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Last Updated: December 15, 2025

OXYCODONE AND ASPIRIN Drug Patent Profile


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Which patents cover Oxycodone And Aspirin, and when can generic versions of Oxycodone And Aspirin launch?

Oxycodone And Aspirin is a drug marketed by Actavis Labs Fl Inc, Ani Pharms, Dr Reddys Labs Sa, Epic Pharma Llc, Sun Pharm Industries, and Roxane. and is included in seven NDAs.

The generic ingredient in OXYCODONE AND ASPIRIN is aspirin; oxycodone hydrochloride; oxycodone terephthalate. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; oxycodone hydrochloride; oxycodone terephthalate profile page.

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Drug patent expirations by year for OXYCODONE AND ASPIRIN
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SponsorPhase
University of North Carolina, Chapel HillPhase 4
Albany Medical CollegePhase 4
Genentech, Inc.Phase 1

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US Patents and Regulatory Information for OXYCODONE AND ASPIRIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
Roxane OXYCODONE AND ASPIRIN (HALF-STRENGTH) aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 087742-001 Jun 4, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Epic Pharma Llc OXYCODONE AND ASPIRIN aspirin; oxycodone hydrochloride TABLET;ORAL 040910-001 Jul 16, 2020 AA RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ani Pharms OXYCODONE AND ASPIRIN aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 040255-001 Feb 27, 1998 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Dr Reddys Labs Sa OXYCODONE AND ASPIRIN aspirin; oxycodone hydrochloride TABLET;ORAL 091670-001 Mar 16, 2011 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
>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 Oxycodone and Aspirin

Last updated: August 2, 2025

Introduction

The pharmaceutical landscape surrounding analgesics and pain management drugs remains historically complex, driven by regulatory changes, market demand, and evolving medical guidelines. This analysis examines the current and projected market dynamics, focusing on two widely used medications: oxycodone and aspirin. As both drugs serve analgesic purposes yet differ distinctly in regulation, usage, and market size, understanding their trajectories provides valuable insights for stakeholders across pharmaceutical companies, investors, and healthcare policymakers.


Market Overview of Oxycodone and Aspirin

Oxycodone: A High-Value Opioid Analgesic

Oxycodone is a semi-synthetic opioid primarily prescribed for moderate to severe pain. It is marketed under various brand names, notably OxyContin and Percocet (when combined with acetaminophen). The high potency and efficacy of oxycodone have cemented its role in pain management, especially in chronic or postoperative settings. However, the opioid crisis has significantly impacted its market, leading to regulatory crackdowns, reformulations, and societal scrutiny.

Aspirin: An Ancient, Widely Used NSAID

Aspirin (acetylsalicylic acid), discovered in the late 19th century, remains one of the most accessible and inexpensive over-the-counter analgesics. It serves multiple roles, including pain relief, anti-inflammatory purposes, and cardiovascular disease prevention via antiplatelet activity. Its longstanding history underpins a broad, stable market, though recent shifts toward newer therapies have moderated growth prospects.


Market Dynamics Influencing Oxycodone

Regulatory Environment and Legal Risks

The past decade has seen extensive regulatory interventions aimed at curbing opioid misuse. The US Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and other global agencies have implemented stricter prescribing guidelines, reformulated oxycodone to deter abuse (e.g., abuse-deterrent formulations), and imposed tighter distribution controls [1].

Market Demand and Prescription Trends

While demand remains significant, especially in pain management for cancer, palliative care, and acute post-surgical scenarios, prescription volumes declined markedly post-2010s. In the US, prescriptions for opioids have decreased by approximately 40–50% from their peak, reflecting regulatory and societal pressures [2].

Manufacturing and Supply Chain Shifts

Pharmaceutical companies are investing in tamper-resistant formulations and alternative pain therapies. Some producers have exited the oxycodone market due to legal liabilities and declining demand, consolidating remaining players [3].

Legal and Litigation Risks

Major litigation related to opioid addiction has resulted in multi-billion-dollar settlements and increased scrutiny over marketing practices. These risks add cost and uncertainty, impacting product valuation and R&D investments.

Emerging Alternatives and Market Competition

New multimodal analgesia approaches and non-opioid pain drugs are gaining traction, potentially reducing oxycodone’s share in market segments previously dominated by opioids [4].


Market Dynamics Influencing Aspirin

Market Stability and Consumer Accessibility

Aspirin benefits from its affordability, OTC status, and extensive historical use. Its role in cardiovascular prophylaxis is well documented, and guidelines endorse its continued use in specific populations [5].

Regulatory and Clinical Guidelines

Recent shifts, such as the US Preventive Services Task Force (USPSTF) recommendations against routine low-dose aspirin in certain age groups due to bleeding risks, have tempered enthusiasm for its universal use [6]. This influences prescribing habits and market size.

Innovative Applications and Niche Markets

Research into aspirin’s anti-inflammatory and anti-cancer properties has opened niche markets, potentially extending its utility beyond traditional pain and cardiovascular uses. Nonetheless, these remain experimental, with limited immediate commercial impact [7].

Competitive Pressure from Newer NSAIDs and Alternatives

The proliferation of selective COX-2 inhibitors and other NSAIDs offers alternatives that may outweigh aspirin’s advantages in some contexts. These newer agents often have better safety profiles for long-term use but may be more expensive [8].

Supply Chain and Manufacturing Considerations

Aspirin’s manufacturing remains straightforward with established global supply chains. The low cost and established patent expirations ensure continued market presence, barring major regulatory or safety concerns.


Financial Trajectory Analysis

Oxycodone: Revenue Trends and Market Valuation Outlook

The opioid epidemic has led to a significant market restructuring. While historically, oxycodone generated billions globally, recent years show a declining trend:

  • Sales Decline: US sales peaked around $10 billion in 2017, declining approximately 45% by 2022, influenced by regulatory restrictions and societal backlash [9].

  • Market Valuation: Major manufacturers’ valuations have adjusted accordingly; Purdue Pharma’s insolvency and lawsuits exemplify the financial risks. The transition toward abuse-deterrent formulations and non-opioid alternatives presents a mixed outlook—potential stabilization but limited growth prospects.

  • Forecasts: Long-term projections suggest a plateauing or slight decline in oxycodone sales, with some markets possibly phased out due to regulatory bans or market saturation [10].

Aspirin: Steady, Low-Growth Market With Opportunities

  • Revenue Consistency: Global sales are estimated to hover around $1–2 billion annually, with minimal fluctuations. Aspirin’s OTC nature ensures a consistent cash flow for generic manufacturers.

  • Market Expansion: Niche indications such as cancer prevention or anti-inflammatory uses could drive moderate growth, particularly with validated clinical data and targeted marketing.

  • Patent and Competition: Since aspirin’s patent expired decades ago, price erosion and competition have kept profit margins low. Still, its low-cost manufacturing secures its position as an accessible analgesic.

Impact of Regulatory and Scientific Developments

  • Strict regulations on opioids imply diminished revenue, while ongoing research on aspirin’s broader applications might catalyze new product lines, offering modest upside.

Strategic Implications for Industry Stakeholders

  • Manufacturers should navigate regulatory landscapes carefully, investing in reformulations and alternative pain management portfolios.

  • Investors must assess the declining valuation of opioid-centric companies against stable or niche markets in OTC aspirin products.

  • Policymakers ought to balance pain management needs with addiction risks, influencing future market trajectories.


Key Takeaways

  • The oxycodone market faces a pronounced decline due to regulatory, societal, and legal pressures, with growth prospects limited. Innovating in abuse-deterrent formulations and diversifying into non-opioid therapies remain crucial.

  • Aspirin’s long-standing market offers stability, though growth is constrained by recent clinical guidelines and competition from newer NSAIDs. Expanding indications through research could provide incremental growth.

  • Market resilience for opioids will depend on regulatory adaptability, legal risk management, and innovation. For aspirin, focus on niche indications and maintaining low-cost production secures its place in the analgesic market.

  • Stakeholders must monitor evolving clinical data, policy changes, and societal attitudes to anticipate future shifts and adapt strategies accordingly.


FAQs

1. How has the opioid epidemic impacted oxycodone's market valuation?
The opioid epidemic has led to regulatory crackdowns, increased litigation, and declined prescribing, collectively decreasing market valuation by approximately 45% since 2017, especially in North America.

2. Are there any promising new formulations of oxycodone that address abuse concerns?
Yes. Abuse-deterrent formulations, such as tamper-resistant tablets and implants, have been developed to reduce misuse, but their market adoption varies and faces regulatory hurdles.

3. What are the main factors limiting aspirin’s growth despite its longstanding market presence?
Recent clinical guidelines suggest cautious use due to bleeding risks, and competition from newer NSAIDs with better safety profiles and targeted therapies limits aspirin's expansion.

4. Could aspirin’s anti-cancer properties drive a new market segment?
Ongoing research indicates potential, but clinical validation remains limited. Widespread adoption for anti-cancer use is unlikely in the near term, though future approvals could create niche markets.

5. What regulatory trends should stakeholders monitor to anticipate market shifts?
Stakeholders should track guidelines on opioid prescribing, FDA approvals for new formulations, and emerging evidence on aspirin’s expanded indications to inform strategic decisions.


References

[1] U.S. Food and Drug Administration, “Abuse-Deterrent Opioid Formulations,” 2022.
[2] Centers for Disease Control and Prevention, “Annual Surveillance Report of Drug-Related Risks and Outcomes,” 2021.
[3] IMS Health, “Pharmaceutical Market Trends,” 2022.
[4] American Pain Society, “Multimodal Pain Management Strategies,” 2020.
[5] U.S. Preventive Services Task Force, “Aspirin Use for Prevention,” 2019.
[6] U.S. Preventive Services Task Force, “Final Recommendations on Aspirin,” 2019.
[7] National Cancer Institute, “Aspirin and Cancer Risk,” 2022.
[8] European Medicines Agency, “NSAID Market Report,” 2021.
[9] IQVIA, “Global Analgesic Market Data,” 2022.
[10] MarketsandMarkets, “Pain Management Market,” 2022.

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