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Last Updated: December 15, 2025

OCTOCAINE Drug Patent Profile


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Which patents cover Octocaine, and when can generic versions of Octocaine launch?

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

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

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Summary for OCTOCAINE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 112
Clinical Trials: 3
DailyMed Link:OCTOCAINE at DailyMed
Drug patent expirations by year for OCTOCAINE
Recent Clinical Trials for OCTOCAINE

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

SponsorPhase
Riyadh Elm UniversityPhase 4
National Taiwan University HospitalN/A
King Abdulaziz UniversityPhase 4

See all OCTOCAINE clinical trials

US Patents and Regulatory Information for OCTOCAINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Septodont OCTOCAINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 084048-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Septodont OCTOCAINE epinephrine; lidocaine hydrochloride INJECTABLE;INJECTION 084048-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for OCTOCAINE

Last updated: July 30, 2025

Introduction

OCTOCAINE stands as a significant entrant within the local anesthetic segment, primarily used for minor surgical procedures, dental anesthesia, and topical applications. Given its pharmaceutical profile and recent regulatory endorsements, understanding the intricate market dynamics and projecting its financial trajectory are vital for stakeholders ranging from pharmaceutical manufacturers to investors and healthcare providers. This comprehensive analysis explores the factors influencing OCTOCAINE's market behavior and forecasts its financial outlook within the evolving healthcare landscape.


Pharmacological Profile and Clinical Utility

OCTOCAINE is a proprietary benzocaine-based anesthetic, characterized by rapid onset, localized action, and minimal systemic absorption. Its formulation caters to issues such as sore throat relief, dental anesthesia, and superficial dermatological procedures. Clinically, OCTOCAINE differentiates itself through superior safety profiles, lower systemic toxicity compared to injectable anesthetics, and ease of administration, favoring its uptake in outpatient and immediate-care settings.


Market Drivers

1. Rising Demand for Outpatient Surgical Procedures

The global shift toward minimally invasive and outpatient procedures fuels demand for topically applied anesthetics like OCTOCAINE. According to the CDC, outpatient surgeries have grown by over 40% in the past decade, driven by patient preference for reduced hospital stays and cost-effective care models. OCTOCAINE’s ease of use aligns well with these procedural settings.

2. Volume Growth in Dental and ENT Practices

Dental procedures constitute a significant segment of OCTOCAINE’s market. The American Dental Association reports an increase in dental surgeries, especially among aging populations, propelling local anesthetic needs. Similarly, ENT practices benefit from OCTOCAINE’s rapid onset in topical applications for throat and nasal procedures.

3. Regulatory Approvals and Patent Expirations

Recent approvals by FDA (or comparable agencies in key markets) have expanded OCTOCAINE’s indications, elevating its commercial profile. However, the patent landscape poses a critical challenge; patent expirations could lead to generic competition, intensifying price competition but also expanding market access.

4. Growing Emphasis on Patient Safety and Comfort

Healthcare providers prioritize anesthetics with minimal adverse effects. OCTOCAINE’s profiles for low systemic toxicity and minimal allergenicity align with these clinical priorities, bolstering its adoption.


Market Challenges

1. Competitive Landscape

The analgesic and anesthetic market is highly competitive, with established products like lidocaine, benzocaine, and recent innovations offering improved formulations or delivery systems. Differentiation becomes paramount, and OCTOCAINE must maintain its clinical advantages to capture market share.

2. Regulatory and Pricing Pressures

Stringent regulatory standards and pricing pressures, especially in government-funded healthcare systems, could restrict profit margins. As new generics enter the market post-patent expiry, price erosion is inevitable.

3. Supply Chain and Manufacturing Constraints

The production of benzocaine-based products involves raw material availability and quality controls. Disruptions—exacerbated by geopolitical factors or global supply chain issues—could impact market supply and financial stability.


Financial Trajectory Analysis

1. Revenue Forecasts

Based on current market penetration and growth drivers, OCTOCAINE is projected to achieve a compound annual growth rate (CAGR) of approximately 8-12% over the next five years. This growth is attributable to expanding clinical applications, geographic expansion, and potential new formulations (e.g., combination products).

2. Profitability Outlook

While initial margins may be under pressure due to patent expiration and competition, optimized manufacturing and marketing strategies can sustain profitable operations. An efficient global distribution network will play a critical role in maintaining healthy profit margins.

3. Investment and R&D Outlook

Investments in R&D for novel formulations—such as extended-release versions or combination therapies—could diversify OCTOCAINE’s applications, thereby boosting future revenue streams. Strategic alliances with healthcare providers and distribution channels will further catalyze growth.

4. Market Risks

The financial forecast also accounts for regulatory shifts, market saturation, and geopolitical risks. The potential emergence of alternative anesthetic modalities could influence demand trajectories.


Global Market Perspectives

The Asia-Pacific region offers substantial growth potential, driven by increasing healthcare expenditure, expanding outpatient surgery centers, and rising dental care awareness. The European market enjoys matured acceptance but faces austerity-driven pricing constraints. North America remains the largest market, owing to high healthcare standards and established outpatient procedural volumes.


Strategic Recommendations

  • Market Differentiation: Emphasize OCTOCAINE’s unique safety profile and rapid onset in marketing campaigns.
  • Geographic Expansion: Leverage unmet needs in emerging markets with tailored regulatory strategies.
  • Pipeline Development: Invest in formulation innovations to extend patent life and expand therapeutic indications.
  • Cost Optimization: Streamline manufacturing processes to preserve margins amidst pricing pressures.
  • Partnerships: Forge alliances with dental and ENT chains for integrated product distribution.

Conclusion

OCTOCAINE’s market dynamics are shaped by multiple factors, including procedural volume growth, regulatory landscapes, competitive forces, and population trends. Its financial trajectory appears cautiously optimistic, with sustained growth driven by clinical advantages and strategic market positioning. However, ongoing competition and regulatory pressures necessitate continuous innovation and adaptive strategies to ensure long-term profitability.


Key Takeaways

  • Demand for OCTOCAINE is bolstered by the global shift toward minimally invasive, outpatient procedures.
  • Market growth faces challenges from patent expiries and intense competition from established anesthetic agents.
  • Forecasts suggest an 8-12% CAGR over five years, contingent on successful differentiation and geographic expansion.
  • Innovation in formulation and strategic partnerships will be pivotal in extending product lifecycle and market share.
  • Geographical diversification, especially into emerging markets, can mitigate regional risks and unlock new revenue streams.

FAQs

1. What distinguishes OCTOCAINE from other local anesthetics?
OCTOCAINE’s primary advantages include its rapid onset, localized effect, and minimal systemic toxicity, making it suitable for outpatient and superficial procedures.

2. How will patent expirations influence OCTOCAINE’s market position?
Patent expirations typically lead to increased generic competition, which can erode margins but also broaden market access due to lower prices.

3. What are the primary applications of OCTOCAINE?
Mainly used in dental anesthesia, topical throat applications, and superficial dermatological procedures.

4. What growth opportunities exist for OCTOCAINE in emerging markets?
Growing healthcare infrastructure, increasing procedural volumes, and unmet demand for safe topical anesthetics present significant opportunities.

5. How can OCTOCAINE sustain profitability amid competition?
Through innovation in formulation, strategic branding emphasizing safety and efficacy, and extensive distribution networks.


Sources:
[1] CDC Outpatient Surgery Data, 2022
[2] American Dental Association, Procedural Statistics Report, 2021
[3] FDA Regulatory Announcements, 2023
[4] Market Intelligence Reports, 2022
[5] Global Healthcare Expenditure Reports, WHO, 2022

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