Lidocaine hydrochloride - Generic Drug Details

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

Lidocaine hydrochloride is the generic ingredient in thirty-five branded drugs marketed by Thea Pharma, Carlisle, Abbott, Abraxis Pharm, Afaxys, Am Regent, Aspiro, B Braun Medical Inc, Bel Mar, Belmora Llc, Dell Labs, Elkins Sinn, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Huons, Intl Medication, Luitpold, Lyphomed, Mankind Pharma, Miles, Rising, Sintetica Us, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Baxter Hlthcare, B Braun, Hikma, Pharmaton, Meridian Medcl Techn, Astrazeneca, Dentsply Pharm, Bionpharma, Sagent Pharms Inc, Cosette, Sentiss, Watson Labs Inc, Rubicon, Wockhardt Bio Ag, Actavis Mid Atlantic, Chartwell Molecular, Pai Holdings Pharm, Kendall Il, Lannett Co Inc, Novitium Pharma, Paco, Taro, The J Molner, Powder Pharms, and Pfizer, and is included in one hundred and thirteen NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lidocaine hydrochloride has nineteen patent family members in ten countries.

There are nine drug master file entries for lidocaine hydrochloride. Fifty-three suppliers are listed for this compound.

Summary for lidocaine hydrochloride

International Patents:	19
US Patents:	4
Tradenames:	35
Applicants:	54
NDAs:	113
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	53
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	1,820
Patent Applications:	5
What excipients (inactive ingredients) are in lidocaine hydrochloride?	lidocaine hydrochloride excipients list
DailyMed Link:	lidocaine hydrochloride at DailyMed

Recent Clinical Trials for lidocaine hydrochloride

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

Sponsor	Phase
Sichuan Cancer Hospital and Research Institute	N/A
Jessyka Lighthall	Phase 3
Sawanpracharak hospital	N/A

See all lidocaine hydrochloride clinical trials

Pharmacology for lidocaine hydrochloride

Drug Class	Amide Local Anesthetic Antiarrhythmic Catecholamine alpha-Adrenergic Agonist beta-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Adrenergic beta-Agonists
Physiological Effect	Local Anesthesia

Anatomical Therapeutic Chemical (ATC) Classes for lidocaine hydrochloride

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

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 hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	XYLOCAINE	lidocaine hydrochloride	INJECTABLE;INJECTION	010418-007	Approved Prior to Jan 1, 1982		DISCN	No	No
Powder Pharms	ZINGO	lidocaine hydrochloride	SYSTEM;INTRADERMAL	022114-001	Aug 16, 2007		RX	No	No	9,358,338
Am Regent	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	080850-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Astrazeneca	XYLOCAINE 5% W/ GLUCOSE 7.5%	lidocaine hydrochloride	INJECTABLE;SPINAL	010496-002	Jul 7, 1982		DISCN	No	No

Expired US Patents for lidocaine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Powder Pharms	ZINGO	lidocaine hydrochloride	SYSTEM;INTRADERMAL	022114-001	Aug 16, 2007	5,630,796
Powder Pharms	ZINGO	lidocaine hydrochloride	SYSTEM;INTRADERMAL	022114-001	Aug 16, 2007	6,881,200
Powder Pharms	ZINGO	lidocaine hydrochloride	SYSTEM;INTRADERMAL	022114-001	Aug 16, 2007	6,004,286
Powder Pharms	ZINGO	lidocaine hydrochloride	SYSTEM;INTRADERMAL	022114-001	Aug 16, 2007	5,899,880

International Patents for lidocaine hydrochloride

Country	Patent Number	Title	Estimated Expiration
China	106163500	用于递送颗粒的装置 (Device for delivering particles)
World Intellectual Property Organization (WIPO)	2008135719
Japan	6369551
Australia	2015222937	Device for delivering particles

Lidocaine hydrochloride Market Analysis and Financial Projection Experimental

Lidocaine Hydrochloride Market Dynamics and Financial Trajectory

Market Overview

The lidocaine hydrochloride market is poised for significant growth, driven by its versatile applications in medical and surgical procedures, as well as its therapeutic benefits in pain management. Here’s a detailed look at the market dynamics and financial trajectory of lidocaine hydrochloride.

Market Size and Growth Projections

• The global lidocaine hydrochloride market is expected to reach USD 838.60 million by 2032, growing at a CAGR of 5.7% from 2024 to 2032[4][5].
• In the shorter term, the market is projected to grow at a CAGR of 10.2% from 2022 to 2027, with an estimated market size of $680 million by 2027[2].

Geographical Segmentation

• North America: Currently holds the largest revenue share, driven by advancements in surgical procedures, a surge in cosmetic treatments, and the widespread use of lidocaine for postoperative pain management. The region is characterized by continuous growth, technological advancements, and a strong emphasis on preventive healthcare practices[3][5].
• Asia-Pacific: Expected to dominate the market over the forecast period due to the rising prevalence of acute and chronic illnesses, particularly among the aging population. The region's growing GDP and increased government financing for research and development also contribute to its rapid growth[2][3].

Distribution Channel Analysis

• Hospital Pharmacies: Currently hold the largest share due to the widespread use of lidocaine in various surgical and medical procedures. However, retail pharmacies are expected to be the fastest-growing segment, with a CAGR of 10.9% from 2022 to 2027, driven by government and private sector support and the increasing number of independent pharmacies[2][3].

Dosage and Application Segmentation

• Dosage Forms: The market is segmented into injections, creams, patches, and others. Creams are expected to witness the highest growth during the forecast period due to their anti-itching and pain relief properties[3][5].
• Applications: Dental procedures are expected to dominate the market, driven by the increasing aging population and the rising need for effective pain management solutions. Other significant applications include surgical procedures, cosmetic treatments, and the treatment of pain-related disorders such as epilepsy and heart arrhythmia[1][3].

Drivers of Market Growth

• Increasing Aging Population: The global aging population presents a significant opportunity for the lidocaine hydrochloride market, as it addresses the escalating demand for effective pain management solutions[3][5].
• Advancements in Drug Delivery Technologies: The market observes a trend towards innovative formulations like patches and gels, which leverage advancements in drug delivery technologies for enhanced efficacy[3][5].
• Resumption of Surgical Procedures: The relaxation of strict regulations on surgical procedures post-pandemic and the resumption of services are expected to drive the demand for lidocaine hydrochloride[1].

Challenges and Limitations

• Regulatory Approval Processes: Rigorous regulatory approval processes pose a challenge to market growth. Ensuring safety amid potential side effects and allergies is also a persistent issue[3][5].
• Pricing Pressures: Intense competition in the market leads to pricing pressures, which can affect the profitability of market players[3].

Impact of COVID-19

• The COVID-19 pandemic had a significant impact on the lidocaine hydrochloride market. The potential anesthetic and anti-inflammatory properties of lidocaine made it a candidate for adjunctive treatment in COVID-19 patients, particularly for severe respiratory symptoms. This temporary boost in demand contributed to the market's growth during the pandemic period[1].

Key Players

• The market is highly competitive, with major players including Pfizer Inc., Merck KGaA, Lupin Limited, Mylan N.V., Qilu Pharmaceutical Co., Ltd., and Sintetica S.A. among others. These companies are driving innovation and market expansion through strategic collaborations and the introduction of new products[1][3][4].

Financial Trajectory

• The market is expected to grow steadily, with a projected CAGR ranging from 4.1% to 10.2% over different forecast periods. The revenue is anticipated to increase from USD 538.44 million in 2024 to USD 838.60 million by 2032[2][4][5].

Key Takeaways

• The lidocaine hydrochloride market is driven by its extensive applications in surgical and dental procedures, as well as its therapeutic benefits in pain management.
• The market is expected to grow significantly, driven by the increasing aging population and advancements in drug delivery technologies.
• North America currently dominates the market, but Asia-Pacific is expected to be the fastest-growing region.
• Retail pharmacies are anticipated to be the fastest-growing distribution channel.
• Despite challenges such as regulatory approvals and pricing pressures, the market is poised for steady growth.

Frequently Asked Questions (FAQs)

1. What is the current market size of the lidocaine hydrochloride market?

• The global lidocaine hydrochloride market size is currently valued at USD 512.70 million in 2023[4].

2. What is the expected CAGR of the lidocaine hydrochloride market from 2024 to 2032?

• The market is expected to grow at a CAGR of 5.7% from 2024 to 2032[4].

3. Which region is expected to dominate the lidocaine hydrochloride market in the future?

• Asia-Pacific is expected to dominate the market over the forecast period due to the rising prevalence of acute and chronic illnesses among the aging population[2][3].

4. What are the primary drivers of the lidocaine hydrochloride market?

• The primary drivers include the increasing aging population, advancements in drug delivery technologies, and the resumption of surgical procedures post-pandemic[1][3].

5. Who are the key players in the lidocaine hydrochloride market?

• Key players include Pfizer Inc., Merck KGaA, Lupin Limited, Mylan N.V., Qilu Pharmaceutical Co., Ltd., and Sintetica S.A. among others[1][3][4].

Sources:

1. Mordor Intelligence - Lidocaine Hydrochloride Market Size - Mordor Intelligence
2. IndustryArc - Lidocaine Hydrochloride Market - Forecast(2024 - 2030)
3. Polaris Market Research - Lidocaine Hydrochloride Market Share, Size, Trends, Industry ...
4. GlobeNewswire - Global Lidocaine Hydrochloride Market Size/Share Value
5. Polaris Market Research - Lidocaine Hydrochloride Market Expect $838.6 Mn By 2032,CAGR ...