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Last Updated: December 22, 2024

MARCAINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Marcaine Hydrochloride, and what generic alternatives are available?

Marcaine Hydrochloride is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in MARCAINE HYDROCHLORIDE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.

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Drug patent expirations by year for MARCAINE HYDROCHLORIDE
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Recent Clinical Trials for MARCAINE HYDROCHLORIDE

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

SponsorPhase
Rutgers, The State University of New JerseyPhase 2/Phase 3
Pacira Pharmaceuticals, IncPhase 2/Phase 3
Hartford HospitalPhase 4

See all MARCAINE HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for MARCAINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira MARCAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 016964-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira MARCAINE HYDROCHLORIDE W/ EPINEPHRINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 016964-008 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira MARCAINE HYDROCHLORIDE PRESERVATIVE FREE bupivacaine hydrochloride INJECTABLE;INJECTION 016964-005 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 016964-013 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira MARCAINE HYDROCHLORIDE bupivacaine hydrochloride INJECTABLE;INJECTION 016964-006 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira MARCAINE HYDROCHLORIDE PRESERVATIVE FREE bupivacaine hydrochloride INJECTABLE;INJECTION 016964-012 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  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

MARCAINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Marcaine Hydrochloride

Overview of Marcaine Hydrochloride

Marcaine Hydrochloride, also known as bupivacaine hydrochloride, is a local anesthetic commonly used for producing local or regional anesthesia or analgesia in various medical procedures, including surgery, dental, and oral procedures[2].

Market Size and Forecast

The global market for bupivacaine hydrochloride is experiencing significant growth. As of 2023, the market was valued at approximately $251 million and is forecasted to reach $361.9 million by 2030, with a Compound Annual Growth Rate (CAGR) of 5.4% during the forecast period of 2024-2030[1].

However, when considering the broader market for bupivacaine injections, the figures are more expansive. The global bupivacaine injection market was valued at $1,120.21 million in 2023 and is estimated to reach $2,088.37 million by 2032, growing at a CAGR of 5.6% during the forecast period of 2024-2032[3].

Regional Market Analysis

The market for bupivacaine hydrochloride is segmented geographically into several regions, including North America, Europe, Asia-Pacific, and the Middle East and Africa.

  • North America: This region is expected to have the highest CAGR during the forecast period, driven by technological advancements in healthcare, an aging population with increasing chronic pain conditions, and a high rate of surgical procedures[4].
  • Asia-Pacific: This region is also a significant market, with countries like China, India, and Japan contributing to the growth due to increasing healthcare needs and infrastructure development[3][4].
  • Europe: Europe is another key market, with a growing demand driven by the need for effective anesthetic solutions in various medical procedures[3].

Key Players and Market Competition

The bupivacaine hydrochloride market is highly competitive, with several key players:

  • Pfizer Inc.
  • Fresenius Kabi AG
  • Hikma Pharmaceuticals
  • Baxter International Inc.
  • AstraZeneca
  • AuroMedics Pharma LLC
  • Shanghai Harvest Pharmaceutical Co.
  • Southwest Pharma
  • Hunan Kelun Pharmaceutical
  • Aurobindo Pharma
  • Sagent Pharmaceuticals[4].

The presence of generic versions of bupivacaine hydrochloride injections introduces price competition, which can erode profit margins for branded manufacturers. This competition may lead to mergers, acquisitions, or partnerships to achieve economies of scale and maintain profitability[4].

Pricing and Cost Analysis

The pricing of Marcaine Hydrochloride varies based on concentration and volume:

  • 0.25% preservative-free solution: Around $51.95 for 100 milliliters[5].
  • 0.5% preservative-free solution: Approximately $59.46 for 100 milliliters[5].
  • 0.75% preservative-free solution: About $59.74 for 100 milliliters[5].

Generic versions of bupivacaine hydrochloride are also available at lower prices, such as $10.24 for 10 milliliters, which further influences market dynamics[5].

Applications and Uses

Marcaine Hydrochloride is used in various medical applications:

  • Local Infiltration: For procedures requiring local anesthesia.
  • Peripheral Nerve Block: For surgeries and pain management.
  • Retrobulbar Block: For ophthalmic procedures.
  • Sympathetic Block: For managing chronic pain.
  • Caudal Block: For lower back and pelvic procedures.
  • Lumbar Epidural Block: For surgeries and pain relief in the lower back and legs[2].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the bupivacaine hydrochloride market. While there was an initial disruption in supply chains and healthcare services, the long-term effect has been an increased demand for anesthetic solutions due to the surge in medical procedures and the need for effective pain management[4].

Growth Factors and Trends

Several factors drive the growth of the bupivacaine hydrochloride market:

  • High Prevalence of Chronic Pain: Increasing cases of chronic pain conditions drive the demand for effective anesthetic solutions.
  • Growing Opportunities in Anesthetic Drug Approvals: New approvals and advancements in anesthetic drugs contribute to market growth.
  • Technological Advancements in Healthcare: Improved healthcare infrastructure and technological advancements in North America and other regions boost the market[3][4].

Challenges and Limitations

Despite the growth, the market faces several challenges:

  • Price Competition from Generic Versions: Generic versions entering the market at lower prices can erode profit margins for branded manufacturers.
  • Market Saturation: High competition and the presence of multiple manufacturers can lead to market saturation.
  • Regulatory Hurdles: Strict regulatory requirements can slow down the approval process for new anesthetic solutions[4].

Key Developments

The market is witnessing several key developments, including research and development initiatives, partnerships, and mergers and acquisitions among manufacturers to maintain competitiveness and achieve economies of scale[4].

"Generic versions of bupivacaine hydrochloride injections typically enter the market at lower prices than their branded counterparts. This can lead to price competition and erosion of profit margins for the original manufacturer." - Source: StrategyMRC[4]

Conclusion

The market for Marcaine Hydrochloride is poised for significant growth, driven by increasing demand for effective anesthetic solutions, technological advancements, and growing healthcare needs. However, the market also faces challenges such as price competition from generic versions and regulatory hurdles.

Key Takeaways

  • The global bupivacaine hydrochloride market is forecasted to reach $361.9 million by 2030.
  • The broader bupivacaine injection market is estimated to reach $2,088.37 million by 2032.
  • North America is expected to have the highest CAGR during the forecast period.
  • Key players include Pfizer, Fresenius Kabi, and Hikma Pharmaceuticals.
  • Generic versions introduce price competition, affecting profit margins.
  • The market is driven by chronic pain prevalence, anesthetic drug approvals, and technological advancements.

FAQs

Q: What is the forecasted market size for bupivacaine hydrochloride by 2030? A: The global market for bupivacaine hydrochloride is forecasted to reach $361.9 million by 2030[1].

Q: Which region dominates the global bupivacaine injection market? A: North America dominates the global bupivacaine injection market, with the highest CAGR during the forecast period[4].

Q: What are the primary applications of Marcaine Hydrochloride? A: Marcaine Hydrochloride is used for local infiltration, peripheral nerve block, retrobulbar block, sympathetic block, caudal block, and lumbar epidural block[2].

Q: How does the presence of generic versions affect the market? A: Generic versions of bupivacaine hydrochloride injections introduce price competition, which can erode profit margins for branded manufacturers and lead to market saturation[4].

Q: What are the key factors driving the growth of the bupivacaine hydrochloride market? A: The market is driven by the high prevalence of chronic pain, growing opportunities in anesthetic drug approvals, and technological advancements in healthcare[3][4].

Sources

  1. Valuates Reports: Bupivacaine Hydrochloride - Market Size.
  2. Drugs.com: Marcaine: Package Insert / Prescribing Information.
  3. StraitsResearch: Bupivacaine Injection Market Size, Share & Trends Analysis Report.
  4. StrategyMRC: Bupivacaine Hydrochloride Injection Market CAGR, size, share.
  5. Drugs.com: Marcaine HCl Prices, Coupons, Copay Cards & Patient Assistance.

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