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 six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-two patent family members in thirty-two 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 December 28, 2030. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for KLISYRI

International Patents:	142
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Patent Applications:	450
Drug Prices:	Drug price information for KLISYRI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

Paragraph IV (Patent) Challenges for KLISYRI

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

US Patents and Regulatory Information for KLISYRI

KLISYRI is protected by six US patents and one FDA Regulatory Exclusivity.

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

Expired US Patents for KLISYRI

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 KLISYRI

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 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:

Canada

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
Australia	2007340350
Australia	2008254500
Canada	2673974
Canada	2686267
China	101616915

Supplementary Protection Certificates for KLISYRI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1836169	LUC00235	Luxembourg		PRODUCT NAME: KLISYRI - TIRBANIBULINE; AUTHORISATION NUMBER AND DATE:
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	122021000066	Germany		PRODUCT NAME: KLISYRI TIRBANIBULIN; REGISTRATION NO/DATE: EU/1/21/1558 20210716
1836169	2021C/001	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT

Last updated: July 26, 2026

Klisyri (tirbanibulin) Market Dynamics and Financial Trajectory: Exclusivity, Competition, Reimbursement, and Launch Economics

Klisyri (tirbanibulin) is positioned in the U.S. for actinic keratosis (AK), with commercial performance driven by (1) how dermatology prescribing shifts between lesion-directed field therapy and procedural cryotherapy, (2) payer coverage for OTC-like “skin cancer prevention” language, and (3) the timing of generic and low-cost competitive entries after exclusivity. Financial trajectory is therefore tightly coupled to exclusivity clocks, formulary uptake, channel inventory behavior, and the presence or absence of patent-reasonable generic substitution in the same strength and regimen.

Because Klisyri’s revenue depends on U.S.-centric adoption patterns and dermatology channel structure, the market dynamics are best modeled around: number of eligible patients with AK treated in a defined field size, dosing adherence (course-complete behavior), and steady-state prescriptions as seasonal skin exposure increases in summer months. The product’s financial trajectory is also sensitive to any payer step edits that push patients toward cryotherapy.

How is Klisyri (tirbanibulin) performing commercially in the U.S. and why do AK dynamics matter?

What drives demand for actinic keratosis field therapy

Actinic keratosis is highly prevalent in older populations with chronic UV exposure. Commercial adoption for topical AK therapies typically reflects three demand channels:

• Dermatology-first diagnosis leading to office-based AK mapping and lesion count documentation.
• Treatment selection that weighs time-to-clearance, tolerability, and downtime.
• Patient willingness to accept non-procedural therapy over cryotherapy.

Field therapies like tirbanibulin compete against cryotherapy and other topical regimens (including those with longer or more irritating courses). Buyers and clinicians tend to respond to short-course regimens where tolerability supports completion.

How prescribing patterns influence revenue

Revenue ramps usually track:

• Early uptake as prescribers trial the new mechanism.
• Stable growth as patients return for follow-up clearance assessments and repeat annual treatment if lesions recur.
• Channel learnings such as sampling, starter uptake via dermatologist practices, and conversion of early prescriber champions.

Key “financial trajectory” inflection points for Klisyri are typically:

• Formulary and coverage decisions (preferred vs. non-preferred status).
• Dermatology contract pharmacy adoption and inventory stabilization.
• Any competitive shift from other AK topicals or procedural mix changes.

What KPIs track Klisyri’s trajectory

Common board-level KPIs for topical oncology-dermatology products include:

• Script volume vs. prescriptions per treating provider.
• Average selling price (ASP) dynamics through rebate rates and contract coverage.
• Gross-to-net spread (rebates, chargebacks, patient assistance).
• Inventory turns and returns (channel stocking behavior).

What patents and exclusivity determine Klisyri’s long-term revenue runway?

How exclusivity timelines shape market entry risk

Klisyri’s revenue protection depends on two layers:

1. Drug-related regulatory exclusivity (data exclusivity and 3-year/5-year exclusivity outcomes as applicable to the approval pathway).
2. Patent estate coverage in the Orange Book for the NDA, which can delay generic substitution and impose litigation-driven entry barriers.

If patent coverage is fragmented across multiple claims (composition, formulation, method of use), generics can seek partial carve-outs and still launch “at risk” or after settlements.

What matters for financial modeling

For a topical AK product like Klisyri, revenue downside typically accelerates under one or more conditions:

• A generic can launch with bioequivalence acceptance and minimal clinical differentiation.
• Payer policy reacts to lower-cost competitors through switching programs.
• Dermatology practices reduce use due to price preference or copay changes.

The strongest revenue runway scenarios are when:

• Patent claims cover the exact dosage form and regimen with no design-around.
• Litigation results in an entry delay via settlement or injunction.
• Exclusivity and patent term overlap creates a “double lock” against low-cost alternatives.

Patent estate mapping framework used in diligence

Revenue protection is evaluated by mapping:

• Composition-of-matter patents: direct generic substitution risk.
• Formulation and stability patents: ability to market alternate compositions.
• Method-of-use patents: risk of “skin disease indication carving” or off-label substitution.
• Expiration by jurisdiction: U.S. controls launch timing for generic entry, but international assets affect licensing value.

When does Klisyri lose exclusivity and what generic entry risks exist?

What determines launch delay in U.S. generics

The U.S. generic pathway risk for a prescription dermatology product like Klisyri typically includes:

• Paragraph IV certifications and the resulting litigation timelines.
• Settlement agreements that define “first commercial marketing” (FCM) dates.
• Patent expiry-driven carve-outs.

Financially, the most material risk is not only “earliest expiration date,” but whether litigation and settlements postpone actual generic FCM beyond the earliest legal date.

What “at risk” looks like in this category

For topical AK drugs, “at risk” entry risk is higher when:

• The patent claims are narrow or have weak enforceability.
• The regulatory approval path supports fast generic substitution.
• Payers can quickly move the product off formulary after price drops.

When claims are broad and settlement terms are tight, entry tends to be slower and revenue erosion is more gradual.

How strong is the patent estate for Klisyri (tirbanibulin) across composition, formulation, and use?

What a strong estate usually includes

A strong AK topical estate typically includes:

• Composition-of-matter coverage for tirbanibulin or key chemical variants.
• Formulation patents covering specific topical vehicle or concentration ranges that affect stability and skin penetration.
• Method-of-use claims tied to dosing schedule and treatment cycles.

Why claim type impacts revenue

• Composition/formulation protection blocks true generic entry.
• Method-of-use protection can still protect brand use even if competitors market, depending on indication labeling and payer switching behavior.
• If competitors can market an equivalent product with different claim coverage, revenue can decline even before full patent expiry.

What is the Orange Book status of Klisyri and how many patents cover the NDA?

Orange Book status directly drives Paragraph IV leverage. The key market question is whether Klisyri’s NDA lists multiple patents across claim types, which increases litigation and entry complexity for generics.

In practice, the market outcome depends on:

• Total number of listed patents by claim category.
• Remaining life by each listed patent.
• Whether patents are subject to terminal disclaimers and expiration aggregation.

What formulation patents protect Klisyri and do they block generic substitution?

Topical formulation risk

For topical small-molecule drugs, formulation patents matter because:

• A generic must meet regulatory requirements for sameness in strength, dosage form, and comparable performance.
• Stability, release, and skin permeation-related differences can create design-around challenges.

If Klisyri’s formulation patents are broad and tied to performance, generic substitution can be slowed even when composition patents expire later.

What method-of-use patents protect Klisyri’s AK treatment regimen?

Method-of-use coverage can affect revenue even after composition/formulation barriers weaken because:

• Dermatologists often follow labeled regimens for reimbursement reliability.
• Payers may prefer labeled regimens that support medical-necessity documentation.

If method-of-use claims constrain the dosing schedule, generic competition may be delayed or restricted to off-label use patterns that do not fully erode brand demand.

Which companies are challenging Klisyri with generics or biosimilar-style substitutes?

For small-molecule topical drugs like tirbanibulin, biosimilar frameworks do not apply. The competitive threat is typically:

• Generic manufacturers preparing ANDAs with Paragraph IV certifications.
• Authorized generics or settlement-driven entry agreements.

Financial trajectory is sensitive to the number of ANDA filers and the aggressiveness of their litigation positions, since multiple filers can accelerate switching pressure.

What patent litigation affects Klisyri and how do settlements change the launch timeline?

Litigation’s direct link to financial performance

Patent litigation and settlement terms affect:

• Entry date certainty for competitors.
• Brand revenue forecasting and inventory planning.
• Payer contracting leverage.

When settlements include delayed FCM dates and “no launch before” provisions, revenue erosion is typically stepwise rather than linear.

What is the FDA regulatory status of Klisyri (pathway, labeling, and exclusivity implications)?

Labeling features that support adoption

For AK indications, revenue depends on:

• Clear labeled dosing instructions that align with clinician workflow.
• Simple regimen adherence that improves completion rates.
• Safety and tolerability profile that supports repeat treatment cycles.

FDA regulatory status also impacts payer coverage because plan medical policy often relies on:

• Indication-specific labeled uses.
• Dosing and treatment schedule documentation.

How does Klisyri compare with other actinic keratosis therapies on clinical and economic factors?

Competitor set dynamics

Klisyri competes against:

• Cryotherapy as a procedure-first standard.
• Other topical AK field therapies with different dosing duration and local skin reactions.
• Adjunctive dermatology prevention strategies.

From a market dynamics standpoint, brand share tends to shift when:

• A competitor’s regimen is easier to complete or has better tolerability.
• Rebate dynamics compress price differences.
• Payers implement step edits that favor one regimen in defined lines of therapy.

What clinicians prioritize

Clinicians typically weight:

• Ease of use in clinic and patient home settings.
• Skin reaction management and patient adherence.
• Need for retreatment timing and follow-up assessment.

How much revenue exposure does Klisyri have if generics launch?

Modeling revenue erosion after first commercial marketing

After generic entry, revenue declines usually depend on:

• Copay and coverage changes: preferred tier placement accelerates switching.
• Prescriber loyalty vs. payer-driven substitution.
• Price compression and rebate renegotiation.

Topical AK products often see:

• Faster decline if the generic captures the same patient cohort quickly via formulary inclusion.
• More gradual decline if the brand remains preferred for tolerability reasons or if patient-specific switching barriers exist.

What are the commercial levers: reimbursement, payer behavior, channel structure, and pricing strategy?

Reimbursement and formulary positioning

Key payer actions that affect financial trajectory:

• Prior authorization criteria for AK field therapy.
• Step therapy requiring prior cryotherapy or other AK treatments.
• Denial management effectiveness and documentation support.

Pricing strategy and net sales

Net sales are driven by:

• List price and contract rebates.
• Distributor chargebacks and wholesaler inventory terms.
• Patient assistance programs, which can protect access but can also increase gross-to-net volatility.

Channel behavior

For dermatology products, channel inventory can amplify volatility:

• Overstock can pull future reorder patterns.
• Understock can cap early growth in new prescriber networks.

Key Takeaways

• Klisyri’s financial trajectory in AK depends on dermatology adoption patterns, patient adherence to short-course topical regimens, and payer coverage behavior that can accelerate or slow switching after any exclusivity window narrows.
• Revenue runway is primarily determined by the interaction between FDA regulatory exclusivity and the Orange Book patent estate, with litigation and settlements defining the timing of generics and stepwise erosion.
• The biggest risk to long-term earnings is not only the “earliest legal expiration” but actual first commercial marketing, driven by Paragraph IV outcomes and settlement terms.
• Commercial outcomes hinge on gross-to-net management and formulary positioning, which determine how quickly price compression translates into scripts.

FAQs

1. How do payer step edits for actinic keratosis affect Klisyri net sales growth?
2. What gross-to-net drivers most influence Klisyri profitability during formulary changes?
3. How do patent settlements in topical oncology-dermatology cases typically shift generic entry timing?
4. Which clinical dosing features of tirbanibulin influence adherence and repeat treatment demand?
5. How does competition from cryotherapy and other AK topicals change the pricing power of Klisyri after generic entry?

References

1. APA reference list would be provided here with only cited sources.

DrugChatter Q&A for KLISYRI

Does medicare cover klisyri?
Can klisyri treat actinic keratosis on the face?