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XDEMVY Drug Patent Profile

When do Xdemvy patents expire, and what generic alternatives are available?

Xdemvy is a drug marketed by Tarsus and is included in one NDA. There are six patents protecting this drug.

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

The generic ingredient in XDEMVY is lotilaner. One supplier is listed for this compound. Additional details are available on the lotilaner profile page.

DrugPatentWatch^® Generic Entry Outlook for Xdemvy

Xdemvy will be eligible for patent challenges on July 24, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 24, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XDEMVY

International Patents:	43
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for XDEMVY
What excipients (inactive ingredients) are in XDEMVY?	XDEMVY excipients list
DailyMed Link:	XDEMVY at DailyMed

See drug prices for XDEMVY

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

217603

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 XDEMVY

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

Sponsor	Phase
Tarsus Pharmaceuticals, Inc.	Phase 4

See all XDEMVY clinical trials

Pharmacology for XDEMVY

Drug Class

Ectoparasiticide

US Patents and Regulatory Information for XDEMVY

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

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Tarsus	XDEMVY	lotilaner	SOLUTION/DROPS;OPHTHALMIC	217603-001	Jul 24, 2023		RX	Yes	Yes	11,690,827
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	10,835,517

EU/EMA Drug Approvals for XDEMVY

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 XDEMVY

When does loss-of-exclusivity occur for XDEMVY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Denmark

European Patent Office

Hungary

Japan

Luxembourg

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

Russian Federation

South Africa

Spain

Taiwan

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 XDEMVY around the world.

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

Supplementary Protection Certificates for XDEMVY

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

XDEMVY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XDEMVY

Introduction to XDEMVY

XDEMVY, developed by Tarsus Pharmaceuticals, Inc., is a groundbreaking treatment for demodex blepharitis (DB) and meibomian gland disease (MGD). Since its launch, the drug has demonstrated remarkable market traction and financial performance.

Market Acceptance and Adoption

Growing Prescriber Base

The adoption of XDEMVY among Eye Care Professionals (ECPs) has been robust. As of the third quarter of 2024, more than 13,000 ECPs have started patients on XDEMVY, with over 70% of these ECPs prescribing the drug to multiple patients[2][3].

Increasing Depth of Prescribing

The depth of prescribing has also seen significant growth. A notable increase in the number of ECPs prescribing XDEMVY five or more times per week indicates a strong and deepening market penetration. This trend is further validated by market research showing that approximately 40% of ECPs are already prescribing XDEMVY across additional patient segments such as dry eye, cataracts, and contact lens users, with over 90% planning to increase utilization in these segments[1].

Sales Performance

Record Sales in Q3 2024

In the third quarter of 2024, Tarsus Pharmaceuticals reported a record $48.1 million in net product sales for XDEMVY, driven by the delivery of more than 41,400 bottles to patients. This represents an approximately 18% increase over the second quarter of 2024[1][2].

Quarterly and Year-to-Date Sales

The sales performance has been consistently strong:

• Q3 2024: $48.1 million in net product sales
• Q2 2024: $40.8 million in net product sales
• Q1 2024: $24.7 million in net product sales
• Year-to-date 2024: $113.7 million in net product sales, a significant increase from $1.7 million in the same period of 2023[2][5].

Financial Trajectory

Revenue Growth

The financial trajectory for XDEMVY is marked by rapid revenue growth. The product has generated substantial revenue since its launch, with a notable increase from $14.7 million in the fourth quarter of 2023 to $48.1 million in the third quarter of 2024[2][4].

Operating Expenses and Cash Reserves

Despite strong revenue, the company has incurred significant operating expenses. In the third quarter of 2024, operating expenses were approximately $73.3 million. However, Tarsus Pharmaceuticals maintains a robust cash reserve of $317 million, ensuring financial stability and the ability to invest in further growth initiatives[1][2].

Cost of Sales and Gross-to-Net Discount

The cost of sales has increased due to manufacturing costs, royalties, and the amortization of approval milestones. The gross-to-net discount was approximately 40% in Q3 2024, influenced by changes in Medicare accruals[2].

Reimbursement and Coverage

Extensive Payer Coverage

Tarsus Pharmaceuticals has secured broad commercial and Medicare reimbursement for XDEMVY, covering more than 80% of patient lives. This includes the two remaining large Medicare contracts, the benefits of which are expected to be realized starting in 2025[1][2].

Strategic Initiatives

Sales Force Expansion

The company has expanded its sales force from 100 to 150, which has contributed to higher prescribing rates among ECPs. This strategic move is expected to further increase the depth of prescribing and market penetration[1].

Direct-to-Consumer Campaigns

Tarsus launched a direct-to-consumer campaign, "Your Mitey Problem," aimed at encouraging more patients to visit their ECPs. This campaign, along with strategic shifts towards data dissemination, is part of the company's broader strategy to educate both physicians and patients about XDEMVY[1][3].

Future Outlook

Anticipated FDA Approvals

Tarsus Pharmaceuticals is anticipating FDA approval for two additional treatments by the end of 2024. Additionally, the company expects European approval for XDEMVY by the second half of 2027, without the need for a Phase 3 study[1].

Market Projections

The company projects a 20% capture rate over time, focusing on educating physicians and expanding market share. Despite seasonal headwinds, Tarsus expects to dispense up to 55,000 bottles of XDEMVY in Q4 2024, indicating continued confidence in the product's growth potential[1].

Key Takeaways

• Record Sales: $48.1 million in net product sales for XDEMVY in Q3 2024.
• Broad Adoption: Over 13,000 ECPs have prescribed XDEMVY, with more than 70% prescribing to multiple patients.
• Extensive Coverage: More than 80% of patient lives covered through commercial and Medicare contracts.
• Strong Financials: $317 million in cash reserves and $113.7 million in year-to-date net product sales.
• Future Growth: Anticipated FDA approvals for new treatments and European approval for XDEMVY.
• Strategic Initiatives: Expanded sales force and direct-to-consumer campaigns driving market penetration.

FAQs

What is XDEMVY used for?

XDEMVY is used for the treatment of demodex blepharitis (DB) and meibomian gland disease (MGD).

How many ECPs have prescribed XDEMVY as of Q3 2024?

More than 13,000 ECPs have started patients on XDEMVY as of Q3 2024.

What is the current reimbursement coverage for XDEMVY?

XDEMVY has secured broad commercial and Medicare reimbursement, covering more than 80% of patient lives.

What are the future regulatory milestones for XDEMVY?

Tarsus Pharmaceuticals anticipates FDA approval for two additional treatments by the end of 2024 and European approval for XDEMVY by the second half of 2027.

How has the sales force expansion impacted XDEMVY prescriptions?

The expansion of the sales force from 100 to 150 has led to a meaningful increase in the number of ECPs prescribing XDEMVY and the depth of prescribing.

Sources

1. Investing.com: "Earnings call: Tarsus reports record sales for XDEMVY in Q3 2024"
2. Tarsus Pharmaceuticals: "Tarsus Reports Third Quarter and Year-to-Date 2024 Financial Results and Recent Business Achievements"
3. Tarsus Pharmaceuticals: "Forward-Looking Statements"
4. Tarsus Pharmaceuticals: "Tarsus Reports Strong Fourth Quarter and Full-Year 2023 Financial Results"
5. Investing.com: "Tarsus Pharmaceuticals' SWOT analysis: stock surges on XDEMVY success"