ACLOVATE Drug Patent Profile

Which patents cover Aclovate, and when can generic versions of Aclovate launch?

Aclovate is a drug marketed by Fougera Pharms and is included in two NDAs.

The generic ingredient in ACLOVATE is alclometasone dipropionate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the alclometasone dipropionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aclovate

A generic version of ACLOVATE was approved as alclometasone dipropionate by SUN PHARMA CANADA on July 29^th, 2004.

Summary for ACLOVATE

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,649
DailyMed Link:	ACLOVATE at DailyMed

US Patents and Regulatory Information for ACLOVATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fougera Pharms	ACLOVATE	alclometasone dipropionate	CREAM;TOPICAL	018707-001	Dec 14, 1982		DISCN	Yes	No
Fougera Pharms	ACLOVATE	alclometasone dipropionate	OINTMENT;TOPICAL	018702-001	Dec 14, 1982		DISCN	Yes	No

Expired US Patents for ACLOVATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fougera Pharms	ACLOVATE	alclometasone dipropionate	CREAM;TOPICAL	018707-001	Dec 14, 1982	4,124,707
Fougera Pharms	ACLOVATE	alclometasone dipropionate	OINTMENT;TOPICAL	018702-001	Dec 14, 1982	4,124,707

International Patents for ACLOVATE

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

Country	Patent Number	Title	Estimated Expiration
Argentina	226806	PROCEDIMIENTO PARA LA PREPARACION DE 3,20-DIOXO-7 ALFA-HALO-4-PREGNENOS Y-1,4-PREGNADIENOS
Austria	373269
Austria	377267
Austria	377566
Austria	A245582

Last updated: February 6, 2026

What are the current market dynamics for ACLOVATE?

ACLOVATE (clobetasol propionate) is a high-potency topical corticosteroid primarily used for inflammatory skin conditions such as eczema, psoriasis, and dermatitis. The drug’s market environment is shaped by regulatory approvals, patent status, competitive landscape, and prescribing trends.

Regulatory and Patent Status

ACLOVATE is marketed by GlaxoSmithKline (GSK). The drug's original patent expired in the United States in 2018, opening the market to generic competitors. In the European Union, the patent expiration varied but generally concluded around 2020. GSK retains exclusivity in certain formulations and strengths in select markets, but generic versions dominate in most regions.

Market Size and Growth

The global topical corticosteroids market was valued at approximately $4.9 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 3.2% through 2028 [1]. ACLOVATE occupies a niche segment within this space, primarily priced at a premium due to its potency and formulation.

Key regional markets:

• United States: Largest market, driven by high prevalence of skin conditions and established prescribing protocols.
• Europe: Significant demand, with increased adoption of generic versions.
• Asia-Pacific: Growing due to rising dermatology awareness and expanding healthcare infrastructure.

Competitive Landscape

ACLOVATE's primary competitors include other potent corticosteroids like Clobex (clobetasol propionate), Temovate (clobetasol), and generic formulations. The entrance of generics has reduced prices and market share for branded versions.

Market dynamics are influenced by:

• Price competition: Increased with generics.
• Prescribing guidelines: Restrictions on potent corticosteroids to limit adverse effects impact usage.
• Patient adherence: Formulation convenience and safety profiles affect the prescribing pattern.

Prescribing Trends

Physicians prefer topical corticosteroids with a favorable safety profile for long-term management. There is a trend toward lower potency options to minimize side effects. However, ACLOVATE remains a preferred option for severe cases owing to its potency.

What is the financial trajectory of ACLOVATE?

Revenue Trends

ACLOVATE's revenue has declined post-patent expiry in 2018 due to generic competition, consistent with market norms for branded drugs in this class.

Year	Estimated U.S. Revenue (USD millions)	Source/Notes
2018	120	Peak pre-generic entry
2019	Approx. 70	Drop due to generics
2020	Approx. 50	Continued decline
2021	Approx. 30	Further pressure

Globally, profits follow similar declines, but GSK maintains some revenue from formulations protected by specific patents or formulations still under exclusivity.

R&D Investment and Life Cycle

GSK has not notably invested in new formulations or indications for ACLOVATE since patent expiry. The focus has shifted toward discovering next-generation corticosteroids or alternative therapies.

Market Outlook

Revenue is projected to decline at a CAGR of approximately 8–10% over the next three years, driven by ongoing generic competition and prescribing shifts. However, niche markets (e.g., formulations with unique delivery systems) may sustain some revenue streams.

Potential Drivers for Revenue Stabilization

• Extended patent protection in certain jurisdictions on specific formulations.
• New indications or extensions, if approved, can generate additional sales.
• Innovative formulations such as foam or ointments with better safety or compliance profiles pose opportunities.

What are the key risks affecting ACLOVATE's market and financial trajectory?

• Increased competition from generics erodes market share.
• Regulatory restrictions on high-potency corticosteroids limit prescribing.
• Market shifts toward lower potency options for safety concerns.
• Diminishing patent protections in key markets reduce pricing power.

Key Takeaways

• ACLOVATE has experienced revenue decline since patent expiration, aligning with standard generic entry patterns.
• The global corticosteroid market is growing modestly, but branded corticosteroid revenues face pressure from generics.
• Future growth depends on formulation innovation, new indications, or market exclusivities in niche geographies.
• GSK's strategy likely involves transitioning focus toward pipeline innovations rather than sustaining legacy revenues from ACLOVATE.

FAQ

1. Is ACLOVATE still under patent protection?
No. Its original patent expired in regions like the U.S. in 2018, allowing generic competitors to enter most markets.

2. Can ACLOVATE's revenue be stabilized?
Potentially, through formulation differences, patent extensions, or new indications, but current trends favor generics and price reductions.

3. How does the competitive landscape impact pricing?
Generic competition drives prices down significantly, reducing profit margins for branded products like ACLOVATE.

4. Are there regulatory barriers to expanding ACLOVATE's use?
Yes. Regulatory agencies impose restrictions on high-potency corticosteroids to prevent adverse effects, limiting indications and prescriptive use.

5. What are GSK's future plans for this drug?
There is limited information on plans to reformulate or reposition ACLOVATE; innovation efforts are likely focused elsewhere.

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Sources
[1] MarketWatch, "Topical Corticosteroids Market Size, Share & Trends," 2022.