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Last Updated: December 12, 2025

Ibuprofen; oxycodone hydrochloride - Generic Drug Details


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What are the generic sources for ibuprofen; oxycodone hydrochloride and what is the scope of patent protection?

Ibuprofen; oxycodone hydrochloride is the generic ingredient in two branded drugs marketed by Forest Labs, Actavis Elizabeth, Barr Labs Inc, and Watson Labs, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ibuprofen; oxycodone hydrochloride
US Patents:0
Tradenames:2
Applicants:4
NDAs:4
Clinical Trials: 81
DailyMed Link:ibuprofen; oxycodone hydrochloride at DailyMed
Recent Clinical Trials for ibuprofen; oxycodone hydrochloride

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

SponsorPhase
Texas Scottish Rite Hospital for ChildrenPHASE2
University of North Carolina, Chapel HillPHASE4
Keck School of Medicine of USCPHASE3

See all ibuprofen; oxycodone hydrochloride clinical trials

US Patents and Regulatory Information for ibuprofen; oxycodone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Elizabeth OXYCODONE HYDROCHLORIDE AND IBUPROFEN ibuprofen; oxycodone hydrochloride TABLET;ORAL 078769-001 Jan 4, 2008 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Barr Labs Inc OXYCODONE HYDROCHLORIDE AND IBUPROFEN ibuprofen; oxycodone hydrochloride TABLET;ORAL 078316-001 Nov 29, 2007 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Forest Labs COMBUNOX ibuprofen; oxycodone hydrochloride TABLET;ORAL 021378-001 Nov 26, 2004 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Watson Labs OXYCODONE HYDROCHLORIDE AND IBUPROFEN ibuprofen; oxycodone hydrochloride TABLET;ORAL 078394-001 Nov 26, 2007 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 Pharmaceutical Drugs: Ibuprofen and Oxycodone Hydrochloride

Last updated: August 10, 2025


Introduction

The pharmaceutical landscape for analgesic medications like ibuprofen and oxycodone hydrochloride exhibits significant variability driven by factors such as regulatory policies, market demand, healthcare practices, patent expirations, and societal concerns over misuse. Understanding the distinct market dynamics and forecasted financial trajectories of these drugs is essential for stakeholders—including pharmaceutical companies, investors, regulators, and healthcare providers—aiming to navigate the evolving therapeutic landscape effectively.


Market Overview of Ibuprofen

1. Market Fundamentals and Therapeutic Profile

Ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), is widely used for pain relief, fever reduction, and inflammation control. Its extensive over-the-counter (OTC) availability and established efficacy have cemented its dominance in the analgesic market. The global ibuprofen market was valued at approximately USD 7.2 billion in 2021, with expectations for steady growth driven by chronic pain management, aging populations, and increased self-medication trends [1].

2. Market Drivers

  • Widespread OTC Penetration: Its OTC status in most markets enhances accessibility, fueling consistent demand.
  • Aging Population: Increasing prevalence of chronic pain in aging demographics boosts consumption.
  • Product Innovation: Introduction of formulations with improved bioavailability and combination products extends market reach.
  • Regulatory Environment: Favorable regulatory assessments due to established safety profiles reinforce its market position.

3. Challenges and Market Restraints

  • Safety Concerns: Risks associated with NSAIDs, particularly gastrointestinal and cardiovascular adverse effects, necessitate cautious use and impact prescribing patterns.
  • Competitive Landscape: Presence of multiple NSAID alternatives, such as naproxen and aspirin, intensifies competition.
  • Regulatory Changes: Potential OTC reclassification or formulation restrictions in some regions could impact sales.

4. Market Forecast and Financial Trajectory

Projections suggest a compounded annual growth rate (CAGR) of approximately 4-5% over the next five years, reaching around USD 10.8 billion by 2026 [1]. Market expansion is attributed to increasing health awareness, OTC availability, and product diversification. The stable patent landscape, with most formulations being off-patent, ensures steady revenue streams for generic manufacturers.


Market Overview of Oxycodone Hydrochloride

1. Market Fundamentals and Therapeutic Profile

Oxycodone hydrochloride, a potent opioid analgesic, is primarily prescribed for moderate to severe pain. It often features in extended-release formulations for chronic pain management. The global oxycodone market was valued at approximately USD 6.5 billion in 2021, with substantial growth prospects aligned with rising opioid prescriptions, especially in North America and Europe [2].

2. Market Drivers

  • Chronic Pain Prevalence: The opioid's efficacy in managing complex pain conditions sustains demand.
  • Formulation Advancements: Development of abuse-deterrent formulations aims to address misuse concerns.
  • Physician Acceptance: Continued reliance on opioids in pain management protocols sustains market needs.

3. Challenges and Market Restraints

  • Regulatory and Legal Constraints: Stricter prescribing guidelines and regulatory crackdowns have curtailed prescribing volumes, notably in the US post-2010 opioid crisis.
  • Epidemic of Misuse and Overdose: Rising addiction rates and fatalities have led to legislative tightening and increased scrutiny.
  • Market Saturation and Patent Expiry: Generic versions dominate, leading to price erosion.

4. Market Forecast and Financial Trajectory

The financial trajectory for oxycodone is complex, heavily influenced by regulatory landscapes. Although regional markets like North America remain significant, growth prospects are tempered by legal restrictions. A conservative CAGR estimate of 1-2% over the next five years applies, projecting the market to reach approximately USD 7 billion by 2026 [2]. The focus shifts toward formulation innovation, abuse-deterrent strategies, and alternative pain management solutions to sustain revenue streams.


Market Dynamics: Comparative Analysis

Aspect Ibuprofen Oxycodone Hydrochloride
Regulatory Status Predominantly OTC Strict prescription-only
Market Growth Steady, driven by aging, OTC demand Volatile, impacted by regulation
Manufacturing Focus Generics, formulations, combination drugs Generics, abuse-deterrent formulations
Societal Concerns Moderate, safety profile established High, misuse and overdose risks
Innovation Trend New formulations, delivery systems Abuse-deterrent, extended-release

This contrast underscores divergent drivers—while ibuprofen benefits from stable, incremental growth, oxycodone's trajectory is heavily moderated by societal concerns and legislative controls.


Future Outlook and Strategic Implications

1. Legal and Regulatory Environment

For ibuprofen, regulatory stability bodes well for continued market penetration. Conversely, oxycodone faces increasing regulation; companies must innovate to mitigate misuse, promote safer formulations, and navigate legislative shifts.

2. Patent Expiry and Generic Competition

Generic competition is intense for both drugs, necessitating differentiation through new formulations, delivery options, and combination therapies to sustain profitability.

3. Societal and Ethical Factors

Heightened awareness of opioid misuse compels companies to invest in abuse-deterrent technologies and responsible marketing. For NSAIDs, safety profile improvements remain critical.

4. Market Expansion Opportunities

Emerging markets present expansion avenues, particularly where OTC regulations are relaxed and healthcare infrastructure improves—for ibuprofen, in developing countries; for oxycodone, within frameworks ensuring responsible prescribing.


Key Takeaways

  • The ibuprofen market exhibits consistent growth driven by OTC availability, aging populations, and product innovation, with an expected CAGR of approximately 4-5% to 2026.
  • The oxycodone hydrochloride market faces considerable headwinds from regulatory restrictions and societal concerns about misuse but maintains a substantial base due to its clinical efficacy, albeit with modest growth projections (CAGR 1-2%).
  • Strategic focus for pharmaceutical companies should include product innovation, regulatory compliance, and addressing societal concerns—particularly for opioids.
  • Market diversification and exploring emerging markets can mitigate risks associated with generics and regulation.
  • Abuse-deterrent formulations represent a pivotal innovation to balance efficacy and safety, especially for opioids.

FAQs

1. What factors most influence the growth of ibuprofen?
The primary drivers include OTC accessibility, demographic shifts toward aging populations, and ongoing product innovations like combination formulations for enhanced efficacy.

2. How has the opioid crisis impacted oxycodone's market prospects?
The crisis has led to regulatory tightening, reduced prescribing, and a focus on abuse-deterrent formulations. While demand persists for pain management, growth is tempered by legal and societal challenges.

3. Are there emerging risks for ibuprofen in the future?
Yes. Increased safety concerns regarding gastrointestinal and cardiovascular risks could lead to regulatory restrictions or formulation modifications, impacting sales.

4. How are pharmaceutical companies addressing societal concerns over opioids?
Through the development of abuse-deterrent formulations, stricter prescribing guidelines, and educational initiatives to promote responsible use.

5. What are potential growth opportunities for opioids like oxycodone?
Innovations in safer formulations, targeted therapies for specific pain conditions, and expansion into new markets with regulated prescribing protocols offer avenues for growth.


References

[1] Market Research Future. "Ibuprofen Market Analysis." 2022.
[2] Mordor Intelligence. "Oxycodone Hydrochloride Market Report." 2022.

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