TIRBANIBULIN - Generic Drug Details

What are the generic drug sources for tirbanibulin and what is the scope of freedom to operate?

Tirbanibulin is the generic ingredient in one branded drug marketed by Almirall and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for TIRBANIBULIN

International Patents:	114
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	7
Patent Applications:	189
What excipients (inactive ingredients) are in TIRBANIBULIN?	TIRBANIBULIN excipients list
DailyMed Link:	TIRBANIBULIN at DailyMed

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

Constraining patent/regulatory exclusivity:

10,669,236

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.

Recent Clinical Trials for TIRBANIBULIN

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

Sponsor	Phase
Centre Hospitalier Universitaire de Nice	Phase 2
Medical University of Graz	Phase 4
Austin Institute for Clinical Research	Phase 2

See all TIRBANIBULIN clinical trials

Pharmacology for TIRBANIBULIN

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

Anatomical Therapeutic Chemical (ATC) Classes for TIRBANIBULIN

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

US Patents and Regulatory Information for TIRBANIBULIN

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	7,300,931		Y	Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes	10,617,693
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes	11,497,750
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes	7,851,470		Y	Y
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020		RX	Yes	Yes

EU/EMA Drug Approvals for TIRBANIBULIN

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 TIRBANIBULIN

Country	Patent Number	Title	Estimated Expiration
Canada	2673974	COMPOSITION ET METHODE DE MODULATION D'UNE CASCADE DE KINASES. (COMPOSITION AND METHODS FOR MODULATING A KINASE CASCADE)
World Intellectual Property Organization (WIPO)	2019051147
Japan	6329871
Brazil	112019018687	métodos de tratamento e/ou prevenção da ceratose actínica
World Intellectual Property Organization (WIPO)	2008144045

Supplementary Protection Certificates for TIRBANIBULIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1836169	49/2021	Austria		PRODUCT NAME: TIRBANIBULIN ODER EIN SALZ, SOLVAT ODER HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/21/1558 (MITTEILUNG) 20210719
1836169	301145	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1836169	CA 2021 00042	Denmark		PRODUCT NAME: TIRBANIBULIN, ELLER ET SALT, SOLVAT ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/21/1558 20210719
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:

TIRBANIBULIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tirbanibulin

Introduction to Tirbanibulin

Tirbanibulin is a relatively new treatment for actinic keratosis (AK), a precancerous condition that can progress to invasive squamous-cell carcinoma if left untreated. Approved for use on the face and scalp, tirbanibulin has been making significant waves in the dermatology market.

Market Size and Growth

The actinic keratosis treatment market, within which tirbanibulin operates, is experiencing steady growth. The U.S. actinic keratosis treatment market was valued at USD 2.32 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 3.03% from 2023 to 2030, reaching USD 2.94 billion by 2030[1].

Segment Dominance

Tirbanibulin is part of the topical/drugs segment, which dominates the market. This segment is driven by the strong commercial performance of products like Fluroplex, Carac, and Efudex, as well as tirbanibulin itself. The rising awareness about the diagnosis and treatment of AK has further fueled the growth of this segment[1].

Product Performance and Approval

Tirbanibulin has shown promising results in clinical trials and has been approved recently. Its strong commercial performance and satisfactory clinical trial results have contributed to its high growth rate. For instance, Almirall, the company behind tirbanibulin, expects potential peak sales for the product to exceed €250 million[2].

Cost-Effectiveness

Studies have indicated that tirbanibulin is a cost-effective treatment option. A budget impact analysis showed that the per member per month (PMPM) cost for tirbanibulin ranged from $0.19 to $0.57, which is comparable to or lower than other FDA-approved field therapies like diclofenac, imiquimod, and 5-fluorouracil[3].

Economic Evaluation

An economic evaluation conducted for the Scottish Healthcare System found that tirbanibulin is a cost-saving intervention compared to other frequently prescribed treatments like diclofenac sodium 3%, imiquimod 5%, and fluorouracil 5%. Tirbanibulin's lower rate of severe local skin reactions and shorter treatment duration also improve treatment adherence[5].

Market Share and Adoption

The adoption of tirbanibulin is expected to increase as it gains more market share. The product's inclusion in healthcare formularies is seen as cost-effective, with estimated market shares between 5-15% indicating a favorable cost profile[3].

Distribution Channels

The growth of tirbanibulin is also influenced by distribution channels. While hospitals currently hold the largest revenue share due to the high penetration of surgery and other therapies, the homecare segment is expected to be the fastest-growing segment. This is driven by the rising adoption of topical products, patient convenience, and the availability of over-the-counter (OTC) products[1].

Competitive Landscape

Almirall, the company behind tirbanibulin, has demonstrated resilience in its business performance despite challenges such as the COVID-19 pandemic and generic competition. The company's investment in research and development (R&D) and in-licensing projects, exceeding €100 million annually, positions it strongly for future growth[2].

Regional Dynamics

The North American market, particularly the U.S., remains a dominant region for actinic keratosis treatments, including tirbanibulin. This is due to the high prevalence of AK, advanced healthcare facilities, and significant R&D activities in the region[4].

Future Outlook

The future outlook for tirbanibulin is promising. With its cost-effectiveness, lower side effects, and shorter treatment duration, it is poised to capture a significant share of the actinic keratosis treatment market. Almirall's strategic investments and partnerships, such as the one with Euromelanoma to raise awareness about skin conditions, further support the product's growth trajectory[1][2].

Key Takeaways

• Market Growth: The U.S. actinic keratosis treatment market is expected to grow at a CAGR of 3.03% from 2023 to 2030.
• Cost-Effectiveness: Tirbanibulin is a cost-effective treatment option compared to other therapies.
• Product Performance: Strong commercial performance and satisfactory clinical trial results drive tirbanibulin's growth.
• Distribution Channels: Homecare segment is expected to be the fastest-growing due to the adoption of topical products.
• Regional Dynamics: North America, particularly the U.S., is a dominant market for actinic keratosis treatments.

FAQs

1. What is the current market size of the U.S. actinic keratosis treatment market? The U.S. actinic keratosis treatment market was valued at USD 2.32 billion in 2022[1].

2. What is the expected CAGR for the U.S. actinic keratosis treatment market from 2023 to 2030? The market is expected to expand at a CAGR of 3.03% from 2023 to 2030[1].

3. How cost-effective is tirbanibulin compared to other treatments? Tirbanibulin is estimated to be cost-saving compared to diclofenac sodium 3%, imiquimod 5%, and fluorouracil 5%, with lower rates of severe local skin reactions and shorter treatment durations[5].

4. What factors drive the growth of the tirbanibulin segment? The growth is driven by strong commercial performance, satisfactory clinical trial results, and increasing awareness among the target population[1].

5. Which distribution channel is expected to be the fastest-growing for tirbanibulin? The homecare segment is expected to be the fastest-growing due to the rising adoption of topical products and patient convenience factors[1].

Sources

1. Grand View Research, "U.S. Actinic Keratosis Treatment Market Size Report, 2030"
2. Almirall, "Almirall demonstrates resilient performance year to date despite COVID-19 impacts"
3. Jefferson Digital Commons, "Budget Impact Analysis of Tirbanibulin Field Therapy for Actinic Keratosis"
4. Allied Market Research, "Actinic Keratosis Treatment Market Size, Share and Forecast, 2026"
5. PubMed, "Economic Evaluation of Tirbanibulin for the Treatment of Actinic Keratosis"