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Last Updated: December 22, 2024

CITANEST FORTE Drug Patent Profile


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Summary for CITANEST FORTE
US Patents:0
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 88
Clinical Trials: 2
What excipients (inactive ingredients) are in CITANEST FORTE?CITANEST FORTE excipients list
DailyMed Link:CITANEST FORTE at DailyMed
Drug patent expirations by year for CITANEST FORTE
Recent Clinical Trials for CITANEST FORTE

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

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US Patents and Regulatory Information for CITANEST FORTE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca CITANEST FORTE epinephrine bitartrate; prilocaine hydrochloride INJECTABLE;INJECTION 014763-008 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dentsply Pharm CITANEST FORTE DENTAL epinephrine bitartrate; prilocaine hydrochloride INJECTABLE;INJECTION 021383-001 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

CITANEST FORTE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Citanest Forte

Introduction

Citanest Forte, a local anesthetic containing prilocaine hydrochloride and epinephrine bitartrate, is widely used in dentistry for nerve block and infiltration techniques. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Demand and Usage

Local anesthetics, including Citanest Forte, are among the most frequently used drugs in clinical dentistry. A survey of Ontario dentists revealed that formulations with epinephrine, such as Citanest Forte, are highly prevalent. Specifically, formulations with epinephrine 1:200,000, like Citanest Forte, accounted for 30.77% of total local anesthetic use[4].

Competitive Landscape

The pharmaceutical market for local anesthetics is competitive, with several drugs available for similar indications. However, Citanest Forte holds a significant position due to its efficacy and safety profile. The market is characterized by the presence of other local anesthetics like lidocaine and articaine, but Citanest Forte's unique formulation and clinical benefits help it maintain market share[4].

Regulatory Environment

Citanest Forte is approved by regulatory bodies such as the FDA and is classified under the New Drug Application (NDA) category. It does not fall under any DEA schedule, indicating it is not considered a controlled substance[1][2].

Pricing and Cost Considerations

The pricing of Citanest Forte can vary based on factors such as the volume of the injection, the presence of epinephrine, and the geographical location. Generally, the cost is influenced by the dosage and the specific technique of anesthesia required. For instance, the dosage varies depending on the physical status of the patient, the area of the oral cavity to be anesthetized, and the vascularity of the oral tissues[1][2].

Financial Performance

The financial performance of Citanest Forte is tied to the overall demand for local anesthetics in dentistry. Given its widespread use, Citanest Forte contributes significantly to the revenue of its manufacturer, Dentsply Pharmaceutical Inc. The drug's financial trajectory is also influenced by market trends, such as changes in clinical practice guidelines and the availability of different formulations[4].

Market Trends and Changes

Over the years, there have been changes in the patterns of local anesthetic use. For example, from 1993 to 2007, there was an increase in the use of formulations with epinephrine 1:100,000 and a decrease in those with epinephrine 1:200,000. However, Citanest Forte, with its 1:200,000 epinephrine concentration, remains a preferred choice for many dental procedures[4].

Development and Approval Process

The development of follow-on drugs, including local anesthetics like Citanest Forte, has become more competitive over time. Studies have shown that the period of marketing exclusivity for breakthrough drugs has decreased, leading to faster entry of follow-on drugs into the market. This competitive environment drives innovation and potentially affects the financial trajectory of established drugs like Citanest Forte[3].

Clinical Efficacy and Safety

Citanest Forte is known for its rapid onset and prolonged duration of action. For inferior alveolar nerve blocks, the time of onset averages less than three minutes, with a duration of soft tissue anesthesia of approximately 3 hours. This efficacy, combined with its safety profile, contributes to its market stability and financial performance[1][2].

Hemodynamic Effects

The presence of epinephrine in Citanest Forte can cause hemodynamic changes, such as alterations in cardiac output, total peripheral resistance, and mean arterial pressure. These effects are crucial for clinicians to consider when administering the drug, and they can impact the drug's market position if alternative anesthetics with fewer systemic effects become available[1].

Dosage and Administration

The dosage of Citanest Forte is tailored to the specific needs of the patient and the procedure. The least volume of injection that results in effective local anesthesia should be administered. This approach helps in managing costs and optimizing patient outcomes, which are key factors in the drug's financial success[1][2].

Future Outlook

The future outlook for Citanest Forte is positive, given its established position in the market and the ongoing demand for local anesthetics in dentistry. However, the drug's financial trajectory will be influenced by factors such as changes in clinical guidelines, the introduction of new anesthetic agents, and shifts in market preferences.

Key Takeaways

  • Market Demand: Citanest Forte is widely used in dentistry due to its efficacy and safety.
  • Competitive Landscape: The market is competitive, but Citanest Forte maintains a significant share.
  • Regulatory Environment: Approved by regulatory bodies with no DEA scheduling.
  • Pricing and Cost: Varies based on dosage and technique.
  • Financial Performance: Tied to overall demand for local anesthetics.
  • Market Trends: Changes in clinical practice guidelines and availability of formulations impact use.
  • Clinical Efficacy and Safety: Known for rapid onset and prolonged duration of action.
  • Hemodynamic Effects: Consideration of systemic effects is crucial.
  • Dosage and Administration: Tailored to patient needs and procedure.

FAQs

What is Citanest Forte used for?

Citanest Forte is used for the production of local anesthesia in dentistry by nerve block or infiltration techniques.

How quickly does Citanest Forte take effect?

The time of onset of Citanest Forte averages less than three minutes for inferior alveolar nerve blocks.

What is the duration of anesthesia provided by Citanest Forte?

Citanest Forte provides approximately 3 hours of soft tissue anesthesia.

Does Citanest Forte contain epinephrine?

Yes, Citanest Forte contains epinephrine bitartrate, which can affect hemodynamic parameters.

How does the presence of epinephrine in Citanest Forte impact its use?

The epinephrine in Citanest Forte can cause changes in cardiac output, total peripheral resistance, and mean arterial pressure, which clinicians must consider when administering the drug.

Sources

  1. DailyMed: Citanest Dental (prilocaine HCl) Injection.
  2. FDA: 4% Citanest® Forte DENTAL with Epinephrine.
  3. PubMed: The economics of follow-on drug research and development.
  4. CDA-ADC: Survey of Local Anesthetic Use by Ontario Dentists.

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