CLOBETASOL PROPIONATE - Generic Drug Details

What are the generic sources for clobetasol propionate and what is the scope of patent protection?

Clobetasol propionate is the generic ingredient in thirteen branded drugs marketed by Alembic, Glenmark Pharms Ltd, Novast Labs, Padagis Israel, Taro, Pharmobedient, Amneal, Aurobindo Pharma Usa, Chartwell Rx, Cosette, Encube, Fougera Pharms Inc, Glenmark Speclt, Lupin Ltd, Pai Holdings Pharm, Rising, Sun Pharma Canada, Teva Pharms Usa, Torrent, Xiromed, Zydus Pharms, Ani Pharms, Beach Prods, Fougera Pharms, Hikma, Primus Pharms, Padagis Us, Actavis Mid Atlantic, Epic Pharma Llc, Zydus Lifesciences, Galderma Labs Lp, Macleods Pharms Ltd, Novel Labs Inc, Galderma Labs, Prinston Inc, Quagen, Saptalis Pharms, Wockhardt Bio Ag, Apotex, Sciegen Pharms Inc, and Harrow Eye, and is included in ninety-nine NDAs. There are eight patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Clobetasol propionate has seventy-two patent family members in twenty-five countries.

There are eleven drug master file entries for clobetasol propionate. Forty-three suppliers are listed for this compound.

Summary for CLOBETASOL PROPIONATE

International Patents:	72
US Patents:	8
Tradenames:	13
Applicants:	41
NDAs:	99
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	73
Patent Applications:	6,660
Drug Prices:	Drug price trends for CLOBETASOL PROPIONATE
Drug Sales Revenues:	Drug sales revenues for CLOBETASOL PROPIONATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLOBETASOL PROPIONATE
What excipients (inactive ingredients) are in CLOBETASOL PROPIONATE?	CLOBETASOL PROPIONATE excipients list
DailyMed Link:	CLOBETASOL PROPIONATE at DailyMed

See drug prices for CLOBETASOL PROPIONATE

See drug sales revenues for CLOBETASOL PROPIONATE

Recent Clinical Trials for CLOBETASOL PROPIONATE

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

Sponsor	Phase
Gazi University	NA
University of Palermo	PHASE2
Kantonsspital Winterthur KSW	N/A

See all CLOBETASOL PROPIONATE clinical trials

Pharmacology for CLOBETASOL PROPIONATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for CLOBETASOL PROPIONATE

Anti-Inflammatory Agents

Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for CLOBETASOL PROPIONATE

D07AD	Corticosteroids, very potent (group IV)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

Paragraph IV (Patent) Challenges for CLOBETASOL PROPIONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IMPOYZ	Cream	clobetasol propionate	0.025%	209483	1	2019-12-06
OLUX E	Emulsion Foam	clobetasol propionate	0.05%	022013	1	2010-02-25
CLOBEX	Spray	clobetasol propionate	0.05%	021835	1	2008-09-29
CLOBEX	Topical Shampoo	clobetasol propionate	0.05%	021644	1	2008-01-09
CLOBEX	Lotion	clobetasol propionate	0.05%	021535	1	2006-03-27
OLUX	Topical Foam	clobetasol propionate	0.05%	021142	1	2005-06-27

US Patents and Regulatory Information for CLOBETASOL PROPIONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmobedient	IMPEKLO	clobetasol propionate	LOTION;TOPICAL	213691-001	May 19, 2020		DISCN	Yes	No
Sun Pharma Canada	CLOBETASOL PROPIONATE	clobetasol propionate	LOTION;TOPICAL	200302-001	Jul 2, 2012	AB	RX	No	No
Harrow Eye	BYQLOVI	clobetasol propionate	SUSPENSION/DROPS;OPHTHALMIC	218158-001	Mar 4, 2024		RX	Yes	Yes	10,588,913		Y

Expired US Patents for CLOBETASOL PROPIONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fougera Pharms	TEMOVATE	clobetasol propionate	OINTMENT;TOPICAL	019323-001	Dec 27, 1985	3,721,687
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	5,990,100
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	8,066,976

International Patents for CLOBETASOL PROPIONATE

Country	Patent Number	Title	Estimated Expiration
Spain	2937023
European Patent Office	3267978	COMPOSITIONS TOPIQUES COMPRENANT UN CORTICOSTÉROÏDE (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID)
Brazil	112017024000

Market Dynamics and Financial Trajectory for Clobetasol Propionate

Last updated: July 27, 2025

Introduction

Clobetasol Propionate is a potent topical corticosteroid widely used in dermatology for the treatment of inflammatory skin conditions such as psoriasis, eczema, and dermatitis. Since its approval, it has established itself as a key player in the dermatological pharmacopoeia, with significant influence on the pharmaceutical landscape. This analysis explores the market dynamics, competitive environment, regulatory influences, and financial projections shaping the trajectory of Clobetasol Propionate.

Market Landscape and Key Drivers

Therapeutic Demand and Clinical Utilization

Clobetasol Propionate remains one of the most prescribed topical corticosteroids due to its high potency, frequently used in moderate to severe dermatological cases. The prevalence of skin-related conditions like psoriasis, which affects over 125 million people globally, fuels demand for effective corticosteroids (source: World Psoriasis Atlas [1]). Additionally, rising global awareness and advancements in dermatological care expand clinical use, underpinning steady demand.

Rising Dermatological Disease Incidence

Urbanization, environmental pollution, and lifestyle changes contribute to increased dermatological disease burdens worldwide. According to the Global Burden of Disease Study, skin diseases rank among the top 10 conditions affecting global health. The rise in cases directly correlates with increased prescription volumes for Clobetasol Propionate, especially in developing economies experiencing healthcare infrastructure expansion.

Market Adoption and Prescription Trends

Physicians favor Clobetasol Propionate for its efficacy, which sustains high prescription rates. However, its potency also introduces concerns about adverse effects, prompting responsible prescribing practices. The advent of clinical guidelines emphasizing topical corticosteroid safety modulates prescription trends, with a move toward reduced usage and alternative therapies in some markets.

Economic Factors and Pricing Dynamics

The drug’s affordability influences market penetration, particularly in emerging markets where price sensitivity is high. Generic formulations have significantly lowered treatment costs, expanding access and compelling brand manufacturers to adapt pricing strategies. Patents for the original formulations have largely expired, facilitating increased competition and impacting revenue streams.

Regulatory Environment

Patent Expirations and Generic Competition

Patent cliffs have historically caused declines in branded sales of Clobetasol Propionate. Generics now dominate markets like India, China, and parts of Europe, attenuating revenues for original developers. Regulatory agencies such as the FDA and EMA enforce strict requirements for approval of generics, impacting the pace and volume of market entry.

Reformulation and Novel Delivery Systems

Innovative formulations—such as nanoemulsions, foam-based applications, or combination products—aim to differentiate offerings amidst generic competition. Regulatory pathways for these are more complex, requiring substantial clinical data, which may delay commercialization but potentially command premium pricing.

Safety and Usage Guidelines

Regulatory bodies emphasize safety profiles, especially considering Clobetasol’s potency. Updated guidelines recommend limited treatment durations and restricted use in vulnerable populations, influencing formulary decisions and market penetration.

Competitive Environment

Major Players and Market Share

Key players include Johnson & Johnson, GlaxoSmithKline (GSK), and Teva Pharmaceuticals. GSK’s older formulations and its diversified dermatology portfolio maintain a dominant position in certain regions. The proliferation of generics exerts pressure on branded products, leading to pricing erosion but also fostering innovation in delivery systems.

Emerging Market Dynamics

India and China host a vibrant generics manufacturing ecosystem, with local companies producing cost-effective Clobetasol Propionate formulations. These markets are witnessing increased adoption driven by expanding healthcare access and government initiatives supporting dermatology treatment.

Brand vs. Generic Competition

The commoditization of Clobetasol Propionate has shifted revenue focus toward branded formulations with added benefits (e.g., reduced side effects, improved adherence). Nonetheless, the price competition from generics caps potential profit margins, compelling companies to explore differentiated product offerings.

Financial Trajectory and Forecasts

Revenue Trends

Historical data indicate a peak in revenue for branded Clobetasol Propionate products in the early 2010s, with subsequent declines due to patent expirations and generics. The global market was valued at approximately USD 400 million in 2020, with projections pointing toward a compound annual growth rate (CAGR) of around 3-4% through 2030, driven mainly by emerging markets and reformulation innovations.

Market Segmentation and Regional Insights

• North America: Mature market with high generic penetration. Revenue stabilization is expected, with incremental growth from new formulations.
• Europe: Similar dynamics to North America; stringent regulatory environment influences product development timelines.
• Asia-Pacific: Fastest growth segment, with expanding dermatological needs, increasing healthcare access, and low-cost generics. CAGR estimates range between 5-7%.

Price and Cost Dynamics

Pricing pressures from generics compress margins. However, innovation in delivery systems and niche marketing sustain premium pricing in developed markets. The cost of clinical development for new formulations remains high, though manufacturing efficiencies and biosimilar strategies may offset some expenses.

Future Opportunities and Challenges

• Opportunities: Development of reduced potency or targeted delivery formulations to extend patent life and address safety concerns.
• Challenges: Heightened regulatory scrutiny, safety warnings limiting maximum duration or dosing, and stiff generic price competition.

Impact of Innovation and Regulatory Trends

Emerging technologies such as liposomal formulations, microneedle patches, and combination topical products offer differentiation advantages. However, bringing these innovations to market involves regulatory hurdles, including demonstrating bioequivalence and safety, which influence time-to-market and R&D costs.

Additionally, global regulatory agencies are increasingly emphasizing sustainable practices and transparent safety data, imposing additional compliance costs but potentially offering competitive advantages for compliant firms.

Conclusion: The Outlook for Clobetasol Propionate

The future of Clobetasol Propionate involves navigating a complex interplay of patent expirations, regulatory mandates, and market demand. While generic proliferation suppresses margins globally, opportunities exist in innovative formulation development and expanding markets. Strategic investments in research and regulatory compliance are crucial to capitalize on emerging trends.

Key Takeaways

• Growing Global Demand: Rising prevalence of dermatological conditions, coupled with expanding healthcare infrastructure in developing markets, sustains long-term demand.

• Market Saturation in Developed Economies: Patent expirations and fierce generic competition suppress revenues, compelling firms to invest in formulation innovation.

• Regional Variability: Asia-Pacific represents the fastest-growing region due to economic development and healthcare expansion, while North America and Europe focus on maintaining market share through differentiation.

• Regulatory Landscape: Stricter safety guidelines influence prescribing practices and formulation development timelines, impacting revenue trajectories.

• Innovation as a Growth Driver: Investment in advanced delivery systems and combination products may unlock higher margins and extend product lifecycle.

FAQs

1. What are the main factors affecting Clobetasol Propionate's market growth?
   The primary factors include the rising incidence of dermatological conditions, patent expirations leading to generic competition, regulatory safety guidelines, and innovation in formulation technology.

2. How does patent expiry influence the financial trajectory of Clobetasol Propionate?
   Patent expiry fosters generic entry, significantly reducing revenues for original developers but also expanding access in emerging markets. This shift pressures branded formulations to innovate or diversify to maintain profitability.

3. What role does regional variation play in the Clobetasol Propionate market?
   Emerging markets like India and China offer high-growth opportunities through affordable generics, while mature markets emphasize innovative formulations and safety compliance to sustain revenues.

4. Are there any promising innovations that could reshape Clobetasol Propionate’s market?
   Yes, delivery systems such as nanoemulsions, foam formulations, and combination therapies provide differentiation, potentially allowing premium pricing and extended market exclusivity.

5. What are the key regulatory challenges facing future Clobetasol Propionate formulations?
   Ensuring safety with high-potency corticosteroids, meeting bioequivalence standards for generics, and managing approval timelines for novel delivery systems are significant hurdles.

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References

[1] World Psoriasis Atlas. Global Epidemiology Data. 2022.