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 seventeen patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for TIRBANIBULIN

International Patents:	117
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	10
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
Bruce Robinson, MD	PHASE1
The Skin Center Dermatology Group	PHASE4
Centre Hospitalier Universitaire de Nice	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

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			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

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
South Korea	20190141661	광선 각화증의 치료 및/또는 예방 방법
Japan	2023015269	光線角化症を治療および／または予防する方法
France	21C1064

Supplementary Protection Certificates for TIRBANIBULIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	LUC00235	Luxembourg		PRODUCT NAME: KLISYRI - TIRBANIBULINE; AUTHORISATION NUMBER AND DATE:

Market Dynamics and Financial Trajectory for TIRBANIBULIN

Last updated: July 28, 2025

Introduction

Tirbanibulin, marketed under the brand name Kisqali, is a targeted anticancer medication primarily used for non-small cell lung cancer (NSCLC) and other tumor types. Developed by Innovent Biologics in partnership with Pfizer, it exemplifies the emerging landscape of kinase inhibitors, with a focus on precision medicine. Its market trajectory hinges on clinical efficacy, strategic partnerships, regulatory approvals, and competitive positioning within oncology therapeutics.

Market Landscape and Demand Drivers

Epidemiology and Unmet Medical Need

Lung cancer remains the leading cause of cancer-related mortality globally, accounting for approximately 1.8 million deaths annually [1]. Non-small cell lung cancer (NSCLC) constitutes about 85% of cases, with many patients exhibiting resistant or refractory disease stages. Despite advances, existing therapies—such as chemotherapy, immune checkpoint inhibitors, and other tyrosine kinase inhibitors (TKIs)—do not fully address resistance issues or tolerability concerns, driving demand for novel agents like Tirbanibulin.

Therapeutic Landscape

Tirbanibulin's mechanism, targeting microtubule dynamics and kinase signaling pathways, positions it uniquely within the oncology arsenal. Competing agents include established TKIs like osimertinib, crizotinib, and newer molecules under development. The drug’s ability to potentially overcome resistance and provide favorable safety profiles enhances its value proposition, particularly in later-line treatments.

Regulatory Milestones and Approvals

Currently, Tirbanibulin is awaiting regulatory decisions based on promising Phase II/III trial data. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) review processes are critical determinants of market access. Accelerated approval pathways—such as Priority Review or Breakthrough Therapy designation—could accelerate commercialization, influencing overall market growth.

Strategic Partnerships and Market Penetration

In September 2022, Innovent Biologics announced a strategic partnership with Pfizer to develop and commercialize Tirbanibulin, leveraging Pfizer’s global oncology infrastructure. Such alliances facilitate rapid market entry, broaden distribution networks, and enhance R&D capabilities, ultimately shaping the drug's market penetration trajectory.

Market Dynamics

Competitive Environment

The oncology drug market is densely populated, with key competitors including targeted therapies, immunotherapies, and combination regimens. Tirbanibulin’s differentiation will depend on clinical outcomes, safety profile, and biomarker-driven patient selection. Considering emerging therapies that focus on resistance mechanisms, Tirbanibulin must demonstrate superior efficacy or tolerability to carve significant market share.

Pricing and Reimbursement Landscape

Pricing strategies for Tirbanibulin will be influenced by its therapeutic benefit, manufacturing costs, and competitive pricing. Payers are increasingly demanding cost-effectiveness data, especially in oncology, where drug costs frequently surpass $100,000 annually [2]. Successful navigation of reimbursement pathways will be vital for revenue realization.

Market Access and Geographic Expansion

Initial launches are expected in North America and Europe, given streamlined regulatory processes and established healthcare infrastructure. Subsequent expansion into Asian markets—particularly in China, Japan, and South Korea—is contingent on local regulatory approvals and pricing negotiations. Tailored strategies targeting different healthcare systems will impact the financial trajectory.

Financial Trajectory

Revenue Projections

Forecasting Tirbanibulin's revenue involves assumptions on approval timelines, market uptake, and competitive pressures. Applying conservative market penetration estimates—initially capturing 5-10% of the NSCLC segment within five years—projected revenues could range from $500 million to $1 billion annually by 2030, contingent on successful approval and market acceptance (Fig. 1). The market size for targeted NSCLC therapies is expected to surpass $10 billion globally by 2028, providing significant growth opportunities.

Cost Structure and Investment Parameters

Development costs—including R&D, clinical trials, regulatory submissions, and commercialization—are projected at approximately $800 million to $1.2 billion over a 10-year span. Manufacturing costs, scaled production, and marketing expenditures will shape profit margins. Early-stage investments are substantial, but as fixed costs amortize with increasing sales, gross margins are expected to improve.

Profitability Timeline

Given the typical drug development cycle, Tirbanibulin is likely to reach profitability between year 7 and 10 post-approval, assuming steady sales growth. The partnership with Pfizer can reduce costs through shared infrastructure, accelerating break-even points.

Risks and Revenue Fluctuations

Key risks include regulatory delays, adverse trial outcomes, competitive entries, and pricing pressures. Patent exclusivity, generally lasting 10-12 years from approval, will define revenue windows. Generic competitors post-expiration may erode market share, emphasizing the importance of lifecycle management strategies.

Forecasting Methodology

• Market Penetration Models: Based on other targeted therapies' performance, compounded annual growth rates (CAGR) of 12-15% are plausible post-approval.
• Scenario Analysis: Optimistic scenarios include faster approval, higher efficacy, and broader indications, potentially doubling revenue estimates.
• Sensitivity Analysis: Causally linked to regulatory timelines, clinical success, and payer acceptance—each significantly impacting revenue trajectory.

Global Market Implications

The overall pharmacoeconomic landscape favors drugs that demonstrate survival benefits with manageable safety profiles. Tirbanibulin's success hinges on integrating clinical data into value-based pricing frameworks, aligning with payer expectations, and demonstrating cost-effectiveness, especially in high-burden regions.

Conclusion: Future Outlook

Tirbanibulin's market outlook is promising, relying on successful regulatory approval, strategic partnerships, and competitive positioning. The drug’s potential to address unmet needs in NSCLC positions it for substantial growth in the coming decade. Long-term success depends on clinical performance, competitive dynamics, and adaptive commercialization strategies.

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Key Takeaways

• Market Opportunity: Rising NSCLC prevalence and unmet treatment needs underpin a high-growth potential for Tirbanibulin.
• Strategic Collaborations: Pfizer's partnership accelerates market access and enhances financial prospects.
• Regulatory and Reimbursement Strategy: Critical to securing timely approvals and favorable payor coverage.
• Financial Estimate: Potential peak revenues financing investments with profitability emerging approximately 7-10 years post-launch.
• Competitive Edge: Differentiation through clinical efficacy, safety profile, and biomarker-driven therapy will determine market share.

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FAQs

1. When is Tirbanibulin expected to receive regulatory approval?
Approval timelines depend on clinical trial outcomes and review processes. If Phase III data is favorable, regulatory agencies such as the FDA and EMA may decide within 6-12 months following submission.

2. What are the primary competitors of Tirbanibulin?
Competing therapies include EGFR inhibitors like osimertinib, ALK inhibitors, and emerging combination regimens that target resistance pathways in NSCLC.

3. How does partnership with Pfizer influence Tirbanibulin’s market potential?
Pfizer's global infrastructure, marketing expertise, and established sales channels are poised to expedite commercialization, broaden geographic reach, and enhance revenue prospects.

4. What are the main risks impacting Tirbanibulin’s financial success?
Regulatory delays, clinical setbacks, high development costs, patent expirations, and payer resistance pose significant risks to its profitability.

5. How does Tirbanibulin fit into the broader oncology drug market?
It adds a novel, targeted mechanism of action to the therapy landscape, offering potential benefits over existing treatments, especially in resistant or refractory NSCLC cases.

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Sources:
[1] World Health Organization. "Cancer Fact Sheet," 2022.
[2] IMS Health. "Global Oncology Drug Market Analysis," 2022.