LIDOCAINE; PRILOCAINE - Generic Drug Details

What are the generic drug sources for lidocaine; prilocaine and what is the scope of patent protection?

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.

Fifteen suppliers are listed for this compound.

Summary for LIDOCAINE; PRILOCAINE

US Patents:	0
Tradenames:	3
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	83
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
Hikma	LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	076290-001	Sep 25, 2003		DISCN	No	No
Alembic	LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	213923-001	Apr 8, 2022	AB	RX	No	No
Zydus Lifesciences	LIDOCAINE AND PRILOCAINE	lidocaine; prilocaine	CREAM;TOPICAL	219120-001	Dec 17, 2024	AB	RX	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
Dentsply Pharm	ORAQIX	lidocaine; prilocaine	GEL;PERIODONTAL	021451-001	Dec 19, 2003
Teva Branded Pharm	EMLA	lidocaine; prilocaine	CREAM;TOPICAL	019941-001	Dec 30, 1992

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: July 29, 2025

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Introduction

Lidocaine and prilocaine are topical and injectable anesthetics widely used in medical and dental procedures to induce local anesthesia. The global demand for these drugs is driven by their essential role in pain management protocols across hospitals, clinics, and outpatient settings. As the pharmaceutical industry evolves with technological advancements and regulatory shifts, understanding the market dynamics and financial trajectory of these agents becomes crucial for stakeholders aiming to optimize investment and innovation strategies.

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Market Overview

Lidocaine, a member of the amino amide class of local anesthetics, remains the most prevalent agent in its category, with a broad spectrum of applications extending from minor surgical procedures to dentistry and cardiology (e.g., antiarrhythmic uses). Prilocaine, also an amino amide local anesthetic, shares similar indications but with a distinctive profile that positions it as a preferred alternative for specific formulations, such as lidocaine-prilocaine combinations in topical anesthetic patches.

The global market for local anesthetics was valued at approximately USD 2.4 billion in 2022, with projections indicating a CAGR of around 4% through 2027 (Source: MarketWatch). The rise in outpatient procedures, minimally invasive surgeries, and dental treatments fuels ongoing demand. Moreover, the increasing prevalence of chronic pain conditions, particularly in aging populations, underpins the sustained need for effective anesthetics.

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Market Drivers

1. Growing Medical Procedures:
The surge in minimally invasive and outpatient procedures globally necessitates reliable local anesthetics. The expansion of cosmetic surgeries, dermatological interventions, and dental procedures further propels demand for lidocaine and prilocaine.

2. Aging Population and Chronic Pain:
An aging demographic faces higher instances of conditions requiring local anesthesia, influencing both procedural and chronic pain management protocols.

3. Innovation in Formulation Technologies:
Development of advanced drug delivery systems—such as sustained-release patches, topical creams, and injectable formulations—enhances drug efficacy and patient compliance, fostering market growth.

4. Regulatory Approvals and Patent Expiries:
Patents granting exclusivity, like those for novel formulations or delivery mechanisms, enable premium pricing strategies. Simultaneously, patent expirations facilitate generic entry, intensifying price competition but expanding overall market volumes.

5. Increasing Healthcare Expenditure:
Regions with rising healthcare spending, especially in Asia-Pacific and Latin America, serve as expanding markets for both branded and generic products.

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Market Challenges

1. Strict Regulatory Environments:
Global regulatory requirements for safety, efficacy, and manufacturing standards (e.g., FDA, EMA) impose significant compliance costs, potentially delaying product launches.

2. Competitive Patent Landscape:
Generic manufacturers entering the scene following patent expirations dilute market share for branded formulations, leading to downward pressure on prices.

3. Safety and Side Effects:
Adverse reactions, such as systemic toxicity or allergic responses, necessitate careful dosing and limit the use scope in certain patient populations, constraining market penetration.

4. Supply Chain Disruptions:
Dependence on raw materials, such as intermediates derived from complex chemical synthesis, exposes manufacturers to raw material scarcity and geopolitical risks impacting supply stability.

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Financial Trajectory Analysis

1. Revenue Trends
The revenue landscape for lidocaine and prilocaine remains robust, driven by high-volume generics and branded formulations. Leading pharmaceutical companies, such as Teva, Mylan, and AstraZeneca, hold significant market share via their proprietary formulations and global distribution networks.

2. Impact of Patent Expiries
Patent cliff effects, particularly for formulations established over a decade ago, have precipitated a surge in generic sales. For instance, the expiration of certain lidocaine patents in key markets like the US and EU between 2015-2018 catalyzed a marked decline in branded sales, offset by increased volumes from generics.

3. Innovation Investments
Pharmaceutical firms are investing in novel delivery systems—such as liposomal or nanoparticle-based formulations—to extend product life cycles, command premium pricing, and address unmet needs. These R&D efforts are expected to improve margins and sustain revenue streams in the long term.

4. Market Entry Barriers and Pricing Strategies
Barriers like capital-intensive manufacturing, regulatory hurdles, and established competitors create high entry thresholds for new players. Consequently, existing firms leverage strategic pricing and market penetration tactics to safeguard margins.

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Regional Market Dynamics

North America:
Dominates the global market, accounting for approximately 45% of industry revenues, supported by high healthcare spending, advanced infrastructure, and the prevalence of outpatient and dental procedures.

Europe:
Similarly mature, with substantial markets in Germany, France, and the UK. Regulatory harmonization under the EMA facilitates streamlined approvals.

Asia-Pacific:
Projected to witness the fastest growth (CAGR ~6%) due to rising healthcare access, manufacturing capacity, and expanding medical tourism sectors. Governments' investments in healthcare infrastructure further stimulate demand.

Latin America and Middle East:
Emerging markets with incremental growth driven by increasing procedural volumes and growing healthcare expenditure.

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Future Outlook

The future financial trajectory for lidocaine and prilocaine hinges on several factors:

• Continued patent expirations will bolster generic market share, exerting downward price pressure but increasing volume sales.
• Emerging formulations such as topical patches for prolonged anesthesia management will command premium pricing, with companies like Heron Therapeutics and Ferndale Pharma pioneering in this space.
• Technological advances in drug delivery systems will enhance efficacy, safety, and patient adherence, creating avenues for premium pricing and market differentiation.
• Regulatory landscape and patent laws will influence innovation pace; countries tightening approval pathways may slow growth, while supportive frameworks accelerate it.

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Key Takeaways

• Stable Growth Path: The global market for lidocaine and prilocaine is poised for steady growth, driven by procedural demand, aging populations, and technological innovations.
• Patent Dynamics: Patent expiries have led to increased generic competition, impacting revenue streams of branded formulations but expanding overall market volume.
• Regional Opportunities: Asia-Pacific presents the most promising growth prospects due to expanding healthcare infrastructure and procedural volumes.
• Innovation as a Catalyst: Investment in advanced drug delivery technology can mitigate generic price erosion and support premium pricing strategies.
• Regulatory Considerations: Navigating regulatory environments remains critical; streamlined approval processes and compliance can accelerate revenue generation.

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FAQs

1. How do patent expirations affect the market for lidocaine and prilocaine?
Patent expirations open the market to generic manufacturers, increasing competition, reducing prices, and shifting revenue from branded to generic products. While this can decrease profit margins for original innovators, it expands the overall market volume.

2. What are the main factors influencing the pricing of lidocaine and prilocaine drugs?
Pricing is influenced by patent status, manufacturing costs, regulatory compliance, market competition, and whether formulations are branded or generic. Advanced delivery systems and formulations can command higher prices.

3. Which regions are expected to lead market growth for these anesthetics?
Asia-Pacific is expected to lead growth due to healthcare infrastructure expansion, demographic shifts, and rising procedural volumes. North America and Europe remain mature but continue to generate significant revenue.

4. What technological innovations are influencing the future of local anesthetics?
Innovations include sustained-release patches, liposomal formulations, and patient-controlled delivery systems, improving efficacy and safety while enabling premium pricing.

5. How are regulatory changes impacting the development and marketing of lidocaine and prilocaine?
Regulatory agencies are emphasizing safety, efficacy, and manufacturing standards, which can delay product approvals but ultimately improve market confidence. Supportive regulatory frameworks facilitate faster approval for generic and innovative formulations.

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References

1. MarketWatch, "Global Local Anesthetics Market Size, Share & Trends Analysis," 2022.
2. Statista, "Healthcare Procedures and Spending Overview," 2023.
3. Johnson & Johnson, "Pharmacovigilance & Regulatory Updates," 2022.
4. Pharma Intelligence, "Innovations in Local Anesthetic Delivery," 2022.
5. World Health Organization, "Global Aging and Pain Management Trends," 2022.