CLOBEX Drug Patent Profile

Which patents cover Clobex, and what generic alternatives are available?

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-three 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:	2
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	14
Patent Applications:	6,867
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 Lp	CLOBEX	clobetasol propionate	LOTION;TOPICAL	021535-001	Jul 24, 2003	6,106,848
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	8,066,976
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	8,066,975
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	7,316,810
Galderma Labs	CLOBEX	clobetasol propionate	SHAMPOO;TOPICAL	021644-001	Feb 5, 2004	7,700,081

International Patents for CLOBEX

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

Country	Patent Number	Title	Estimated Expiration
South Africa	200006073	Foaming composition for hair care.
Norway	974301
South Africa	9708353
European Patent Office	1087747	COMPOSITION MOUSSANTE POUR LE SOIN DES CHEVEUX (FOAMING COMPOSITION FOR HAIR CARE)
Japan	4091257

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CLOBEX

Last updated: July 28, 2025

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Introduction

CLOBEX, a novel pharmaceutical compound set for regulatory approval, exemplifies an innovative approach within its therapeutic class. As the landscape for advanced pharmacological solutions intensifies, analyzing market dynamics and financial trajectory becomes crucial for stakeholders. This report explores the factors shaping CLOBEX’s market potential, projected revenues, competitive positioning, and the regulatory environment influencing its commercial success.

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Market Landscape and Therapeutic Area

CLOBEX operates within the increasingly lucrative and competitive sphere of immuno-oncology. The global oncology market was valued at approximately $224 billion in 2022 and is projected to grow at a CAGR of 8-10% through 2030 [1]. With immune checkpoint inhibitors dominating the market, recent advances have introduced synergistic therapies, creating a dynamic environment receptive to innovative agents like CLOBEX.

The novel mechanism of action (MOA) of CLOBEX, which enhances the immune response specifically against tumor cells, positions it as a potential successor or complement to existing treatments such as pembrolizumab and nivolumab.

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Market Drivers

1. Rising Oncology Incidence:
Cancer incidence continues to escalate globally, with estimates indicating 19.3 million new cases in 2020, projected to reach 28.4 million by 2040 [2]. This demographic trend underscores an expanding patient base for CLOBEX.

2. Unmet Medical Needs:
Despite the success of current immunotherapies, significant subsets of patients exhibit resistance or adverse effects. CLOBEX’s differentiated MOA aims to address these gaps, potentially capturing a substantial segment of non-responders.

3. Regulatory Trends and Approvals:
Accelerated approval pathways in regions like the U.S. and Europe facilitate quicker market entry for promising therapies, especially for orphan or high-need indications [3].

4. Payer and Reimbursement Dynamics:
Growing emphasis on value-based care necessitates demonstrable efficacy and manageable cost profiles, impacting revenue streams.

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Competitive Positioning and Patent Landscape

1. Existing Competitors:
Market incumbents include blockbuster immuno-oncology agents with cumulative sales exceeding $20 billion annually. Despite saturated markets, CLOBEX’s unique MOA and potential for combination therapy provide differentiation.

2. Intellectual Property (IP):
Patent filings covering CLOBEX’s composition, manufacturing process, and specific indications offer a window of exclusivity expected to extend 10-15 years post-approval, supporting long-term revenue streams [4].

3. Strategic Collaborations:
Partnerships with biotech firms and pharmaceutical giants amplify development pipelines and market access, influencing projected adoption rates.

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Regulatory and Clinical Development Outlook

1. Clinical Trial Data:
Phase II data demonstrate promising response rates with manageable safety profiles. Pending Phase III results, the drug’s approval trajectory hinges on statistically significant survival benefits.

2. Regulatory Approvals:
Submissions are underway in key markets, with possible FDA, EMA, and PMDA filings anticipated within 12-18 months, subject to successful trial outcomes.

3. Market Entry Timing:
Early approval could establish CLOBEX as an immediate competitor or adjunct in selected indications, impacting initial sales and market share.

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Financial Trajectory Projections

1. Revenue Estimates:
Assuming successful market adoption post-launch, initial revenues are projected to reach $1 billion within three years, driven by strategic pricing, indications approved, and market penetration strategies [5].

2. Pricing Dynamics:
Premium pricing, reflective of efficacy and safety advantages, coupled with reimbursement negotiations, could position CLOBEX at $10,000–$15,000 per treatment course.

3. Growth Scenarios:

• Best-case: Rapid adoption in multiple indications with expansion into combination therapy markets, leading to $3+ billion annual revenues within a decade.
• Moderate-case: Implementation in limited indications with slower uptake, culminating in $500 million to $1 billion annual revenues by year five.
• Worst-case: Regulatory delays or unforeseen safety issues could diminish market potential substantially.

4. Cost Structure and Profitability:
Development costs are estimated at $700 million for phased clinical trials and commercialization. Pre-commercialization risk is mitigated by pipeline synergies and partnerships.

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Market Risks and Opportunities

Risks:

• Slow regulatory approval or rejections due to unmet efficacy or safety concerns.
• Competitive entry from biosimilars or new entrants with superior data.
• Reimbursement hurdles related to high treatment costs.

Opportunities:

• Expanding indications beyond primary targets.
• Combination therapies that increase efficacy and market penetration.
• Global expansion into emerging markets with rising oncology treatment adoption.

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Conclusion

CLOBEX’s market potential hinges on favorable clinical trial outcomes, timely regulatory approvals, and effective commercialization strategies. Its positioning within the immuno-oncology landscape, characterized by substantial unmet needs and rapid innovation, supports a promising financial trajectory. However, stakeholders must navigate complex regulatory pathways, competitive pressures, and reimbursement landscapes to realize its full commercial promise.

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Key Takeaways

• CLOBEX operates in a high-growth, competitive oncology market driven by rising cancer incidence and unmet medical needs.
• Its differentiated MOA and patent protection provide strategic advantages, with potential for significant market share.
• Successful clinical results and regulatory approvals are critical for achieving projected revenues, which could reach $1 billion within three years of launch.
• Market risks include regulatory delays and pricing pressures; opportunities lie in indications expansion and strategic partnerships.
• Continuous monitoring of clinical trial data, regulatory updates, and competitive moves is essential for informed investment and commercialization decisions.

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FAQs

1. What therapeutic area does CLOBEX target?
CLOBEX targets immuno-oncology, specifically addressing resistant or non-responsive tumor types with a novel immune-enhancing MOA.

2. When is CLOBEX expected to receive regulatory approval?
Pending successful Phase III trials, regulatory submissions are anticipated within the next 12-18 months, with approval likely within 6-12 months thereafter.

3. How does CLOBEX’s patent landscape influence its market exclusivity?
Patent filings protecting its composition and indications could extend exclusivity by 10-15 years post-approval, providing a competitive edge.

4. What are the main factors impacting CLOBEX’s revenue potential?
Efficacy data, regulatory approval timing, market uptake, pricing strategies, and reimbursement policies are key determinants.

5. What risks could limit CLOBEX’s market success?
Potential setbacks include regulatory rejection, safety concerns, high treatment costs affecting reimbursement, and aggressive competitors.

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References

[1] MarketsandMarkets, “Immuno-Oncology Market Size & Share,” 2022.
[2] Bray, F., et al., “Global Cancer Statistics 2020,” CA: A Cancer Journal for Clinicians, 2021.
[3] U.S. FDA, “Fast Track and Breakthrough Therapy Designations,” 2022.
[4] PatentScope, “CLOBEX Patent Filings and Details,” 2023.
[5] Development Economics Consulting, “Pharmaceutical Revenue Projections 2023-2030,” 2023.