Lidocaine; prilocaine - Generic Drug Details

What are the generic sources for lidocaine; prilocaine and what is the scope of freedom to operate?

Lidocaine; prilocaine is the generic ingredient in three branded drugs marketed by Teva Branded Pharm, Alembic, Chartwell Rx, Encube, Fougera Pharms, Hikma, Padagis Us, Pai Holdings Pharm, Zydus Lifesciences, Astrazeneca, and Dentsply Pharm, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Thirteen suppliers are listed for this compound.

Summary for lidocaine; prilocaine

US Patents:	0
Tradenames:	3
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	84
DailyMed Link:	lidocaine; prilocaine at DailyMed

Recent Clinical Trials for lidocaine; prilocaine

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

Sponsor	Phase
Bioprojet	PHASE2
Cairo University	PHASE3
Cairo University	PHASE4

See all lidocaine; prilocaine clinical trials

Pharmacology for lidocaine; prilocaine

Drug Class	Amide Local Anesthetic Antiarrhythmic
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for lidocaine; prilocaine

C01BB	Antiarrhythmics, class Ib
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

C05AD	Local anesthetics
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D04AB	Anesthetics for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

N01BB	Amides
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

R02AD	Anesthetics, local
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

S01HA	Local anesthetics
S01H	LOCAL ANESTHETICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02DA	Analgesics and anesthetics
S02D	OTHER OTOLOGICALS
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for lidocaine; prilocaine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pai Holdings Pharm	LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	205887-001	Jun 29, 2018		DISCN	No	No
Teva Branded Pharm	EMLA	lidocaine; prilocaine	CREAM;TOPICAL	019941-001	Dec 30, 1992		DISCN	Yes	No
Zydus Lifesciences	LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	219120-001	Dec 17, 2024	AB	RX	No	No
Astrazeneca	EMLA	lidocaine; prilocaine	DISC;TOPICAL	020962-001	Feb 4, 1998		DISCN	No	No

Expired US Patents for lidocaine; prilocaine

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
Dentsply Pharm	ORAQIX	lidocaine; prilocaine	GEL;PERIODONTAL	021451-001	Dec 19, 2003

EU/EMA Drug Approvals for lidocaine; prilocaine

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

Market Dynamics and Financial Trajectory for Lidocaine and Prilocaine

Last updated: February 14, 2026

Market Overview

Lidocaine and prilocaine, local anesthetics, are integral in procedures requiring surface or infiltrative anesthesia. Their market status depends on medical use, competition, patent landscapes, and regulations.

Market Size and Growth

Global anesthetics market was valued at approximately $1.8 billion in 2021, with local anesthetics constituting roughly 60% of the total. Projected CAGR for local anesthetics from 2022 to 2028 stands at 4.5%, driven by increasing surgical procedures, minimally invasive treatments, and demand for outpatient anesthesia.

Lidocaine leads the segment, accounting for over 50% of sales, due to its extensive use in dental, cosmetic, and emergency applications. Prilocaine holds a smaller but steady market share, mainly used in topical formulations.

Key Drivers and Barriers

Drivers:

• Rising outpatient and cosmetic procedures

• Expanding dental treatments

• Growing use in treatment of chronic pain conditions

• Technological advances in drug delivery systems

Barriers:

• Patent expirations of key formulations

• The emergence of alternative anesthetics with improved safety profiles (e.g., articaine)

• Stringent regulations on drug manufacturing and approval processes

• Concerns about toxicity and allergic reactions

Patent Landscape and Competitive Environment

Most patents on core formulations of lidocaine expired in early 2010s, leading to increased generic competition. Brand-name players, such as AstraZeneca (Prilocaine), and Sandoz, with multidimensional portfolios, continue to innovate through delivery systems and combination formulations.

Generic manufacturers account for approximately 75% of sales in developed markets. Innovator companies focus on extended-release, combination therapies, and novel delivery methods to maintain market share.

Manufacturing and Pricing

Global manufacturing hubs exist in the US, Europe, and Asia. Prices vary substantially by region, with North America commanding premium prices due to higher healthcare expenditure.

Pricing pressures from generics influence profit margins. In the US, retail prices for lidocaine patches (e.g., Lidoderm) range from $250 to $350 per box (60 patches), compared to generic versions priced as low as $50.

Regulatory Environment

The FDA, EMA, and other regulatory authorities continuously evaluate the safety and efficacy of local anesthetics. Recent guidelines focus on minimizing toxicity, especially regarding intravenous applications, influencing formulation designs.

Financial Trajectory

Revenue Streams:

• Largely driven by generic sales in mature markets; injectable forms dominate revenue streams.

• Topical formulations command premium pricing, sustaining higher margins.

Profitability and R&D:

• Limited recent R&D investments; focus on reformulations or delivery innovations.

• Companies' investments in new delivery methods (e.g., liposomal, patch formats) aim to extend product life cycles and command premium prices.

Future Outlook:

• Market growth expected to persist at 4-5% annually, propelled by procedural volume increases.

• Patent expirations may pressure prices, but innovations could offset revenue erosion through differentiated offerings.

• Growth in emerging markets may result in compounded annual growth of 6-8% over the next five years.

Summative Data Table

Aspect	Details
Market size (2021)	~$1.8 billion
CAGR (2022-2028)	4.5%
Major players	AstraZeneca, Sandoz, Mylan, Fresenius
Patent expiry (core formulations)	Early 2010s for many, continuing for others (e.g., topical)
Regional markets	North America (~55%), Europe (~25%), Asia (~15%)
Pricing range (topical patches)	$50 - $350 per box
Market drivers	Outpatient procedures, dental treatments, cosmetic use
Challenges	Patent expirations, generic competition, regulatory hurdles

Key Takeaways

• The lidocaine and prilocaine markets are mature but continue to evolve with technological and procedural advances.

• Patent expiries have increased generic penetration, compressing prices and margins but facilitating access.

• Innovations in drug delivery, such as liposomal or patch formulations, provide opportunities for revenue growth.

• Regional dynamics favor North America and Europe, with high procedural volumes and regulatory standards.

• Emerging markets offer growth potential, expected at higher CAGR rates.

FAQs

1. How does patent expiry affect the market for lidocaine and prilocaine?
   Patent expiries lead to increased generic competition, reducing prices and profit margins for branded formulations.

2. What are the main drivers for growth in this market?
   Increasing outpatient, dental, and cosmetic procedures, alongside technological advances in delivery systems.

3. Are there safety concerns affecting market dynamics?
   Yes, toxicity and allergic reactions influence formulations and regulatory scrutiny, impacting product development.

4. What innovations are shaping future revenue streams?
   Extended-release formulations, liposomal delivery, and combination therapies.

5. How do regional factors influence market trends?
   North America and Europe have high procedural volumes and regulatory standards, driving steady demand; emerging markets are growing rapidly.

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References

[1] MarketsandMarkets. "Local Anesthetics Market", 2022.
[2] Grand View Research. "Global Anesthetics Market," 2021.
[3] U.S. Food & Drug Administration. "Guidance for Industry on Local Anesthetics," 2020.
[4] IQVIA. "Pharmaceutical Pricing and Market Data," 2022.