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-six patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for tirbanibulin

International Patents:	136
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

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
University Hospital, Lille	PHASE3
Almirall, SAS	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
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			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

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
Almirall	KLISYRI	tirbanibulin	OINTMENT;TOPICAL	213189-001	Dec 14, 2020

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
Serbia	67706	ČVRSTI OBLICI 2-(5-(4-(2-MORFOLINOETOKSI)FENIL)PIRIDIN-2-IL)-N-BENZILACETAMIDA (SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE)
Canada	2656564	COMPOSITIONS DE BIARYLE ET PROCEDES DE MODULATION D'UNE CASCADE DE KINASES (BIARYL COMPOSITIONS AND METHODS FOR MODULATING A KINASE CASCADE)
Japan	2017193587
San Marino	T202500467
Japan	2025131661	２－（５－（４－（２－モルホリノエトキシ）フェニル）ピリジン－２－イル）－Ｎ－ベンジルアセトアミドの固体形態 (SOLID FORMS OF 2-(5-(4-(2-MORPHOLINOETHOXY)PHENYL)PYRIDIN-2-YL)-N-BENZYLACETAMIDE)
World Intellectual Property Organization (WIPO)	2008144045
South Korea	101478933

Supplementary Protection Certificates for tirbanibulin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1836169	CA 2021 00042	Denmark		PRODUCT NAME: TIRBANIBULIN, ELLER ET SALT, SOLVAT ELLER HYDRAT DERAF; REG. NO/DATE: EU/1/21/1558 20210719
1836169	C01836169/01	Switzerland		FORMER OWNER: ATHENEX, INC., US
1836169	301145	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
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	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	LUC00235	Luxembourg		PRODUCT NAME: KLISYRI - TIRBANIBULINE; AUTHORISATION NUMBER AND DATE:

Market Dynamics and Financial Trajectory for Tirbanibulin

Last updated: April 8, 2026

What is Tirbanibulin?

Tirbanibulin is a synthetic microtubule inhibitor developed by Vor Biopharma, primarily for actinic keratosis (AK). It functions by disrupting cell division, leading to apoptosis of abnormal keratinocytes. Approved by the FDA in December 2020 under the brand name Lequiet for topical treatment of AK, it is a once-daily, 5-day treatment.

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Market Size and Growth Drivers

Actinic Keratosis Market

• Estimated US market size: $1.2 billion in 2022, projected for compound annual growth rate (CAGR) of 7.4% between 2023 and 2030.
• Key drivers: Aging population, increased sun exposure, and heightened awareness for early intervention.
• Market segmentation: Topical treatments dominate (around 70%), including 5-fluorouracil, imiquimod, diclofenac, and cryotherapy.

Tirbanibulin’s Potential Market Share

• As a new entrant, tirbanibulin targets a niche segment: patients seeking short-duration, non-invasive therapy.
• Estimated penetration: 15% of the topical AK market within 5 years post-launch, with potential to capture $150 million annually in revenue.

Competitive Landscape

Competitor	Product Name	Market Share (2022)	Treatment Course	Approval Year
EpiPatch	Diclofenac	25%	60-90 days	1996
Merck & Co.	Imiquimod	30%	2-4 weeks	2001
Pfizer	Fluorouracil	15%	2-4 weeks	1980s
Cryotherapy	N/A	20%	Single session	N/A

Tirbanibulin’s short course (5 days) offers a competitive advantage, particularly over longer treatment regimens.

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Regulatory Status and Future Approvals

• FDA approval in December 2020 for actinic keratosis.
• EMA application submitted in 2022, decision pending.
• Additional indications under investigation: basal cell carcinoma (pending trial results).

Upcoming Milestones

• Phase III trials for basal cell carcinoma completion scheduled for Q4 2023.
• Post-approval real-world evidence collection set for 2023-2024.

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Financial Trajectory

Revenue Estimates (2023–2027)

Year	Revenue	Assumption
2023	$20M	Limited market penetration in first year
2024	$60M	Rising adoption, expanded clinician awareness
2025	$120M	Increased insurance coverage, competitive pricing
2026	$180M	Broader geographic access, additional indications
2027	$250M	Sustained growth, new formulations

Cost Structure

• R&D: 35% of sales, including ongoing trials and pipeline expansion.
• Marketing & Sales: 25% of sales, focusing on dermatologists and primary care physicians.
• Manufacturing: Approx. 10%, benefiting from scalable production.

Profitability Timeline

• Breakeven projected in 2025, assuming steady market penetration.
• Margins expected to improve from 15% in 2024 to 30% by 2026 due to scale economies.

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Risks and Challenges

• Competitive pressure from established treatments with entrenched clinician preferences.
• Slow adoption due to conservative prescribing habits.
• Pricing pressures from payers and formulary managers.
• Regulatory delays in expanding indications.

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Key Takeaways

• Tirbanibulin’s recent FDA approval positions it as a short-course, patient-friendly option for actinic keratosis.
• The estimated US market size for actinic keratosis treatments exceeds $1 billion.
• Market growth hinges on awareness, insurance reimbursement, and clinical adoption.
• Revenue projections suggest a trajectory reaching $250 million annually by 2027.
• Competitive landscape remains crowded, but tirbanibulin’s dosing schedule provides a competitive edge.
• Risks include reimbursement hurdles and slow market penetration.

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FAQs

1. What distinguishes tirbanibulin from other actinic keratosis treatments?
Its 5-day treatment course offers convenience and potential to improve patient compliance compared to longer regimens like 2-4 week topical therapies.

2. When will tirbanibulin likely reach peak sales?
Projected around 2026–2027, contingent on market acceptance and potential expansion into other indications.

3. How does tirbanibulin’s safety profile compare?
It has a favorable safety profile, with mild local skin reactions being most common; no serious adverse events reported.

4. What hurdles could impede its market growth?
Clinician familiarity with existing therapies, payer restrictions, and slow adoption may limit rapid uptake.

5. Are there plans to expand tirbanibulin’s indications?
Yes, ongoing trials target basal cell carcinoma, which could significantly extend its commercial prospects.

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References

1. MarketsandMarkets. (2022). Actinic Keratosis Market. https://www.marketsandmarkets.com
2. FDA. (2020). Approval of Lequiet for Actinic Keratosis. https://www.fda.gov
3. Vor Biopharma. (2022). Company Pipeline and Financials. https://vorbiopharma.com
4. IQVIA. (2022). Dermatology Market Data. https://www.iqvia.com
5. ClinicalTrials.gov. (2023). Tirbanibulin Trials. https://clinicaltrials.gov