You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 15, 2025

Aspirin; oxycodone hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


Summary for aspirin; oxycodone hydrochloride
US Patents:0
Tradenames:6
Applicants:8
NDAs:10
Finished Product Suppliers / Packagers: 1
Clinical Trials: 6
DailyMed Link:aspirin; oxycodone hydrochloride at DailyMed
Recent Clinical Trials for aspirin; oxycodone hydrochloride

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

SponsorPhase
University of North Carolina, Chapel HillPhase 4
Albany Medical CollegePhase 4
Roche Pharma AGPhase 1

See all aspirin; oxycodone hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for aspirin; oxycodone hydrochloride

US Patents and Regulatory Information for aspirin; oxycodone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Operations PERCODAN-DEMI aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 007337-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Sun Pharm Industries OXYCODONE AND ASPIRIN aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 087794-001 May 26, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Actavis Labs Fl Inc OXYCODONE AND ASPIRIN aspirin; oxycodone hydrochloride TABLET;ORAL 090084-001 Mar 22, 2011 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 Aspirin and Oxycodone Hydrochloride

Last updated: July 29, 2025

Introduction

This analysis explores the market landscape and financial prospects of two pivotal pharmaceuticals: aspirin and oxycodone hydrochloride. Both drugs exemplify diverse therapeutic uses, regulatory challenges, and market forces that influence their commercial trajectory. By dissecting these elements, we aim to provide a comprehensive outlook tailored for stakeholders across the healthcare, manufacturing, and investment sectors.

Aspirin: Market Dynamics and Financial Outlook

Historical Context and Therapeutic Role

Aspirin (acetylsalicylic acid) remains one of the world's most widely used over-the-counter (OTC) medications. Initially discovered in the late 19th century, aspirin's analgesic, antipyretic, and anti-inflammatory properties facilitated its widespread adoption. Additionally, low-dose aspirin's antiplatelet effects have cemented its role in cardiovascular disease (CVD) prevention, particularly in secondary prevention and primary prevention contexts, as endorsed by multiple guidelines (e.g., American Heart Association).

Market Size and Growth Trends

The global aspirin market was valued at approximately $1.2 billion in 2022, with an expected compound annual growth rate (CAGR) of 4-5% over the next five years. The OTC segment dominates, driven by consumer demand for accessible and cost-effective pain relief. Emerging markets, especially in Asia-Pacific, are expanding rapidly due to increased healthcare awareness and growing cardiovascular disease prevalence.

Key Market Drivers

  • Cardiovascular diseases prevalence: Rising incidence of coronary artery disease bolsters demand for low-dose aspirin.
  • Preventive therapy adoption: Increased adoption of aspirin for primary and secondary prevention, influenced by updated clinical guidelines.
  • OTC accessibility: Regulatory liberalization in developing economies promotes OTC availability.
  • Generic competition: Presence of multiple generics has maintained competitive pricing, influencing profit margins positively.

Market Challenges and Regulatory Landscape

  • Safety concerns: Risks of gastrointestinal bleeding, hemorrhagic stroke, and gastrointestinal ulcers have prompted regulatory warnings. The US FDA issued black-box warnings in 2014, impacting usage patterns.
  • Declining use in primary prevention: Recent guidelines recommend more conservative use of aspirin for primary prevention, potentially constraining growth.
  • Patent expiries and commoditization: Generic proliferation has eroded profit margins; however, market stability persists due to robust demand in specific indications.

Financial Trajectory

The mature nature of the aspirin market suggests incremental growth primarily driven by expansion in emerging markets and increased preventive use in specific populations. Companies focusing on formulation innovations (e.g., sustained-release formulations) or combination therapies could unlock additional revenue streams. Strategic positioning involves balancing regulatory compliance with consumer safety messaging to sustain brand reputation.

Oxycodone Hydrochloride: Market Dynamics and Financial Outlook

Pharmacological Profile and Therapeutic Use

Oxycodone hydrochloride is a potent semi-synthetic opioid analgesic used primarily for managing moderate to severe pain. Its formulations range from immediate-release to extended-release, often combined with other agents like acetaminophen. Its efficacy in pain management has led to widespread prescription practices in the US and Europe.

Market Size and Trends

The oxycodone market was valued at over $4 billion in 2022, with an anticipated CAGR of 3-6% over the next five years. North America dominates this market, accounting for the lion's share due to high prescription rates and opioid-based therapy protocols.

Key Market Drivers

  • Chronic pain prevalence: Increasing incidence drives demand for potent analgesics.
  • Advances in formulations: Approval of abuse-deterrent formulations (ADFs) aims to address misuse concerns.
  • Regulatory initiatives: Policies aimed at curbing opioid misuse impact prescribing behaviors but also influence market structures.
  • Medical necessity: For cancer-related pain and palliative care, oxycodone remains a mainstay, ensuring consistent demand.

Challenges and Regulatory Environment

  • Opioid epidemic and abuse: Growing awareness of addiction risks has led to stringent prescribing controls, prescription drug monitoring programs (PDMPs), and reformulated products.
  • Legal liabilities: Manufacturers face litigation related to opioid misuse and public health crises, affecting financial stability.
  • Market restructuring: The shift toward multimodal pain management reduces sole reliance on opioids, influencing future sales.

Financial Outlook

Despite regulatory headwinds, oxycodone retains a significant market share in patient pain management, especially in Hospice and oncology settings. Companies investing in abuse-deterrent formulations and novel delivery systems may mitigate some market risks. Balancing innovation with compliance remains crucial to maintaining financial health in this segment.

Comparative Market Analysis

Aspect Aspirin Oxycodone Hydrochloride
Market Size (2022) ~$1.2 billion ~$4.0 billion
CAGR (2022-2027) 4-5% 3-6%
Main Markets Global, with emphasis on OTC markets North America, Europe, emerging markets
Regulatory Environment Moderate, safety warnings affecting use Stringent, abuse prevention measures
Market Stability Mature, steady demand Disrupted by regulatory reforms and abuse concerns

Strategic Implications for Stakeholders

  • Manufacturers and Investors: Focus on innovation—developing formulations minimizing adverse effects and abuse potential can safeguard market share. Diversification into combination therapies enhances resilience.
  • Regulatory Bodies: Opportunities exist to balance access with safety, encouraging responsible use without stifling therapeutic benefits.
  • Healthcare Providers: Emphasize evidence-based prescribing, especially regarding aspirin's role in primary prevention and opioids' risk management.

Key Takeaways

  • Aspirin remains a stable, growth-oriented drug primarily driven by cardiovascular prevention. Market growth hinges on expanding use in emerging economies and innovating formulations, despite regulatory warnings on safety.
  • Oxycodone hydrochloride faces a complex landscape characterized by high demand for pain relief weighed against a global opioid misuse crisis. Innovations like abuse-deterrent formulations and emerging pain management modalities will define future financial trajectories.
  • Regulatory trends are critical determinants of market dynamics, with safety and misuse concerns influencing prescribing practices and formulation development.
  • Emerging markets present significant growth opportunities for both drugs, contingent on regulatory acceptance and healthcare infrastructure development.
  • Stakeholders must navigate balancing access, safety, and innovation to capitalize on market opportunities while mitigating risks.

FAQs

  1. What factors most influence aspirin's market growth?
    Increasing cardiovascular disease prevalence, adoption of preventive therapy guidelines, and expanding availability in emerging markets drive growth.

  2. How are regulatory warnings impacting aspirin's prescription patterns?
    Safety concerns leading to warnings about gastrointestinal bleeding have slightly curtailed prophylactic use in certain populations, but demand remains stable where benefits outweigh risks.

  3. What are the primary risks confronting oxycodone's market profitability?
    The opioid epidemic has led to tighter prescribing regulations, litigation risks, and a shift towards alternative pain management options, all threatening sustained sales.

  4. Are there innovations that could boost the future sales of these drugs?
    For aspirin, sustained-release formulations and combination therapies; for oxycodone, abuse-deterrent formulations and multimodal pain management solutions.

  5. Which emerging markets offer the most opportunity for these pharmaceuticals?
    Asia-Pacific, Latin America, and parts of Africa represent expanding markets, with rising healthcare infrastructure and disease burden driving demand.

References

[1] MarketResearch.com. “Global Aspirin Market Report,” 2022.
[2] ResearchAndMarkets.com. “Oxycodone Market Forecast to 2027,” 2023.
[3] FDA. “Black Box Warnings on Aspirin,” 2014.
[4] Centers for Disease Control and Prevention. “Prescription Opioid Use and Misuse,” 2022.
[5] World Health Organization. “Cardiovascular Disease Statistics,” 2021.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.