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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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
Tarsus	XDEMVY	lotilaner	SOLUTION/DROPS;OPHTHALMIC	217603-001	Jul 24, 2023		RX	Yes	Yes			Y	Y
Tarsus	XDEMVY	lotilaner	SOLUTION/DROPS;OPHTHALMIC	217603-001	Jul 24, 2023		RX	Yes	Yes			Y
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			Y

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
World Intellectual Property Organization (WIPO)	2019118928
Brazil	PI0923009
Mexico	2024000828	FORMULACIONES DE PARASITICIDA DE ISOXAZOLINA Y METODOS PARA EL TRATAMIENTO DE LA BLEFARITIS. (ISOXAZOLINE PARASITICIDE FORMULATIONS AND METHODS FOR TREATING BLEPHARITIS.)
New Zealand	766141
World Intellectual Property Organization (WIPO)	2019118928
Spain	2981130
Netherlands	300891

Supplementary Protection Certificates for LOTILANER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2379537	2017/037	Ireland		PRODUCT NAME: LOTILANER AND SALTS THEREOF.; REGISTRATION NO/DATE: EU/2/17/206 20170425
2379537	1790037-4	Sweden		PRODUCT NAME: LOTILANER AND SALTS THEREOF; REG. 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
2379537	699	Finland
2379537	2017048	Norway		PRODUCT NAME: LOTILANER; REG. NO/DATE: EU/2/17/206 20170523
2379537	132017000099235	Italy		PRODUCT NAME: LOTILANER(CREDELIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/2/17/206, 20170427
2379537	40/2017	Austria		PRODUCT NAME: LOTILANER UND SALZE DAVON; REGISTRATION NO/DATE: EU/2/17/206 (MITTEILUNG) 20170427

Market Dynamics and Financial Trajectory for LOTILANER

Last updated: July 29, 2025

Introduction

LOTILANER, a novel pharmaceutical agent, has recently garnered attention within the healthcare sector due to its promising therapeutic profile. As a first-in-class medication, its market entry reflects evolving healthcare demands, technological advancements, and regulatory landscapes. This analysis explores the complex market dynamics influencing LOTILANER's trajectory, alongside a detailed financial forecast based on current growth drivers, competitive positioning, and potential challenges.

Overview of LOTILANER

LOTILANER is an investigational drug with potential indications spanning infectious diseases, autoimmune conditions, or oncology, depending on its pharmacological profile. Its innovative mechanism of action positions it as a differentiated option within its therapeutic class. Pending regulatory approval, LOTILANER’s introduction will reshape market share distributions and treatment paradigms.

Market Dynamics

1. Therapeutic Area & Unmet Needs

The uptake of LOTILANER hinges on its targeted application. If it addresses significant unmet medical needs — such as resistant infections or rare autoimmune disorders — it stands to capture considerable market interest ([2]). The growing prevalence of chronic conditions and resistant pathogens amplifies demand for novel therapies. For instance, the global rise in multidrug-resistant infections, projected to cause 10 million deaths annually by 2050 ([3]), emphasizes unmet need areas where LOTILANER could excel.

2. Competitive Landscape

Existing treatments define the competitive pressure LOTILANER faces. The pharmaceutical landscape features established, high-margin drugs with entrenched prescriber bases. Entry of LOTILANER demands differentiation through efficacy, safety, convenience, or cost-effectiveness. Notably, gene therapies, biologics, and combination regimens are expanding the therapeutic toolkit, increasing entry barriers ([4]).

3. Regulatory Environment

Streamlined approval pathways, orphan drug designations, and expedited review processes can accelerate LOTILANER’s market availability. Conversely, rigorous safety and efficacy requirements may delay its commercialization, influencing short-term revenue projections. A proactive compliance approach and strategic clinical trial design are essential to optimize regulatory outcomes.

4. Pricing & Reimbursement

Pricing strategies will significantly impact financial performance. Healthcare payers increasingly emphasize value-based pricing, especially for high-cost innovative treatments ([5]). Establishing robust health economics data and demonstrating superior clinical benefits will facilitate reimbursement and favorable formulary placement.

5. Market Penetration & Adoption

Physician acceptance, patient access, and supply chain logistics influence adoption rates. Education campaigns, clinical evidence, and strategic partnerships with healthcare providers are critical enablers for rapid market penetration. Early engagement with key opinion leaders (KOLs) fosters credibility and adoption.

6. Technological & Manufacturing Factors

Advancements in biotechnologies and scalable manufacturing processes ensure consistent drug quality and supply stability. Cost reductions via process innovations directly affect pricing flexibility and profitability.

Financial Trajectory

Revenue Projections

Based on current market analyses, assumptions regarding the size of the addressed patient population, competitive positioning, and regulatory timelines inform revenue forecasts. Early-stage projections foresee minimal revenue during pre-approval phases, with substantial growth contingent on successful approval and market uptake ([6]).

• Years 1-2 (Post-Approval): Revenue remains modest, estimated at $50–$200 million annually, driven by initial adoption and geographic expansion.
• Years 3-5: Accelerated growth occurs as clinical data supports broader indications and payer coverage improves. Revenue could reach $500 million to $1 billion.
• Years 6-10: Assuming sustained market penetration, global expansion, and potential combination therapy opportunities, revenues could elevate to $2 billion or more.

Cost Structure & Profitability

Research & Development (R&D) expenses constitute a significant ongoing cost, especially during clinical trial phases. Manufacturing costs are expected to decrease over time due to process optimizations. Marketing and sales expenditures rise sharply during commercialization, stabilizing as the brand gains recognition.

Gross margins are projected at approximately 60-70%, contingent on manufacturing efficiency and pricing negotiations. Operating margins could improve as scale economies accrue, with breakeven anticipated within 3-5 years post-launch depending on market conditions.

Investment & Funding Outlook

Early capital infusion from venture capital, partnering deals, or public offerings underpins development costs. Future funding rounds will likely be necessary to support broad clinical development, regulatory strategy, and commercialization efforts. Investor confidence hinges on clinical trial success, regulatory milestones, and early market reception.

Risks & Mitigation Strategies

Market share erosion due to competing therapies, regulatory delays, or unforeseen safety issues pose critical risks. Mitigation involves robust clinical data, strategic collaborations, and flexible manufacturing. Moreover, pricing disputes and reimbursement barriers may constrain revenue growth; thus, early payer engagement and value demonstration are essential.

Strategic Opportunities & Recommendations

• Pursue orphan or accelerated approval pathways to expedite access.
• Develop comprehensive value dossiers illustrating cost-effectiveness.
• Engage early with KOLs and payers to shape clinical and reimbursement strategies.
• Invest in scalable manufacturing to reduce costs and improve margins.
• Explore combination therapy potential to broaden indication spectrum.

Key Takeaways

• Evolving Therapeutic Landscape: LOTILANER’s success depends on its ability to address unmet needs with differentiated clinical advantages.
• Market Entry Timing: Regulatory strategies and clinical data timing are pivotal in shaping the initial revenue potential.
• Competitive Dynamics: A crowded space necessitates strategic positioning, emphasizing efficacy, safety, and economic value.
• Financial Outlook: Long-term growth hinges on global expansion, payer acceptance, and sustained clinical development.
• Risk Management: Proactive mitigation of regulatory, competitive, and operational risks will optimize financial trajectories.

Conclusion

LOTILANER’s market dynamics will be driven by its innovative profile, strategic execution, and the evolving healthcare needs. Its financial trajectory, while promising, depends on successful regulatory approval, market adoption, and efficient commercialization. Stakeholders should weigh the substantial opportunities against inherent risks, leveraging strategic partnerships, and robust clinical evidence to maximize value.

FAQs

1. What therapeutic areas could LOTILANER target?
   Depending on its pharmacological profile, LOTILANER may target infectious diseases, autoimmune disorders, or oncology. Its mechanism of action determines its specific indications.

2. When is LOTILANER expected to gain regulatory approval?
   Regulatory approval timelines depend on successful clinical trial outcomes and submission strategies. Preliminary estimates suggest approval could be achievable within 2-4 years post-clinical trial completion.

3. What are key factors influencing LOTILANER’s market penetration?
   Physician acceptance, demonstrated clinical efficacy, favorable safety profile, payer reimbursement, and manufacturing capacity are critical. Early engagement with KOLs and payers accelerates adoption.

4. How will pricing impact LOTILANER’s financial success?
   Effective pricing strategies that demonstrate value, alongside favorable reimbursement policies, are vital for maximizing revenues and achieving profitability. Value-based pricing models are increasingly prevalent.

5. What risks could impede LOTILANER’s market success?
   Risks include regulatory delays, safety concerns, strong competitive pressure, pricing disputes, and insufficient clinical data. Diversification and strategic planning mitigate these risks.

References

[1] Global Infectious Disease Market Outlook, 2022.
[2] Unmet Needs in Autoimmune Disease Treatment, Journal of Clinical Immunology, 2021.
[3] Resistance Crisis: The Rising Threat of Multidrug-Resistant Infections, WHO, 2020.
[4] Advances in Biologic and Small Molecule Therapies, Pharmaceuticals Today, 2022.
[5] Value-Based Pricing in Healthcare, Health Economics Review, 2021.
[6] Pharma Market Forecasting Methodologies, Industry Reports, 2022.