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Last Updated: December 22, 2024

ROXICODONE Drug Patent Profile


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

Roxicodone is a drug marketed by Roxane and Specgx Llc and is included in two NDAs.

The generic ingredient in ROXICODONE is oxycodone hydrochloride. There are nineteen drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the oxycodone hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Roxicodone

A generic version of ROXICODONE was approved as oxycodone hydrochloride by SPECGX LLC on June 30th, 2004.

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Summary for ROXICODONE
Drug patent expirations by year for ROXICODONE
Drug Prices for ROXICODONE

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Recent Clinical Trials for ROXICODONE

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

SponsorPhase
University of MiamiPhase 2
West Virginia UniversityPhase 4
West Virginia Clinical and Translational Science InstitutePhase 4

See all ROXICODONE clinical trials

Pharmacology for ROXICODONE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for ROXICODONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roxane ROXICODONE oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 020932-001 Oct 26, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Specgx Llc ROXICODONE oxycodone hydrochloride TABLET;ORAL 021011-001 Aug 31, 2000 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roxane ROXICODONE oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 020932-002 Oct 26, 1998 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Specgx Llc ROXICODONE oxycodone hydrochloride TABLET;ORAL 021011-003 May 15, 2009 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Specgx Llc ROXICODONE oxycodone hydrochloride TABLET;ORAL 021011-002 Aug 31, 2000 AB RX 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

ROXICODONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Roxicodone

Overview of Roxicodone

Roxicodone, a brand name for oxycodone, is a potent opioid medication widely used for managing moderate to severe pain. The market dynamics of Roxicodone are influenced by several key factors, including the increasing prevalence of chronic pain conditions, regulatory changes, and advancements in drug delivery methods.

Market Size and Growth Projections

The global oxycodone market, which includes Roxicodone, is anticipated to experience significant growth over the next decade. According to Future Market Insights, the market is projected to expand from a valuation of US$ 5.11 billion in 2023 to US$ 8.92 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 5.7% during this period[1].

Drivers of Market Growth

Several factors are driving the growth of the oxycodone market:

Increasing Prevalence of Chronic Pain Conditions

The rising incidence of chronic diseases such as arthritis, cancer, and trauma conditions is a major driver. These conditions necessitate effective pain management solutions, leading to increased demand for oxycodone-based medications[3][4].

Improved Recognition and Treatment of Pain

Enhanced awareness and treatment protocols for pain management have contributed significantly to the growth of the oxycodone market. This includes increased prescriptions for opioids like oxycodone for various pain-related conditions[1].

Advancements in Drug Delivery Methods

Companies are developing new delivery methods for oxycodone, such as patches and nasal sprays, which offer faster onset of action, improved pain relief, and reduced risk of abuse. These innovations are expected to further boost market growth[1].

Regulatory Environment

The oxycodone market has faced increased scrutiny due to concerns about misuse, addiction, and the opioid crisis. Regulatory interventions aimed at curbing opioid abuse have influenced the market's growth trajectory. Despite these challenges, the market continues to grow, albeit with more stringent prescribing practices and monitoring[1][5].

Competitive Landscape

The global oxycodone market is highly fragmented, with numerous key players competing for market share. Strategies such as developing new delivery methods, strategic investments, licensing agreements, and acquisitions are common among market players. Additionally, investments in research and development and collaborations with generic drug distributors are critical for expansion plans[1][3].

Financial Trajectory

Historically, the oxycodone market has shown substantial growth. From 2018 to 2022, the market experienced a CAGR of 4.8%, reaching a market size of US$ 4.84 billion. The projected CAGR of 5.7% from 2023 to 2033 indicates a continued upward trend in market value[1].

Revenue Projections

By 2033, the global oxycodone market is expected to reach a revenue of US$ 8.92 billion. This growth is driven by the increasing demand for effective pain management solutions and the rising prevalence of chronic diseases[1].

Impact of Generic Products

The market is also influenced by the increasing consumption of generic oxycodone products. As patent expirations for branded products occur, generic versions become more prevalent, contributing significantly to the revenue of the global oxycodone market[3].

Regional Analysis

The demand for oxycodone remains uniform across various age groups and regions. However, North American countries are particularly significant due to the high prevalence of chronic diseases and the increasing demand for parenteral formulations in these regions[3].

Challenges and Opportunities

Despite the growth potential, the oxycodone market faces challenges related to opioid abuse and regulatory scrutiny. However, these challenges also present opportunities for innovation, such as developing abuse-deterrent formulations and new delivery methods that can mitigate these risks while providing effective pain relief[1][5].

"Data analytics and modeling are valuable tools to understand and forecast the epidemic trajectory, and to guide and evaluate policies." - U.S. Drug Enforcement Administration Diversion Control Division[2]

Key Strategies for Market Players

To gain an edge in the market, companies are focusing on several key strategies:

  • Developing New Delivery Methods: Innovations such as oxycodone patches and nasal sprays offer advantages over traditional oral formulations.
  • Strategic Investments and Collaborations: Investments in research and development, licensing agreements, and acquisitions are crucial for market expansion.
  • Generic Product Expansion: Capitalizing on the increased consumption of generic oxycodone products as branded product patents expire.
  • Regulatory Compliance: Adapting to changing regulatory environments to ensure continued market presence[1][3].

Conclusion

The market for Roxicodone, as part of the broader oxycodone market, is poised for significant growth driven by increasing demand for pain management solutions and advancements in drug delivery methods. Despite regulatory challenges, the market is expected to expand substantially, reaching a valuation of US$ 8.92 billion by 2033.

Key Takeaways

  • The global oxycodone market is projected to grow at a CAGR of 5.7% from 2023 to 2033.
  • Increasing prevalence of chronic diseases and trauma conditions drive market growth.
  • New delivery methods such as patches and nasal sprays are being developed.
  • Regulatory scrutiny and opioid abuse concerns influence market dynamics.
  • Generic product consumption is on the rise as branded product patents expire.
  • Strategic investments, licensing agreements, and acquisitions are key market strategies.

FAQs

What is the projected market size of the oxycodone market by 2033?

The global oxycodone market is expected to reach a valuation of US$ 8.92 billion by 2033[1].

What is the primary driver of the oxycodone market growth?

The primary driver is the increasing prevalence of chronic pain conditions and the need for effective pain management solutions[3][4].

How is the regulatory environment impacting the oxycodone market?

The regulatory environment, with a focus on curbing opioid abuse, has led to more stringent prescribing practices and monitoring, but the market continues to grow[1][5].

What new delivery methods are being developed for oxycodone?

New delivery methods include oxycodone patches and nasal sprays, which offer faster onset of action and reduced risk of abuse[1].

How significant is the role of generic products in the oxycodone market?

Generic products contribute significantly to the revenue of the global oxycodone market, especially as branded product patents expire[3].

Sources

  1. Future Market Insights, "Oxycodone Market Size, Trends, Outlook & Forecast 2033"
  2. U.S. Drug Enforcement Administration Diversion Control Division, "Drugs of Abuse and Trends"
  3. BioSpace, "Oxycodone Market: Increasing Prevalence of Chronic Diseases and Trauma Conditions Likely to Boost Industry Growth"
  4. Grand View Research, "Oxycodone Drugs Market Size, Share & Growth Report, 2030"
  5. University of Utah Law Review, "Federal Regulatory Responses to the Prescription Opioid Crisis"

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