EMLA Drug Patent Profile

Which patents cover Emla, and what generic alternatives are available?

Emla is a drug marketed by Teva Branded Pharm and Astrazeneca and is included in two NDAs.

The generic ingredient in EMLA is lidocaine; prilocaine. There are twenty-nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the lidocaine; prilocaine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Emla

A generic version of EMLA was approved as lidocaine; prilocaine by FOUGERA PHARMS on August 18^th, 2003.

Summary for EMLA

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Patent Applications:	100
DailyMed Link:	EMLA at DailyMed

US Patents and Regulatory Information for EMLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	EMLA	lidocaine; prilocaine	CREAM;TOPICAL	019941-001	Dec 30, 1992		DISCN	Yes	No
Astrazeneca	EMLA	lidocaine; prilocaine	DISC;TOPICAL	020962-001	Feb 4, 1998		DISCN	No	No

Expired US Patents for EMLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	EMLA	lidocaine; prilocaine	CREAM;TOPICAL	019941-001	Dec 30, 1992
Teva Branded Pharm	EMLA	lidocaine; prilocaine	CREAM;TOPICAL	019941-001	Dec 30, 1992

EU/EMA Drug Approvals for EMLA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Recordati Ireland Ltd.	Fortacin	lidocaine, prilocaine	EMEA/H/C/002693 Treatment of primary premature ejaculation in adult men.	Authorised	no	no	no	2013-11-15
Plethora Pharma Solutions Limited	Senstend	lidocaine, prilocaine	EMEA/H/C/005298 Senstend is indicated for the treatment of primary premature ejaculation in adult men.	Withdrawn	no	no	no	2019-11-14

International Patents for EMLA

See the table below for patents covering EMLA around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	154187
Australia	4196078
Germany	2861326
New Zealand	189026	TOPICAL LOCAL ANAESTHETIC COMPOSITIONS
United Kingdom	2008946	EMULSION CREAM COMPOSITION PROCESS FOR ITS PREPARATION ANDMETHOD OF OBTAINING LOCAL ANESTHESIA
European Patent Office	0002425	LOCAL ANESTHETIC MIXTURE FOR TOPICAL APPLICATION, AND PROCESS FOR ITS PREPARATION
Japan	S54101414	LOCAL ANAESTHETICS MIXTURE

EMLA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EMLA Cream

Introduction to EMLA Cream

EMLA cream, a topical anesthetic containing a mixture of lidocaine and prilocaine, is widely used to numb the skin before various medical procedures, such as injections, biopsies, and minor surgeries. This cream is a key player in the local anesthesia drugs market, which is experiencing significant growth driven by several factors.

Global Local Anesthesia Drugs Market Overview

The global local anesthesia drugs market, which includes EMLA cream, was valued at USD 4.01 billion in 2023 and is projected to grow at a CAGR of 3.6% from 2024 to 2030[1]. By 2031, the market is expected to reach USD 4.7 billion, growing at a CAGR of 6.4% from 2022 to 2031[4].

Key Drivers of Market Growth

Increasing Geriatric Population

The rise in the geriatric population is a significant driver for the local anesthesia drugs market. This demographic is more prone to chronic diseases and surgeries, thereby increasing the demand for local anesthetics like EMLA cream[1].

Rise in Surgical Procedures

An increase in surgical procedures, including cosmetic surgeries, plastic surgeries, and dental procedures, is further driving the market growth. These procedures often require the use of local anesthetics to ensure patient comfort during the procedure[1][4].

Improved Access to Healthcare

Regions like North America, which dominate the market with a 35.4% share in 2023, benefit from improved access to healthcare facilities, rapid advancements in the healthcare sector, and high per capita income. These factors contribute to the increased use of local anesthesia drugs, including EMLA cream[1][4].

Regional Market Dynamics

North America

North America is the leading region in the local anesthesia drugs market, driven by the high prevalence of chronic diseases, a growing geriatric population, and advanced healthcare infrastructure. For instance, more than 53% of the geriatric population in this region has periodontitis disorders, which increases the demand for local anesthetics in dental procedures[1].

Middle East and Africa (MEA)

The MEA region, although holding a low market share, is anticipated to witness significant growth due to growing public awareness, urbanization, and lifestyle changes that lead to an increase in chronic diseases. This region presents a promising market for local anesthesia drugs, including EMLA cream[1].

Impact of COVID-19

The COVID-19 pandemic had a moderate impact on the local anesthesia drugs market. Despite initial disruptions due to social distancing and business closures, the need to address the increasing demand for essential healthcare services and to enhance healthcare system capacity led to a moderate increase in market demand during the pandemic[4].

Financial Trajectory and Market Strategies

Mergers and Acquisitions (M&A)

The pharmaceutical industry, including companies involved in local anesthesia drugs, is experiencing a frenzy of M&A activity. This trend is driven by the need to replace revenues from expiring patents and to drive growth. Companies like Johnson & Johnson, Pfizer, AstraZeneca, and Novartis are actively engaging in M&A, collaborations, and new product launches to grow their market revenue[1][3].

Financing and Debt Issuance

Pharma companies, including those in the local anesthesia segment, are leveraging debt markets heavily for acquisition financing. The robust debt issuance is a result of the high level of M&A activity in the industry. Equity issuance, however, remains modest as pharma companies generally do not need significant equity financing due to their strong earnings and cash flows[3].

Key Market Players

Companies such as Pacira Pharmaceuticals, Mylan N.V., Aspen Holdings, Septodont Healthcare India Pvt. Ltd., Teva Pharmaceutical Industries Ltd., Fresenius Kabi AG, Pfizer Inc., Sagent Pharmaceuticals, Baxter International Inc., and Novartis AG are key players in the local anesthesia drugs market. These companies are focusing on strategic partnerships, new product launches, and geographical expansions to maintain their market positions[4].

Clinical and Economic Evidence

Studies have demonstrated the efficacy of EMLA cream in reducing pain during medical procedures. For example, a study published on ScienceDirect showed that topical application of EMLA cream reduces the pain of intramuscular injections[5].

"EMLA cream, a topical lidocaine-prilocaine anesthetic, reduces the pain of intramuscular injection." - ScienceDirect[5]

Conclusion

The market for local anesthesia drugs, including EMLA cream, is poised for significant growth driven by demographic shifts, increased surgical procedures, and improved healthcare access. The financial trajectory of this market is influenced by M&A activities, robust debt financing, and strategic market expansions by key players.

Key Takeaways

• The global local anesthesia drugs market is projected to grow at a CAGR of 3.6% from 2024 to 2030 and reach USD 4.7 billion by 2031.
• The geriatric population and rise in surgical procedures are key drivers of market growth.
• North America dominates the market, while the MEA region is expected to witness significant growth.
• COVID-19 had a moderate impact on the market, with increased demand for essential healthcare services.
• M&A and debt financing are crucial for market growth and company strategies.

FAQs

What is the projected growth rate of the global local anesthesia drugs market?

The global local anesthesia drugs market is projected to grow at a CAGR of 3.6% from 2024 to 2030 and at a CAGR of 6.4% from 2022 to 2031[1][4].

Which region dominates the local anesthesia drugs market?

North America dominates the local anesthesia drugs market, with a market share of 35.4% in 2023[1].

How has the COVID-19 pandemic affected the local anesthesia drugs market?

The COVID-19 pandemic had a moderate impact on the market, with increased demand for essential healthcare services and a need to enhance healthcare system capacity[4].

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

Key drivers include the increasing geriatric population, rise in surgical procedures, and improved access to healthcare facilities[1][4].

Which companies are key players in the local anesthesia drugs market?

Key players include Pacira Pharmaceuticals, Mylan N.V., Aspen Holdings, Septodont Healthcare India Pvt. Ltd., Teva Pharmaceutical Industries Ltd., Fresenius Kabi AG, Pfizer Inc., Sagent Pharmaceuticals, Baxter International Inc., and Novartis AG[4].

What is the role of M&A in the local anesthesia drugs market?

M&A activities are significant in the pharmaceutical industry, including the local anesthesia segment, to replace revenues from expiring patents and drive growth[3].

Sources

1. Grand View Research: Local Anesthesia Drugs Market Size & Share Report, 2030
2. PMC: Health economic evidence of 5% lidocaine medicated plaster in post...
3. Pharm Exec: Pharma M&A and Financial Trends: The Frenzy and Risks Escalate
4. Allied Market Research: Local Anesthesia Drugs Market Size & Share | Report - 2031
5. ScienceDirect: Topical application of lidocaine-prilocaine (EMLA) cream reduces...