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Last Updated: December 22, 2024

CITANEST PLAIN Drug Patent Profile


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When do Citanest Plain patents expire, and when can generic versions of Citanest Plain launch?

Citanest Plain is a drug marketed by Astrazeneca and Dentsply Pharm and is included in two NDAs.

The generic ingredient in CITANEST PLAIN is prilocaine hydrochloride. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the prilocaine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Citanest Plain

A generic version of CITANEST PLAIN was approved as prilocaine hydrochloride by SEPTODONT INC on September 29th, 2010.

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Summary for CITANEST PLAIN
Drug patent expirations by year for CITANEST PLAIN
Recent Clinical Trials for CITANEST PLAIN

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

SponsorPhase
Bozyaka Training and Research HospitalPhase 4
Diskapi Teaching and Research HospitalPhase 4

See all CITANEST PLAIN clinical trials

US Patents and Regulatory Information for CITANEST PLAIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca CITANEST PLAIN prilocaine hydrochloride INJECTABLE;INJECTION 014763-007 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dentsply Pharm CITANEST PLAIN DENTAL prilocaine hydrochloride INJECTABLE;INJECTION 021382-001 Approved Prior to Jan 1, 1982 DISCN Yes 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

CITANEST PLAIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Citanest Plain Dental

Introduction

Citanest Plain Dental, a local anesthetic containing prilocaine hydrochloride, has been a significant player in the dental anesthesia market. However, to understand its market dynamics and financial trajectory, it is crucial to delve into various aspects including its usage, competition, and regulatory environment.

Product Description and Clinical Use

Citanest Plain Dental is a sterile, non-pyrogenic isotonic solution administered parenterally by injection. It is indicated for the production of local anesthesia in dentistry through nerve block or infiltration techniques[1][2][5].

Market Position and Usage

In the dental anesthesia market, Citanest Plain Dental competes with other local anesthetics such as lidocaine and articaine. According to a survey of Ontario dentists, formulations incorporating lidocaine and articaine are more commonly used, with lidocaine accounting for 39.70% and articaine for 44.20% of total anesthetic use. Plain local anesthetics, like Citanest Plain Dental, are administered less frequently, at about 9.39% of the time[4].

Competitive Landscape

The dental anesthesia market is highly competitive, with multiple local anesthetic agents available. The choice of anesthetic often depends on the specific procedure, the dentist's preference, and the patient's health status. Citanest Plain Dental faces competition from other prilocaine formulations as well as from different types of local anesthetics.

Regulatory Environment

The regulatory environment plays a significant role in the market dynamics of pharmaceutical products. Citanest Plain Dental, like other drugs, must comply with FDA regulations and guidelines. However, the product has been discontinued in some forms, which could impact its market presence and financial performance[2].

Financial Trajectory

Historical Sales and Revenue

Historical data on the sales and revenue of Citanest Plain Dental is not readily available, but its market share and usage patterns suggest it has been a niche player in the dental anesthesia market.

Impact of Discontinuation

The discontinuation of certain forms of Citanest Plain Dental has likely affected its financial trajectory negatively. This discontinuation could be due to various factors such as market demand, competition, or regulatory issues. The absence of these forms in the market reduces the product's overall revenue potential[2].

Pricing and Cost Factors

The pricing of Citanest Plain Dental is influenced by several factors including production costs, market demand, and competition. The cost of the drug can vary based on the volume and technique of administration, as well as the physical status of the patient and the area of the oral cavity being anesthetized[5].

Market Trends and Changes

Market trends in the dental anesthesia sector have shown shifts in the use of different local anesthetic formulations over time. For example, there has been a reduction in the use of 4% solutions for nerve block injections, which could impact the sales of Citanest Plain Dental. Additionally, changes in clinical practice guidelines and the availability of certain formulations can influence market dynamics[4].

Economic Factors

The economics of the pharmaceutical industry, including the development and marketing of follow-on drugs, play a crucial role in the financial trajectory of products like Citanest Plain Dental. The period of marketing exclusivity for breakthrough drugs has decreased over time, leading to increased competition and potentially affecting the revenue of established products[3].

Patient and Dentist Preferences

Patient and dentist preferences also influence the market dynamics. For instance, some dentists may prefer other local anesthetics due to their longer duration of action or fewer side effects. Persistent paresthesias, a known side effect of prilocaine, might deter some practitioners from using Citanest Plain Dental[2].

Side Effects and Safety Profile

The safety profile of Citanest Plain Dental, including its potential side effects such as methemoglobinemia and persistent paresthesias, can impact its market acceptance and financial performance. Adverse experiences, especially those that are systemic or long-lasting, can reduce the product's appeal to both dentists and patients[2][5].

Pharmacokinetics and Metabolism

The pharmacokinetics and metabolism of prilocaine, including its absorption, protein binding, and crossing of blood-brain and placental barriers, are critical for its efficacy and safety. These factors can influence the drug's market position by affecting its dosing and administration guidelines[5].

Dosage and Administration

The dosage and administration guidelines for Citanest Plain Dental are specific and depend on various factors such as the patient's physical status and the area of the oral cavity being anesthetized. The need to use the least volume of injection that results in effective local anesthesia can affect the product's usage and revenue[5].

Contraindications and Warnings

Contraindications and warnings associated with Citanest Plain Dental, such as hypersensitivity to local anesthetics and the risk of methemoglobinemia, are important considerations for its market dynamics. These factors can limit its use in certain patient populations and impact its financial performance[5].

Key Takeaways

  • Market Share: Citanest Plain Dental holds a niche position in the dental anesthesia market, with other local anesthetics like lidocaine and articaine being more widely used.
  • Regulatory Impact: The discontinuation of certain forms of the drug has negatively affected its market presence and financial performance.
  • Pricing and Cost: Pricing is influenced by production costs, market demand, and competition.
  • Market Trends: Changes in clinical practice guidelines and formulation availability impact the drug's market dynamics.
  • Economic Factors: Decreased marketing exclusivity periods for breakthrough drugs increase competition.
  • Safety Profile: Side effects such as persistent paresthesias and methemoglobinemia affect market acceptance.

FAQs

What is Citanest Plain Dental used for?

Citanest Plain Dental is used for the production of local anesthesia in dentistry through nerve block or infiltration techniques.

Why has Citanest Plain Dental been discontinued in some forms?

The discontinuation is likely due to factors such as market demand, competition, or regulatory issues.

What are the common side effects of Citanest Plain Dental?

Common side effects include swelling, persistent paresthesia, and in rare cases, methemoglobinemia.

How does the dosage of Citanest Plain Dental vary?

The dosage varies based on the patient's physical status, the area of the oral cavity to be anesthetized, and the technique of anesthesia.

What are the contraindications for Citanest Plain Dental?

Citanest Plain Dental is contraindicated in patients with a known history of hypersensitivity to local anesthetics and in cases where methemoglobinemia is a concern.

Sources

  1. Drugs.com: Citanest Plain Dental Injection: Package Insert / Prescribing Info.
  2. RxList: Citanest Plain Dental (Prilocaine hydrochloride Injection).
  3. PubMed: The economics of follow-on drug research and development.
  4. CDA-ADC: Survey of Local Anesthetic Use by Ontario Dentists.
  5. FDA: 4% Citanest® Plain Dental - accessdata.fda.gov.

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