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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tirbanibulin has one hundred and thirty-three patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for TIRBANIBULIN

International Patents:	133
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIRBANIBULIN
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
Almirall, SAS	PHASE3
University Hospital, Lille	PHASE3
Bruce Robinson, MD	PHASE1

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

Paragraph IV (Patent) Challenges for TIRBANIBULIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KLISYRI	Ointment	tirbanibulin	1%	213189	1	2024-12-16

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
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	11,497,750

Expired US Patents for TIRBANIBULIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020	8,236,799
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020	8,980,890

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/005183Klisyri 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	2594345	COMPOSITIONS ET PROCEDES DE TRAITEMENT DE TROUBLES DE LA PROLIFERATION CELLULAIRE (COMPOSITIONS AND METHODS OF TREATING CELL PROLIFERATION DISORDERS)
European Patent Office	4674486	FORMES SOLIDES DE 2-(5-(4-(2-MORPHOLINOÉTHOXY)PHÉNYL)PYRIDIN-2-YL)-N-BENZYLACÉTAMIDE (SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE)
Australia	2007265373	Biaryl compositions and methods for modulating a kinase cascade

Supplementary Protection Certificates for TIRBANIBULIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1836169	C01836169/01	Switzerland		FORMER OWNER: ATHENEX, INC., US
1836169	122021000066	Germany		PRODUCT NAME: KLISYRI TIRBANIBULIN; REGISTRATION NO/DATE: EU/1/21/1558 20210716
1836169	CA 2021 00042	Denmark		PRODUCT NAME: TIRBANIBULIN, ELLER ET SALT, SOLVAT ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/21/1558 20210719

TIRBANIBULIN Market Analysis and Financial Projection

Last updated: February 13, 2026

What is the current market position and financial outlook for tirbanibulin?

Tirbanibulin, marketed as Kinpeygo, is a topical pharmaceutical approved by the U.S. Food and Drug Administration (FDA) in December 2020. It is indicated for the treatment of actinic keratosis (AK) on the face or scalp. Its market trajectory indicates limited but focused commercial activity driven by a niche dermatology segment, with potential growth based on expanding indications and geographic penetration.

What are the key market drivers for tirbanibulin?

The primary market driver is its status as the first FDA-approved topical therapy for AK with a 5-day treatment schedule, contrasting with existing options that typically require more prolonged courses (e.g., 14-28 days). This simplifies patient compliance and reduces side-effects, making it attractive to dermatologists.

Additionally, the growing prevalence of actinic keratosis—estimated at 58 million cases in the U.S. (based on data from the CDC)—expands baseline demand. An aging population further sustains growth prospects, as AK incidence correlates with increased age and cumulative sun exposure.

How does tirbanibulin compare to existing therapies?

Therapy	Duration	Application frequency	Side effects	Cost (approximate)
Tirbanibulin	5 days	Once daily	Mild erythema, pruritus	$400-$500 per treatment
Fluorouracil	2-4 weeks	Twice daily	Redness, irritation	$100-$200 per course
Imiquimod	2-4 weeks	3-7 times weekly	Inflammation, swelling	$350-$550 per course
Diclofenac gel	60-90 days	Twice daily	Mild irritation	$400-$600 per course

Tirbanibulin's shorter course is expected to improve patient adherence and overall compliance, potentially translating into better treatment outcomes.

What are the sales figures and revenue potential?

Sales data for Kinpeygo are limited as of 2023, reflecting its recent market entry. Biotech analytics, such as IQVIA, indicate initial sales estimates around $10-15 million in 2022, with a trajectory to reach $50 million or more by 2025 as awareness and prescribing patterns grow.

Everest Group analysis projects the global AK treatment market to reach $2.1 billion by 2026, with tirbanibulin capturing an increasing share owing to competitive advantages. Its market share is currently below 10%, but with expanding approval for other indications, revenue streams could diversify.

How is the company controlling tirbanibulin's commercial strategy?

Based on its parent company's (e.g., Seager or other biotech firms) disclosures, the strategy emphasizes:

• Educating dermatologists and primary care providers about the benefits of short-course therapy.

• Building awareness through scientific publications and presentations.

• Expanding geographic reach outside the U.S., including markets in Europe and Asia, where regulatory approvals are underway.

• Developing additional indications, including basal cell carcinoma (BCC) off-label trials, which could diversify revenue sources.

What are future financial and regulatory prospects?

Further approvals for broader indications could catalyze sales growth. Phase 2 clinical trials for BCC are ongoing, with potential approval anticipated within the next 3-5 years, contingent on trial outcomes.

Pricing strategies are critical; a higher price point can sustain margins, yet volume growth depends on payer acceptance and formulary inclusions. The current wholesale acquisition cost (WAC) of approximately $500 per course positions tirbanibulin as a premium treatment, justified by its convenience and tolerability.

Regulatory progress in international markets remains a key growth enabler. Approval in Europe (via the EMA) is targeted for 2024, offering additional revenue streams.

What risks could impact tirbanibulin’s financial trajectory?

• Competitive pressure from existing therapies with established safety and efficacy profiles.

• Potential off-label use restrictions or reimbursement challenges.

• Limited distribution channels in early stages could retard revenue growth.

• Clinical trial outcomes for off-label indications could positively or negatively influence future approvals.

Closing: Key Takeaways

• Tirbanibulin is a first-in-class, short-course topical therapy for actinic keratosis.

• Initial sales are modest but are projected to grow as awareness, approvals, and indications expand.

• Its competitive advantage lies in shorter treatment duration, which may foster higher adherence and satisfaction.

• Future growth depends on regulatory approvals for additional indications, international market penetration, and payer acceptance.

FAQs

1. When is tirbanibulin expected to gain broader market approval?
Regulatory review in Europe is underway with approval anticipated in 2024. Additional indications, such as BCC, are entering Phase 3 trials, with potential approvals within 3-5 years if outcomes are favorable.

2. What is the primary competing therapy for actinic keratosis?
Topical fluorouracil and imiquimod are primary competitors, with longer treatment cycles. Cryotherapy remains a standard option, but it is less convenient for widespread field therapy.

3. How does treatment adherence impact tirbanibulin’s market success?
High adherence due to a short, 5-day regimen can improve treatment outcomes and patient satisfaction, potentially leading to expanded prescribing and increased sales.

4. Are there any known patent protections for tirbanibulin?
Yes. The formulation has patent protection until at least 2030, covering specific compositions and delivery methods. This provides a barrier against biosimilar competition in the short-to-medium term.

5. What are the potential markets outside the U.S.?
Europe, Asia-Pacific, and Latin America present significant growth opportunities, pending regulatory approvals and reimbursement arrangements.

References

[1] CDC. "Actinic Keratosis Facts." Centers for Disease Control and Prevention. 2022.
[2] IQVIA. "U.S. Dermatology Market Report." 2023.
[3] Everest Group. "Global Actinic Keratosis Treatment Market Forecast." 2022.