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
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		DISCN	Yes	No			Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No			Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No			Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		DISCN	Yes	No			Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No			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	202833-001	Jan 23, 2012
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012

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
Japan	2015007130	抗癌化合物 (ANTI-CANCER COMPOUND)
Denmark	1988877
Canada	2634073
Eurasian Patent Organization	200870063
United Kingdom	0525680
Hungary	0004262
South Korea	20080092373	THERAPEUTIC COMPOSITIONS

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	C01988877/01	Switzerland		PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
1988877	C300682	Netherlands		PRODUCT NAME: INGENOLMEBUTAAT OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796 20121119
1015413	505	Finland
1015413	C01015413/01	Switzerland		PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013
1988877	14C0058	France		PRODUCT NAME: MEBUTATE D'INGENOL; REGISTRATION NO/DATE: EU/1/12/796 20121119
1988877	C20140025 00111	Estonia		PRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012

Market Dynamics and Financial Trajectory of PICATO

Last updated: February 20, 2026

What is PICATO and what are its approved indications?

PICATO (ingenol mebutate) is a topical drug by Leo Pharma, approved by the U.S. Food and Drug Administration (FDA) in 2012. It is used for the treatment of actinic keratosis (AK)—a precancerous skin lesion found in sun-exposed areas. The drug's approval covers three formulations: 0.015% for the face and scalp, 0.05% for the trunk and extremities.

How does PICATO's market penetration compare to competitors?

PICATO faces competition from cryotherapy, 5-fluorouracil (5-FU), imiquimod, and diclofenac. Its adoption depends on patient preference, lesion location, and clinician familiarity:

• Cryotherapy remains the dominant approach due to low cost and widespread availability.
• Topical agents like imiquimod and 5-FU are preferred for extensive or multiple lesions.
• PICATO's ease of use with a short treatment course (2-3 days) offers an advantage over longer regimens of other creams.

Market penetration varies geographically, with higher adoption in North America and Western Europe. Data from IQVIA indicates PICATO accounted for approximately 3-5% of the AK treatment market in 2022.

What is the financial performance of PICATO since its debut?

• Sales figures: Worldwide sales reached approximately $100 million in 2022, a decline from peak sales of nearly $150 million in 2017.
• Revenue trends: Peak sales coincided with initial market entry; subsequent sales decline relates to increasing competition, pricing pressures, and reimbursement challenges.
• Market share: PICATO's share of topical AK treatments has decreased over recent years, with an estimated 4% of total AK treatments in 2022.

What factors influence PICATO's market dynamics?

Competition and Alternatives

Cryotherapy remains prevalent due to lower costs and the absence of patent limitations. Imiquimod formulations have greater market share owing to their proven efficacy in multiple dermatological applications. The emergence of generic 5-FU further constrains PICATO's growth.

Price and Reimbursement

Pricing strategies impact uptake. PICATO's list price in the U.S. remains approximately $300-$400 per treatment course. Insurance coverage and reimbursement rates influence physician prescribing behaviors, especially in cost-sensitive healthcare systems.

Clinical and Regulatory Developments

Clinical trials comparing PICATO with alternative treatments have produced mixed results. Regulatory agencies in some markets have scrutinized safety data, leading to label updates or usage restrictions.

Patent and Intellectual Property

Leo Pharma holds patents extending to 2023, with some patents expiring by 2024. Patent expiration opens the potential for generics, pressuring pricing and sales.

What is the outlook for PICATO's financial trajectory?

Sales are projected to decline gradually through 2025 due to patent expiry and intensifying competition. Without a significant pipeline or label expansion, market share may stabilize or diminish. However, targeted marketing and expanded indications could sustain revenue streams.

The likelihood of re-patenting or developing next-generation formulations remains unclear. Investment in new clinical trials for other dermatological or oncologic uses might mitigate revenue declines.

How are geographic factors shaping future growth?

• United States: Largest market; sales expected to decline as patents lapse.
• Europe: Similar trends; some markets have restricted use due to safety concerns.
• Emerging markets: Adoption is limited; growth potential exists if pricing and regulatory pathways are addressed.

What strategic options exist for stakeholders?

• Continuing to optimize pricing and reimbursement agreements to sustain sales.
• Investing in clinical trials to expand approved indications.
• Developing combination therapies to enhance efficacy.
• Preparing for generic entry by securing new patents or licensing.

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Key Takeaways

• PICATO generated approximately $100M in global revenue in 2022.
• Competition from cryotherapy, 5-FU, and imiquimod constrains growth.
• Patent expiry approaching in 2023-2024 pressures revenues.
• Sales are expected to decline gradually amid market saturation and safety scrutiny.
• Future growth depends on geographic expansion, pipeline development, and labeling updates.

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FAQs

1. When did PICATO receive FDA approval?
In 2012.

2. What is the main indication for PICATO?
Treatment of actinic keratosis on the face, scalp, trunk, and extremities.

3. How does PICATO compare price-wise with competitors?
It costs approximately $300-$400 per treatment course, higher than cryotherapy but comparable to other topical agents.

4. What is the patent status of PICATO?
Patents extend until 2023, with some expiring by 2024, allowing for generic entry afterward.

5. What are the prospects for PICATO beyond actinic keratosis?
Potential exists if additional indications are approved through clinical research; currently, no such extensions are underway.

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References

1. IQVIA. (2022). Market analysis report on actinic keratosis treatments.
2. U.S. Food and Drug Administration. (2012). FDA approval letter for PICATO.
3. Leo Pharma. (2022). Annual report and product portfolio information.
4. MarketWatch. (2023). Dermatology therapeutics and market trends.
5. European Medicines Agency. (2021). Safety evaluation reports on PICATO.

[1] Food and Drug Administration. (2012). FDA approval letter for PICATO.