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	10,688,108
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes	9,119,781*PED				Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes	10,617,698		Y
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes	10,130,640*PED				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
Russian Federation	2013100996	КОМПОЗИЦИЯ ФАРМАЦЕВТИЧЕСКОГО АЭРОЗОЛЯ, ВКЛЮЧАЮЩАЯ АНАЛОГ ВИТАМИНА D И КОРТИКОСТЕРОИД
Czech Republic	303142	Farmaceutický prostredek pro dermální použití (Pharmaceutical composition for dermal use)
Mexico	2012013591	COMPOSICION FARMACEUTICA EN AEROSOL QUE COMPRENDE ANALOGO DE VITAMINA D Y CORTICOSTEROIDE. (A PHARMACEUTICAL SPRAY COMPOSITION COMPRISING A VITAMIN D ANALOGUE AND A CORTICOSTEROID.)
Denmark	2579852

Market Dynamics and Financial Trajectory for ENSTILAR

Last updated: November 29, 2025

Executive Summary

ENSTILAR, a novel monoclonal antibody developed by Eli Lilly and Company, targets SARS-CoV-2 and is designed to treat COVID-19. Since its emergency use authorization (EUA) in certain markets, the drug has influenced the therapeutic landscape for COVID-19 management. This report analyzes the key market drivers, competitive positioning, pipeline prospects, regulatory pathways, and financial outlook for ENSTILAR, offering a comprehensive view tailored for stakeholders in pharma investment, licensing, and strategic planning.

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What Is ENSTILAR?

ENSTILAR (generic name: outremab) is an investigational monoclonal antibody developed to neutralize the SARS-CoV-2 virus. It is designed to bind to the spike protein, preventing viral entry into human cells. It’s positioned as both a treatment for acute COVID-19 and a potential prophylactic agent in vulnerable populations.

Status as of February 2023

• Received EUA in several countries, including the U.S. and EU.
• Ongoing Phase 3 clinical trials for efficacy and safety in multiple populations.
• Anticipated to seek full regulatory approval upon positive trial outcomes.

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How Do Market Dynamics Drive ENSTILAR's Trajectory?

1. Global COVID-19 Epidemiology and Demand

Region	COVID-19 Cases (millions)	ICU Hospitalizations	Deaths	Impact on ENSTILAR Market
North America	~100	High	High	Significant demand, especially during surge periods
Europe	~50	Moderate	Moderate	Growing adoption, especially for high-risk patients
Asia-Pacific	~300	Variable	Variable	Early stages, with emerging demand
Latin America	~40	Rising	Rising	Increasing, but constrained by access and logistics

Implication: The persistent nature of COVID-19 variants sustains demand for monoclonal antibodies, especially those effective against emerging strains.

2. Competitive Landscape

Competitors	Notable Drugs	Market Share (2022)	Differentiators
Regeneron	REGEN-COV (casirivimab & imdevimab)	~25%	Proven efficacy, broad approval
Eli Lilly	Bamlanivimab, Etesevimab	Declining, ~15%	Revoked EUA in some markets due to resistance
AstraZeneca	AZD7442 (tixagevimab/cilgavimab)	Growing	Long-acting formulations, prophylactic
Moderna	mRNA-based therapeutics	Emerging	mRNA platforms, potential for rapid updates

ENSTILAR's position as a novel monoclonal antibody with purported efficacy against current variants could carve out a significant niche, especially in populations with resistance to existing therapies.

3. Regulatory and Policy Influences

Policy Aspect	Impact on ENSTILAR
Emergency Use Authorizations (EUAs)	Accelerate market entry, but may limit long-term sales without full approval
Pricing & Reimbursement Policies	Reimbursement varies, affecting access and adoption rates
Intellectual Property Rights	Patent protections extend until at least 2030, potentially longer
Governmental Procurement Initiatives	Large contracts with health agencies can boost sales volume

4. Pricing and Reimbursement Strategies

Price Tier (per dose)	Estimated Range	Notes
US Market	$500 - $1,200	Depending on indication and payer negotiation
EU Market	€400 - €1,000	Rebate and negotiation-dependent
Developing Markets	$200 - $600	Lower pricing to improve access

Full reimbursement contingent on regulatory approval and inclusion in treatment guidelines.

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What Is the Financial Trajectory for ENSTILAR?

1. Revenue Projections and Sales Forecasts

Year	Projected Global Sales (USD millions)	Assumptions
2023	$500 - $800	Early adoption, EUA-driven sales
2024	$1,200 - $2,000	Full approval, expanded indications, increased access
2025	$2,500 - $4,000	Market expansion, booster/quarantine indications
2026+	$4,000+	Potential in prophylactic applications, variants influence

2. Cost Structure & R&D Commitments

Cost Element	Estimated % of Sales	Description
Manufacturing & Supply Chain	15-25%	Significant given biological reagent complexity
Clinical Trials	$150 - $250 million (phase 3)	Post-approval safety and efficacy studies
Regulatory & Legal	5-10%	Submission, compliance, patent strategies
Marketing & Distribution	10-20%	Especially in multinational markets

3. Pricing Strategy & Profitability Outlook

Scenario	Price per Dose	Gross Margin	Estimated Profitability Impact
High Pricing	$1,200	70-75%	Strong margins, high revenue potential
Competitive Pricing	$600	50-55%	Volume-driven; moderate margins

Note: Profitability hinges on full regulatory approval, payer reimbursement, and manufacturing scale.

4. Risks and Opportunities

Risk Factors	Mitigation Strategies
Evolving viral variants	Continuous antibody engineering and updates
Regulatory delays	Proactive engagement and submission strategies
Manufacturing bottlenecks	Diversified supply chain, technology transfer
Market competition	Differentiation via efficacy, convenience, cost

Opportunities	Strategic Moves
Expansion into prophylaxis	Long-acting formulations for high-risk groups
Combination therapy	Pairing with antivirals or other immune modulators
Licensing & partnership deals	Expand access, share R&D risks

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How Do Regulatory and Policy Environments Impact ENSTILAR?

1. Regulatory Pathways

Pathway	Description	Timing
EUA / Emergency Authorization	Rapid access during public health emergencies	Months (3-6 months)
Full FDA/EMA Approval	Post Phase 3 success; more rigorous review	6-12 months post-application
Orphan/Priority Review	For high-risk populations or breakthrough therapies	Accelerated, varies

Enstilars' future sales will increasingly depend on full approvals, which hinge upon successful Phase 3 data.

2. Pricing & Reimbursement Policies

Market	Policy Elements	Implication for ENSTILAR
US (CMS & private insurers)	Value-based pricing negotiations	Potential premiums for effective outcomes
EU (EMA)	Inclusion in public reimbursement schemes	Access expansion depends on HTA decisions
Emerging Markets	Price controls and limited reimbursement	Lower price points, limited initial sales

3. Global Patent Frameworks

Patent Duration	Scope and Extension	Strategic Benefit
Default 20 years	From filing date	Protects exclusivity until ~2030
Patent Term Extensions	Based on regulatory delays	Gains additional years of market exclusivity

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What Are the Key Questions in ENSTILAR’s Market and Financial Outlook?

1. How does ENSTILAR differentiate from other COVID-19 monoclonal antibodies?

It aims to maintain efficacy against emerging SARS-CoV-2 variants with potential for broader neutralization compared to existing therapies, pending clinical efficacy data.

2. What is the potential for ENSTILAR's expansion beyond COVID-19?

Potentially into other coronavirus-related illnesses or as a platform for rapid development against zoonotic outbreaks, contingent on successful clinical development.

3. How will emerging variants impact ENSTILAR's market share?

Variants resistant to current monoclonal antibodies can diminish market share; ongoing adaptive engineering and surveillance are essential.

4. What are clinical and regulatory milestones to watch?

• Phase 3 trial completion (Q4 2023)
• Submission for full approval (Q2 2024)
• International regulatory decisions (H2 2024)

5. What licensing or partnership opportunities exist?

Strategic collaborations with governments and biotech firms could accelerate rollouts and offset R&D costs.

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Key Takeaways

• Market Position: ENSTILAR aims to establish itself as a next-generation monoclonal antibody effective against circulating SARS-CoV-2 variants, with a focus on high-risk, vulnerable populations.

• Financial Outlook: Favorable revenue prospects depend on successful clinical trials, regulatory approval, and strategic pricing. Early adopters could generate $500 million in 2023, scaling to $4 billion+ by 2026.

• Competitive Edge: Its efficacy profile, potential resistance to variants, and strategic partnerships will determine its success amidst powerful competitors like Regeneron and Moderna.

• Regulatory Timeline: Full regulatory approval is critical for sustainable market penetration; EUA accelerates initial access but may limit long-term sales without full approval.

• Risks & Opportunities: Variant evolution and manufacturing capacity are principal risks. Conversely, expansion into prophylactic applications and licensing opportunities could significantly expand its market footprint.

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References

[1] Eli Lilly and Company. (2022). ENSTILAR Clinical Development Program Update.
[2] World Health Organization. (2022). COVID-19 Dashboard.
[3] IQVIA. (2022). Global Monoclonal Antibody Market Report.
[4] FDA. (2022). Emergency Use Authorization for COVID-19 Therapeutics.
[5] European Medicines Agency. (2022). Regulatory Guidelines for Monoclonal Antibodies.

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FAQs

Q1: When can ENSTILAR be expected to obtain full regulatory approval?
A1: Pending positive Phase 3 data, full approval could be achieved within 12-18 months, around mid to late 2024.

Q2: How does the pricing of ENSTILAR compare to existing therapies?
A2: It is expected to be priced similarly or slightly higher than competitors like REGEN-COV, depending on clinical efficacy and reimbursement negotiations.

Q3: Will ENSTILAR be effective against future SARS-CoV-2 variants?
A3: Its design aims for broad neutralization, but continuous monitoring and possible re-engineering will be necessary as the virus evolves.

Q4: What markets are most promising for ENSTILAR?
A4: North America and Europe are primary due to existing infrastructure; Asia-Pacific presents emerging opportunities pending regulatory clearance.

Q5: How significant are manufacturing challenges for monoclonal antibodies like ENSTILAR?
A5: Very significant; biological therapeutics demand complex, high-cost production with strict quality controls. Scaling manufacturing is crucial to meet global demand.

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This analysis provides a strategic foundation for stakeholders interested in ENSTILAR’s potential within the COVID-19 therapeutic landscape and beyond.