LIDOCAINE; TETRACAINE - Generic Drug Details

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

Lidocaine; tetracaine is the generic ingredient in two branded drugs marketed by Crescita Therap and Galen Specialty, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lidocaine; tetracaine has seven patent family members in seven countries.

One supplier is listed for this compound.

Summary for LIDOCAINE; TETRACAINE

International Patents:	7
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	64
DailyMed Link:	LIDOCAINE; TETRACAINE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LIDOCAINE; TETRACAINE

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 LIDOCAINE; TETRACAINE

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

Sponsor	Phase
Hexsel Dermatology Clinic	PHASE2
Dartmouth-Hitchcock Medical Center	PHASE4
Kalpna Kay Durairaj, MD, FACS	PHASE1

See all LIDOCAINE; TETRACAINE clinical trials

Pharmacology for LIDOCAINE; TETRACAINE

Drug Class	Amide Local Anesthetic Antiarrhythmic Ester Local Anesthetic
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for LIDOCAINE; TETRACAINE

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

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

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

N01BA	Esters of aminobenzoic acid
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

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; TETRACAINE

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		RX	Yes	Yes			Y
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005		DISCN	Yes	No
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		RX	Yes	Yes			Y
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006		RX	Yes	Yes			Y

Expired US Patents for LIDOCAINE; TETRACAINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005
Crescita Therap	PLIAGLIS	lidocaine; tetracaine	CREAM;TOPICAL	021717-001	Jun 29, 2006
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005
Galen Specialty	SYNERA	lidocaine; tetracaine	PATCH;TOPICAL	021623-001	Jun 23, 2005

International Patents for LIDOCAINE; TETRACAINE

Country	Patent Number	Title	Estimated Expiration
Canada	2822220	FORMULATIONS POUR ANESTHESIE LOCALE SE SOLIDIFIANT POUR LA GESTION DE LA DOULEUR (SOLID-FORMING LOCAL ANESTHETIC FORMULATIONS FOR PAIN CONTROL)
Brazil	112012017554	formulações de anestésicas locais formadoras de sólido para controle da dor
Australia	2011205730	Solid-forming local anesthetic formulations for pain control
Mexico	2012008168	FORMULACIONES ANESTESICAS LOCALES QUE FORMAN SOLIDOS PARA CONTROL DEL DOLOR. (SOLID-FORMING LOCAL ANESTHETIC FORMULATIONS FOR PAIN CONTROL.)
China	102834096	Solid-forming local anesthetic formulations for pain control
Brazil	112012017554	formulações de anestésicas locais formadoras de sólido para controle da dor
Canada	2822220	FORMULATIONS POUR ANESTHESIE LOCALE SE SOLIDIFIANT POUR LA GESTION DE LA DOULEUR (SOLID-FORMING LOCAL ANESTHETIC FORMULATIONS FOR PAIN CONTROL)

Market Dynamics and Financial Trajectory for Lidocaine and Tetracaine

Last updated: February 15, 2026

Overview

Lidocaine and tetracaine are Local Anesthetics used across multiple medical fields. The global market's growth depends on factors such as rising surgical procedures, expanding dental applications, and developments in patch delivery systems. The financial trajectory reflects shifting patent statuses, regulatory approvals, and emerging generic competition.

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What Are the Current Market Sizes and Growth Rates for Lidocaine and Tetracaine?

Lidocaine

• The global market was valued at approximately $963 million in 2022.
• Compound annual growth rate (CAGR) estimated at 4.5% from 2023 to 2030.
• Major application areas include anesthesia for dental, dermatology, and minor surgical procedures.

Tetracaine

• The global market was valued around $150 million in 2022.
• Projected CAGR is approximately 3.8% over the next eight years.
• Mainly used in ophthalmic procedures and for topical anesthesia in allergy testing.

Key Drivers

• Increasing minimally invasive procedures.
• Growth in outpatient care.
• Adoption of patch formulations for lidocaine.

Year	Lidocaine Market ($ millions)	Tetracaine Market ($ millions)
2022	963	150
2025	1,124	173
2030	1,370	195

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How Do Patent and Regulatory Factors Affect Market Dynamics?

Lidocaine

• Many formulations are off-patent since the late 2000s.
• New patch delivery systems (e.g., Lidoderm) have patents expiring between 2025–2028.
• The expiration of key patents enables greater generic competition, resulting in price reductions.

Tetracaine

• Patent protections ended in the early 2000s.
• No significant recent patents; off-patent status implies reliance on generic manufacturing.
• Regulatory approvals primarily revolve around topical and ophthalmic indications.

Regulatory Landscape

• The FDA has streamlined approval pathways for combination patch systems and generic formulations.
• Recent approvals include generic lidocaine patches approved post-patent expiry, increasing market penetration.

Patent Status	Impact on Market	Patent Expiry (approximate)
Lidocaine patches	Increased competition	2025–2028
Tetracaine formulations	Saturation	2000s

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What Are the Main Competitive Dynamics?

Market Players

• For lidocaine, Johnson & Johnson, Amphastar, and Teva lead in patch and injectable formulations.
• For tetracaine, Akorn, Allergan, and Santen dominate topical ophthalmic products.

Pricing Trends

• Post-patent expiry, generic lidocaine patches' prices have decreased by over 40%.
• Tetracaine products see consistent pricing, with incremental declines aligned with generic entry.

Innovation and Pipeline

• Development of liposomal and patch-based delivery systems improves patient compliance.
• Upcoming drugs focus on sustained-release formulations and combination therapies.

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What Is the Financial Outlook for Manufacturers?

Revenue Forecasts

• Lidocaine's revenue is expected to decline gradually due to generic price erosion but remain significant due to volume.
• Tetracaine revenues stabilize with consistent demand in ophthalmology and dermatology.

Cost Implications

• High R&D costs for new delivery systems offset by lower manufacturing costs for generics.
• Regulatory compliance incurs ongoing expenses, especially for biosimilar and specialty products.

Investment Opportunities

• Companies investing in innovative patch or sustained-release formulations may capture premium market segments.
• Patent expiries represent both a risk and an opportunity; early entry into generics for lidocaine patches could capitalize on market share.

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What Are the Emerging Trends that Could Influence Future Market Trajectory?

• Adoption of transdermal patch technology accelerates due to patient preference for non-invasive routes.
• Expansions into developing markets driven by increased healthcare access and surgical volume.
• Growing focus on combination products (e.g., lidocaine with prilocaine) expands market scope.

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Key Takeaways

• Market size for lidocaine exceeds that of tetracaine but is shrinking due to patent expiries.
• The rise of generic products has driven down prices, impacting revenue but increasing volume.
• Innovation in delivery systems presents growth opportunities despite patent expiries.
• Regulatory pathways favor generic and biosimilar development, facilitating market entry.
• Future growth hinges on technological advancements and expanding application areas, particularly in outpatient and minimally invasive procedures.

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FAQs

1. How will patent expiries affect lidocaine’s market share?
Patent expiries from 2025–2028 enable generic manufacturers to increase market penetration, leading to price competition and revenue declines for branded products but growth in overall volume.

2. Which applications drive the demand for lidocaine and tetracaine?
Lidocaine is used in dental, dermatologic, and minor surgical procedures. Tetracaine primarily serves ophthalmic anesthesia and allergy testing.

3. Are there new formulations expected to disrupt the market?
Yes, sustained-release patches and liposomal formulations aim to improve patient compliance and expand therapeutic applications.

4. How significant is international market growth?
Emerging markets are experiencing increased adoption due to rising healthcare infrastructure and outpatient procedure rates, representing substantial growth potential.

5. What are key risks for companies in this sector?
Patent cliffs, pricing pressure from generics, and regulatory hurdles for new formulations pose risks to revenue stability.

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References

1. MarketWatch. "Lidocaine Market Size to Reach $1.37 Billion by 2030," 2023.
2. Grand View Research. "Global Tetracaine Market Analysis," 2022.
3. FDA. "Guidance on Generic Drug Approvals," 2021.
4. IQVIA. "Pharmaceuticals Market Dynamics," 2022.
5. Allied Market Research. "Local Anesthetics Market Forecast," 2023.

(Note: Data points are based on industry reports and market analyses valid as of 2022–2023.)