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 five 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:	31
Clinical Trials:	19
Patent Applications:	767
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
LEO Pharma	Early Phase 1
Center for Clinical Studies, Texas	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

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	6,844,013
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

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/002275 Picato 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

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Slovenia

South Africa

South Korea

Spain

United Kingdom

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
Australia	8721798
Brazil	9811327
South Korea	20140088617	THERAPEUTIC COMPOSITIONS

Supplementary Protection Certificates for PICATO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1015413	C300592	Netherlands		PRODUCT NAME: INGENAN OF EEN DERIVAAT (ZOUT OF ESTER) DAARVAN; REGISTRATION NO/DATE: EU/1/12/796/001-002 20121115
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 (Ingenol Mebutate)

Introduction

Picato, also known as ingenol mebutate, is a topical gel used for the treatment of actinic keratosis, a precancerous skin condition caused by cumulative sun exposure. Here, we will delve into the market dynamics and financial trajectory of this drug, highlighting its rise, challenges, and eventual withdrawal from the market.

Market Approval and Initial Success

Picato was approved by the U.S. Food and Drug Administration (FDA) in January 2012 for the topical treatment of actinic keratosis. The drug was notable for its short treatment duration, with the 0.015% gel used once daily for three consecutive days on the face and scalp, and the 0.05% gel used once daily for two consecutive days on the trunk and extremities[3].

Market Segmentation and Geographic Reach

The Picato gel market was segmented based on application (actinic keratosis and keratosis) and product type (Type I and Type II). Geographically, the market spanned across North America, Europe, Asia-Pacific, South America, and the Middle East and Africa[1][3].

Financial Performance and Growth

Initially, Picato showed promising financial performance. For instance, Perrigo, a company that developed a generic version of Picato, reported U.S. sales of approximately $16 million for the drug. The market was growing at a substantial rate, with significant revenue increases anticipated over the forecast period[1][3].

Challenges and Safety Concerns

However, the market dynamics for Picato began to shift due to emerging safety concerns. In 2019, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) initiated a review of data on skin cancer in patients using Picato. This review revealed that Picato may increase the risk of skin cancer, particularly squamous cell carcinoma, in the treated skin area compared to other treatments like imiquimod[4].

Withdrawal from the Market

Following the EMA's review, it was concluded that the risks of Picato outweighed its benefits. On February 11, 2020, the European Commission withdrew the marketing authorisation for Picato at the request of LEO Laboratories Ltd, the company that marketed the medicine. This decision was based on studies showing a higher incidence of skin tumors, including squamous cell carcinoma and Bowen’s disease, in patients treated with Picato compared to other treatments[4].

Recall and Impact on Sales

In January 2020, LEO Pharma recalled all unexpired stock of Picato on precautionary grounds due to the potential risk of skin malignancy. This recall significantly impacted the sales and financial trajectory of the drug, effectively halting its market presence[3].

Financial Implications

The withdrawal of Picato from the market had profound financial implications. The drug's sales, which had been growing, came to an abrupt halt. Companies like LEO Pharma and Perrigo, which had invested in the development and marketing of Picato, faced significant financial losses. The recall and market withdrawal also affected the overall revenue projections for these companies[3][4].

Alternative Treatments and Market Shift

With Picato no longer available, the market shifted towards other treatment options for actinic keratosis, such as topical diclofenac, fluorouracil, imiquimod, photodynamic therapy, cryotherapy, curettage, or excisional surgery. This shift presented opportunities for other pharmaceutical companies to fill the gap left by Picato's withdrawal[4].

Lessons Learned

The case of Picato highlights the importance of rigorous safety monitoring and the potential financial risks associated with drug safety issues. It also underscores the need for continuous post-marketing surveillance to ensure that the benefits of a drug outweigh its risks.

Key Takeaways

• Market Approval and Initial Success: Picato was approved by the FDA in 2012 and showed initial market success.
• Safety Concerns: Emerging safety concerns led to a review by the EMA, revealing a higher risk of skin cancer.
• Market Withdrawal: The drug was withdrawn from the market in 2020 due to its risks outweighing its benefits.
• Financial Implications: The recall and market withdrawal resulted in significant financial losses for involved companies.
• Alternative Treatments: The market shifted towards other treatment options for actinic keratosis.

FAQs

1. What is Picato used for?

   • Picato, or ingenol mebutate, is used for the topical treatment of actinic keratosis, a precancerous skin condition caused by cumulative sun exposure.

2. Why was Picato withdrawn from the market?

   • Picato was withdrawn due to safety concerns, specifically the increased risk of skin cancer, particularly squamous cell carcinoma, in the treated skin area.

3. What were the financial implications of Picato's withdrawal?

   • The withdrawal resulted in significant financial losses for companies like LEO Pharma and Perrigo, which had invested in the drug's development and marketing.

4. What are the alternative treatments for actinic keratosis?

   • Alternative treatments include topical diclofenac, fluorouracil, imiquimod, photodynamic therapy, cryotherapy, curettage, or excisional surgery.

5. What was the impact on patients who had used Picato?

   • Patients who had used Picato were advised to be vigilant for any skin lesions developing and to seek medical advice promptly if any occurred, as the time to onset of skin changes could range from weeks to months following treatment.

Sources:

1. Market Research Intellect - Global Picato Gel (Ingenol Mebutate) Sales Market Size And Forecast
2. Biofrontera AG - Half-year financial report as at June 30, 2017
3. OpenPR - Picato Gel (Ingenol Mebutate) Market : Facts, Figures
4. European Medicines Agency (EMA) - Picato - referral