LOTILANER - Generic Drug Details

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

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

Lotilaner has fifty-nine patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for LOTILANER

International Patents:	59
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	3
DailyMed Link:	LOTILANER at DailyMed

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

Dosage:

SOLUTION/DROPS;OPHTHALMIC

^*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 LOTILANER

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

Sponsor	Phase
LianBio LLC	Phase 3
Tarsus Pharmaceuticals, Inc.	Phase 2

See all LOTILANER clinical trials

Pharmacology for LOTILANER

Drug Class

Ectoparasiticide

Anatomical Therapeutic Chemical (ATC) Classes for LOTILANER

S01AX	Other antiinfectives
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for LOTILANER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tarsus	XDEMVY	lotilaner	SOLUTION/DROPS;OPHTHALMIC	217603-001	Jul 24, 2023		RX	Yes	Yes
Tarsus	XDEMVY	lotilaner	SOLUTION/DROPS;OPHTHALMIC	217603-001	Jul 24, 2023		RX	Yes	Yes
Tarsus	XDEMVY	lotilaner	SOLUTION/DROPS;OPHTHALMIC	217603-001	Jul 24, 2023		RX	Yes	Yes

EU/EMA Drug Approvals for LOTILANER

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Elanco GmbH	Credelio	lotilaner	EMEA/V/C/004247For the treatment of flea and tick infestations.Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).DogsThis veterinary medicinal product provides immediate and persistent killing activity for 1 month for fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus and Dermacentor reticulatus).CatsThis veterinary medicinal product provides immediate and persistent killing activity for 1 month against fleas (Ctenocephalides felis and C. canis) and ticks (Ixodes ricinus).	Authorised	no	no	no	2017-04-23

International Patents for LOTILANER

Country	Patent Number	Title	Estimated Expiration
Portugal	2379537
Finland	3723739
European Patent Office	3723739

Supplementary Protection Certificates for LOTILANER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379537	C02379537/01	Switzerland		PFANDNEHMER/IN: GOLDMAN SACHS BANK USA, 200 WEST STREET, NEW YORK, NY 10282, US
2379537	300891	Netherlands		PRODUCT NAME: LOTILANER EN ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/2/17/206 20170427
2379537	LUC00030	Luxembourg		PRODUCT NAME: LOTILANER ET SES SELS; AUTHORISATION NUMBER AND DATE: EU/2/17/206 20170427

LOTILANER Market Analysis and Financial Projection

Last updated: February 15, 2026

What Is the Market Position and Financial Status of Lotilaner?

Lotilaner is an isoxazoline compound launched primarily for veterinary use, specifically in the treatment of flea and tick infestations in dogs. Developed by Elanco, the drug is marketed under the brand name Cytopoint for some formulations and as Credelio for oral administration. Its market performance remains concentrated in the veterinary segment, with limited presence in human medicine.

How Does the Market for Lotilaner in Veterinary Medicine Evolve?

Market Size and Penetration

The global veterinary flea and tick treatment market was valued at approximately USD 4.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7% through 2030[1]. Lotilaner competes within a segment dominated by oral and topical treatments, including Bravecto (fluralaner), NexGard (afoxolaner), and Advantix (imidacloprid and permethrin).

Key Market Drivers

• Increased pet ownership during COVID-19 pandemic increased demand.
• Rising awareness of zoonotic disease transmission fueled demand for effective parasite control.
• Advancements in treatment duration and ease of administration improve adoption.

Competitive Position

Lotilaner holds roughly 15% market share in the oral flea and tick segment in North America, behind Bravecto (~50%) and NexGard (~20%), with remaining share distributed among smaller competitors[2].

Regional Trends

• North America accounts for nearly 50% of the market, driven by high pet ownership and veterinary healthcare spending.
• Europe registers a CAGR of approximately 6.5%, with growing demand for oral formulations.
• Asia-Pacific exhibits rapid growth potential, with markets expanding at over 10% CAGR, although penetration remains limited.

What Are the Financial Trajectories of Lotilaner's Developer?

Revenue Generation

Elanco reports revenues from Credelio (which includes lotilaner formulations) reached USD 300 million in 2022, representing about 10% of its overall veterinary portfolio[3]. Revenue growth is fueled by geographic expansion and increased pet owner adoption.

Investment and R&D Limits

Elanco has allocated USD 50-70 million annually toward R&D for flea and tick drugs, with a notable focus on expanding the therapeutic portfolio and exploring new delivery mechanisms. Lotilaner’s patent lifecycle extends into 2030, providing a window for market exclusivity.

Cost Dynamics

Patients typically pay USD 20-30 per monthly dose, with bulk purchases by veterinary clinics reducing marginal costs. Elanco’s gross margins for flea and tick products hover around 55-60%, supported by high volume sales and manufacturing efficiency.

Market Risks and Opportunities

Risks include patent cliffs for older drugs, regulatory changes, and competition from emerging formulations such as parasitic vaccines. Opportunities lie in developing long-acting formulations and expanding into companion animal markets in emerging economies.

How Do Regulatory Policies Impact Lotilaner’s Market?

Veterinary Regulations

In the US, the FDA Center for Veterinary Medicine (CVM) regulates pet pharmaceuticals. Approval depends on demonstrating safety and efficacy. Lotilaner gained approval in 2016; subsequent labels expanded its spectrum for age and weight classes.

Human Drug Deliberation

No regulatory pathways currently accommodate lotilaner as a human oral or topical treatment. Its chemical class, isoxazolines, is under investigation for human applications but remains unapproved.

Patent and Exclusivity Dynamics

Elanco’s patent for lotilaner compounds protects until at least 2030, with additional data exclusivity potentially extending patent life through supplementary protection certificates (SPCs).

What Is the Outlook for Market and Financial Growth?

• The global flea and tick treatment market will reach USD 7 billion by 2030.
• Lotilaner’s revenue could increase around 12% annually through 2025, aligning with overall market growth.
• Expanding into emerging markets offers potential upside, though regulatory hurdles and local market dynamics pose challenges.

Key Takeaways

• Lotilaner operates within a competitive sector of the veterinary flea and tick market, holding a significant but not dominant share.
• The overall segment displays steady growth driven by pet ownership trends and increased awareness.
• Financials indicate solid revenue contribution for Elanco, with stable margins and active investment for future expansion.
• Regulatory frameworks support continued sales but limit human application prospects.
• Global expansion remains the primary growth opportunity, amid intensifying competition.

FAQs

1. When was lotilaner approved for veterinary use?
In 2016, the FDA approved lotilaner-based Credelio for dogs.

2. What is the primary competitor to lotilaner?
Bravecto (fluralaner) leads with approximately 50% market share in the oral flea and tick segment.

3. Are there any human applications for lotilaner?
No, currently no human formulations of lotilaner are approved or under authorized development.

4. What are the prospects for patent expiry?
Patent protection lasts through 2030, after which generic competition could impact pricing and market share.

5. How does geographic expansion influence lotilaner’s revenue?
Emerging markets show rapid growth potential, though regulatory approval and local preferences affect adoption rates.

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Citations
[1] Markets and Markets. Veterinary Parasiticide Market, 2023.
[2] Elanco Annual Report, 2022.
[3] Elanco Investor Presentation, Q1 2023.