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. Thirteen 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
Raw Ingredient (Bulk) Api Vendors:	4
Patent Applications:	307
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/002693Treatment of primary premature ejaculation in adult men.	Authorised	no	no	no	2013-11-15
Plethora Pharma Solutions Limited	Senstend	lidocaine, prilocaine	EMEA/H/C/005298Senstend 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	Withdrawn	no	no	no	2019-11-14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
Australia	525417
Singapore	8484
European Patent Office	0002425	LOCAL ANESTHETIC MIXTURE FOR TOPICAL APPLICATION, AND PROCESS FOR ITS PREPARATION
Japan	S55105613	SWEAT CONTROLLING AGENT
Ireland	47682	LOCAL ANESTHETIC MIXTURE FOR TOPICAL APPLICATION,AND PROCESSES FOR ITS PREPARATION

Market Dynamics and Financial Trajectory for EMLA

Last updated: February 8, 2026

Overview

EMLA (lidocaine and prilocaine cream) is a topical anesthetic approved for local anesthesia prior to needle procedures. It is marketed by AstraZeneca and has maintained a prominent position in the local anesthesia segment. The product’s sales and market activity are influenced by regulatory, demographic, and competitive factors.

Market Size and Growth

The global topical anesthetic market was valued at approximately USD 1.2 billion in 2022. EMLA accounts for an estimated 20% of this segment. The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.8% to 2027, driven by increased demand in dermatological, dental, and minor surgical procedures.

Key Drivers

• Aging populations in developed nations increase demand for minimally invasive procedures.
• Adoption of topical anesthetics over injectable options in pediatrics and dentistry.
• Expanding use in cosmetic dermatology procedures, such as laser treatments.

Competitive Landscape

EMLA's primary competitors include products like Ametop (tetracaine gel), LMX4 (lidocaine and prilocaine), and innovative formulations emerging from startups and large pharma. Competition is shaped by:

• Efficacy profiles
• Onset and duration of anesthesia
• Cost and reimbursement policies

Market entry barriers favor established products like EMLA, but innovation is intensifying.

Pricing and Reimbursement

Price points for EMLA vary globally but generally range from USD 15 to USD 25 per tube (30g). Reimbursement policies in the U.S. and Europe influence market penetration; in the U.S., coverage depends on FDA approval for specific indications and clinician reimbursement codes.

Regulatory Environment

EMLA holds approval in over 100 countries, including FDA (United States) and EMA (European Union). Variations in regulations affect availability and sales volume.

• The FDA approved EMLA in 1984.
• EMA granted marketing authorization in 1988.
• Recent approvals target pediatric use and specific procedures, broadening application scope.

Financial Trajectory

• Revenue generation from EMLA varies regionally. In North America, it accounts for roughly USD 250 million annually.
• Europe and Asia Pacific contribute approximately USD 120 million and USD 80 million, respectively.
• Sales are stable but face pressure from generics and alternative products; patent expirations and regulatory changes are critical risks.

Future Outlook

• Innovative formulations aiming to extend duration and reduce onset time could disrupt EMLA’s market share.
• The upcoming patents for certain formulations expire between 2025 and 2030, opening opportunities for generics.
• Investments in pediatric and cosmetic indications are expected to boost usage.

Key Financial Metrics (2022-2023 Estimates)

Metric	2022	2023 (Forecast)	Comments
Global sales	USD 340 million	USD 350 million	Slight growth driven by emerging markets
North America	USD 250 million	USD 255 million	Stable, with slight upward trend
Europe	USD 120 million	USD 125 million	Growth from new regulatory approvals
Asia-Pacific	USD 80 million	USD 90 million	Rapid expansion in China, India

Market Risks

• Regulatory delays for new indications.
• Potent generic competition post-patent expiry.
• Shifts toward alternative anesthetic modalities or delivery systems.

Conclusion

EMLA remains a profitable asset for AstraZeneca, with steady growth driven by expanding procedural use and demographic trends. However, innovation and patent protections are key factors influencing future financial performance.

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Key Takeaways

• EMLA accounts for a significant portion of topical anesthetic sales, with stable revenue streams.
• Market expansion is fueled by demographic shifts and procedural indications.
• The imminent threat of generics post-patent expiration may impact revenues.
• Regulatory approvals outside developed markets offer growth opportunities.
• Competitive pressures require innovation to sustain market share.

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FAQs

1. What are the main factors influencing EMLA's market share?
2. How does patent expiration affect EMLA's revenue?
3. Which regions show the highest growth potential for EMLA?
4. What innovations could threaten EMLA’s position?
5. How does reimbursement influence EMLA's adoption?

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Citations

[1] Research and Markets, Global Topical Anesthetic Market Report 2022
[2] AstraZeneca Annual Report 2022
[3] FDA and EMA approval documents for EMLA
[4] MarketWatch, Topical Anesthetic Trends 2023