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KLISYRI Drug Patent Profile

When do Klisyri patents expire, and when can generic versions of Klisyri launch?

Klisyri is a drug marketed by Almirall and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and fourteen patent family members in twenty-six countries.

The generic ingredient in KLISYRI is tirbanibulin. One supplier is listed for this compound. Additional details are available on the tirbanibulin profile page.

DrugPatentWatch^® Generic Entry Outlook for Klisyri

Klisyri was eligible for patent challenges on December 14, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 7, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for KLISYRI

International Patents:	114
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Patent Applications:	126
Drug Prices:	Drug price information for KLISYRI
What excipients (inactive ingredients) are in KLISYRI?	KLISYRI excipients list
DailyMed Link:	KLISYRI at DailyMed

See drug prices for KLISYRI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for KLISYRI

NDA:

213189

Dosage:

OINTMENT;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for KLISYRI

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

US Patents and Regulatory Information for KLISYRI

KLISYRI is protected by eight US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes			Y	Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes			Y	Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes			Y	Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes			Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes

EU/EMA Drug Approvals for KLISYRI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Almirall, S.A.	Klisyri	tirbanibulin	EMEA/H/C/005183 Klisyri is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.	Authorised	no	no	no	2021-07-16

International Patents for KLISYRI

When does loss-of-exclusivity occur for KLISYRI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

Russian Federation

Singapore

South Korea

Taiwan

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 KLISYRI around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	272992
Australia	2005321966	Compositions and methods of treating cell proliferation disorders
China	101616915	Composition and methods for modulating a kinase cascade
Australia	2024201828
China	111278808

Supplementary Protection Certificates for KLISYRI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1836169	CR 2021 00042	Denmark		PRODUCT NAME: TIRBANIBULIN, ELLER ET SALT, SOLVAT ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/21/1558 20210719
1836169	122021000066	Germany		PRODUCT NAME: KLISYRI TIRBANIBULIN; REGISTRATION NO/DATE: EU/1/21/1558 20210716
1836169	C202130061	Spain		PRODUCT NAME: TIRBANIBULINA; NATIONAL AUTHORISATION NUMBER: EU/1/21/1558; DATE OF AUTHORISATION: 20210716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1558; DATE OF FIRST AUTHORISATION IN EEA: 20210716
1836169	SPC/GB22/002	United Kingdom		PRODUCT NAME: TIRBANIBULIN; REGISTERED: UK EU/1/21/1558(FOR NI) 20210719; UK FURTHER MA ON IPSUM 20210719
1836169	LUC00235	Luxembourg		PRODUCT NAME: KLISYRI - TIRBANIBULINE; AUTHORISATION NUMBER AND DATE:

KLISYRI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Klisyri

Introduction

Klisyri, a topical ointment containing tirbanibulin, is a significant player in the treatment of actinic keratosis (AK) on the face or scalp. Developed and marketed by Almirall, a global biopharmaceutical company, Klisyri has been making waves in the dermatology market since its approval. Here, we delve into the market dynamics and financial trajectory of Klisyri.

Regulatory Approvals and Market Entry

Klisyri received FDA approval in December 2020 for the treatment of actinic keratosis on the face or scalp, followed by European approval in mid-2021[2][3]. This dual approval marked the beginning of Klisyri's journey into the global dermatology market, setting the stage for its commercial success.

Market Awareness and Patient Education

One of the significant challenges faced by Klisyri is the low awareness of actinic keratosis among patients. Almirall has identified that 85% of people are unaware of the condition, which poses a barrier to the drug's growth[1]. To address this, Almirall and its partners have been engaged in awareness campaigns. For instance, in May 2022, Almirall partnered with Euromelanoma to raise awareness about skin conditions, including actinic keratosis[4].

Sales Performance

Klisyri has shown robust sales performance since its launch. In the first nine months of 2023, Klisyri achieved net sales of €14.4 million in Europe and the United States, representing a 57% increase compared to the same period in 2022[2][3]. This growth is attributed to the drug's strong adoption in key countries where it has been launched, as well as Almirall's efforts to differentiate Klisyri based on its efficacy, tolerability, and convenience.

Market Growth Drivers

The U.S. actinic keratosis treatment market, where Klisyri operates, is expected to expand at a compound annual growth rate (CAGR) of 3.03% from 2023 to 2030. Key drivers include the increasing prevalence of actinic keratosis, the rising geriatric population, and the surge in novel treatment approaches[4].

Increasing Prevalence

Actinic keratosis affects a significant portion of the older population, with around three of every 10 older Medicare recipients being affected. This increasing prevalence is a major growth factor for the market[4].

Novel Treatment Approaches

The presence of potential investigational candidates in the pipeline and the rising R&D efforts from pharmaceutical companies, including Almirall, are contributing to market expansion. Klisyri's strong commercial performance and satisfactory results in clinical trials have further fueled its growth[4].

Competitive Landscape

Klisyri operates in a competitive market dominated by various treatment options, including surgery, cryotherapy, and other topical treatments. However, the topical/drugs segment, where Klisyri is categorized, is gaining traction due to its convenience and lower risk of adverse effects[4].

Topical Treatments

Klisyri competes with other topical brands such as Carac, Efudex, Tolak, and Aldara. However, its unique profile, including high patient satisfaction and a strong willingness to repeat treatment, sets it apart in the market[4].

Financial Trajectory

Almirall's financial performance has been positively impacted by Klisyri's sales. Here are some key financial highlights:

Net Sales

Klisyri's net sales of €14.4 million in the first nine months of 2023 contributed significantly to Almirall's overall net sales, which reached €674.6 million, a 6.4% year-on-year increase[2][3].

Gross Margin and EBITDA

Almirall's gross margin was 64.9%, in line with expectations, despite the impact of high input costs and inflation. The total EBITDA was €138.2 million, consistent with expectations[2][3].

R&D Investments

Almirall has continued to invest in R&D, with €78.4 million spent in the first nine months of 2023, representing 11.6% of net sales. These investments are expected to normalize for the full year in the range of 12% of net sales[2][3].

Future Outlook

Expanded Label and Pipeline Development

Almirall is working on securing an expanded label for Klisyri, which could give it access to more patients. Additionally, a supplementary New Drug Application (sNDA) was submitted in August 2023, with approval and a subsequent launch expected in the second half of 2024[3].

Market Expansion

The U.S. actinic keratosis treatment market is expected to reach USD 2.94 billion by 2030, driven by increasing awareness, novel treatment approaches, and favorable initiatives from non-profit organizations[4].

Key Takeaways

• Strong Sales Performance: Klisyri has shown significant sales growth, with a 57% increase in the first nine months of 2023 compared to the same period in 2022.
• Market Awareness: Despite low patient awareness of actinic keratosis, Almirall's efforts to educate the market are paying off.
• Competitive Advantage: Klisyri's efficacy, tolerability, and convenience differentiate it from other treatments.
• Future Growth: The market is expected to expand, driven by increasing prevalence and novel treatment approaches, with Klisyri poised to benefit from these trends.

FAQs

What is Klisyri used for?

Klisyri is a topical ointment used for the treatment of actinic keratosis (AK) on the face or scalp.

When was Klisyri approved?

Klisyri was approved by the FDA in December 2020 and by the European regulatory authorities in mid-2021.

How has Klisyri performed in terms of sales?

Klisyri achieved net sales of €14.4 million in Europe and the United States during the first nine months of 2023, representing a 57% increase compared to the same period in 2022.

What are the key drivers of the actinic keratosis treatment market?

The key drivers include the increasing prevalence of actinic keratosis, the rising geriatric population, and the surge in novel treatment approaches.

What is the expected market size of the U.S. actinic keratosis treatment market by 2030?

The U.S. actinic keratosis treatment market is expected to reach USD 2.94 billion by 2030.

Sources

1. FiercePharma: Almirall shows scale of Klisyri awareness challenge, finding 85% of people are unaware of the disease.
2. Business Wire: Almirall's Nine-month 2023 Results.
3. BioSpace: Almirall's Nine-month 2023 Results.
4. Grand View Research: U.S. Actinic Keratosis Treatment Market Size Report, 2030.