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Last Updated: December 22, 2024

LIGNOSPAN STANDARD Drug Patent Profile


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When do Lignospan Standard patents expire, and what generic alternatives are available?

Lignospan Standard is a drug marketed by Deproco and is included in one NDA.

The generic ingredient in LIGNOSPAN STANDARD is epinephrine bitartrate; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the epinephrine bitartrate; lidocaine hydrochloride profile page.

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Summary for LIGNOSPAN STANDARD
Drug patent expirations by year for LIGNOSPAN STANDARD
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US Patents and Regulatory Information for LIGNOSPAN STANDARD

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Deproco LIGNOSPAN STANDARD epinephrine bitartrate; lidocaine hydrochloride INJECTABLE;INJECTION 088390-001 Jan 22, 1985 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

LIGNOSPAN STANDARD Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LIGNOSPAN STANDARD

Introduction

LIGNOSPAN STANDARD, a local anesthetic formulation containing lidocaine HCl 2% and epinephrine 1:100,000, is widely used in dental procedures. Understanding the market dynamics and financial trajectory of this product is crucial for manufacturers, distributors, and healthcare professionals.

Market Overview

Demand and Usage

LIGNOSPAN STANDARD is a preferred choice for most routine dental procedures due to its effective anesthesia and hemostatic properties. A survey among Ontario dentists revealed that formulations with epinephrine 1:100,000, such as LIGNOSPAN STANDARD, were the most commonly used, accounting for 56.03% of total local anesthetic use[1].

Competitive Landscape

The market for local anesthetics is competitive, with several brands and formulations available. However, LIGNOSPAN STANDARD holds a significant market share due to its reliability and effectiveness. The generic drug industry dynamics, as studied by the Federal Trade Commission, indicate that prices fall with the number of competitors, but remain above long-run marginal costs until there are 8 or more competitors[3].

Product Characteristics

Formulation and Indications

LIGNOSPAN STANDARD is formulated with lidocaine HCl 2% and epinephrine 1:100,000, making it suitable for local dental anesthesia by infiltration or nerve block techniques. The no-methylparaben formula and latex-free components reduce the risk of allergic reactions, enhancing patient safety[2][4].

Dosage and Administration

The dosage of LIGNOSPAN STANDARD depends on the patient's physical status, the area of the oral cavity, and the technique of anesthesia used. For most routine procedures, the maximum recommended dosage is 500 mg or 7 mg/kg of body weight for healthy adults[4][5].

Market Trends

Changes in Usage Patterns

A survey among dentists indicated that 15.68% had changed their pattern of local anesthetic use in the past two years, with the most frequent changes involving the reduction or discontinuation of 4% solutions for nerve block injections. However, LIGNOSPAN STANDARD remained a staple due to its efficacy and availability[1].

Regulatory Influences

Regulatory changes, such as increased FDA scrutiny of generic drug applications, can impact the market. These changes may raise the cost of obtaining approval, potentially affecting the entry of new competitors and the overall market dynamics[3].

Financial Trajectory

Pricing and Revenue

The price of LIGNOSPAN STANDARD can vary depending on the vendor and volume of purchase. For instance, a box of 50 cartridges can range from $48.75 to $62.59, depending on the supplier and any applicable discounts[2].

Market Size and Growth

The annual use of local anesthetics, including LIGNOSPAN STANDARD, is substantial. For example, the extrapolated annual use for all Ontario dentists includes over 7 million cartridges of epinephrine 1:100,000 formulations[1]. This high demand indicates a stable and potentially growing market.

Profit Margins

In the generic drug industry, profit margins are influenced by the number of competitors. As more firms enter the market, prices decline, and profit margins are reduced. However, LIGNOSPAN STANDARD, being a well-established product, likely maintains a competitive profit margin despite market competition[3].

Customer and Clinical Perspectives

User Reviews and Feedback

Dental professionals and assistants have consistently praised LIGNOSPAN STANDARD for its fast and effective anesthesia, long-lasting duration, and safety profile. Positive reviews highlight its reliability and effectiveness in various dental procedures[2].

Clinical Efficacy

The clinical efficacy of LIGNOSPAN STANDARD is well-documented. It provides effective local anesthesia with a quick onset time of 2-4 minutes and a duration of 60-90 minutes for nerve blocks and pulpal anesthesia, respectively[2][4].

Challenges and Opportunities

Supply Chain and Availability

Changes in the availability of certain formulations, such as the temporary unavailability of 0.5% bupivacaine with epinephrine 1:200,000 in dental cartridges, can impact market dynamics. Ensuring a stable supply chain is crucial for maintaining market share[1].

Regulatory Compliance

Compliance with regulatory standards is essential. Manufacturers must navigate FDA guidelines and ensure that their products meet all safety and efficacy standards to maintain market approval[3].

Key Takeaways

  • Market Dominance: LIGNOSPAN STANDARD is a leading product in the local anesthetic market, preferred for its efficacy and safety.
  • Regulatory Impact: Regulatory changes can affect the market entry of new competitors and the overall pricing strategy.
  • Financial Stability: The product enjoys a stable financial trajectory due to high demand and established market presence.
  • Clinical Efficacy: Positive clinical feedback and user reviews underscore its effectiveness in dental procedures.
  • Supply Chain Management: Ensuring a stable supply chain is critical to maintaining market share.

FAQs

Q: What is the most common concentration of epinephrine used in local anesthetics by dentists?

A: The most common concentration is epinephrine 1:100,000, which accounts for 56.03% of total local anesthetic use[1].

Q: How does the dosage of LIGNOSPAN STANDARD vary?

A: The dosage depends on the patient's physical status, the area of the oral cavity, and the technique of anesthesia used, with a maximum recommended dosage of 500 mg or 7 mg/kg of body weight for healthy adults[4][5].

Q: What are the key factors influencing the price of LIGNOSPAN STANDARD?

A: Prices are influenced by the number of competitors, regulatory changes, and the vendor's pricing strategy[2][3].

Q: How does LIGNOSPAN STANDARD compare to other local anesthetics in terms of efficacy?

A: It is highly praised for its fast onset time, long-lasting duration, and safety profile, making it a preferred choice for many dental procedures[2].

Q: What are the potential challenges facing the market for LIGNOSPAN STANDARD?

A: Challenges include regulatory compliance, supply chain stability, and market competition from other local anesthetic formulations[1][3].

Sources

  1. Survey of Local Anesthetic Use by Ontario Dentists - JCDA, Vol. 75, No. 9, November 2009.
  2. Lignospan Standard Lidocaine 2% with Epinephrine 1:100,000 Cartridges - Net32.
  3. Generic Drug Industry Dynamics - Federal Trade Commission.
  4. Lignospan Forte (Lidocaine HCl 2% and Epinephrine for Injection) - RxList.
  5. Lignospan Injection Dosage Guide - Drugs.com.

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