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Last Updated: December 22, 2024

DYCLOPRO Drug Patent Profile


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Which patents cover Dyclopro, and what generic alternatives are available?

Dyclopro is a drug marketed by Septodont and is included in one NDA.

The generic ingredient in DYCLOPRO is dyclonine hydrochloride. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dyclonine hydrochloride profile page.

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Summary for DYCLOPRO
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:DYCLOPRO at DailyMed
Drug patent expirations by year for DYCLOPRO

US Patents and Regulatory Information for DYCLOPRO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Septodont DYCLOPRO dyclonine hydrochloride SOLUTION;TOPICAL 200480-001 Nov 20, 2018 RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Septodont DYCLOPRO dyclonine hydrochloride SOLUTION;TOPICAL 200480-002 Nov 20, 2018 RX No 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

DYCLOPRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DycloPro (Dyclonine Hydrochloride)

Introduction to DycloPro

DycloPro, a topical anesthetic containing dyclonine hydrochloride, has recently been reintroduced to the market by Septodont after a several-year absence. This product is significant for dental practitioners due to its versatility and efficacy in anesthetizing mucous membranes without the need for high drug concentrations or multiple prescriptions.

Market Need and Demand

Growing Demand for Local Anesthetics

The global local anesthesia drugs market is projected to grow at a CAGR of 3.6% from 2024 to 2030, reaching an estimated value of USD 5.14 billion by 2030. This growth is driven by an increase in surgical procedures, including dental, cosmetic, and plastic surgeries, which require effective post-operative pain management[4].

Specific Demand for Topical Anesthetics

DycloPro fills a specific niche in the market by offering a reliable, FDA-regulated topical anesthetic that can be used over large surface areas of the oral cavity. This is particularly beneficial for patients with severe gag reflexes or those requiring procedures such as taking radiographs, scaling posterior teeth, or performing intraoral examinations[1].

Competitive Landscape

Unique Selling Points of DycloPro

  • Regulation and Consistency: Unlike compounded versions, DycloPro is regulated by the FDA, ensuring consistent quality and reliable information on indications, contraindications, and maximum recommended doses (MRD)[1][3].
  • Ketone-Based: DycloPro is a ketone-based anesthetic, which reduces the risk of allergic reactions compared to amide or ester-based anesthetics. This makes it a good alternative for patients with such allergies[1][3].
  • Versatility: It can be used for various dental procedures, including gag reflex management, preinjection relief, and anesthesia for aphthous ulcers and other painful lesions[3].

Market Positioning

DycloPro competes in the surface anesthetic segment of the local anesthesia drugs market. While injectable anesthetics dominate the market, advancements in drug delivery systems are expected to drive the demand for surface anesthetics, positioning DycloPro for potential growth[4].

Financial Trajectory

Market Size and Growth

The reintroduction of DycloPro is expected to capture a share of the growing local anesthesia drugs market. Given the specific needs it addresses, such as the lack of reliable topical anesthetics for large surface areas, DycloPro is likely to see steady demand and revenue growth.

Cost and Pricing

The financial impact of DycloPro on dental practices is positive due to its regulated and consistent supply, which eliminates the need for compounding pharmacies and reduces liability issues associated with unregulated compounded drugs. The product is available in 0.5% and 1% concentrations, with a clear MRD, which helps in cost management and reduces the risk of drug toxicity[1].

Revenue Projections

While specific revenue projections for DycloPro are not available, the overall growth of the local anesthesia drugs market and the unique positioning of DycloPro suggest a promising financial trajectory. The product's reliability, consistency, and versatility are likely to contribute to increased adoption and revenue.

Key Drivers and Restraints

Drivers

  • Increasing Surgical Procedures: The rise in dental and other surgical procedures globally drives the demand for effective local anesthetics like DycloPro[4].
  • Regulatory Compliance: Being FDA-regulated, DycloPro offers dental practitioners a compliant and reliable option, reducing legal and medical risks[1].
  • Patient Comfort: The product's fast onset and long duration of action enhance patient comfort, which can lead to higher patient satisfaction and repeat business[3].

Restraints

  • Competition from Established Brands: The market is dominated by well-established brands like lidocaine, which may pose a challenge for DycloPro in gaining market share[4].
  • Cost Sensitivity: Dental practices may be cost-sensitive, and the adoption of DycloPro could be influenced by its pricing relative to other available options[2].

Conclusion

DycloPro, with its unique features and FDA regulation, is well-positioned to capture a significant share of the growing local anesthesia drugs market. Its versatility, consistency, and patient safety profile make it an attractive option for dental practitioners, contributing to its positive financial trajectory.

Key Takeaways

  • Market Growth: The local anesthesia drugs market is expected to grow significantly, driven by increasing surgical procedures.
  • Unique Selling Points: DycloPro's FDA regulation, ketone-based formulation, and versatility make it a valuable addition to dental practices.
  • Financial Impact: The product's consistency and reliability are expected to reduce costs and liability issues associated with compounded drugs.
  • Patient Comfort: DycloPro enhances patient comfort with its fast onset and long duration of action.

FAQs

Q: What is DycloPro and how is it used? A: DycloPro is a topical anesthetic containing dyclonine hydrochloride, used for anesthetizing mucous membranes in the oral cavity. It is versatile and can be used for various dental procedures.

Q: Why was DycloPro reintroduced to the market? A: DycloPro was reintroduced to provide a reliable, FDA-regulated topical anesthetic option after being absent from the market for several years and only available through compounding pharmacies.

Q: What are the benefits of using DycloPro over other topical anesthetics? A: DycloPro is a ketone-based anesthetic, reducing the risk of allergic reactions. It is also FDA-regulated, ensuring consistency and reliability, and has a clear maximum recommended dose.

Q: How does DycloPro impact dental practice costs? A: DycloPro reduces costs and liability issues associated with using unregulated compounded drugs. Its consistent supply and clear MRD help in cost management.

Q: What is the expected market growth for DycloPro? A: While specific projections for DycloPro are not available, the overall growth of the local anesthesia drugs market and its unique positioning suggest a promising financial trajectory.

References

  1. Dimensions of Dental Hygiene: "Favorite Topical Anesthetic Is Reintroduced" - March 2021.
  2. Today's RDH: "Dental Customer Service: The Benefits of a Pleasant Experience for Patients" - December 2021.
  3. RDH Magazine: "Review: DycloPro topical anesthetic by Septodont" - June 2021.
  4. GlobeNewswire: "Local Anesthesia Drugs Market Size, Share & Trends Analysis Report 2024-2030" - November 2024.

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