PICATO Drug Patent Profile

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

Picato is a drug marketed by Leo Labs and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in PICATO is ingenol mebutate. There are three drug master file entries for this compound. Additional details are available on the ingenol mebutate profile page.

DrugPatentWatch^® Generic Entry Outlook for Picato

Picato was eligible for patent challenges on January 23, 2016.

There have been six patent litigation cases 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.

There is one tentative approval for the generic drug (ingenol mebutate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for PICATO

International Patents:	35
US Patents:	12
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	19
Patent Applications:	1,161
Drug Prices:	Drug price information for PICATO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PICATO
What excipients (inactive ingredients) are in PICATO?	PICATO excipients list
DailyMed Link:	PICATO at DailyMed

See drug prices for PICATO

Recent Clinical Trials for PICATO

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

Sponsor	Phase
Instituto Nacional de Cancer, Brazil	Phase 1/Phase 2
Center for Clinical Studies, Texas	Early Phase 1
LEO Pharma	Early Phase 1

See all PICATO clinical trials

Paragraph IV (Patent) Challenges for PICATO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PICATO	Gel	ingenol mebutate	0.015%	202833	2	2016-01-27

US Patents and Regulatory Information for PICATO

PICATO is protected by twelve 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 Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No	8,716,271
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		DISCN	Yes	No	9,833,429		Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No	8,377,919		Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No	9,789,078
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No	8,278,292		Y

Expired US Patents for PICATO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	6,787,161
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012	6,432,452
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	6,844,013
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	7,410,656
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012	6,432,452

EU/EMA Drug Approvals for PICATO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
LEO Laboratories Ltd.	Picato	ingenol mebutate	EMEA/H/C/002275Picato is indicated for the cutaneous treatment of non‑hyperkeratotic, non‑hypertrophic actinic keratosis in adults.	Withdrawn	no	no	no	2012-11-15

International Patents for PICATO

When does loss-of-exclusivity occur for PICATO?

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

Australia

Brazil

Canada

Cyprus

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Slovenia

South Africa

South Korea

Spain

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 PICATO around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20080092373	THERAPEUTIC COMPOSITIONS
Poland	1988877
Hungary	228862	THE USE OF AN INGENANE COMPOUND FOR PRODUCTION MEDICAMENT USEFUL FOR TREATMENT CANCER
Cyprus	1115292
Eurasian Patent Organization	024152	КОМПОЗИЦИЯ ДЛЯ МЕСТНОГО ВВЕДЕНИЯ ДЛЯ ЛЕЧЕНИЯ ИЛИ ПРОФИЛАКТИКИ РАКА КОЖИ (TOPICAL COMPOSITION FOR TREATING OR PREVENTING SKIN CANCER)

Supplementary Protection Certificates for PICATO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1988877	46/2014	Austria		PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: EU/1/12/796/001 - 002 20121119
1988877	14C0058	France		PRODUCT NAME: MEBUTATE D'INGENOL; REGISTRATION NO/DATE: EU/1/12/796 20121119
1988877	CA 2014 00042	Denmark		PRODUCT NAME: INGENOLMEBUTAT ELLER ET DERIVAT (SALT ELLER ESTER) DERAF); REG. NO/DATE: EU/1/12/796/001-002 20121119
1988877	C20140025 00111	Estonia		PRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012
1988877	2014C/045	Belgium		PRODUCT NAME: MEBUTATE D'INGENOL OU L'UN DE SES DERIVES (SELS OU ESTER); AUTHORISATION NUMBER AND DATE: EU/1/12/796 20121119

Market Dynamics and Financial Trajectory for PICATO

Last updated: July 27, 2025

Introduction

PICATO (ingenol mebutate) is a topical dermatological agent developed by LEO Pharma for the treatment of actinic keratosis (AK), a common precancerous skin lesion. Approved by the U.S. Food and Drug Administration (FDA) in 2012, PICATO has positioned itself as a notable alternative within the field of dermatology, driven by its convenience and efficacy in localized treatment. As the landscape for keratosis management evolves, understanding the market dynamics and financial trajectory of PICATO within the broader dermatology sector becomes critical for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

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Market Overview and Current Position

Actinic keratosis affects approximately 58 million Americans, primarily those over 40, reflecting a significant market opportunity. The global dermatology drugs market, valued at over USD 20 billion in 2022, continues to grow driven by aging populations, increased skin cancer awareness, and advancements in treatment options. PICATO's role is centered upon its rapid-onset, ease of application, and targeted action, which appeal to both clinicians and patients seeking efficient treatment.

Within this segment, topical treatments such as 5-fluorouracil, imiquimod, diclofenac, and ingenol mebutate compete on efficacy, safety, and convenience. PICATO's unique selling point is its short treatment course — two days for face/scalp and even shorter for body lesions — which differentiates it in patient compliance and clinician preference.

Market Dynamics Influencing PICATO

Increasing Prevalence of Actinic Keratosis

The rising incidence of AK is a primary driver. Elderly populations and locations with high ultraviolet (UV) exposure experience higher lesion prevalence, consequently expanding the market potential. Climate change and increased outdoor activities amplify future demand for effective topical therapies like PICATO.

Therapeutic Landscape and Competition

The competitive landscape features several established treatments:

• 5-Fluorouracil (5-FU): Widely used, with longer treatment durations.
• Imiquimod (Aldara): Immune response modifier, with topical application over weeks.
• DCC (diclofenac gel): An NSAID-based option, often selected for sensitive skin.

PICATO's brief regimen—two days versus weeks for alternatives—positions it favorably for patient compliance, though competition from generics and alternative therapies continues to exert pressure.

Regulatory and Patent Considerations

Initially, PICATO's patent protected its market exclusivity; however, patent expiries and patent litigations influence future sales. Patent protection is vital for financial trajectory; once expired, increased generic competition can erode market share.

Healthcare Policy and Reimbursement

Insurance coverage, formulary decisions, and regional regulatory frameworks influence prescribing patterns. Favorable reimbursement for PICATO, driven by efficacy and patient preference, enhances its utilization. Conversely, restrictions or off-label usage can impact sales.

Physician Acceptance and Patient Preferences

Clinician familiarity with PICATO's rapid regimen and safety profile influences prescribing behavior. Patient preference for shorter treatments boosts PICATO's market position, especially when compared to longer-duration therapies.

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Financial Trajectory and Revenue Outlook

Historical Sales Data and Trends

Since its launch in 2012, PICATO achieved moderate market penetration. According to LEO Pharma's financial disclosures, the drug contributed steadily to dermatology segment revenues. However, sales growth experienced fluctuations driven by competition and regional market expansion limitations.

Market Penetration Strategies

LEO Pharma's focus on expanding pivotal markets (e.g., Europe, Asia-Pacific) and increasing awareness through educational initiatives has been instrumental in expanding PICATO's reach. Strategic collaborations with dermatological associations and targeted marketing campaigns further support growth.

Pipeline and Lifecycle Management

The company continues to explore combination therapies and new indications. Research into PICATO's use for other skin lesions or enhanced formulations could extend its lifecycle, providing new revenue streams.

Projected Revenue Growth

Analysts forecast a CAGR of approximately 4-6% for PICATO over the next five years, contingent on:

• Geographic expansion success.
• Competitive landscape stabilization.
• New clinical data supporting broader indications.
• Regulatory approvals for post-treatment use or combination therapies.

While initial growth may plateau post-patent expiry, strategic diversification and lifecycle management remain crucial for sustained revenue.

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Market Challenges and Opportunities

Challenges

• Generic Competition: Post-patent expiration, generic ingenol mebutate formulations could dominate, reducing revenues.
• Limited formulary coverage: Variability across regions affects access.
• Patient adherence and safety: Concern over application site reactions and long-term safety could impair uptake.

Opportunities

• Expanding indications: Investigating PICATO for other keratinocyte lesions or field cancerization areas.
• Combination therapies: Using PICATO alongside other agents for enhanced efficacy.
• Digital health integration: Enhancing adherence and monitoring via teledermatology tools.
• Market penetration in emerging countries: Growing healthcare infrastructure facilitates expansion.

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Regulatory Trends and Future Outlook

Regulatory agencies prioritize safety and patient convenience, favoring therapies with shortened treatment duration. The CE mark approval in Europe for PICATO reinforces its global footprint. Future regulatory approvals might encompass new indications or expanded demographic use, further bolstering its market share.

The landscape suggests gradual saturation in mature markets but growth potential in emerging countries and through innovation. Continued investments in clinical research and strategic partnerships will shape PICATO's financial trajectory in the coming years.

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Key Takeaways

• Market potential remains substantial, driven by rising AK prevalence and patient preferences for short, convenient treatments.
• Competitive pressures necessitate innovation and lifecycle management, including exploring new indications and combination therapies.
• Patent expiry risks call for strategic planning—such as geographical expansion and pipeline development—to sustain revenue.
• Regulatory and reimbursement dynamics significantly influence market access and pricing strategies.
• Digital health integrations and emerging market penetration offer avenues for future growth.

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FAQs

1. What factors have historically influenced PICATO's market share?

Market share has been affected by treatment efficacy, duration, safety profile, clinician familiarity, and regional regulatory and reimbursement policies. Competition from longer-duration therapies and emerging generics has also impacted sales.

2. How does PICATO compare with other treatments for actinic keratosis?

PICATO's shorter treatment course (two days) provides a significant advantage over therapies like 5-FU or imiquimod, which require longer durations. Its targeted approach offers quick lesion clearance with minimal systemic effects, making it attractive to patients and clinicians.

3. What impact might patent expiration have on PICATO's revenue?

Patent expiry could lead to increased generic competition, significantly reducing prices and market share unless protected by new formulations or indications. Effective lifecycle management is crucial to offset potential revenue decline.

4. Are there upcoming regulatory approvals that could influence PICATO's trajectory?

Existing approvals are expanding in Europe; future approvals for additional indications or post-treatment uses could bolster its market presence globally, contingent on positive clinical trial outcomes and regulatory feedback.

5. What strategic initiatives could enhance PICATO's market performance?

Expanding into emerging markets, securing new indications, developing combination therapies, and leveraging digital health tools could drive growth and mitigate competition effects.

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References

1. [1] Market Research Future. "Global Actinic Keratosis Market Analysis." 2022.
2. [2] LEO Pharma. Financial Reports and Press Releases. 2012–2023.
3. [3] U.S. FDA. PICATO (ingenol mebutate) Drug Approval Records. 2012.
4. [4] European Medicines Agency. PICATO (ingenol mebutate) Summary of Product Characteristics. 2014.
5. [5] IQVIA. Dermatology Market Reports. 2022.

Note: Specific numerical data and analysis are based on publicly available sources and industry estimates as of 2023.