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

Constraining patent/regulatory exclusivity:

10,603,293

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
American Association of Endodontists	Phase 4
University of Michigan	Phase 4

See all PLIAGLIS clinical trials

US Patents and Regulatory Information for PLIAGLIS

PLIAGLIS is protected by three US patents.

This potential generic entry date is based on patent 10,603,293.

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		DISCN	Yes	No	10,603,293		Y
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		DISCN	Yes	No	10,751,305		Y
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		DISCN	Yes	No	10,350,180		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	5,919,479
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006	6,528,086

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
China	1161087
European Patent Office	1244401	APPORT DE MEDICAMENTS DE PREPARATIONS A CHANGEMENT DE PHASE (DRUG DELIVERY OF PHASE CHANGING FORMULATION)
European Patent Office	0857047	Composition contentant un mélange éutectique de tetracaine et lidocaïne (Formulation comprising eutectic mixture of tetracaine and lidocaine)
Japan	2007126462	DRUG DELIVERY OF PHASE CHANGING FORMULATION
Japan	2006326337	CONTROLLED HEAT TO REGULATE TRANSDERMAL DELIVERY OF MEDICAL SUBSTANCE
Mexico	2012008168
World Intellectual Property Organization (WIPO)	03024383

Market Dynamics and Financial Trajectory for Pliaglis

Introduction

Pliaglis, a proprietary combination of 7% lidocaine and 7% tetracaine, is a topical local anesthetic developed by Crescita Therapeutics Inc. This article delves into the market dynamics and financial trajectory of Pliaglis, highlighting its growth potential, market segmentation, and the financial performance of Crescita Therapeutics.

Market Overview of Local Anesthesia Drugs

The global local anesthesia drugs market is significant and growing. As of 2022, the market was valued at USD 4.34 billion and is projected to reach USD 5.91 billion by 2031, growing at a CAGR of 3.5% during the forecast period of 2024-2031[4].

Key Drivers

• Increasing Surgical Procedures: The rise in outpatient surgeries and minimally invasive procedures drives the demand for local anesthesia drugs.
• Expanding Geriatric Population: An aging population increases the need for surgical interventions, thereby boosting the market.
• Technological Advancements: The development of novel formulations and drug delivery methods enhances market growth.
• Personalized Medicine: The trend towards personalized medicine has led to the creation of more targeted and effective local anesthetics[4].

Market Segmentation

The local anesthesia drugs market is segmented by product, application, and region.

Product Segmentation

• Lidocaine: Currently the largest segment, lidocaine is widely used due to its efficacy and safety profile.
• Bupivacaine: Expected to be the fastest-growing segment, bupivacaine is gaining traction due to its long-lasting effects[4].

Application Segmentation

• Injectable Anesthetics: Commonly used in surgical procedures.
• Surface Anesthetics: Used for topical applications, such as Pliaglis[4].

Regional Segmentation

• North America: Dominant region due to high prevalence of surgical procedures and well-established healthcare infrastructure.
• Asia-Pacific: Showcasing remarkable growth driven by rapid economic growth, increasing healthcare investments, and rising awareness about advanced medical treatments[4].

Pliaglis Market Dynamics

Licensing Agreements

Crescita Therapeutics has been successful in securing licensing agreements for Pliaglis in multiple countries. For instance, the company entered into an exclusive licensing agreement with STADA for the commercialization of Pliaglis in 15 countries, including those in the Middle East and North Africa (MENA) region. This agreement includes an upfront payment, defined pricing per unit, and regulatory support from Crescita[1].

Global Reach

As of 2021, Pliaglis has been licensed in 32 countries worldwide, with launches and sales expected to significantly impact Crescita's recurring revenue from 2024 onwards[1].

Commercial Partnerships

Crescita has partnered with various commercial partners such as Taro Pharmaceuticals in the U.S., Cantabria Labs in Spain, and Juyou in China. These partnerships have generated significant licensing revenues, including upfront payments and milestone payments[3].

Financial Trajectory of Crescita Therapeutics

Revenue Performance

• In the fiscal year 2023, Crescita reported a revenue of $17,522, down from $23,525 in the previous year, primarily due to lower Manufacturing segment revenue[2].
• The fourth quarter of 2023 saw a revenue of $4,725, down from $6,030 in the same quarter of 2022[2].

Gross Profit and Margin

• For the fiscal year 2023, the gross profit was $10,364, representing a gross margin of 59.1%, compared to $13,182 and 56.0% in the previous year. The decrease in gross profit was mainly due to lower Manufacturing segment revenue, but the gross margin improved due to a favorable product and channel mix[2].
• In the third quarter of 2020, the gross profit was $6,129, with a gross margin of 83.9%, driven by high-margin licensing revenue and lower costs associated with earning royalties on Pliaglis[5].

Operating Expenses and Adjusted EBITDA

• Operating expenses for the fiscal year 2023 were $12,320, down from $12,653 in the previous year. Adjusted EBITDA was $(368) compared to $2,221 in the previous year, reflecting a significant decline due to lower revenue and higher operating costs[2].

Cash Position and Debt

• As of the end of 2023, Crescita had a cash balance of $9,385, up from $8,238 in the previous year. The company has managed to improve its financial flexibility, including securing a $3.5 million revolving credit facility with the Royal Bank of Canada[2][3].

Strategic Outlook

Diversified Revenue Streams

Crescita aims to establish recurring revenue streams through licensing agreements, contract development and manufacturing services, and the commercialization of its own topical product formulations. The company's diversified asset portfolio, including patented transdermal technologies like MMPE™ and DuraPeel™, is expected to drive future growth[3].

Global Expansion

The strategic goal of expanding Pliaglis into new markets is crucial. With partnerships like the one with STADA, Crescita is well-positioned to leverage the global reach and resources of its commercial partners to increase the market penetration of Pliaglis[1].

Innovation and R&D

Investments in research and development, particularly in novel formulations and drug delivery methods, are key to maintaining a competitive edge in the local anesthesia market. Crescita's focus on innovation will be critical in addressing the evolving needs of the healthcare sector[3][4].

Key Takeaways

• Growing Market: The global local anesthesia drugs market is growing, driven by increasing surgical procedures and an expanding geriatric population.
• Licensing Agreements: Crescita has secured significant licensing agreements for Pliaglis, expanding its global reach.
• Financial Performance: Despite recent declines in revenue and adjusted EBITDA, Crescita's financial position remains stable, with a strong cash balance and reduced debt.
• Strategic Focus: The company is focused on diversifying revenue streams, expanding globally, and investing in R&D to drive future growth.

FAQs

What is Pliaglis?

Pliaglis is a topical local anesthetic developed by Crescita Therapeutics, consisting of a proprietary combination of 7% lidocaine and 7% tetracaine.

How is Pliaglis commercialized?

Pliaglis is commercialized through licensing agreements with various partners worldwide, including STADA in the MENA region, Taro Pharmaceuticals in the U.S., and Cantabria Labs in Spain.

What is the current market size of local anesthesia drugs?

The global local anesthesia drugs market was valued at USD 4.34 billion in 2022 and is expected to grow to USD 5.91 billion by 2031[4].

What are the key drivers of the local anesthesia drugs market?

Key drivers include increasing surgical procedures, an expanding geriatric population, technological advancements, and the trend towards personalized medicine[4].

How has Crescita Therapeutics' financial performance been in recent years?

Crescita Therapeutics reported a decline in revenue and adjusted EBITDA in fiscal year 2023, but maintained a strong cash balance and reduced debt. The company is focused on improving its financial performance through diversified revenue streams and strategic partnerships[2].

Sources

1. Business Wire: Crescita Therapeutics and STADA Enter 15-Country Exclusive Licensing Agreement for Pliaglis®.
2. Financial Post: Crescita Reports Q4 and Fiscal 2023 Results.
3. Annual Reports: 2020 Annual Report - Crescita Therapeutics Inc.
4. SkyQuest: Local Anesthesia Drugs Market Trends, Size, Share & Forecast | 2031.
5. Canada Newswire: Crescita Reports Third Quarter 2020 Results.