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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lotilaner has forty-three patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for LOTILANER

International Patents:	43
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	3
Patent Applications:	840
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

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			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
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

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/004247 For 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
Colombia	6341475	COMPUESTOS ORGÁNICOS
Israel	275339	פורמולציות קוטלות טפילים המכילות איזוקסאזולין ושיטות לטיפול בדלקת עפעפיים (Isoxazoline parasiticide formulations and methods for treating blepharitis)
Norway	2017048
South Africa	202004155	ISOXAZOLINE PARASITICIDE FORMULATIONS AND METHODS FOR TREATING BLEPHARITIS
Mexico	2011006568	COMPUESTOS ORGANICOS. (ISOXAZOLINE DERIVATIVES AND THEIR USE AS PESTICIDE.)
Canada	2747354	COMPOSES ORGANIQUES (ORGANIC COMPOUNDS)
New Zealand	766141	Isoxazoline parasiticide formulations and methods for treating blepharitis

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	LUC00030	Luxembourg		PRODUCT NAME: LOTILANER ET SES SELS; AUTHORISATION NUMBER AND DATE: EU/2/17/206 20170427
2379537	C201730034	Spain		PRODUCT NAME: LOTILANER Y SALES DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/2/17/206; DATE OF AUTHORISATION: 20170425; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/2/17/206; DATE OF FIRST AUTHORISATION IN EEA: 20170425
2379537	2017048	Norway		PRODUCT NAME: LOTILANER; REG. NO/DATE: EU/2/17/206 20170523
2379537	SPC/GB17/052	United Kingdom		PRODUCT NAME: LOTILANER AND SALTS THEREOF; REGISTERED: UK EU/2/17/206/001 (NI) 20170427; UK EU/2/17/206/002 (NI) 20170427; UK EU/2/17/206/003 (NI) 20170427; UK EU/2/17/206/004 (NI) 20170427; UK EU/2/17/206/005 (NI) 20170427; UK EU/2/17/206/006 (NI) 20170427; UK VM 52127/5008 (GB) 20170427; UK VM 52127/5009 (GB) 20170427; UK VM 52127/5010 (GB) 20170427; UK EU/2/17/206/013 (NI) 20170427; UK EU/2/17/206/014 (NI) 20170427; UK EU/2/17/206/015 (NI) 20170427; UK VM 52127/5004 (GB) 20170427; UK VM 52127/5006 (GB) 20170427; UK VM 52127/5007 (GB) 20170427; UK EU/2/17/206/007 (NI) 20170427; UK EU/2/17/206/008 (NI) 20170427; UK EU/2/17/206/009 (NI) 20170427; UK EU/2/17/206/010 (NI) 20170427; UK EU/2/17/
2379537	CR 2017 00034	Denmark		PRODUCT NAME: LOTILANER OG SALTE DERAF; REG. NO/DATE: EU/2/17/206/001-015 20170427
2379537	40/2017	Austria		PRODUCT NAME: LOTILANER UND SALZE DAVON; REGISTRATION NO/DATE: EU/2/17/206 (MITTEILUNG) 20170427

LOTILANER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Lotilaner

Introduction to Lotilaner

Lotilaner, a compound belonging to the isoxazoline class, has been gaining significant attention in the pharmaceutical and veterinary industries. It is primarily used in the treatment of parasitic infections in pets, such as fleas, ticks, and mites, and is also being explored for its potential in human ophthalmology.

Market Size and Growth

The global isoxazoline drugs market, which includes lotilaner, is projected to experience substantial growth. As of 2023, the global market size was valued at USD 4,648.68 million and is expected to grow to USD 18,283.71 million by 2032, with a CAGR of 14.6% during the forecast period[4].

In the U.S. specifically, the isoxazoline market, driven by lotilaner and other isoxazolines, is anticipated to expand significantly. The market was valued at approximately $847 million in 2019 and is expected to exceed $3.6 billion by 2030, growing at a CAGR of around 14% from 2020 to 2030[1].

Key Drivers of Growth

Several factors are driving the growth of the lotilaner market:

• Increasing Pet Ownership: The rise in pet ownership, particularly in regions like North America and Asia-Pacific, is a significant driver. Nearly 45% of households in the U.S. own at least one dog, contributing to the high adoption rate of isoxazoline drugs for pets[4].
• Clinical Trials and Approvals: Lotilaner is being tested for various indications, including its efficacy against adult cat fleas and its use in treating generalized demodicosis in dogs. The FDA approval of lotilaner-based products, such as XDEMVY for Demodex blepharitis, has opened up new market avenues[1][3].
• Awareness and Precautionary Measures: The COVID-19 pandemic has heightened awareness about standard precautionary measures, leading to increased demand for antiparasitic treatments, including those containing lotilaner[1].

Product Formulations and Innovations

Companies are innovating in the formulation of lotilaner to enhance its efficacy and reduce adverse events. Key developments include:

• Chewables and Spot-On Formulations: These formulations are being experimented with to treat conditions like generalized demodicosis in dogs, offering more convenient and effective treatment options[1].
• Non-Toxic Alternatives: To address concerns about adverse events such as muscle tremors and seizures, manufacturers are exploring non-toxic alternatives like flea shampoos and combs[1].

Financial Performance of Key Players

Tarsus Pharmaceuticals, a biotechnology company leveraging lotilaner, provides a significant case study:

• Revenue Growth: Tarsus reported strong product sales driven by XDEMVY, with $113.7 million in year-to-date 2024 sales, a substantial increase from $1.7 million in the same period in 2023. This growth is attributed to the delivery of over 104,400 bottles of XDEMVY to patients[5].
• Cost of Sales and R&D Expenses: Despite the revenue growth, Tarsus has incurred significant costs, including manufacturing costs, royalties, and R&D expenses. The cost of sales was $7.9 million for the year-to-date 2024 period, and R&D expenses remained consistent at around $12.1 million[5].
• Net Loss and Funding: Tarsus has reported net losses, with a net loss of $135.9 million for the full year 2023. However, the company has secured funding through equity offerings and has enough liquidity to maintain operations for at least 12 months[2][5].

Market Segmentation and Target Markets

The isoxazoline drugs market, including lotilaner, is segmented based on product type and pet type:

• Product Type: Lotilaner, along with other isoxazolines like fluralaner, sarolaner, and afoxolaner, constitutes the market. Afoxolaner held the largest market share in 2021[4].
• Pet Type: The market is primarily driven by the treatment of dogs, which acquired the majority of the market share in 2021 and is expected to grow at a CAGR of 18.11% during the forecast period[4].

Geographical Markets

• North America: This region has the largest share of the isoxazoline drugs market and is expected to grow at a CAGR of 16.8% during the forecast period. The high adoption rate and numerous drug approvals contribute to this growth[4].
• Asia-Pacific: This region is anticipated to hold the highest market share in the future, driven by growing awareness of pet care in countries like India and China. The Indian animal healthcare market, for instance, presents significant opportunities for isoxazoline manufacturers[4].

Challenges and Opportunities

While the market for lotilaner is promising, there are challenges to be addressed:

• Adverse Events: Lotilaner medications have been linked with adverse events such as muscle tremors and seizures in pets. Companies need to invest in novel drug formulations to mitigate these issues[1].
• Competition from Alternatives: Off-label and over-the-counter products, although not rigorously tested, could compete with lotilaner-based products due to their lower price points[3].

Future Outlook

The future outlook for lotilaner is optimistic, driven by its potential in both veterinary and human ophthalmology:

• Blockbuster Potential: XDEMVY, a lotilaner-based product, has the potential to become a blockbuster drug with over $1 billion in annual sales, especially if it captures a significant portion of the Demodex blepharitis market[3].
• Expansion of Clinical Indications: Ongoing trials for other indications such as meibomian gland disease, Rosacea, and Lyme disease could further expand the market for lotilaner[3].

Key Takeaways

• Market Growth: The isoxazoline market, driven by lotilaner, is expected to grow significantly, with a projected market size exceeding $3.6 billion by 2030.
• Innovations: Companies are innovating in formulations to enhance efficacy and reduce adverse events.
• Financial Performance: Tarsus Pharmaceuticals, a key player, has shown strong revenue growth but faces financial challenges.
• Geographical Markets: North America and Asia-Pacific are key regions driving the market growth.
• Challenges and Opportunities: Addressing adverse events and competing with cheaper alternatives are critical challenges.

Frequently Asked Questions

Q: What is the current market size of the isoxazoline drugs market? A: The global isoxazoline drugs market was valued at USD 4,648.68 million in 2023[4].

Q: What is the projected growth rate of the isoxazoline market in the U.S.? A: The U.S. isoxazoline market is expected to grow at a CAGR of around 14% from 2020 to 2030[1].

Q: Which company is leveraging lotilaner for ophthalmology treatments? A: Tarsus Pharmaceuticals is leveraging lotilaner to develop therapies targeting eye diseases like Demodex blepharitis and dry eye disease[3].

Q: What are the main challenges associated with lotilaner medications? A: Lotilaner medications have been linked with adverse events such as muscle tremors and seizures in pets, necessitating the development of novel, safer formulations[1].

Q: What is the potential annual revenue from XDEMVY for Demodex blepharitis? A: XDEMVY has the potential to capture a significant portion of the market, with estimated annual revenues exceeding $1 billion if it achieves substantial market capture[3].

Cited Sources

1. Transparency Market Research - Isoxazoline Market | U.S. Industry Report, 2030
2. Stock Titan - Tarsus Reports Strong Fourth Quarter and Full-Year 2023 Financial
3. Seeking Alpha - Xdemvy: Tarsus' Leading Asset In A Multi-Billion Market Landscape
4. Straits Research - Isoxazoline Drugs Market Size, Demand, Scope, Forecast to 2032
5. Stock Titan - Tarsus Reports Third Quarter and Year-to-Date 2024 Financial Results