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Last Updated: April 15, 2025

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE Drug Patent Profile


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When do Marcaine Hydrochloride W/ Epinephrine patents expire, and when can generic versions of Marcaine Hydrochloride W/ Epinephrine launch?

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

The generic ingredient in MARCAINE HYDROCHLORIDE W/ EPINEPHRINE 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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Summary for MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
Drug patent expirations by year for MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
Recent Clinical Trials for MARCAINE HYDROCHLORIDE W/ EPINEPHRINE

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

SponsorPhase
University of California, San FranciscoPhase 3
Carilion ClinicPhase 3
University of Wisconsin, MadisonPhase 4

See all MARCAINE HYDROCHLORIDE W/ EPINEPHRINE clinical trials

Pharmacology for MARCAINE HYDROCHLORIDE W/ EPINEPHRINE

US Patents and Regulatory Information for MARCAINE HYDROCHLORIDE W/ EPINEPHRINE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Hospira MARCAINE HYDROCHLORIDE W/ EPINEPHRINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 016964-004 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 016964-007 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira MARCAINE HYDROCHLORIDE W/ EPINEPHRINE bupivacaine hydrochloride; epinephrine bitartrate INJECTABLE;INJECTION 016964-008 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
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 ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for MARCAINE Hydrochloride with Epinephrine

Introduction to MARCAINE Hydrochloride with Epinephrine

MARCAINE Hydrochloride with Epinephrine is a widely used local anesthetic and analgesic combination, consisting of bupivacaine, an amide local anesthetic, and epinephrine, an alpha and beta-adrenergic agonist. This medication is indicated for various surgical, dental, and obstetrical procedures to produce local or regional anesthesia or analgesia[1][2].

Market Size and Growth

The global market for bupivacaine injections, which includes MARCAINE Hydrochloride with Epinephrine, is experiencing significant growth. As of 2023, the global bupivacaine injection market was valued at USD 1,120.21 million. It is projected to reach USD 2,088.37 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 5.6% during the forecast period from 2024 to 2032[3].

Regional Market Segmentation

The bupivacaine injection market is segmented into several regions, including the Americas, Europe, Asia-Pacific, and the Middle East and Africa. The American market holds a considerable share and is expected to increase rapidly. However, the fastest-growing market is anticipated to be Europe, while Asia-Pacific is also a significant contributor to the global market[3].

Drivers of Market Growth

Several factors are driving the demand for bupivacaine injections:

  • High Prevalence of Malocclusion: The increasing need for dental and oral surgeries due to malocclusion contributes to the demand for local anesthetics like MARCAINE.
  • Growing Opportunities in Anesthetic Drug Approvals: Advances in medical technology and the approval of new anesthetic drugs are expanding the market.
  • Increasing Surgical Procedures: The rise in surgical procedures across various specialties, including abdominal operations and retrobulbar anesthesia, further boosts the market[3].

Key Applications and Indications

MARCAINE Hydrochloride with Epinephrine is versatile and used in various medical procedures:

  • Surgical Procedures: It is most useful for epidural block in abdominal operations requiring complete muscle relaxation and for retrobulbar anesthesia[2].
  • Dental and Oral Surgery: Commonly used for local or regional anesthesia in dental procedures.
  • Diagnostic and Therapeutic Procedures: Indicated for procedures that require local or regional anesthesia or analgesia.
  • Obstetrical Procedures: However, it is not recommended for obstetrical anesthesia due to specific risks associated with its use[1][2].

Concentrations and Motor Function

The drug is available in different concentrations, each with distinct effects on motor function:

  • 0.25% (2.5 mg/mL): Produces incomplete motor block, suitable for operations where muscle relaxation is not critical.
  • 0.5% (5 mg/mL): Provides motor blockade but may not be sufficient for operations requiring complete muscle relaxation.
  • 0.75% (7.5 mg/mL): Produces complete motor block, ideal for abdominal operations and retrobulbar anesthesia[1][2].

Safety and Precautions

While MARCAINE Hydrochloride with Epinephrine is effective, it comes with several safety considerations:

  • Risk of Cardiac Arrest: Particularly in obstetrical anesthesia and intravenous regional anesthesia (Bier block)[2][5].
  • Dose-Related Toxicity: Excessive plasma levels can lead to adverse reactions[2].
  • Methemoglobinemia: Patients with certain conditions are more susceptible to this condition, which requires close monitoring and immediate treatment if symptoms appear[1][2].
  • Allergic-Type Reactions: Due to the presence of sulfites, which can cause anaphylactic symptoms and asthmatic episodes in susceptible individuals[5].

Pharmacokinetics and Metabolism

The pharmacokinetics of MARCAINE are influenced by several factors:

  • Half-Life: The half-life in adults is approximately 2.7 hours, and in neonates, it is 8.1 hours.
  • Metabolism: Primarily metabolized in the liver via conjugation with glucuronic acid. Patients with hepatic disease may have altered pharmacokinetic parameters[4].

Financial Trajectory

The financial trajectory of the bupivacaine injection market, including MARCAINE Hydrochloride with Epinephrine, is positive and growing. Here are some key financial highlights:

  • Current Market Value: USD 1,120.21 million as of 2023.
  • Projected Market Value: Expected to reach USD 2,088.37 million by 2032.
  • Growth Rate: A CAGR of 5.6% during the forecast period from 2024 to 2032[3].

Competitive Landscape

The market for bupivacaine injections is competitive, with several pharmaceutical companies involved in the production and distribution of these drugs. The competitive landscape is driven by factors such as product innovation, regulatory approvals, and market penetration strategies.

Conclusion

The market for MARCAINE Hydrochloride with Epinephrine is robust and growing, driven by increasing demand for local anesthetics in various medical procedures. The drug's versatility, efficacy, and the expanding global healthcare needs contribute to its financial trajectory. However, it is crucial to consider the safety precautions and potential risks associated with its use.

Key Takeaways

  • Growing Market: The global bupivacaine injection market is projected to grow significantly by 2032.
  • Regional Segmentation: The market is segmented into several regions, with the Americas and Europe being key contributors.
  • Versatile Applications: Used in surgical, dental, and diagnostic procedures.
  • Safety Considerations: Important to monitor for risks such as cardiac arrest, dose-related toxicity, and methemoglobinemia.
  • Pharmacokinetics: Metabolized primarily in the liver, with half-life varying by age and health status.

FAQs

Q: What are the common concentrations of MARCAINE Hydrochloride with Epinephrine? A: The drug is available in 0.25%, 0.5%, and 0.75% concentrations, each with different effects on motor function[1][2].

Q: What are the primary indications for MARCAINE Hydrochloride with Epinephrine? A: It is indicated for surgical, dental, and diagnostic procedures, as well as for certain obstetrical procedures, though with specific limitations[1][2].

Q: What are the potential risks associated with MARCAINE Hydrochloride with Epinephrine? A: Risks include cardiac arrest, dose-related toxicity, methemoglobinemia, and allergic-type reactions due to sulfites[1][2][5].

Q: How is MARCAINE Hydrochloride with Epinephrine metabolized? A: It is primarily metabolized in the liver via conjugation with glucuronic acid[4].

Q: What is the projected market size for bupivacaine injections by 2032? A: The global market is expected to reach USD 2,088.37 million by 2032, growing at a CAGR of 5.6% from 2024 to 2032[3].

Sources

  1. Pfizer Medical Information: MARCAINE AND EPINEPHRINE - VIAL.
  2. DailyMed: bupivacaine hydrochloride injection, solution MARCAINE WITH EPINEPHRINE.
  3. Straits Research: Bupivacaine Injection Market Size, Share & Trends Analysis Report.
  4. FDA: Marcaine Bupivacaine Hydrochloride injection label.
  5. Pfizer Medical Information: MARCAINE AND EPINEPHRINE - VIAL Warnings and Precautions.

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