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Last Updated: December 22, 2024

PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE Drug Patent Profile


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Which patents cover Prilocaine Hydrochloride And Epinephrine Bitartrate, and when can generic versions of Prilocaine Hydrochloride And Epinephrine Bitartrate launch?

Prilocaine Hydrochloride And Epinephrine Bitartrate is a drug marketed by Septodont Inc and is included in one NDA.

The generic ingredient in PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE is epinephrine bitartrate; prilocaine hydrochloride. There are twenty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinephrine bitartrate; prilocaine hydrochloride profile page.

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Summary for PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
Drug patent expirations by year for PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
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US Patents and Regulatory Information for PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Septodont Inc PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE epinephrine bitartrate; prilocaine hydrochloride INJECTABLE;INJECTION 078959-001 Aug 30, 2011 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

PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Prilocaine Hydrochloride and Epinephrine Bitartrate

Introduction to Prilocaine Hydrochloride and Epinephrine Bitartrate

Prilocaine hydrochloride, often combined with epinephrine bitartrate, is a local anesthetic widely used in dentistry for infiltration and nerve block procedures. This combination is crucial for its anesthetic and vasoconstrictive properties, enhancing the duration and efficacy of the anesthesia.

Market Size and Growth Prospects

The global local anesthesia drugs market, which includes prilocaine hydrochloride and epinephrine bitartrate, is anticipated to grow significantly. By 2030, the market is expected to reach USD 5.14 billion, growing at a Compound Annual Growth Rate (CAGR) of 3.6% from 2024 to 2030[3].

Drivers of Market Growth

Increasing Surgical Procedures

The rise in the number of surgical procedures, including dental, cosmetic, and plastic surgeries, is a key driver of the local anesthesia market. Approximately 65% of all surgical procedures require post-operative pain management, which is likely to boost the demand for local anesthetics like prilocaine hydrochloride and epinephrine bitartrate[3].

Advancements in Drug Delivery Systems

Advancements in drug delivery systems, particularly for injectable and surface anesthetics, are expected to drive market growth. New formulations and delivery methods enhance the efficacy and safety of local anesthetics, making them more appealing to healthcare providers[3].

Rising Healthcare Expenditure

Increasing healthcare expenditure in developing countries such as India, China, and Brazil is expected to result in a higher number of surgeries, thereby increasing the demand for local anesthetics[3].

Market Segmentation

By Product

While lidocaine has historically dominated the market, other local anesthetics like prilocaine hydrochloride are gaining traction due to their specific uses and advantages. Prilocaine hydrochloride, especially when combined with epinephrine, is preferred for certain dental procedures due to its rapid onset and moderate duration of action[2][3].

By Application

The market is bifurcated into injectable and surface anesthetics. The injectable segment, which includes prilocaine hydrochloride and epinephrine bitartrate, is expected to dominate the market during the forecast period due to its extensive use in various surgical procedures[3].

Regional Market Analysis

North America

North America holds the largest share in the local anesthesia drugs market, driven by a significant number of surgical procedures performed in the region. The presence of major pharmaceutical companies and advanced healthcare infrastructure also contributes to this dominance[3].

Other Regions

Europe, Asia Pacific, and Latin America are also significant markets, with growing healthcare expenditure and an increasing number of surgical procedures driving the demand for local anesthetics in these regions[3].

Competitive Landscape

The market for local anesthesia drugs is competitive, with several key players such as Aspen Pharmacare, Fresenius Kabi, Novartis, Inc., Sagent Pharmaceutical, Pacira Pharmaceutical, Mylan, and Teva Pharmaceuticals. These companies are involved in continuous research and development to improve existing formulations and introduce new products[3].

Financial Trajectory

Market Value

The estimated market value for local anesthesia drugs was USD 4.01 billion in 2023 and is projected to reach USD 5.14 billion by 2030. This growth indicates a stable and increasing financial trajectory for products like prilocaine hydrochloride and epinephrine bitartrate[3].

Pricing and Cost Considerations

The cost of prilocaine hydrochloride and epinephrine bitartrate can vary based on the manufacturer, region, and specific formulation. However, the overall trend suggests that while prices may fluctuate, the demand-driven growth will support a stable financial outlook for these products.

Challenges and Restraints

Regulatory Hurdles

Stringent regulatory requirements and the need for continuous compliance can pose challenges for manufacturers. Ensuring the safety and efficacy of local anesthetics while adhering to regulatory standards is crucial[2].

Side Effects and Contraindications

Prilocaine hydrochloride, especially when combined with epinephrine, has specific contraindications and potential side effects, such as methemoglobinemia and cardiovascular effects. These factors must be carefully managed by healthcare providers, which can sometimes limit market growth[1][2].

Key Takeaways

  • The global local anesthesia drugs market, including prilocaine hydrochloride and epinephrine bitartrate, is expected to grow significantly, reaching USD 5.14 billion by 2030.
  • Increasing surgical procedures and advancements in drug delivery systems are key drivers of market growth.
  • The injectable segment, which includes prilocaine hydrochloride and epinephrine bitartrate, is expected to dominate the market.
  • North America holds the largest share in the market, but other regions are also growing.
  • The competitive landscape is characterized by several major pharmaceutical companies.

FAQs

Q: What is the primary use of prilocaine hydrochloride and epinephrine bitartrate? A: Prilocaine hydrochloride and epinephrine bitartrate are primarily used for the production of local anesthesia in dentistry through nerve block or infiltration.

Q: What are the key drivers of the local anesthesia drugs market? A: The key drivers include the increasing number of surgical procedures, advancements in drug delivery systems, and rising healthcare expenditure in developing countries.

Q: Which region dominates the local anesthesia drugs market? A: North America holds the largest share in the local anesthesia drugs market.

Q: What are some potential side effects of prilocaine hydrochloride and epinephrine bitartrate? A: Potential side effects include methemoglobinemia, cardiovascular effects, and exaggerated vasoconstrictor responses in certain patients.

Q: Who are some of the key players in the local anesthesia drugs market? A: Key players include Aspen Pharmacare, Fresenius Kabi, Novartis, Inc., Sagent Pharmaceutical, Pacira Pharmaceutical, Mylan, and Teva Pharmaceuticals.

Sources

  1. Prilocaine HCI 4% with Epinephrine 1:200,000 Injection - FDA Label[1]
  2. Dentsply 4% Prilocaine Hydrochloride Dental Injection - Product Monograph[2]
  3. Local Anesthesia Drugs Market Size, Share & Trends Analysis 2024-2030 - GlobeNewswire[3]

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