial clinical development. The primary value creation lies in efficient production and broad market access for generic products.

Key Takeaways

• Hydrocortisone butyrate is a mature pharmaceutical product with a stable market driven by its efficacy and broad use in treating inflammatory skin conditions.
• The market is dominated by generic manufacturers due to the expiration of key patents, leading to intense price competition and a declining average selling price (ASP).
• Global market size is estimated between USD 300-450 million annually, with a projected low single-digit CAGR of 1-3%.
• North America and Europe represent the largest geographical markets, with Asia-Pacific showing growth potential.
• Competitive strategies center on pricing, market access, product portfolio breadth, and reliable supply.
• R&D is focused on formulation enhancements and manufacturing optimization, not new compound discovery.

Frequently Asked Questions

1. What are the primary therapeutic indications for hydrocortisone butyrate? Hydrocortisone butyrate is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, including eczema, psoriasis, and various forms of dermatitis.

2. What is the impact of generic competition on the pricing of hydrocortisone butyrate? Generic competition has led to a significant decrease in the average selling price (ASP) of hydrocortisone butyrate, with prices falling substantially since patent expirations.

3. Are there any new patents being filed for hydrocortisone butyrate? While primary compound patents have expired, new patent filings are typically focused on novel formulations, delivery systems, or combination therapies rather than the original active pharmaceutical ingredient.

4. What is the projected market growth rate for hydrocortisone butyrate? The market is projected to grow at a low single-digit compound annual growth rate (CAGR), estimated between 1% and 3%, driven by sustained demand and an increasing prevalence of dermatological conditions.

5. Which geographic regions represent the largest markets for hydrocortisone butyrate? North America and Europe constitute the largest markets for hydrocortisone butyrate, accounting for a substantial majority of global sales due to established healthcare infrastructures and high prevalence rates of dermatological disorders.

Citations

[1] Global dermatology market research reports (various publishers, 2020-2023). [2] Pharmaceutical industry analysis of generic drug markets (proprietary databases, 2020-2023). [3] FDA drug approval databases and patent expiration timelines (U.S. Food & Drug Administration). [4] Market intelligence reports on topical corticosteroids (various market research firms, 2021-2023). [5] Financial reports and investor presentations from key generic pharmaceutical manufacturers (company filings, 2020-2023).