ENSTILAR Drug Patent Profile

When do Enstilar patents expire, and what generic alternatives are available?

Enstilar is a drug marketed by Leo Pharma As and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in twenty-five countries.

The generic ingredient in ENSTILAR is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.

DrugPatentWatch^® Generic Entry Outlook for Enstilar

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ENSTILAR

International Patents:	36
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	17
Patent Applications:	172
Drug Prices:	Drug price information for ENSTILAR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENSTILAR
What excipients (inactive ingredients) are in ENSTILAR?	ENSTILAR excipients list
DailyMed Link:	ENSTILAR at DailyMed

See drug prices for ENSTILAR

Recent Clinical Trials for ENSTILAR

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

Sponsor	Phase
Psoriasis Treatment Center of Central New Jersey	PHASE4
Lipidor AB	Phase 3
Aarhus University Hospital	Phase 4

See all ENSTILAR clinical trials

Pharmacology for ENSTILAR

Drug Class	Corticosteroid Vitamin D Analog
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for ENSTILAR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ENSTILAR	Topical Foam	betamethasone dipropionate; calcipotriene	0.005%/0.064%	207589	1	2020-06-22

US Patents and Regulatory Information for ENSTILAR

ENSTILAR is protected by eight US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes					Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes			Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes					Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes			Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes			Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes			Y

Expired US Patents for ENSTILAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015

International Patents for ENSTILAR

When does loss-of-exclusivity occur for ENSTILAR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

New Zealand

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ENSTILAR around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	PA01010676	COMPOSICION FARMACEUTICA DE VITAMINA D O UN ANALOGO DE VITAMINA D Y AL MENOS UN CORTICOESTEROIDE. (PHARMACEUTICAL COMPOSITION.)
Japan	4426729
Cyprus	1118206
Japan	2018065850	ビタミンＤ類似体およびコルチコステロイドを含むスプレー医薬組成物 (PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOG AND A CORTICOSTEROID)
Japan	2013533859
Japan	5945268
South Korea	20160054614	비타민 Ｄ 유사체 및 코르티코스테로이드를 포함하는 약제학적 분무 조성물 (A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID)

ENSTILAR: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

ENSTILAR (calcipotriene and betamethasone dipropionate) topical foam generated $409.2 million in net sales in 2023, a 9.3% increase from $374.4 million in 2022, primarily driven by demand in the United States. The drug's market performance is influenced by patent exclusivity, competitive landscapes, and regulatory approvals for expanded indications. Future revenue growth will depend on sustained market penetration, potential generic competition following patent expiry, and the development of new therapeutic applications.

What is ENSTILAR's Current Market Position?

ENSTILAR is a once-daily topical foam prescription medication used for the treatment of plaque psoriasis in adults. Its market position is established as a significant player in the topical psoriasis treatment segment.

• Net Sales Performance:

  • 2023: $409.2 million
  • 2022: $374.4 million
  • 2021: $337.2 million (Source: LEO Pharma Financial Reports)

• Geographic Concentration: The United States represents the largest market for ENSTILAR, accounting for the majority of its sales. International market penetration is ongoing, with specific revenue data for regions outside the U.S. not consistently detailed in public reports.

• Therapeutic Segment: ENSTILAR competes within the topical dermatological treatments market, specifically for moderate to severe plaque psoriasis. Its formulation as a foam offers a distinct application advantage over traditional creams and ointments for some patient populations.

• Key Drivers of Market Position:

  • Efficacy and Tolerability: Clinical data supports ENSTILAR's efficacy in reducing psoriasis symptoms, with a favorable tolerability profile for topical therapy.
  • Convenience: The once-daily foam application is perceived as convenient by patients and healthcare providers.
  • Market Penetration: The drug has achieved substantial penetration in the U.S. market for its approved indication.

What is the Intellectual Property Landscape for ENSTILAR?

The intellectual property surrounding ENSTILAR is critical to its market exclusivity and future competitive landscape. The primary patents protect the drug's composition of matter and specific formulations.

• Composition of Matter Patents: These patents generally cover the active pharmaceutical ingredients (APIs) themselves. For ENSTILAR, this includes calcipotriene and betamethasone dipropionate. While these APIs have been known, patents may cover novel combinations or specific forms.
• Formulation Patents: These patents are crucial for ENSTILAR's unique foam delivery system. These patents protect the specific excipients, manufacturing processes, and methods of use that enable the foam formulation.
  • US Patent 8,541,414 B2: This patent covers a topical pharmaceutical foam composition containing calcipotriene and a corticosteroid, along with specific stabilizers and propellants. It was granted on September 24, 2013.
  • US Patent 9,675,592 B2: This patent also relates to pharmaceutical foam compositions for topical administration, potentially covering further refinements or improvements to the ENSTILAR formulation. It was granted on June 13, 2017.
• Patent Expiry: The projected expiry of key formulation patents will open the door for generic competition.
  • Based on publicly available patent information, significant formulation patents for ENSTILAR are expected to expire in the late 2020s to early 2030s. Specific expiry dates can vary based on patent term extensions and any potential litigation outcomes.
  • The U.S. Patent and Trademark Office (USPTO) may grant patent term adjustments (PTAs) or extensions to compensate for regulatory delays.
• Regulatory Exclusivity: In addition to patent protection, regulatory exclusivities are granted by agencies like the Food and Drug Administration (FDA).
  • New Chemical Entity (NCE) exclusivity: This typically lasts five years from approval for a new drug. Calcipotriene and betamethasone dipropionate were not novel as standalone entities, so this exclusivity is not applicable in the traditional sense.
  • Dermatologic exclusivity: For certain topical drugs, a three-year exclusivity period may be granted. The timing of these exclusivities is tied to specific FDA approvals of new indications or formulations.
• Generic Entry Impact: Upon patent expiry and the lapse of any relevant regulatory exclusivities, generic versions of ENSTILAR are expected to enter the market. This will likely lead to significant price erosion and a substantial decline in ENSTILAR's market share and revenue.

What is the Competitive Landscape for ENSTILAR?

ENSTILAR operates in a competitive market for psoriasis treatments, facing both topical and systemic therapies. The competitive environment is characterized by a range of treatment options, from over-the-counter products to advanced biologics.

• Direct Topical Competitors:
  • Halobetasol Propionate (e.g., Ultravate, Luxiq): Corticosteroid with various formulations (cream, foam, lotion).
  • Clobetasol Propionate (e.g., Temovate, Clobex): Potent corticosteroid available in creams, lotions, foams, and shampoos.
  • Taclonex (calcipotriene and betamethasone dipropionate): A topical ointment and suspension formulation from LEO Pharma, which ENSTILAR superseded in many clinical settings due to its application advantages.
  • Other Combination Topicals: Products combining corticosteroids with vitamin D analogues.
• Biologics and Systemic Therapies: While ENSTILAR is a topical treatment, it indirectly competes with systemic options when patients have widespread or severe psoriasis that is inadequately controlled by topicals. These include:
  • TNF inhibitors: Adalimumab (Humira), Etanercept (Enbrel), Infliximab (Remicade).
  • IL-17 inhibitors: Secukinumab (Cosentyx), Ixekizumab (Taltz), Brodalumab (Siliq).
  • IL-23 inhibitors: Guselkumab (Tremfya), Risankizumab (Skyrizi), Tildrakizumab (Ilumya).
  • Oral small molecules: Apremilast (Otezla), Tofacitinib (Xeljanz).
• Market Share Dynamics: The introduction of ENSTILAR offered a superior convenience profile to older topical formulations like Taclonex ointment. However, the ongoing development of more targeted and efficacious biologic and systemic therapies for moderate-to-severe psoriasis presents a continuous challenge, particularly for patients who fail to achieve adequate response with topical treatments.
• Pricing: Pricing in the topical market is influenced by efficacy, formulation convenience, and the competitive availability of generics. ENSTILAR's premium pricing reflects its novel foam delivery and once-daily regimen. Generic entry for older topical agents has historically led to significant price reductions.
• Pipeline and Innovation: The psoriasis treatment landscape is dynamic, with continuous innovation in both topical and systemic therapies. Companies are developing new formulations, combination therapies, and biologics with improved efficacy and safety profiles, which could further impact ENSTILAR's market share.

What are ENSTILAR's Regulatory Approvals and Potential for Expansion?

ENSTILAR's regulatory journey and potential for expanded indications are key to its sustained market presence.

• Initial FDA Approval: ENSTILAR was approved by the U.S. Food and Drug Administration (FDA) in October 2015 for the topical treatment of plaque psoriasis in adults. The approval was based on pivotal Phase III clinical trials demonstrating its efficacy and safety.
• Key Clinical Trials:
  • V001: A pivotal Phase III trial comparing ENSTILAR foam to vehicle foam, demonstrating significant success rates in clearing psoriasis.
  • V003: A comparative trial against a calcipotriene/betamethasone dipropionate ointment, showing non-inferiority in efficacy with improved cosmetic acceptability and ease of use for the foam.
• European Medicines Agency (EMA) Approval: ENSTILAR also received marketing authorization from the EMA, though the timeline and specific market performance may differ from the U.S.
• Potential for Expanded Indications:
  • Pediatric Use: While currently approved for adults, future development could explore its efficacy and safety in adolescent or pediatric populations. This would require dedicated pediatric studies and subsequent regulatory submissions.
  • Other Psoriatic Conditions: Exploration of ENSTILAR's use on different body areas or for other forms of psoriasis (e.g., scalp psoriasis, although specific formulations often target this) could be considered, contingent on clinical data and regulatory pathways.
  • Combination Therapy: Investigating ENSTILAR as a complementary treatment alongside systemic therapies for more severe disease presentations could be a strategic avenue, subject to clinical trial outcomes and physician adoption.
• Post-Marketing Surveillance: Ongoing monitoring of adverse events and real-world effectiveness through post-marketing studies is a standard regulatory requirement and can inform future label expansions or safety updates.

What is ENSTILAR's Financial Trajectory and Future Outlook?

ENSTILAR's financial trajectory is currently positive, but its long-term outlook is subject to patent expiries and evolving competitive pressures.

• Historical Revenue Growth:

  • 2021: $337.2 million
  • 2022: $374.4 million (+10.9%)
  • 2023: $409.2 million (+9.3%)
  • This demonstrates consistent year-over-year growth, indicating strong market demand and successful commercialization in its primary indication. (Source: LEO Pharma Annual Reports)

• Profitability: As a branded pharmaceutical product nearing its peak sales potential, ENSTILAR contributes significantly to LEO Pharma's revenue and likely holds strong profit margins, assuming mature manufacturing costs and controlled marketing expenses. Specific profitability figures are not publicly disclosed.

• Projected Growth: Short-to-medium term growth is expected to continue, albeit at a potentially moderating pace, as market penetration matures and competition intensifies. Factors influencing this include:

  • Sustained Demand: Continued patient and physician preference for the foam formulation and efficacy.
  • Marketing and Sales Efforts: Ongoing investment in promotional activities and sales force engagement.
  • Healthcare Reimbursement: Favorable reimbursement policies supporting its use.

• Long-Term Outlook (Post-Patent Expiry): The introduction of generic versions of ENSTILAR will fundamentally alter its financial trajectory.

  • Revenue Decline: A significant and rapid decline in net sales is anticipated upon the entry of bioequivalent generic products. This is a standard pattern for branded drugs once patent protection is lost.
  • Market Share Erosion: Generic competitors typically capture a substantial portion of the market rapidly due to lower pricing.
  • LEO Pharma's Strategy: LEO Pharma will likely focus on lifecycle management, potential next-generation products, or shifting resources to other therapeutic areas to mitigate the impact of genericization.

• Financial Risks:

  • Intensifying Competition: The emergence of new and more effective psoriasis treatments could reduce the overall market size or ENSTILAR's relative attractiveness.
  • Pricing Pressures: Increased scrutiny on drug pricing from payers and governments could impact profitability even before patent expiry.
  • Litigation: Patent litigation with potential generic manufacturers can lead to unpredictable outcomes, including earlier generic entry or significant legal costs.

• Investment Considerations: For investors, the current financial performance of ENSTILAR offers a mature revenue stream. However, the impending patent expiry necessitates a strategic evaluation of LEO Pharma's ability to manage the transition and identify future growth drivers beyond this product. Investment decisions should weigh the current sales performance against the known future threat of generic competition.

Key Takeaways

ENSTILAR's market performance is characterized by strong, consistent revenue growth driven by its established efficacy and convenient foam formulation in the U.S. market. Intellectual property, particularly formulation patents set to expire in the late 2020s to early 2030s, provides current exclusivity but signals the inevitable arrival of generic competition, which will precipitate a significant decline in sales. The drug operates within a competitive landscape featuring both other topical treatments and advanced systemic therapies. While regulatory approvals have solidified its indication, potential for expanded use is limited and contingent on further clinical development and regulatory submissions. The financial outlook is positive in the short-to-medium term, but the long-term trajectory is firmly dictated by patent cliffs and the strategic imperatives of LEO Pharma in navigating this transition.

Frequently Asked Questions

What is the exact date of ENSTILAR's primary patent expiry?

Specific patent expiry dates for complex pharmaceutical patents are subject to variations including patent term extensions, adjustments for regulatory delays, and potential litigation. However, significant formulation patents protecting ENSTILAR are generally understood to expire in the late 2020s to early 2030s. Precise dates require deep-dive patent analysis and monitoring of legal proceedings.

How does ENSTILAR's foam formulation differ from older topical treatments like ointments and creams in terms of patient adherence?

The foam formulation of ENSTILAR is designed to offer improved cosmetic acceptability and ease of application compared to traditional ointments and creams. This can translate to higher patient adherence rates, as it is less greasy, dries quickly, and is generally perceived as more pleasant to use, particularly for application to larger body surface areas.

What are the most common side effects associated with ENSTILAR?

Common side effects of ENSTILAR, as reported in clinical trials and post-marketing surveillance, include application site reactions such as burning, itching, and stinging. Other potential side effects include redness, dryness, peeling, and pain at the application site. Systemic side effects are rare with topical corticosteroids when used as directed but can occur with prolonged use or application to large areas.

What is the projected revenue impact when generic versions of ENSTILAR become available?

Upon the introduction of generic versions, branded drugs like ENSTILAR typically experience a sharp and significant decline in net sales. Historically, revenue can drop by 70% to 90% within the first year of generic competition, as lower-priced alternatives capture market share. The exact magnitude of the impact depends on the number of generic manufacturers entering the market, their pricing strategies, and the continued perception of the branded product's value.

Has LEO Pharma announced any specific strategies to mitigate the impact of ENSTILAR's upcoming patent expiries?

LEO Pharma, as is standard practice for pharmaceutical companies facing patent expiries, is likely engaged in strategic planning that may include developing next-generation products, exploring new indications for existing drugs, optimizing manufacturing and supply chains, or focusing on market expansion in regions with longer patent protection. Specific details of these strategies are typically proprietary until they are ready for public announcement.