CLOBEX Drug Patent Profile

When do Clobex patents expire, and when can generic versions of Clobex launch?

Clobex is a drug marketed by Galderma Labs Lp and Galderma Labs and is included in three NDAs.

The generic ingredient in CLOBEX is clobetasol propionate. There are fourteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the clobetasol propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Clobex

A generic version of CLOBEX was approved as clobetasol propionate by COSETTE on February 16^th, 1994.

Summary for CLOBEX

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	14
Patent Applications:	4,476
Drug Prices:	Drug price information for CLOBEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLOBEX
What excipients (inactive ingredients) are in CLOBEX?	CLOBEX excipients list
DailyMed Link:	CLOBEX at DailyMed

See drug prices for CLOBEX

See drug sales revenues for CLOBEX

Recent Clinical Trials for CLOBEX

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

Sponsor	Phase
MC2 Therapeutics	Phase 1
Drug Delivery Solutions Ltd. (part of MC2 Therapeutics)	Phase 1
University of California, San Francisco	Phase 4

See all CLOBEX clinical trials

Pharmacology for CLOBEX

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for CLOBEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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

US Patents and Regulatory Information for CLOBEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	CLOBEX	clobetasol propionate	LOTION;TOPICAL	021535-001	Jul 24, 2003	AB	RX	Yes	Yes
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	AB	RX	Yes	Yes
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	AT	RX	Yes	Yes

Expired US Patents for CLOBEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	8,066,976
Galderma Labs Lp	CLOBEX	clobetasol propionate	LOTION;TOPICAL	021535-001	Jul 24, 2003	6,106,848
Galderma Labs Lp	CLOBEX	clobetasol propionate	SPRAY;TOPICAL	021835-001	Oct 27, 2005	5,990,100

International Patents for CLOBEX

See the table below for patents covering CLOBEX around the world.

Country	Patent Number	Title	Estimated Expiration
France	2753626	NOUVELLES COMPOSITIONS TOPIQUES SOUS FORME D'EMULSION FLUIDE H/E A FORTE TENEUR EN GLYCOL PRO-PENETRANT
Poland	344365
Japan	4091257

CLOBEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CLOBEX (Clobetasol Propionate)

Introduction to CLOBEX

CLOBEX, formulated with clobetasol propionate, is a super-high potent topical corticosteroid used primarily for the treatment of scalp psoriasis and other dermatological conditions. Understanding its market dynamics and financial trajectory involves analyzing various factors, including market size, growth drivers, competitive landscape, and regulatory influences.

Market Size and Growth

The global clobetasol propionate market is expected to exhibit significant growth over the forecast period from 2025 to 2031. This growth is driven by increasing demand for effective treatments for psoriasis and other skin conditions, as well as the expanding patient population globally[1].

Historical and Forecasted Data

The market size and revenue for clobetasol propionate have been steadily increasing. The base year for calculations is 2023, with historical data from 2019 to 2023 and forecasted data from 2025 to 2031. This period is crucial for understanding the market's trajectory and potential future growth[1].

Key Drivers of the Market

Several factors drive the growth of the clobetasol propionate market:

Increasing Prevalence of Psoriasis

The rising prevalence of psoriasis and other skin conditions is a significant driver. As the global population grows and ages, the demand for effective treatments increases, contributing to market expansion[1].

Advances in Pharmaceutical R&D

Advancements in pharmaceutical research and development (R&D), particularly in leveraging data and digital technology, enhance the efficacy and safety of treatments like clobetasol propionate. This innovation attracts more investors and patients, boosting market growth[3].

Regulatory Environment

Regulatory approvals and compliance play a critical role. Drugs like CLOBEX must undergo rigorous clinical trials and meet stringent regulatory standards, which, once achieved, can significantly boost market confidence and adoption[4].

Competitive Landscape

The competitive landscape for clobetasol propionate is characterized by several key players and market dynamics:

Market Segmentation

The market is segmented by type (Type I and Type II), application, and region. By type, the segment that accounted for the largest share of the global clobetasol propionate market is typically the super-high potent corticosteroids, such as clobetasol propionate[1].

Regional Analysis

The global market is dominated by regions with high healthcare spending and advanced pharmaceutical infrastructures. North America and Europe are expected to be key regions driving the market, followed by Asia-Pacific, which is growing rapidly due to increasing healthcare awareness and spending[1].

Financial Trajectory

The financial performance of CLOBEX and similar products is influenced by several financial metrics:

Revenue and Market Share

Companies manufacturing clobetasol propionate formulations, such as Galderma, experience significant revenue from these products. The market share is distributed among various players, with leading companies holding a substantial portion due to their brand recognition and product efficacy[4].

Cost and Pricing

The cost of developing and marketing clobetasol propionate formulations is high, but the pricing strategy is often justified by the product's efficacy and the unmet medical needs it addresses. The expected revenue potential and willingness to pay by governments and insurance companies significantly influence the supply and distribution of these drugs[3].

Clinical Trials and Regulatory Approvals

The financial trajectory is also influenced by the outcomes of clinical trials and regulatory approvals. Successful trials and approvals can lead to increased market share and revenue, while adverse outcomes can result in significant financial setbacks[4].

Adverse Reactions and Safety Profile

The safety profile of CLOBEX is a critical factor in its market dynamics:

Clinical Trial Adverse Reactions

Clinical trials have shown that CLOBEX can cause adverse reactions, primarily dermatological, which can lead to discontinuation in some cases. However, the overall safety profile supports its use for treating scalp psoriasis and other conditions[4].

Systemic Absorption and HPA Axis Suppression

The potential for systemic absorption and HPA axis suppression is a concern, especially with prolonged use or application over large surface areas. This requires periodic evaluation and potential adjustments in treatment[4].

Market Trends and Opportunities

Several trends and opportunities shape the market for clobetasol propionate:

Increasing Focus on Personalized Medicine

The trend towards personalized medicine and targeted therapies could influence the development of more specific and effective treatments, potentially impacting the market for clobetasol propionate[3].

Expanding Patient Population

The growing patient population, especially in emerging markets, presents a significant opportunity for market expansion. Companies are increasingly focusing on these regions to tap into the untapped potential[1].

Challenges and Restraints

Despite the growth potential, the market faces several challenges:

Regulatory Hurdles

Stringent regulatory requirements and the need for extensive clinical trials can delay market entry and increase development costs[4].

Affordability and Willingness to Pay

Affordability issues and the willingness to pay by governments and insurance companies can impact the supply and distribution of clobetasol propionate. Lower expected willingness to pay could result in fewer novel drugs being developed[3].

Technological and Scientific Advances

Technological and scientific advances are crucial for the market:

Leveraging Data and Digital Technology

The ability to leverage data and digital technology advances to inform innovative clinical trial designs is a key factor in the development and success of clobetasol propionate formulations[3].

Innovative Clinical Trial Designs

Innovative clinical trial designs that incorporate advanced data analytics and digital technologies can enhance the efficacy and safety of treatments, making them more attractive to patients and investors[3].

Conclusion

The market dynamics and financial trajectory for CLOBEX (clobetasol propionate) are influenced by a complex interplay of factors including market size, growth drivers, competitive landscape, regulatory environment, and technological advances. As the demand for effective treatments for psoriasis and other skin conditions continues to grow, companies manufacturing clobetasol propionate formulations are poised for significant market expansion.

Key Takeaways

• The global clobetasol propionate market is expected to grow significantly from 2025 to 2031.
• Increasing prevalence of psoriasis and advances in pharmaceutical R&D drive market growth.
• Regulatory approvals and compliance are critical for market success.
• The competitive landscape is characterized by key players and regional dominance.
• Financial performance is influenced by revenue, market share, cost, and pricing strategies.
• Adverse reactions and safety profiles are crucial for market acceptance.
• Trends towards personalized medicine and expanding patient populations present opportunities.
• Regulatory hurdles and affordability issues are significant challenges.

FAQs

What is CLOBEX used for?

CLOBEX is a super-high potent topical corticosteroid used primarily for the treatment of scalp psoriasis and other dermatological conditions.

What are the key drivers of the clobetasol propionate market?

Key drivers include the increasing prevalence of psoriasis, advances in pharmaceutical R&D, and a favorable regulatory environment.

What are the potential adverse reactions of CLOBEX?

CLOBEX can cause dermatological adverse reactions, and there is a risk of systemic absorption and HPA axis suppression, especially with prolonged use.

How does the regulatory environment impact the market?

Stringent regulatory requirements and the need for extensive clinical trials can delay market entry and increase development costs, but successful approvals can significantly boost market confidence.

What are the trends shaping the future of the clobetasol propionate market?

Trends include a focus on personalized medicine, expanding patient populations in emerging markets, and the leveraging of data and digital technology advances in clinical trials.

Sources

1. Clobetasol Propionate Market Report 2024 (Global Edition) - Cognitivemarketresearch.com
2. CLOs Prove Resilient As Rate Cuts Begin - VanEck
3. The Financial Ecosystem of Pharmaceutical R&D - RAND
4. CLOBEX® SHAMPOO (clobetasol propionate shampoo) - Galderma
5. Leveraging the Perrigo - Annual Reports