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Last Updated: December 22, 2024

BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE - Generic Drug Details


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

Bupivacaine hydrochloride; lidocaine hydrochloride is the generic ingredient in one branded drug marketed by Amphastar Pharms Inc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 225
DailyMed Link:BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE

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SponsorPhase
Montefiore Medical CenterN/A
Jessyka LighthallPhase 3
Jamia Millia IslamiaN/A

See all BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amphastar Pharms Inc DUOCAINE bupivacaine hydrochloride; lidocaine hydrochloride INJECTABLE;INJECTION 021496-001 May 23, 2003 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bupivacaine Hydrochloride and Lidocaine Hydrochloride

Introduction to Bupivacaine Hydrochloride and Lidocaine Hydrochloride

Bupivacaine hydrochloride and lidocaine hydrochloride are two widely used local anesthetics in the medical field. Understanding their market dynamics and financial trajectories is crucial for stakeholders, including pharmaceutical companies, healthcare providers, and investors.

Market Dynamics of Bupivacaine Hydrochloride

Market Size and Growth Projections

The global market for bupivacaine hydrochloride has been experiencing significant growth. As of 2023, the market was valued at approximately $251 million and is projected to reach $361.9 million by 2030, with a Compound Annual Growth Rate (CAGR) of 5.4% during the forecast period of 2024-2030[4].

Segmentation by Type and Application

The market is segmented by type, including injections and gels, and by application, which includes hospitals, clinics, and other healthcare facilities. These segments are critical in understanding the diverse uses and demand for bupivacaine hydrochloride across different healthcare settings[1][4].

Geographical Regions

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America is expected to hold a significant share due to the presence of major market players and the high volume of surgical procedures in the region[1][4].

Drivers and Opportunities

Key drivers include the increasing number of surgical procedures, the rise in chronic and acute pain-related disorders, and the effectiveness of bupivacaine hydrochloride in postoperative pain management. For instance, liposomal bupivacaine has shown promise in reducing postoperative pain, although it may require more opioid use compared to standard bupivacaine[2].

Challenges and Restraints

Despite the positive outlook, the market faces challenges such as regulatory hurdles and the need for additional clinical trials to address FDA requirements. For example, Innocoll’s XARACOLL, a surgically implantable and bioresorbable collagen matrix delivering bupivacaine, faced regulatory delays and the need for further studies[5].

Market Dynamics of Lidocaine Hydrochloride

Market Size and Growth Projections

The lidocaine hydrochloride market is expected to grow at a CAGR of 4.1% by 2027. The market's growth is driven by the high prevalence of dental disorders, the increase in surgical procedures, and the potential benefits of lidocaine in treating COVID-19 patients[3].

Segmentation by Application

The market is segmented by application, with significant growth anticipated in the dental procedure segment. Lidocaine hydrochloride is extensively used in dental surgical procedures, such as buccal infiltration and lingual anesthesia, which are essential for various dental treatments[3].

Geographical Regions

North America is expected to hold a significant share in the lidocaine hydrochloride market due to the presence of major market players and the high efficiency of lidocaine in various surgical procedures in the region[3].

Drivers and Opportunities

Key drivers include the high prevalence of dental disorders, the rise in chronic and acute pain-related disorders, and the anti-inflammatory and pain reduction properties of lidocaine hydrochloride. For example, the WHO estimates that severe periodontal diseases affect around 14% of the global adult population, driving the demand for lidocaine hydrochloride in dental treatments[3].

Challenges and Restraints

The market faces challenges such as the impact of the COVID-19 pandemic on surgical procedures and the potential for regulatory changes. However, the relaxation of strict regulations post-pandemic and the resumption of surgical services are expected to drive the demand for lidocaine hydrochloride[3].

Financial Trajectory

Revenue Forecast

For bupivacaine hydrochloride, the revenue is expected to grow from $251 million in 2023 to $361.9 million by 2030, indicating a robust financial trajectory. Similarly, the lidocaine hydrochloride market is poised to grow with a CAGR of 4.1% by 2027, driven by increasing demand in dental and surgical procedures[3][4].

Key Players and Competitive Landscape

Both markets are characterized by the presence of major pharmaceutical companies. For bupivacaine hydrochloride, key players include Pfizer, Fresenius Kabi, Hikma Pharmaceuticals, and others. In the lidocaine hydrochloride market, the competitive landscape includes companies that specialize in anesthetic products and are well-positioned to capitalize on the growing demand[3][4].

Impact of COVID-19

Bupivacaine Hydrochloride

The COVID-19 pandemic had a mixed impact on the bupivacaine hydrochloride market. While there were initial disruptions in surgical procedures, the market is expected to recover and grow as healthcare services resume and new products like XARACOLL are developed to address postoperative pain[5].

Lidocaine Hydrochloride

Lidocaine hydrochloride saw potential benefits during the pandemic due to its proposed use in treating COVID-19 patients. Nebulized lidocaine was suggested as a treatment to reduce cytokines and protect patients' lungs, which temporarily boosted its market growth[3].

Key Takeaways

  • Growth Projections: Both bupivacaine hydrochloride and lidocaine hydrochloride markets are expected to grow significantly, with bupivacaine hydrochloride projected to reach $361.9 million by 2030 and lidocaine hydrochloride growing at a CAGR of 4.1% by 2027.
  • Segmentation: The markets are segmented by type, application, and geographical regions, with North America holding a significant share in both markets.
  • Drivers: Increasing surgical procedures, chronic pain disorders, and the effectiveness of these anesthetics are key drivers.
  • Challenges: Regulatory hurdles, COVID-19 impacts, and the need for additional clinical trials are significant challenges.
  • Financial Trajectory: Both markets show robust financial growth, driven by increasing demand and the presence of major pharmaceutical companies.

FAQs

Q: What is the projected market size for bupivacaine hydrochloride by 2030?

A: The global market for bupivacaine hydrochloride is forecast to reach $361.9 million by 2030[4].

Q: What are the key drivers for the lidocaine hydrochloride market?

A: The high prevalence of dental disorders, the increase in surgical procedures, and the anti-inflammatory and pain reduction properties of lidocaine hydrochloride are key drivers[3].

Q: How did the COVID-19 pandemic impact the bupivacaine hydrochloride market?

A: The pandemic had a mixed impact, with initial disruptions in surgical procedures but potential for recovery and growth as healthcare services resume[5].

Q: Which regions are expected to hold significant shares in the bupivacaine hydrochloride and lidocaine hydrochloride markets?

A: North America is expected to hold significant shares in both markets due to the presence of major market players and the high volume of surgical procedures[1][3].

Q: What are some of the challenges faced by the bupivacaine hydrochloride market?

A: Regulatory hurdles, the need for additional clinical trials, and the impact of COVID-19 on surgical procedures are significant challenges[5].

Sources

  1. Market Research Intellect: Bupivacaine Hydrochloride (CAS 14252-80-3) Market Size, Scope ...
  2. JAMA Network: Standard vs Liposomal Bupivacaine for Postoperative Pain Control ...
  3. Mordor Intelligence: Lidocaine Hydrochloride Market - Share, Trends & Size
  4. Valuates Reports: Bupivacaine Hydrochloride - Market Size
  5. BioSpace: Innocoll Announces Regulatory Path Forward After Receiving Formal FDA Type A Meeting Minutes Regarding Its XARACOLL (Bupivacaine Hcl Collagen-Matrix) ...

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