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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PICATO

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
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		DISCN	Yes	No	9,833,428		Y

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
Hungary	0004262
Canada	2634073	COMPOSITIONS THERAPEUTIQUES (THERAPEUTIC COMPOSITIONS COMPRISING INGENOL-3-ANGELATE)
Luxembourg	92185
Germany	69839586
European Patent Office	1015413	UTILISATION D'UN COMPOSE INGENANE POUR L'OBTENTION D'UN MEDICAMENT POUR LE TRAITEMENT DU CANCER (USE OF AN INGENANE COMPOUND FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF CANCER)
Japan	2013049715	THERAPEUTIC COMPOSITION

Supplementary Protection Certificates for PICATO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1988877	C 2014 032	Romania		PRODUCT NAME: INGENOL MEBUTAT; NATIONAL AUTHORISATION NUMBER: EU/1/12/796; DATE OF NATIONAL AUTHORISATION: 20121115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/796; DATE OF FIRST AUTHORISATION IN EEA: 20121115
1988877	300682	Netherlands		PRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119
1015413	505	Finland
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
1988877	46/2014	Austria		PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: EU/1/12/796/001 - 002 20121119

Investment Scenario and Fundamentals Analysis for PICATO (Ingenol Mebutate)

Last updated: February 3, 2026

What is PICATO and How Does It Fit into the Market?

PICATO (ingenol mebutate) is a topical drug used to treat actinic keratosis (AK), a precancerous skin condition. Approved in 2012 by the U.S. FDA and the European Medicines Agency, it offers a non-invasive, office-based therapy for AK lesions. The drug is marketed by Leo Pharma, a Danish pharmaceutical company.

Its primary competitive edge lies in a short treatment regimen, typically two to three days, which distinguishes it from alternatives like cryotherapy, 5-fluorouracil, or imiquimod. The global market for actinic keratosis treatments was valued at approximately $450 million in 2022, with growth driven by aging populations and increased sun exposure awareness [1].

What Are the Key Financial and Market Fundamentals?

Revenue Generation

• Market Reach: Leo Pharma reports that PICATO has obtained approvals in numerous countries, with a significant presence in the U.S. and Europe.
• Market Penetration: Despite its advantages, sales plateaued due to competition from generics and alternative treatments, though expansion into new markets and indications remains ongoing.
• Pricing Strategy: PICATO is priced around $200-250 per treatment course in the U.S., with some variability across regions.

Market Competition

• Main Competitors: Cryotherapy (performed in-office), topical agents like 5-fluorouracil, imiquimod, and newer lithium-based therapies.
• Generic Competition: Approved generics for similar indications threaten PICATO’s market share, especially as patent exclusivity is limited to the original formulation.

Regulatory and Patent Landscape

• Patents: The original patent expired in 2020, and secondary patents covering formulations or delivery methods have challenges in enforcement.
• Regulatory Approvals: Approved in over 60 countries; ongoing efforts aim to expand indications or formulations such as combination therapies or new delivery systems.

Clinical Data and Efficacy

• Efficacy Metrics: Complete lesion clearance rates range from 70% to 80% at 12 weeks post-treatment.
• Safety Profile: Common side effects include local skin reactions, which generally subside within a week.

What Are the Investment Risks and Opportunities?

Risks

• Patent Expiry: Loss of patent protection in 2020 exposes PICATO to generic competition.
• Market Penetration: Competition from well-established therapies continues to limit growth potential.
• Regulatory Hurdles: Approvals for new indications or formulations face delays or rejections.

Opportunities

• Expanding Indications: The drug's mechanism permits potential use for other skin lesions or cancers.
• Combination Therapies: Possible integration with other treatments like topical immune modulators.
• Market Expansion: Focus on emerging markets with increasing skin cancer awareness and healthcare infrastructure development.

How Could Future Developments Impact Investment?

• Pipeline Enhancements: Ongoing research into formulations such as nano-delivery or new applications could extend product lifecycle.
• Partnerships: Collaborations with biotech firms for combination or enhanced formulations could bolster market relevance.
• Regulatory Pathways: Fast-track or orphan drug statuses in certain jurisdictions could accelerate revenue streams.

Key Takeaways

• PICATO has a limited patent life, with sales affected by generic competition.
• Market growth depends on expanding indications and geographic penetration.
• Clinical efficacy and a fast treatment regimen support its competitive position.
• Risks include patent expiration and market saturation.
• Opportunities lie in new formulations, additional indications, and emerging markets.

FAQs

1. How does PICATO compare in price to alternative actinic keratosis treatments?
PICATO costs approximately $200-250 per course, whereas cryotherapy incurs procedural costs, often higher cumulatively, but may lack drug-related expenses. Topical agents like 5-fluorouracil or imiquimod vary between $50 and $150, with additional clinic or application costs.

2. What is the patent status of PICATO?
The primary patent expired in 2020. Secondary patents related to formulations or delivery devices have faced legal challenges, increasing competitive pressure.

3. Are there upcoming regulatory approvals for PICATO?
No announced pending approvals, but ongoing research may lead to expanded indications approved in future years.

4. How significant are competitors' generic products?
Generics have entered several markets post-patent expiry, reducing sales and forcing pricing competition.

5. Could new formulations revive PICATO’s market position?
Yes; innovations like nano-delivery systems or combination therapies could change its competitive landscape if approved.

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References

[1] Market data sourced from GlobalData's report on actinic keratosis treatments, 2022.
[2] Leo Pharma annual report, 2022.
[3] FDA drug approval archives, 2012.