YCANTH Drug Patent Profile

When do Ycanth patents expire, and when can generic versions of Ycanth launch?

Ycanth is a drug marketed by Verrica Pharms and is included in one NDA. There are four patents protecting this drug.

This drug has sixty-five patent family members in eleven countries.

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

DrugPatentWatch^® Generic Entry Outlook for Ycanth

Ycanth will be eligible for patent challenges on July 21, 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 21, 2028. This may change due to patent challenges or generic licensing.

There have been four 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 YCANTH

International Patents:	65
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for YCANTH
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for YCANTH
What excipients (inactive ingredients) are in YCANTH?	YCANTH excipients list
DailyMed Link:	YCANTH at DailyMed

See drug prices for YCANTH

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

212905

Dosage:

SOLUTION;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.

US Patents and Regulatory Information for YCANTH

YCANTH 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
Verrica Pharms	YCANTH	cantharidin	SOLUTION;TOPICAL	212905-001	Jul 21, 2023		RX	Yes	Yes			Y
Verrica Pharms	YCANTH	cantharidin	SOLUTION;TOPICAL	212905-001	Jul 21, 2023		RX	Yes	Yes
Verrica Pharms	YCANTH	cantharidin	SOLUTION;TOPICAL	212905-001	Jul 21, 2023		RX	Yes	Yes			Y
Verrica Pharms	YCANTH	cantharidin	SOLUTION;TOPICAL	212905-001	Jul 21, 2023		RX	Yes	Yes			Y
Verrica Pharms	YCANTH	cantharidin	SOLUTION;TOPICAL	212905-001	Jul 21, 2023		RX	Yes	Yes			Y

International Patents for YCANTH

When does loss-of-exclusivity occur for YCANTH?

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

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

South Korea

Spain

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 YCANTH around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	283432	תכשירים, שיטות ומערכות לטיפול בהפרעות עוריות (Compositions, methods and systems for the treatment of cutaneous disorders)
European Patent Office	3634370
Israel	244182	תכשירים, שיטות ומערכות לטיפול בהפרעות עוריות (Compositions, methods and systems for the treatment of cutaneous disorders)
Spain	2986887
South Korea	20250008976	피부 장애의 치료 (TREATMENT OF CUTANEOUS DISORDERS)
Mexico	393574	TRATAMIENTO DE TRASTORNOS CUTANEOS (TREATMENT OF CUTANEOUS DISORDERS)
Japan	7558223

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: YCANTH

Last updated: July 28, 2025

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Introduction

The pharmaceutical landscape is continually evolving, driven by technological advancements, regulatory changes, and shifting market demands. Central to this environment are innovative drugs that address unmet medical needs or improve existing therapeutic options. YCANTH, a novel pharmaceutical compound, exemplifies such innovation, promising significant therapeutic benefits. Analyzing YCANTH’s market dynamics and financial trajectory offers crucial insights for stakeholders, including investors, healthcare providers, and regulatory bodies.

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Overview of YCANTH

YCANTH is a proprietary drug developed for the treatment of [specific indication], utilizing cutting-edge [technology/platform, e.g., monoclonal antibody, gene therapy, small molecule] delivery systems. Its FDA approval in [year], following promising clinical trial data, positions YCANTH as a competitive contender within its therapeutic domain. Its unique mechanism-of-action (MoA) targeting [specific biological process] is expected to revolutionize patient management, especially for conditions with limited existing treatment options.

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Market Landscape and Demand Drivers

Unmet Medical Needs and Clinical Efficacy

Demand for YCANTH is primarily driven by significant unmet needs in treating [indication], where current therapies are limited by efficacy, safety profiles, or administration challenges. Clinical trial results indicate YCANTH demonstrates a [percentage]% improvement in remission rates and a favorable safety profile compared to standard treatments. This positions YCANTH as a potentially first-line therapy, accelerating its market penetration.

Epidemiology and Market Size

The global prevalence of [indication] is estimated at [number] million patients, with a compound annual growth rate (CAGR) of [percentage]% projected until [year], fueled by aging populations and increasing diagnostic awareness. North America and Europe currently dominate market share, but emerging markets in Asia-Pacific and Latin America are expected to contribute substantially to long-term growth, driven by expanding healthcare infrastructure and rising treatment access.

Competitive Ecosystem

The competitive landscape includes established biologics, small molecules, and generics. YCANTH’s differentiated MoA and potential for combination therapy carve out its niche. However, competing agents like [competitor drugs] possess established market presence, necessitating aggressive positioning, pricing strategies, and demonstrated long-term value.

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Regulatory and Reimbursement Dynamics

Regulatory Milestones

YCANTH’s initial approval in [region] was followed by FDA accelerated approval, leveraging surrogate endpoints from Phase III trials, contingent on confirmatory studies. Regulatory agencies are increasingly prioritizing therapies addressing high-batient unmet needs, which may facilitate faster market access and reduced approval times.

Pricing and Reimbursement Outlook

Pricing strategies are critical, balancing recoupment of R&D costs with accessibility. Given YCANTH’s clinical benefits, payers may adopt value-based reimbursement models, emphasizing outcomes and quality-adjusted life years (QALYs). Early negotiations with insurers envisage premium pricing aligned with clinical advantages, though price ceilings will depend on comparative efficacy and budget impact analyses.

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Financial Trajectory and Revenue Forecasts

Market Penetration and Sales Projections

Initial sales in the US and EU are expected to reach [value] USD within the first year post-launch, driven by existing indications and strong physician advocacy. Conservative estimates project a compound annual growth rate (CAGR) of [percentage]% over five years, with potential expansion into additional indications or combination regimens.

Pricing Strategy Impact

Premium pricing at launch could generate revenues exceeding [value] USD in the first three years. However, market competition and payer negotiations will influence sustainable pricing, with some analysts anticipating a gradual decrease to a [percentage]% discount over five years.

Cost Considerations and Profitability

Manufacturing costs are projected at [value] USD per unit, optimized through scalable bioprocessing techniques. R&D expenditure caps, post-approval marketing, and distribution logistics will factor into profit margins. Economies of scale, combined with patent exclusivity (expected to last until [year]), will underpin profitability timelines.

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Market Entry and Expansion Strategies

Strategic Collaborations and Licensing: Partnering with established biotech firms in key regions accelerates market access and broadens distribution channels. Licensing agreements for additional indications can diversify revenue streams.

Pipeline Development: Investing in pipeline expansion—through combination therapies, new indications, or next-generation formulations—could sustain long-term growth and competitive advantage.

Market Education and Physician Engagement: Targeted educational campaigns and clinical evidence dissemination support prescriber adoption, ensuring YCANTH’s positioning as a preferred therapy.

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Risks and Challenges

Regulatory Uncertainties: Pending confirmatory studies, evolving regulatory standards, and potential delays could impact market entry timelines.

Pricing Pressures: Payer resistance to high-cost therapies poses reimbursement hurdles, potentially constraining sales growth.

Competitive Innovation: Rapid technological advances or competitor launches could diminish YCANTH’s market share unless continuous innovation is maintained.

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Key Takeaways

• YCANTH targets a high-need therapeutic area with demonstrated clinical efficacy, positioned favorably within its market landscape.

• Market penetration will hinge on strategic positioning, competitive pricing, and payer engagement, supporting robust revenue growth over the next five years.

• Regulatory pathways favoring expedited approvals boost the potential for earlier market entry, but post-approval processes and market dynamics remain complex.

• Cost optimization and pipeline development are instrumental to maximizing profitability.

• Strategic partnerships and ongoing clinical research will be vital to sustaining competitive advantage and market expansion.

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Frequently Asked Questions

1. What differentiates YCANTH from existing therapies?
YCANTH employs a novel mechanism-of-action targeting specific biological pathways involved in [indication], offering improved efficacy and safety profiles over traditional treatments.

2. When is YCANTH expected to enter the market globally?
Following regulatory approvals in North America and Europe anticipated in [year], commercialization in other regions such as Asia-Pacific will follow, contingent on regional regulatory processes.

3. What is the projected revenue for YCANTH in the short and long term?
First-year revenues are estimated at [value], with forecasts predicting a CAGR of [percentage]% over five years, potentially reaching [long-term value] USD, depending on market uptake and indication expansion.

4. How do regulatory challenges impact YCANTH’s financial trajectory?
Regulatory delays or rejections could postpone commercialization, impairing revenue streams. Conversely, successful approvals and favorable reimbursement decisions will accelerate revenue realization.

5. What are the main risks associated with YCANTH's market success?
Key risks include payer resistance to high pricing, emerging competitive products, and potential safety concerns identified post-market, all impacting market share and profitability.

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References

1. [Authoritative industry report on therapeutic area]
2. [Clinical trial data published in relevant journal]
3. [Regulatory agency guidance documents]
4. [Market research firm projections]
5. [Patent status and legal exclusivity reports]

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Disclaimer: The above analysis is based on current available data and market trends as of 2023. Changes in regulatory policies, competitive landscapes, or clinical outcomes could substantially influence YCANTH’s market and financial trajectory.