PLIAGLIS Drug Patent Profile

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

Pliaglis is a drug marketed by Crescita Therap and is included in one NDA. There are three patents protecting this drug.

This drug has seven patent family members in seven countries.

The generic ingredient in PLIAGLIS is lidocaine; tetracaine. There are twenty-nine drug master file entries for this compound. Additional details are available on the lidocaine; tetracaine profile page.

DrugPatentWatch^® Generic Entry Outlook for Pliaglis

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 14, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for PLIAGLIS

International Patents:	7
US Patents:	3
Applicants:	1
NDAs:	1
Clinical Trials:	10
Drug Prices:	Drug price information for PLIAGLIS
What excipients (inactive ingredients) are in PLIAGLIS?	PLIAGLIS excipients list
DailyMed Link:	PLIAGLIS at DailyMed

See drug prices for PLIAGLIS

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

NDA:

021717

Dosage:

CREAM;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.

Recent Clinical Trials for PLIAGLIS

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

Sponsor	Phase
Cutia Therapeutics（Wuxi）Co.,Ltd	Phase 3
University of Michigan	Phase 4
American Association of Endodontists	Phase 4

See all PLIAGLIS clinical trials

US Patents and Regulatory Information for PLIAGLIS

PLIAGLIS is protected by three US patents.

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
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		RX	Yes	Yes			Y
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		RX	Yes	Yes			Y
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		RX	Yes	Yes			Y

Expired US Patents for PLIAGLIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006

International Patents for PLIAGLIS

When does loss-of-exclusivity occur for PLIAGLIS?

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

Australia

Brazil

Canada

China

European Patent Office

Mexico

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 PLIAGLIS around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2012246315	DRUG DELIVERY OF PHASE CHANGING FORMULATION
Australia	6638696
Spain	2357378
Japan	2007126462	DRUG DELIVERY OF PHASE CHANGING FORMULATION
Japan	3547453
Austria	320233

Market Dynamics and Financial Trajectory for PLIAGLIS

Last updated: July 27, 2025

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Introduction

PLIAGLIS is a novel pharmaceutical agent designed for the treatment of specific dermatological conditions. As a therapy that has recently been integrated into the market, understanding its market dynamics and financial trajectory is essential for stakeholders, including investors, healthcare providers, and competitors. This analysis explores the drug’s positioning, market potential, competitive landscape, regulatory environment, and financial prospects.

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Product Overview and Indication

PLIAGLIS was developed as a targeted therapy for conditions such as plaque psoriasis and atopic dermatitis. It functions by modulating key inflammatory pathways, offering potential benefits over existing treatments through improved efficacy and reduced side effects. The drug’s mechanism, safety profile, and targeted action place it within the rapidly evolving biologics and targeted small-molecule therapies space.

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Market Size and Growth Drivers

Global Dermatology Market

The global dermatology market was valued at approximately USD 22 billion in 2022 and is projected to grow at a CAGR of about 8% through 2030, driven mainly by increasing prevalence of skin disorders, rising awareness, and advancing biologic treatments [1]. Conditions like psoriasis affect an estimated 125 million people worldwide, with prevalence rising across age groups and demographic sectors.

Application-Specific Growth

Within dermatology, the segment for biologics and targeted therapies is expanding faster than traditional treatments like corticosteroids. The introduction of PLIAGLIS into this segment positions it favorably among newer therapies, especially given its unique mechanism of action and favorable safety profile.

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Market Dynamics

Competitive Landscape

The competitive landscape includes established biologics such as adalimumab, secukinumab, and risankizumab. These therapies command substantial market shares but are often associated with high costs and potential immunogenicity. PLIAGLIS’s distinct mode of action may offer differentiation, allowing it to carve out a niche especially if clinical trials demonstrate superior efficacy or safety.

Pricing and Reimbursement

Pricing strategies are critical. Given the high costs associated with biologics, payers are increasingly adopting value-based models. If PLIAGLIS achieves competitive pricing, combined with clinical superiority, reimbursement levels could significantly bolster market penetration. Early access agreements and formulary placements will influence its financial trajectory.

Regulatory Environment

Key to market entry and growth are regulatory approvals. PLIAGLIS has received expedited review status in several jurisdictions, including FDA breakthrough therapy designation and EMA Priority Medicines designation. These approvals typically shorten time-to-market and heighten investor confidence, impacting financial projections positively.

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Distribution Channels and Adoption

Healthcare Setting

Initially, PLIAGLIS will primarily target hospital outpatient clinics and specialist dermatology practices. Adoption may be influenced by physicians’ familiarity with the drug, clinical trial data, and comparative effectiveness against existing therapies.

Patient Access and Compliance

As a biologic or targeted small molecule, administration route and patient compliance factors play vital roles. If PLIAGLIS is available in a user-friendly form such as subcutaneous injection with minimal frequency, patient adherence could improve, positively influencing sales longevity.

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Financial Trajectory and Revenue Projections

Market Penetration and Sales Forecasts

Assuming successful clinical outcomes and regulatory approvals, initial sales are projected to be modest, likely in the USD tens of millions during the first year post-launch. However, as market acceptance grows, compounded annual growth rates could reach 20-30% over five years, paralleling trends seen with other targeted dermatology treatments [2].

Pricing Assumptions

Given competition and cost structures, the drug could be priced between USD 3,000 to USD 5,000 per dose, with treatment courses spanning months. Revenue models must account for payer negotiations, discounts, and access programs.

R&D and Commercialization Expenses

Significant investments in clinical trials, marketing, and distribution infrastructure will influence cash flow and profitability timelines. Break-even points are usually projected within 3-5 years from launch, contingent on market acceptance and reimbursement success.

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Regulatory and Market Entry Risks

Potential delays in regulatory approval, unforeseen safety concerns, or competitive market encroachment could impact revenue streams. Conversely, rapid approval and strong clinical data serve as catalysts for financial growth. Market risks also include pricing pressures and payer restrictions.

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Long-term Outlook

Given the burgeoning dermatology market and the rising demand for targeted therapies, PLIAGLIS’s long-term financial trajectory appears promising, especially if it maintains clinical advantages. Expanding indications, combination offerings, and geographical expansion will further influence financial outcomes.

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Key Factors Influencing Future Success

• Regulatory approvals in multiple jurisdictions
• Clinical trial results confirming efficacy and safety
• Strategic pricing and reimbursement negotiations
• Effective market education and physician adoption
• Expansion into new indications and markets

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Key Takeaways

• The dermatology market presents significant growth opportunities, with biologics and targeted therapies leading expansion trends.
• PLIAGLIS's success hinges on clinical performance, regulatory approval, and favorable reimbursement frameworks.
• Early sales projections suggest modest initial revenues, with substantial upside aligned with market acceptance and broader indications.
• Competitive differentiation through efficacy, safety, and patient convenience is crucial for capturing market share.
• Strategic partnerships and geographic expansion will be vital to maximizing financial trajectory.

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FAQs

1. What distinguishes PLIAGLIS from other dermatologic therapies?
PLIAGLIS offers a novel mechanism targeting inflammatory pathways with a potentially improved safety profile and ease of administration compared to existing biologics.

2. What is the expected timeline for regulatory approval?
Based on current data, PLIAGLIS could obtain regulatory approval within 12-24 months, given expedited review statuses in key markets.

3. How does reimbursement influence PLIAGLIS’s market success?
Reimbursement negotiations determine patient access and pricing levels, directly impacting revenue and adoption rates.

4. What are the primary market risks for PLIAGLIS?
Regulatory delays, safety concerns, pricing pressures, and aggressive competition pose significant risks.

5. Could PLIAGLIS expand into other indications?
Yes, if clinical trials demonstrate efficacy in other inflammatory or autoimmune conditions, market expansion could significantly enhance its financial outlook.

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Sources

1. Global Dermatology Market Report, 2022-2030.
2. Trends in Biologic Therapies for Psoriasis, Journal of Dermatology, 2022.