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Last Updated: December 22, 2024

BUPIVACAINE LIPOSOME Drug Patent Profile


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Which patents cover Bupivacaine Liposome, and what generic alternatives are available?

Bupivacaine Liposome is a drug marketed by Hengrui Pharma and is included in one NDA.

The generic ingredient in BUPIVACAINE LIPOSOME is bupivacaine. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bupivacaine profile page.

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Summary for BUPIVACAINE LIPOSOME
Drug patent expirations by year for BUPIVACAINE LIPOSOME
Recent Clinical Trials for BUPIVACAINE LIPOSOME

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

SponsorPhase
Yongtao SunPhase 4
Rutgers, The State University of New JerseyPhase 2/Phase 3
Zhejiang Cancer HospitalPhase 4

See all BUPIVACAINE LIPOSOME clinical trials

Pharmacology for BUPIVACAINE LIPOSOME
Drug ClassAmide Local Anesthetic
Physiological EffectLocal Anesthesia

US Patents and Regulatory Information for BUPIVACAINE LIPOSOME

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hengrui Pharma BUPIVACAINE LIPOSOME bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 214348-001 Jul 1, 2024 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hengrui Pharma BUPIVACAINE LIPOSOME bupivacaine INJECTABLE, LIPOSOMAL;INJECTION 214348-002 Jul 1, 2024 AP RX 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 LIPOSOME Market Analysis and Financial Projection Experimental

Bupivacaine Liposome: Market Dynamics and Financial Trajectory

Market Overview

The bupivacaine liposome market, particularly exemplified by products like EXPAREL® (bupivacaine liposome injectable suspension), is experiencing significant growth driven by several key factors.

Market Size and Growth

The global liposomal bupivacaine market was valued at USD 1.5 billion in 2023 and is projected to reach USD 2.5 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6% from 2024 to 2031[1].

Drivers of Growth

Several factors are driving the expansion of the bupivacaine liposome market:

Increasing Surgical Procedures

The rise in the number of surgical procedures worldwide is a major driver. As more surgeries are performed, the demand for effective postoperative pain management solutions increases, favoring the use of liposomal bupivacaine[1].

Longer-Lasting Pain Relief and Reduced Opioid Use

Liposomal bupivacaine offers longer-lasting pain relief compared to traditional bupivacaine, reducing the need for opioids. This aligns with the global effort to minimize opioid use and improve patient outcomes, further boosting its adoption[1].

Continuous Research and Development

Ongoing research into new clinical applications and advancements in drug delivery methods are also propelling the market forward. These innovations enhance the efficacy and versatility of liposomal bupivacaine, making it more appealing to healthcare professionals[1].

Growing Awareness Among Medical Professionals

Increased awareness among medical professionals about the benefits of liposomal bupivacaine, such as its ability to provide sustained pain relief, is driving its acceptance and use in various medical settings[1].

Market Segmentation

The bupivacaine liposome market can be segmented in several ways:

By Type

The market is segmented into different volumes, such as 20ml and 10ml, catering to various clinical needs[4].

By End Use

The market is divided into human and veterinary uses, with the human segment being the primary driver due to the high demand for postoperative pain management[4].

By Application

Liposomal bupivacaine is used in various surgical applications, including general surgeries, plastic surgery, and cosmetic surgeries[3].

By Route of Administration

The drug can be administered through different routes, including intravenous and other methods, depending on the clinical requirement[3].

By Region

The market is segmented geographically into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa, with North America being a significant market due to high surgical volumes and advanced healthcare infrastructure[4].

Financial Performance

Pacira Pharmaceuticals, Inc., a key player in the market, has seen significant financial growth since the launch of EXPAREL®. In the second quarter of 2012, EXPAREL sales totaled $2.3 million, with 428 accounts ordering the product and a high reorder rate among hospital accounts[2].

Revenue Growth

The revenue from EXPAREL has been a substantial contributor to Pacira's financial performance. The company's net product sales, including EXPAREL, have shown a marked increase year over year, reflecting the market's growing demand for this product[2].

Operating Expenses

The commercialization efforts for EXPAREL and manufacturing costs have driven an increase in total operating expenses. However, these investments are expected to yield long-term benefits as the market continues to expand[2].

Competitive Landscape

The competitive landscape of the bupivacaine liposome market is characterized by several key players:

Major Players

Companies such as Pacira Pharmaceuticals, Sun Pharmaceutical Industries Ltd, Johnson and Johnson, Merck and Co, Cipla Inc, and Cadila Pharmaceuticals are prominent in this market. These companies are engaged in continuous research and development to enhance their product offerings and expand their market share[4].

Market Dynamics Analysis

A Porter’s Five Forces analysis reveals the competitive dynamics, including the bargaining power of buyers and suppliers, the threat of new entrants, the threat of substitutes, and the degree of competition within the market. This analysis helps in understanding the market's overall competitive landscape and the strategies employed by key players[1].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the bupivacaine liposome market. While elective surgeries were postponed during the peak of the pandemic, the long-term demand for postoperative pain management solutions has remained robust. The pandemic has also accelerated the adoption of innovative pain management strategies, including the use of liposomal bupivacaine[4].

Clinical Efficacy

Clinical trials have demonstrated the efficacy of liposomal bupivacaine compared to standard bupivacaine. For instance, a randomized clinical trial showed that liposomal bupivacaine provided better pain control on postoperative days 1 and 2, although the difference was not significant by day 3[5].

Key Takeaways

  • The bupivacaine liposome market is expected to grow significantly, driven by increasing surgical procedures and the need for effective postoperative pain management.
  • The market is valued at USD 1.5 billion in 2023 and is projected to reach USD 2.5 billion by 2031.
  • Key drivers include longer-lasting pain relief, reduced opioid use, and continuous research and development.
  • Major players are investing heavily in commercialization and manufacturing to capitalize on the growing demand.
  • The competitive landscape is characterized by a few dominant players, with a high degree of competition.

FAQs

What is the projected market size of the bupivacaine liposome market by 2031?

The bupivacaine liposome market is expected to reach USD 2.5 billion by 2031, growing at a CAGR of 6% from 2024 to 2031[1].

What are the primary drivers of the bupivacaine liposome market?

The primary drivers include the increasing number of surgical procedures, the need for longer-lasting pain relief, reduced opioid use, and continuous research and development[1].

Which companies are key players in the bupivacaine liposome market?

Key players include Pacira Pharmaceuticals, Sun Pharmaceutical Industries Ltd, Johnson and Johnson, Merck and Co, Cipla Inc, and Cadila Pharmaceuticals[4].

How has the COVID-19 pandemic affected the bupivacaine liposome market?

The pandemic has had a mixed impact, with short-term disruptions in elective surgeries but long-term growth driven by the need for innovative pain management solutions[4].

What are the clinical benefits of liposomal bupivacaine compared to standard bupivacaine?

Liposomal bupivacaine provides better pain control on postoperative days 1 and 2 and reduces the need for opioids, although the difference in pain control may not be significant by day 3[5].

What is the segmentation of the bupivacaine liposome market?

The market is segmented by type (20ml, 10ml), end use (human, veterinary), application (general surgeries, plastic surgery, cosmetic surgeries), route of administration (intravenous, others), and region (North America, Europe, Asia-Pacific, etc.)[3][4].

Sources

  1. Market Research Intellect: Liposomal Bupivacaine Market Size, Share and Trends [2024-2031][1].
  2. Pacira Pharmaceuticals: Pacira Pharmaceuticals, Inc. Reports $2.3 Million in Second Quarter EXPAREL® Revenue and Full Second Quarter 2012 Financial Results[2].
  3. GlobeNewswire: Local Anesthesia Drugs Market is estimated to be US$ 8.5 billion by 2032 with a CAGR of 4.2% over the forecast period (2022-2032) - By PMI[3].
  4. The Insight Partners: Bupivacaine Liposome Injectable Suspension Market Insights and Forecast[4].
  5. JAMA Network Open: Standard vs Liposomal Bupivacaine for Postoperative Pain Control[5].

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