Ingenol mebutate - Generic Drug Details

What are the generic sources for ingenol mebutate and what is the scope of freedom to operate?

Ingenol mebutate is the generic ingredient in two branded drugs marketed by Padagis Israel and Leo Labs, and is included in three NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ingenol mebutate has thirty-five patent family members in twenty-one countries.

There are three drug master file entries for ingenol mebutate. There is one tentative approval for this compound.

Summary for ingenol mebutate

International Patents:	35
US Patents:	12
Tradenames:	2
Applicants:	2
NDAs:	3
Drug Master File Entries:	3
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	50
Patent Applications:	978
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ingenol mebutate
What excipients (inactive ingredients) are in ingenol mebutate?	ingenol mebutate excipients list
DailyMed Link:	ingenol mebutate at DailyMed

Recent Clinical Trials for ingenol mebutate

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

Sponsor	Phase
Nova Scotia Health Authority	Phase 4
Instituto Nacional de Cancer, Brazil	Phase 1/Phase 2
University of California, San Francisco	Phase 1

See all ingenol mebutate clinical trials

Generic filers with tentative approvals for INGENOL MEBUTATE

Applicant	Application No.	Strength	Dosage Form
		0.05%	GEL; TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for ingenol mebutate

D06BX	Other chemotherapeutics
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

Paragraph IV (Patent) Challenges for INGENOL MEBUTATE

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 ingenol mebutate

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

Expired US Patents for ingenol mebutate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	202833-002	Jan 23, 2012
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012

EU/EMA Drug Approvals for ingenol mebutate

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 ingenol mebutate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2399571	Compositions thérapeutiques comprenant de l'ingénol-2-angelate (Therapeutic compositions comprising ingenol-3-angelate)
Canada	2634073	COMPOSITIONS THERAPEUTIQUES (THERAPEUTIC COMPOSITIONS COMPRISING INGENOL-3-ANGELATE)
Japan	2013049715	THERAPEUTIC COMPOSITION
European Patent Office	1988877	COMPOSITIONS THERAPEUTIQUES COMPRENANT DE L'INGÉNOL-3-ANGELATE (THERAPEUTIC COMPOSITIONS COMPRISING INGENOL-3-ANGELATE)

Supplementary Protection Certificates for ingenol mebutate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1988877	132014902287215	Italy		PRODUCT NAME: INGENOLO MEBUTATO O UN SUO DERIVATO (SALE O ESTERE)(PICATO); AUTHORISATION NUMBER(S) AND DATE(S): 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	46/2014	Austria		PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: EU/1/12/796/001 - 002 20121119
1988877	C01988877/01	Switzerland		PRODUCT NAME: INGENOLMEBUTAT; REGISTRATION NO/DATE: SWISSMEDIC 62763 12.06.2013

Ingenol mebutate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ingenol Mebutate

Introduction

Ingenol mebutate, marketed under the brand name Picato, is a topical treatment for actinic keratosis (AK), a precancerous condition caused by cumulative sun exposure. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key aspects such as market size, growth projections, application segments, and geographical distribution.

Market Size and Growth Projections

The global Picato gel (ingenol mebutate) market is anticipated to grow at a moderate pace. According to recent market research, the market is expected to increase at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent from 2024 to 2031[1][4].

Application Segments

The market for ingenol mebutate is primarily segmented based on its applications:

Actinic Keratosis

Actinic keratosis is the primary indication for ingenol mebutate. This condition, caused by prolonged sun exposure, has the potential to progress to squamous cell carcinoma, the second most common type of skin cancer. Picato gel is specifically designed to treat AK on different body areas, such as the face, scalp, and trunk/extremities[3].

Keratosis

In addition to actinic keratosis, ingenol mebutate may be used for other forms of keratosis, although this is less common. The drug's mechanism of action involves removing sun-damaged cells and activating the body's defenses, making it effective for various keratotic conditions[4].

Product Types

The market is also segmented based on the product types:

Type I and Type II

Picato gel comes in two concentrations: 0.015% and 0.05%. The 0.015% gel is used once daily for three consecutive days on the face and scalp, while the 0.05% gel is used once daily for two consecutive days on the trunk and extremities[3].

Geographical Distribution

The market for ingenol mebutate is geographically diverse, with key regions including:

North America

North America is a significant market due to high awareness and prevalence of actinic keratosis. The region benefits from advanced healthcare infrastructure and high disposable income, contributing to the demand for Picato gel[1][4].

Europe

Europe is another major market, driven by similar factors such as high sun exposure and advanced healthcare systems. However, the market faced a temporary setback due to a precautionary recall by LEO Pharma following concerns over potential skin malignancy risks[3].

Asia-Pacific

The Asia-Pacific region is expected to grow significantly due to increasing awareness of skin health and expanding healthcare infrastructure. Countries like China, Japan, and India are key contributors to this growth[1][4].

South America and Middle-East & Africa

These regions also present opportunities for growth, although at a slower pace compared to North America and Europe. The market here is driven by improving healthcare access and increasing awareness about skin conditions[1][4].

Key Companies

The market for ingenol mebutate is dominated by a few key players:

LEO Pharma

LEO Pharma is the primary manufacturer and marketer of Picato gel. The company has faced challenges, including a precautionary recall in 2020, but remains a significant player in the market[3].

Perrigo

Perrigo has gained tentative approvals from the FDA for generic versions of ingenol mebutate gel, both 0.015% and 0.05% concentrations. This has introduced competition into the market and is expected to impact the financial trajectory of the drug[3].

Financial Performance

The financial performance of ingenol mebutate is influenced by several factors, including sales volume, pricing, and competition.

Sales Volume

The sales volume of Picato gel has been steady, with the drug generating approximately $16 million in U.S. sales for Perrigo alone. The market size is expected to grow, driven by increasing demand and expanding geographical reach[3].

Pricing and Competition

The pricing of Picato gel can be affected by the entry of generic versions. Perrigo's tentative approvals for generic ingenol mebutate gels are likely to increase competition, potentially reducing the market share and revenue of the branded version[3].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of ingenol mebutate:

FDA Approvals

Picato gel was approved by the U.S. FDA in 2012 for the treatment of actinic keratosis. This approval was a significant milestone for LEO Pharma and has since been followed by approvals for generic versions[3].

Precautionary Recall

In 2020, LEO Pharma recalled all unexpired stock of Picato gel due to concerns over potential skin malignancy risks. This recall, although precautionary, had a temporary impact on the market and highlighted the importance of ongoing safety monitoring[3].

Consumer Willingness to Pay

Studies have shown that consumers are willing to pay extra for ingenol mebutate gel compared to competitor products, especially when considering the convenience and efficacy of the treatment. This willingness to pay extra underscores the value that patients place on effective treatments for actinic keratosis[2].

Future Outlook

The future outlook for the ingenol mebutate market is positive, driven by increasing awareness of skin health, expanding healthcare infrastructure, and the introduction of new production methods that could enhance supply and reduce costs.

"The invention described in the patent application provides, for the first time, suspension cell cultures suitable for mass production of ingenol mebutate," highlighting potential improvements in production efficiency[5].

Key Takeaways

• The global Picato gel (ingenol mebutate) market is expected to grow at a CAGR of 3 to 5 percent from 2024 to 2031.
• The market is segmented based on application (actinic keratosis, keratosis) and product type (Type I, Type II).
• Key geographical regions include North America, Europe, Asia-Pacific, South America, and Middle-East & Africa.
• LEO Pharma and Perrigo are major players in the market.
• Regulatory challenges, such as the precautionary recall in 2020, have temporarily impacted the market.
• Consumer willingness to pay extra for ingenol mebutate gel indicates its perceived value.

FAQs

1. What is ingenol mebutate used for? Ingenol mebutate, marketed as Picato gel, is used for the topical treatment of actinic keratosis (AK), a precancerous condition caused by cumulative sun exposure.

2. What are the different concentrations of Picato gel? Picato gel comes in two concentrations: 0.015% and 0.05%. The 0.015% gel is used on the face and scalp, while the 0.05% gel is used on the trunk and extremities.

3. Why was Picato gel recalled in 2020? Picato gel was recalled in 2020 on precautionary grounds due to concerns over potential skin malignancy risks. This recall was initiated by LEO Pharma while investigations were ongoing.

4. Who are the key players in the ingenol mebutate market? The key players in the ingenol mebutate market include LEO Pharma and Perrigo, with Perrigo having gained tentative approvals for generic versions of the drug.

5. What is the expected growth rate of the ingenol mebutate market? The global Picato gel (ingenol mebutate) market is expected to grow at a CAGR of 3 to 5 percent from 2024 to 2031.

Sources

1. Market Research Intellect - Global Picato Gel Ingenol Mebutate Sales Market Size And Forecast[1].
2. ResearchGate - Incremental WTP for Treatment with the Ingenol Mebutate Gel Profile[2].
3. OpenPR - Picato Gel (Ingenol Mebutate) Market : Facts, Figures and Analytical Insights 2020-2026[3].
4. Market Research Intellect - Global Picato Gel (Ingenol Mebutate) Market Size | Trend and Forecast[4].
5. PR Newswire - Patent Application Covering a Novel Production Method for Ingenol Mebutate[5].