XOLEGEL Drug Patent Profile

Which patents cover Xolegel, and what generic alternatives are available?

Xolegel is a drug marketed by Almirall and is included in one NDA.

The generic ingredient in XOLEGEL is ketoconazole. There are fifteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xolegel

A generic version of XOLEGEL was approved as ketoconazole by TARO on June 15^th, 1999.

Summary for XOLEGEL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	3
Patent Applications:	4,116
Drug Prices:	Drug price information for XOLEGEL
What excipients (inactive ingredients) are in XOLEGEL?	XOLEGEL excipients list
DailyMed Link:	XOLEGEL at DailyMed

See drug prices for XOLEGEL

See drug sales revenues for XOLEGEL

Recent Clinical Trials for XOLEGEL

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

Sponsor	Phase
Wake Forest University Health Sciences	Early Phase 1
Mayo Clinic	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1

See all XOLEGEL clinical trials

US Patents and Regulatory Information for XOLEGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	XOLEGEL	ketoconazole	GEL;TOPICAL	021946-001	Jul 28, 2006		DISCN	Yes	No

Expired US Patents for XOLEGEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	XOLEGEL	ketoconazole	GEL;TOPICAL	021946-001	Jul 28, 2006
Almirall	XOLEGEL	ketoconazole	GEL;TOPICAL	021946-001	Jul 28, 2006
Almirall	XOLEGEL	ketoconazole	GEL;TOPICAL	021946-001	Jul 28, 2006

EU/EMA Drug Approvals for XOLEGEL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
HRA Pharma Rare Diseases	Ketoconazole HRA	ketoconazole	EMEA/H/C/003906 Ketoconazole HRA is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.	Authorised	no	no	yes	2014-11-18

International Patents for XOLEGEL

See the table below for patents covering XOLEGEL around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	60122827
China	1714869
Australia	1841200
China	1292707
Japan	2002531526

XOLEGEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XOLEGEL

Introduction

XOLEGEL, a 2% ketoconazole gel, is a topical treatment for seborrheic dermatitis, a common skin condition characterized by inflammation and flaking. To understand the market dynamics and financial trajectory of XOLEGEL, it is essential to delve into its clinical efficacy, safety profile, market performance, and the financial health of its parent company.

Clinical Efficacy and Safety Profile

XOLEGEL has been evaluated in several clinical trials to assess its efficacy and safety. Here are some key findings:

• Efficacy: In clinical trials, XOLEGEL demonstrated significant efficacy in treating seborrheic dermatitis. For instance, in a pivotal study, 25.3% of patients treated with XOLEGEL were effectively treated, compared to 13.9% in the vehicle control group[1][4].
• Safety: The safety profile of XOLEGEL is generally favorable. Common adverse reactions include application site burning, dermatitis, and other local irritations, which are typically transient and resolve upon discontinuation of the treatment[1][4].

Market Performance

Therapeutic Area

XOLEGEL operates within the dermatology segment, which has been a growth driver for several pharmaceutical companies.

• Dermatology Market: The dermatology market has seen significant growth, driven by increasing demand for effective treatments for various skin conditions. Almirall, the company behind XOLEGEL, reported that dermatology accounted for 39% of their group sales and grew by 37% in the first quarter of 2015[2].

Competitive Landscape

The market for seborrheic dermatitis treatments includes various topical and oral medications. XOLEGEL's unique selling point is its non-corticosteroid mechanism of action, which avoids the corticosteroid rebound phenomenon associated with long-term use of corticosteroids[1].

Financial Trajectory of Almirall

To understand the financial trajectory of XOLEGEL, it is crucial to look at the financial performance of its parent company, Almirall.

Revenue and Growth

• Revenue: Almirall reported strong revenue growth in the dermatology segment. In the first quarter of 2015, total revenues reached €217.2 million, with dermatology driving a significant portion of this growth[2].
• Net Sales: Net sales for Almirall were €180.0 million, with dermatology products contributing substantially to this figure. The company maintained a guidance of €650-680 million in net sales for the full year 2015[2].

Profitability

• Gross Profit: Almirall's gross profit for the first quarter of 2015 was €126.2 million, representing 70.1% of net sales. This increase was attributed to a higher share of proprietary products and contributions from the US affiliate[2].
• EBIT and EBITDA: The company saw significant increases in EBIT (€54.4 million) and EBITDA (€73.1 million) during the first quarter of 2015, driven by higher margins and milestone payments[2].

Cash Position and Debt

• Cash Position: Almirall had a strong cash position of €832.4 million at the end of the first quarter of 2015, partly due to a $150 million milestone payment from the AstraZeneca transaction[2].
• Financial Debt: The company's financial debt was €316.3 million, representing 12% of total assets[2].

Research and Development

Almirall's commitment to research and development is crucial for the continued success of products like XOLEGEL.

• R&D Expenses: In the first quarter of 2015, Almirall's R&D expenses were €17.5 million, or 9.7% of sales, which was a reduction from the previous year. This reflects the company's move towards a leaner business model[2].

Vision for the Future

Almirall's strategic focus is on capitalizing on growth opportunities in dermatology to become a leading specialty pharmaceutical company.

• Growth Opportunities: The company plans to use its strong cash position to fund growth opportunities, particularly in the dermatology segment. This includes investing in innovative products and expanding its market presence[2].

Key Takeaways

• Clinical Efficacy: XOLEGEL has demonstrated significant efficacy in treating seborrheic dermatitis.
• Market Growth: The dermatology market, particularly for seborrheic dermatitis treatments, has shown strong growth.
• Financial Performance: Almirall's financial performance is robust, with significant revenue and profitability growth driven by its dermatology segment.
• R&D Commitment: Almirall continues to invest in research and development to maintain and expand its product portfolio.
• Future Outlook: The company is focused on leveraging its strong financial position to drive further growth in the dermatology segment.

FAQs

What is XOLEGEL used for?

XOLEGEL is a topical gel used for the treatment of seborrheic dermatitis, a skin condition characterized by inflammation and flaking.

What are the common side effects of XOLEGEL?

Common side effects include application site burning, dermatitis, dryness, erythema, irritation, pain, pruritus, and pustules[1][4].

How does XOLEGEL compare to other treatments for seborrheic dermatitis?

XOLEGEL has a non-corticosteroid mechanism of action, avoiding the corticosteroid rebound phenomenon associated with long-term corticosteroid use[1].

What is the financial performance of Almirall related to XOLEGEL?

Almirall has reported strong revenue and profitability growth driven by its dermatology segment, which includes XOLEGEL. The company's net sales and gross profit have seen significant increases[2].

What are Almirall's future plans for growth in the dermatology segment?

Almirall plans to use its strong cash position to fund growth opportunities in dermatology, focusing on innovative products and expanding its market presence[2].

Sources

1. PRODUCT MONOGRAPH - XOLEGEL™ Topical Gel, 2% w/w. Retrieved from https://pdf.hres.ca/dpd_pm/00004046.PDF
2. Almirall's Q1 results 2015: growth acceleration driven by Dermatology. Retrieved from https://www.almirall.es/web/almirall.com/media/newsroom/news-detail?p_p_id=com_liferay_asset_publisher_web_portlet_AssetPublisherPortlet_INSTANCE_FQ996dqlGmV9&p_p_lifecycle=0&p_p_state=normal&p_p_mode=view&_com_liferay_asset_publisher_web_portlet_AssetPublisherPortlet_INSTANCE_FQ996dqlGmV9_delta=1&p_r_p_resetCur=false&_com_liferay_asset_publisher_web_portlet_AssetPublisherPortlet_INSTANCE_FQ996dqlGmV9_cur=455
3. Late-stage Product Development and Approvals by Biotechnology Companies. Retrieved from https://scholars.bentley.edu/cgi/viewcontent.cgi?article=1019&context=nas_facpubs
4. XOLEGEL Gel - FDA Label. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021946s007lbl.pdf