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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:	16
Patent Applications:	68
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
Lipidor AB	Phase 3
Aarhus University Hospital	Phase 4
University of Alabama at Birmingham	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	AB	RX	Yes	Yes	10,688,108
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	AB	RX	Yes	Yes	9,119,781*PED				Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	AB	RX	Yes	Yes	10,617,698		Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	AB	RX	Yes	Yes	10,130,640*PED				Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	AB	RX	Yes	Yes	10,660,908		Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	AB	RX	Yes	Yes	9,566,286		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	6,753,013

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
Japan	5721926
Slovenia	2915534
Montenegro	P39108
Hong Kong	1182321
New Zealand	515142	Pharmaceutical composition
Australia	2278300

ENSTILAR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Enstilar

Introduction

Enstilar, a topical treatment for plaque psoriasis developed by LEO Pharma, has been a significant player in the dermatology market. Here, we will delve into the market dynamics and financial trajectory of Enstilar, highlighting its performance, growth drivers, and future prospects.

Market Position and Growth

Enstilar has consistently demonstrated strong market performance, particularly in the context of the broader dermatology landscape.

Revenue Growth

In 2020, despite the challenges posed by the COVID-19 pandemic, Enstilar showed a 3% increase in revenue to DKK 1,125 million, with a notable 10% growth in Europe. This growth was achieved even as the topical market for psoriasis treatments declined by 2% during the same period[1].

Market Share Expansion

Enstilar has successfully expanded its market share, outpacing the overall market growth. For instance, in the first half of 2024, LEO Pharma's dermatology portfolio, led by Enstilar, saw a 13% revenue growth in constant exchange rates (CER), contributing to the company's overall revenue increase of 11% CER[2].

Competitive Landscape

Enstilar operates in a competitive market, but its unique profile and efficacy have helped it stand out.

Comparative Performance

In the psoriasis treatment market, Enstilar has performed better than many of its competitors. For example, while the biologics market for psoriasis grew by 16%, Kyntheum, another LEO Pharma product, saw a 40% revenue increase, and Enstilar continued to gain market share despite the broader market decline[1].

Global Expansion

LEO Pharma has been actively expanding Enstilar's availability globally. Recently, the company submitted a New Drug Application (NDA) to the National Medical Products Administration (NMPA) in China, aiming to bring Enstilar to the Chinese market, which is estimated to have around seven million adult patients living with plaque psoriasis[4].

Financial Performance

The financial performance of Enstilar is closely tied to LEO Pharma's overall financial health.

Revenue Contribution

Enstilar is a significant contributor to LEO Pharma's revenue. In the first half of 2024, the company's strong revenue growth was largely driven by its dermatology portfolio, with Enstilar being a key product[2].

Operational Efficiency

The revenue growth from Enstilar and other products has been complemented by operational efficiencies. For instance, in the first half of 2024, LEO Pharma reported an EBITDA margin of 9%, reflecting improved operational performance[2].

Impact of COVID-19

During the COVID-19 pandemic, LEO Pharma's net sales, including those of Enstilar, were impacted by lockdowns, generics in Europe, and price pressure in the US. However, the company managed to mitigate these effects through strategic planning and execution, ensuring business continuity and the progression of strategic projects[1].

Regulatory and Clinical Milestones

Enstilar's success is also driven by its regulatory and clinical milestones.

Clinical Efficacy

The efficacy of Enstilar has been supported by clinical trials. For example, the NDA submission in China was backed by a phase 3 trial comparing Enstilar with Daivobet ointment in adult Chinese patients, demonstrating its safety and efficacy[4].

Regulatory Approvals

Enstilar has been approved in over 50 markets worldwide, with the recent submission in China marking a significant step in its global expansion. Regulatory approvals are crucial for expanding its market reach and increasing patient access[4].

Future Prospects

The future outlook for Enstilar is promising, driven by several factors.

Pipeline Expansion

LEO Pharma is committed to expanding its pipeline, which includes potential new treatments for atopic dermatitis and other dermatological indications. The launch of new products and the progression of pipeline projects will likely enhance Enstilar's market position[1][2].

Market Growth in Dermatology

The dermatology market, particularly in regions like China, is growing rapidly. LEO Pharma's strong performance in this sector, led by products like Enstilar, positions the company well for continued growth[2][4].

Strategic Execution

The company's focus on strategic execution, cost structure optimization, and commercial success will continue to drive the financial performance of Enstilar and other products in the portfolio[2].

Key Takeaways

• Revenue Growth: Enstilar has shown consistent revenue growth, even during challenging times like the COVID-19 pandemic.
• Market Share: It has expanded its market share in the psoriasis treatment market.
• Global Expansion: Enstilar is being expanded to new markets, including China.
• Financial Performance: The product contributes significantly to LEO Pharma's revenue and operational efficiency.
• Regulatory and Clinical Milestones: Strong clinical efficacy and regulatory approvals support its market position.
• Future Prospects: The product is poised for continued growth driven by pipeline expansion, market growth in dermatology, and strategic execution.

FAQs

What was the impact of COVID-19 on Enstilar's revenue?

The COVID-19 pandemic led to a decline in total revenue for LEO Pharma, but Enstilar continued to grow, with a 3% increase in revenue despite market challenges[1].

How has Enstilar performed in comparison to other psoriasis treatments?

Enstilar has outperformed the broader topical market for psoriasis treatments and has shown stronger growth compared to some biologic treatments in the same market[1].

What is the significance of the NDA submission for Enstilar in China?

The NDA submission in China marks a significant step in Enstilar's global expansion, targeting a large market with an estimated seven million adult patients living with plaque psoriasis[4].

How does Enstilar contribute to LEO Pharma's financial health?

Enstilar is a key contributor to LEO Pharma's revenue, particularly within the dermatology portfolio, which has driven the company's solid financial performance and improved operational efficiencies[2].

What are the future prospects for Enstilar?

Enstilar is expected to continue growing, driven by pipeline expansion, market growth in dermatology, and LEO Pharma's strategic execution and commercial success[1][2][4].

Sources

1. LEO Pharma Delivered on Strategic Ambitions and Showed Resilience During COVID-19 Pandemic in 2020 - Business Wire
2. LEO Pharma delivers 11% revenue growth (CER) in H1 and upgrades financial outlook for the year - Via Ritzau
3. February 13, 2023 Financial Results and Business Update for the Roivant Sciences - Investor Roivant
4. LEO Pharma Submits New Drug Application for Enstilar® for Adults with Plaque Psoriasis in China - BioSpace