Betamethasone valerate - Generic Drug Details

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

Betamethasone valerate is the generic ingredient in eight branded drugs marketed by Alembic, Novast Labs, Padagis Israel, Taro, Xiromed, Pharmobedient, Cosette, Roaco, Fougera Pharms Inc, Perrigo New York, Pharmaderm, Pharmafair, Sun Pharma Canada, Savage Labs, Schering, Actavis Mid Atlantic, Senores Pharms, and Teva Pharms, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for betamethasone valerate. Fourteen suppliers are listed for this compound.

Summary for betamethasone valerate

US Patents:	0
Tradenames:	8
Applicants:	18
NDAs:	33
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	20
Patent Applications:	7,025
Drug Prices:	Drug price trends for betamethasone valerate
What excipients (inactive ingredients) are in betamethasone valerate?	betamethasone valerate excipients list
DailyMed Link:	betamethasone valerate at DailyMed

See drug prices for betamethasone valerate

Recent Clinical Trials for betamethasone valerate

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

Sponsor	Phase
Sohag University	NA
Queen Mary Hospital, Hong Kong	PHASE3
Assiut University	Phase 1

See all betamethasone valerate clinical trials

Pharmacology for betamethasone valerate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for betamethasone valerate

Anti-Inflammatory Agents

Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for betamethasone valerate

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

Paragraph IV (Patent) Challenges for BETAMETHASONE VALERATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LUXIQ	Foam	betamethasone valerate	0.12%	020934	1	2007-08-10

US Patents and Regulatory Information for betamethasone valerate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmobedient	LUXIQ	betamethasone valerate	AEROSOL, FOAM;TOPICAL	020934-001	Feb 28, 1999		DISCN	Yes	No
Schering	VALISONE	betamethasone valerate	OINTMENT;TOPICAL	016740-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sun Pharma Canada	DERMABET	betamethasone valerate	CREAM;TOPICAL	072041-001	Jan 6, 1988	AB	RX	No	No

Expired US Patents for betamethasone valerate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmobedient	LUXIQ	betamethasone valerate	AEROSOL, FOAM;TOPICAL	020934-001	Feb 28, 1999	6,126,920
Pharmobedient	LUXIQ	betamethasone valerate	AEROSOL, FOAM;TOPICAL	020934-001	Feb 28, 1999	7,078,058

Market Dynamics and Financial Trajectory for Betamethasone Valerate

Last updated: July 27, 2025

Introduction

Betamethasone valerate, a synthetic corticosteroid, is a potent anti-inflammatory and immunosuppressive agent predominantly used in dermatology to treat various skin conditions. As the global dermatological drug market expands, understanding the market dynamics and financial trajectory specific to betamethasone valerate (BV) offers essential insights for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

This analysis delves into the key market drivers, competitive landscape, regulatory environment, and financial outlook for BV, contextualizing its current position within the broader corticosteroid and dermatological therapeutics sectors.

Market Overview

The dermatology therapeutics market is experiencing robust growth, driven by increasing prevalence of skin disorders such as psoriasis, eczema, dermatitis, and allergic reactions. Corticosteroids like BV remain mainstays in topical treatment due to efficacy, safety profile, and cost-effectiveness.

Betamethasone valerate, marketed under various brand names worldwide, benefits from an extensive patent portfolio, though many formulations have entered generic stages, impacting revenue streams. The compound’s versatility in low to high-potency formulations positions it as a critical product in dermatology drug pipelines.

Market Drivers

1. Rising Prevalence of Skin Disorders

The global mushrooming incidence of dermatology conditions fuels demand for corticosteroids. According to the World Health Organization, skin diseases affect over 900 million people worldwide, with eczema and psoriasis among the most common. This expanding patient base sustains steady consumption of BV-containing formulations.

2. Increasing Adoption of Topical Corticosteroids

Topical corticosteroids like BV are preferred due to their rapid action and minimal systemic side effects compared to oral or injectable steroids. The convenience and targeted delivery enhance adoption rates, especially in outpatient settings.

3. Expanding Dermatology Therapeutics Market

Advancements in formulation technology, such as liposomal and nano-based topical systems, improve drug penetration and reduce side effects. These innovations heighten market attractiveness, bolstering demand for established corticosteroids like BV.

4. Growing Awareness and Healthcare Infrastructure

In emerging economies, improving healthcare facilities and awareness campaigns promote early intervention for skin conditions, further driving topical steroid use.

5. Regulatory Approvals and Off-label Uses

Efforts to expand approved indications for BV or develop combination therapies increase market penetration. Additionally, off-label uses in inflammatory ocular and joint conditions, although less prominent, contribute to overall consumption figures.

Market Challenges

1. Side Effects and Safety Concerns

Prolonged or improper use of corticosteroids can cause skin atrophy, telangiectasia, and systemic absorption risks. This has led to regulatory warnings and increased emphasis on prescribing guidelines, potentially constraining aggressive usage.

2. Competition from Alternative Therapies

Emerging biologics and non-steroidal topical agents, such as calcineurin inhibitors, offer alternative options with fewer side effects, challenging BV’s dominance in certain indications.

3. Patent Expirations and Generic Competition

Many BV formulations have faced patent cliffs, leading to widespread generic manufacturing. While this reduces costs and expands accessibility, it compresses profit margins for branded versions.

4. Pricing and Reimbursement Policies

Healthcare payers seek cost-effective treatments, leading to price pressures and stricter reimbursement policies that influence market revenues.

Regulatory Environment

The global regulatory landscape significantly influences market growth. Agencies like the U.S. FDA and EMA impose strict safety and efficacy standards, impacting product registration and continuation. Notably, regulatory agencies emphasize appropriate potency prescribing and risk management, which can impact market expansion strategies.

Regulatory Focus on Generics: The patent expirations have intensified generic penetration, leading to price competitions but also to regulatory scrutiny of formulation equivalence.

Inclusion in Formularies: An increasing number of BV formulations are included in national and regional formularies, enhancing access but demanding adherence to guidelines that favor safety.

Financial Trajectory

Revenue Patterns

The pharmacoeconomic landscape suggests that the revenue for BV-based products will continue to grow incrementally in markets with expanding dermatology treatment needs. According to IQVIA data, global sales of topical corticosteroids, including BV, surpassed USD 4 billion in 2021, with a compounded annual growth rate (CAGR) of approximately 2-3% over five years [1].

Impact of Patent Expirations

The transition from branded to generic formulations has a pronounced impact on profit margins. While branded products may generate high margins pre-expiry, the surge in generics increases volume but reduces per-unit revenue, compelling companies to innovate or secure new formulations.

Market Segmentation

• Geographic: North America and Europe dominate with mature markets, though growth in Asia-Pacific and Latin America is accelerating due to rising dermatology disease prevalence and expanding healthcare infrastructure.
• Therapeutic: Primary use in psoriasis, eczema, and dermatitis; niche uses in other dermatological inflammatory conditions.
• Formulation: Creams, ointments, lotions, and emulsions, with creams constituting the largest share.

Forecast Trends

Projected growth for BV formulations aligns with the broader corticosteroid market, with an expected CAGR of 2-3% over the next five years [2]. This modest growth reflects market maturity, patent expiries, and competitive pressures but also underscores opportunities in emerging markets and formulation innovations.

Investment Outlook

Pharmaceutical companies investing in novel delivery systems, combination therapies, or expanding clinical indications for BV can capitalize on shifting demand. Additionally, biosimilar development and strategic licensing agreements will influence revenue trajectories.

Competitive Landscape

Major players include Mylan, Sun Pharmaceutical Industries, Perrigo, and Teva Pharmaceuticals, among others, offering various BV formulations. Competitive differentiation relies on formulation efficacy, safety profiles, cost, and regional market access strategies.

Innovation in topical delivery systems, formulation stability, and combination drugs signifies strategic priorities to extend product lifecycle and market share.

Conclusion

Betamethasone valerate remains a key corticosteroid in dermatological therapeutics, supported by its efficacy and affordability. Its market trajectory, however, faces challenges from generics, safety considerations, and emerging treatments. Success hinges on strategic formulation, regulatory compliance, and targeted expansion into growing markets.

The outlook suggests steady but tempered growth, underscored by opportunities in emerging economies and advances in formulation technology. Industry stakeholders must monitor regulatory developments and competitive innovations to optimize their positioning.

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Key Takeaways

• Steady Demand: The global rise in skin disorders sustains consistent demand for BV, especially in topical corticosteroid markets.
• Generic Competition: Patent expirations have increased availability of low-cost generics, pressuring margins but expanding market access.
• Innovation as a Differentiator: Advances in formulation and combination therapy development are critical for sustaining growth.
• Regulatory Stringency: Compliance with safety and efficacy standards influences market expansion and product lifecycle.
• Emerging Markets: Regions like Asia-Pacific represent significant growth opportunities due to rising prevalence and healthcare investments.

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FAQs

1. How does patent expiration impact the profitability of betamethasone valerate formulations?
Patent expiration leads to increased availability of generics, which typically causes a significant price decline for branded products, reducing profit margins. Companies often counter this by developing new formulations or expanding indications to sustain revenue.

2. What are the primary dermatological indications for betamethasone valerate?
BV is primarily used for inflammatory skin conditions such as eczema, psoriasis, dermatitis, allergic skin conditions, and certain autoimmune dermatoses.

3. How are emerging therapies affecting the market for corticosteroids like BV?
Biologics and non-steroidal topical agents are increasingly offering alternative options with fewer side effects, which may limit corticosteroids' growth in certain severe or resistant cases but generally complement rather than replace BV in standard treatments.

4. What opportunities exist in emerging markets for betamethasone valerate?
Growing healthcare infrastructure, increased awareness, and rising prevalence of skin conditions present opportunities for market expansion, especially through cost-effective formulations suited to local patient needs.

5. What is the future outlook for betamethasone valerate in the dermatology market?
While growth is expected to remain modest primarily due to generics and market maturity, innovation, expanding indications, and regional market penetration can sustain positive trajectories for BV.

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Sources:
[1] IQVIA, 2022. Global Corticosteroid Market Analysis.
[2] MarketsandMarkets, 2022. Topical Corticosteroids Market by Region and Potency.