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. One supplier is listed 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
Finished Product Suppliers / Packagers:	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

Pharmacology for PLIAGLIS

Drug Class	Amide Local Anesthetic Antiarrhythmic Ester Local Anesthetic
Physiological Effect	Local Anesthesia

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	2004321819	METHOD AND APPARATUS FOR IMPROVED ADMINISTRATION OF PHARMACEUTICALLY ACTIVE COMPOUNDS
Canada	2408585	APPAREIL ET PROCEDES AMELIORANT L'ADMINISTRATION CUTANEE NONINVASIVE DE PRODUITS PHARMACEUTIQUES (APPARATUS AND METHODS FOR IMPROVED NONINVASIVE DERMAL ADMINISTRATION OF PHARMACEUTICALS)
Japan	2006326337	CONTROLLED HEAT TO REGULATE TRANSDERMAL DELIVERY OF MEDICAL SUBSTANCE

PLIAGLIS: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

PLIAGLIS, a topical formulation of lidocaine and tetracaine, is a prescription-strength anesthetic cream used for topical local anesthesia. It is primarily indicated for superficial dermatological procedures and intravenous catheter insertion. This analysis examines PLIAGLIS's market position, competitive landscape, and projected financial trajectory based on patent status, regulatory approvals, and market penetration.

What is the Current Market Position of PLIAGLIS?

PLIAGLIS occupies a niche within the topical anesthetic market, targeting specific procedural applications. Its primary competitive advantage lies in its dual-component formulation, which allows for a deeper and longer-lasting anesthetic effect compared to single-agent lidocaine products.

Key Market Segments:

• Dermatological Procedures: This segment includes minor surgical excisions, biopsies, and laser treatments.
• Intravenous (IV) Catheter Insertion: PLIAGLIS is utilized in emergency rooms, outpatient clinics, and for patients with difficult venous access.
• Other Minor Procedures: This encompasses wound debridement and suture removal.

Market Share and Sales Performance:

Data regarding PLIAGLIS's precise market share is proprietary to its manufacturer, Galderma. However, industry reports indicate a steady demand within its target segments. Sales figures for topical anesthetics are often aggregated, making specific product performance difficult to isolate without direct company disclosures. The global market for topical anesthetics is projected to grow due to an aging population, increasing prevalence of dermatological conditions, and rising demand for aesthetic procedures.

Regulatory Status:

PLIAGLIS is approved by the U.S. Food and Drug Administration (FDA) and other regulatory bodies globally for its indicated uses. Its approval was based on clinical trials demonstrating efficacy and safety for topical local anesthesia.

Who are PLIAGLIS's Key Competitors?

The topical anesthetic market is competitive, with both branded and generic products. PLIAGLIS faces competition from single-agent lidocaine formulations, combination products, and alternative anesthetic modalities.

Direct Competitors (Topical Formulations):

• EMLA (lidocaine/prilocaine cream): This is a widely recognized and historically dominant topical anesthetic cream. EMLA is available as a prescription product and has a strong established market presence. It is often used for similar indications, including IV insertion and minor dermatological procedures.
• Generic Lidocaine Creams: Numerous generic versions of lidocaine cream (typically 4% or 5%) are available. These products offer a lower cost alternative, particularly for healthcare providers focused on cost containment.
• Other Combination Topical Anesthetics: While EMLA is the most prominent, other less common combination topical anesthetics may exist depending on regional markets.

Indirect Competitors (Alternative Anesthetic Methods):

• Injectable Local Anesthetics: For deeper or more extensive procedures, injectable lidocaine, bupivacaine, or other local anesthetics are the standard. These are not direct topical competitors but represent an alternative for managing pain.
• Cryotherapy: For certain minor procedures, cold application can provide a degree of local anesthesia.
• Regional Anesthesia Techniques: For more involved procedures, regional nerve blocks are employed.

Competitive Landscape Analysis:

The competitive advantage of PLIAGLIS relies on its specific formulation and demonstrated efficacy in target procedures. While EMLA is a direct competitor with a longer market history, PLIAGLIS offers a distinct pharmacokinetic profile and may be preferred in specific clinical scenarios. The proliferation of generic lidocaine products presents a significant pricing challenge, as cost-effectiveness is a major driver for many healthcare purchasing decisions. Physician preference, ease of application, and patient tolerance also play crucial roles in product selection.

What is the Patent Landscape for PLIAGLIS?

The patent landscape for PLIAGLIS is critical to its market exclusivity and future financial performance. Understanding patent expiry dates and potential for generic entry is essential for forecasting.

Key Patents and Expiry:

Information on specific patent numbers and their exact expiry dates for PLIAGLIS is typically detailed in regulatory filings and patent databases. Based on general timelines for pharmaceutical product development and patent protection, the core composition of matter patents for such formulations would have been filed in the early stages of development.

• Composition of Matter Patents: These are typically the strongest patents, protecting the active ingredients and their specific combination or formulation. These patents generally have a lifespan of 20 years from the filing date, subject to patent term extensions.
• Formulation Patents: These patents protect specific ways the drug is formulated (e.g., cream, gel, specific excipients, concentrations).
• Method of Use Patents: These patents protect specific therapeutic uses of the drug.

Projected Patent Expiry and Generic Entry:

While precise expiry dates are not publicly disclosed here, it is understood that many foundational patents for established topical anesthetic formulations have expired or are nearing expiry. For PLIAGLIS, the expiry of its key composition of matter and formulation patents would open the door for generic manufacturers to produce bioequivalent versions of the drug.

Impact of Generic Competition:

The entry of generic competition typically leads to:

1. Price Erosion: Generic products are usually priced significantly lower than branded counterparts, often by 50% or more.
2. Market Share Shift: Healthcare providers and payers often switch to or favor generic options due to cost savings, leading to a decline in the branded product's market share.
3. Reduced Revenue for Branded Product: The manufacturer of the branded product experiences a substantial drop in revenue.

The timing and impact of generic entry for PLIAGLIS will depend on the specific patent expiry dates, the strength of any remaining secondary patents (e.g., method of use), and the regulatory pathways for generic approval.

What is the Projected Financial Trajectory of PLIAGLIS?

The financial trajectory of PLIAGLIS is influenced by its patent status, competitive pressures, market demand, and the manufacturer's commercial strategies.

Revenue Drivers:

• Procedural Volume: The number of dermatological procedures and IV insertions performed globally directly correlates with demand for PLIAGLIS.
• Pricing Power: The ability to maintain premium pricing is linked to patent exclusivity and perceived clinical superiority over alternatives.
• Market Penetration: Expansion into new geographic markets and broader adoption within existing markets can drive revenue.

Cost Factors:

• Manufacturing Costs: Production expenses for the active pharmaceutical ingredients and formulation.
• Marketing and Sales Expenses: Costs associated with promoting the product to healthcare professionals.
• Regulatory Compliance: Ongoing costs for maintaining regulatory approvals.
• Research and Development: Investment in potential new indications or improved formulations.

Projected Financial Performance:

• Pre-Patent Expiry: During the period of patent exclusivity, PLIAGLIS is expected to generate consistent revenue, driven by its established market presence and relatively unhindered pricing power. Growth in this phase would be contingent on increasing procedural volumes and market penetration.
• Post-Patent Expiry: Upon the expiry of key patents and the subsequent entry of generic competitors, PLIAGLIS will likely experience a significant decline in revenue. The rate of this decline will depend on the speed and aggressiveness of generic competition.
• Continued Revenue (Post-Generic Entry): While revenue will decrease, the branded product may continue to generate some revenue. This can be attributed to physician loyalty, specific payer contracts, or unique formulation benefits that generics may not fully replicate or may face challenges in obtaining approval for. Galderma may also pursue strategies such as marketing authorized generics or developing new formulations to mitigate the impact.

Market Growth Factors:

• Aging Population: Increased prevalence of skin conditions and elective dermatological procedures.
• Advancements in Aesthetics: Growing demand for non-surgical cosmetic procedures, many of which require local anesthesia.
• Healthcare Access: Expanding healthcare infrastructure in emerging markets.

Market Challenges:

• Cost Containment: Increasing pressure from payers and healthcare systems to reduce costs.
• Generic Competition: The inevitable impact of lower-cost generic alternatives.
• Physician Preference Shifts: Changes in prescribing habits based on new research or product availability.

Financial Projections:

Without specific sales data and detailed patent expiry timelines, precise financial projections are speculative. However, a typical pattern for a branded pharmaceutical product like PLIAGLIS involves a growth phase, a period of peak sales under patent protection, followed by a sharp decline upon generic entry. The longevity of revenue post-generic entry is highly variable and depends on the company's lifecycle management strategies.

Key Takeaways

PLIAGLIS is a topical anesthetic with a defined market position in dermatological procedures and IV insertion. Its financial trajectory is intrinsically linked to its patent exclusivity. The anticipated expiry of key patents will introduce generic competition, leading to significant price erosion and market share shifts, necessitating strategic adaptation by the manufacturer.

Frequently Asked Questions

1. What is the primary mechanism of action for PLIAGLIS? PLIAGLIS contains lidocaine and tetracaine, which act as sodium channel blockers in the neuronal cell membrane of peripheral nerves. This blockage prevents the initiation and conduction of nerve impulses, resulting in topical local anesthesia.

2. When is PLIAGLIS expected to face significant generic competition? The exact timing depends on specific patent expiry dates, which are not publicly detailed here. However, based on typical pharmaceutical patent lifecycles, significant generic competition for established topical anesthetic formulations can emerge within the next 3-7 years, assuming no further patent extensions or extensions of market exclusivity.

3. What are the main advantages of PLIAGLIS over single-agent lidocaine creams? PLIAGLIS's advantage lies in its dual-agent formulation, which provides a more profound and longer-lasting anesthetic effect. The combination of lidocaine and tetracaine can achieve a deeper level of skin penetration and sensory nerve blockade compared to lidocaine alone.

4. How does the regulatory approval process for generic PLIAGLIS differ from the original product? Generic drug applications (Abbreviated New Drug Applications or ANDAs) in the U.S. aim to demonstrate bioequivalence to the reference listed drug. This means showing that the generic product has the same active ingredient, dosage form, strength, and route of administration, and that it performs in the same way as the branded drug when administered under similar conditions. It does not require a full set of new clinical trials to establish safety and efficacy.

5. What strategies can a manufacturer employ to mitigate revenue loss after PLIAGLIS faces generic competition? Manufacturers can pursue several strategies, including developing authorized generics, investing in new drug delivery systems or improved formulations with extended patent protection, pursuing new indications for the drug, engaging in aggressive marketing of the branded product based on established trust and specific benefits, or focusing on lifecycle management for other products in their portfolio.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA Orange Book database] (Access date varies by search). [2] World Health Organization. (n.d.). Anatomical Therapeutic Chemical (ATC) Classification System. Retrieved from [WHO ATC index] (Access date varies by search). [3] Pharmaceutical Research and Manufacturers of America (PhRMA). (n.d.). Understanding the Drug Development Process. Retrieved from [PhRMA website] (Access date varies by search). [4] Various market research reports on the global topical anesthetic market (e.g., reports from Mordor Intelligence, Grand View Research, Allied Market Research). Specific report citations are proprietary and not publicly accessible for inclusion.