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Last Updated: December 14, 2025

ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE - Generic Drug Details


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What are the generic drug sources for aspirin; oxycodone hydrochloride; oxycodone terephthalate and what is the scope of freedom to operate?

Aspirin; oxycodone hydrochloride; oxycodone terephthalate is the generic ingredient in six branded drugs marketed by Halsey, Ani Pharms, Sun Pharm Industries, Roxane, and Endo Operations, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
US Patents:0
Tradenames:6
Applicants:5
NDAs:7
DailyMed Link:ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

US Patents and Regulatory Information for ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Industries OXYCODONE AND ASPIRIN aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 040260-001 Jul 17, 1998 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
Roxane ROXIPRIN aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 087743-001 Jun 4, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
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
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
Endo Operations PERCODAN aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 007337-006 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 Aspirin, Oxycodone Hydrochloride, and Oxycodone Terephthalate

Last updated: July 28, 2025


Introduction

The global pharmaceutical landscape is characterized by rapid innovation, regulatory shifts, and shifting consumer demand. Key drugs such as aspirin, oxycodone hydrochloride, and oxycodone terephthalate serve diverse segments within this ecosystem, impacting healthcare outcomes and market economics. Analyzing their market dynamics and financial trajectories offers critical insights for stakeholders seeking strategic investment, regulatory compliance, and competitive advantage.


Aspirin: A Mature Commodity with Evolving Market Dynamics

Overview and Market Position

Aspirin (acetylsalicylic acid) remains one of the most widely used over-the-counter (OTC) medications globally, primarily for analgesic, antipyretic, and anti-inflammatory purposes, with established efficacy in cardiovascular disease prevention [1]. Its introduction dates back to the late 19th century, making it a mature, highly commoditized pharmaceutical.

Market Dynamics

Despite its age, aspirin’s market persists due to enduring consumer recognition, a well-understood safety profile, and broad accessibility. However, its market growth is plateauing, with global sales estimated at approximately USD 1.2–1.5 billion annually [2]. Patent expirations have facilitated widespread generic manufacturing, intensifying price competition and eroding profit margins.

Regulatory scrutiny has increased, especially concerning its use in primary prevention of cardiovascular events, following new clinical guidelines and safety concerns like gastrointestinal bleeding risks [3]. This has led to shifts toward targeted use rather than broad over-the-counter recommendations.

Market Challenges and Opportunities

  • Challenges: Declining usage in prophylactic indications, oversaturation of generic products, and the advent of new antiplatelet agents.
  • Opportunities: Extended indications for low-dose aspirin, combination therapies, and novel formulations such as sustained-release tablets to enhance patient compliance.

Financial Trajectory

Aspirin’s revenues are expected to stabilize or decline modestly in mature markets given saturated demand. In contrast, emerging markets present growth avenues driven by increasing healthcare access and rising cardiovascular disease prevalence. Structured efforts around branding and formulation innovation could mitigate revenue declines.


Oxycodone Hydrochloride: Navigating a High-Growth and Regulatory-Intensive Market

Overview and Market Position

Oxycodone hydrochloride is a potent semi-synthetic opioid analgesic used primarily for moderate to severe pain management. Its high efficacy has made it a staple in pain medicine, with a medical indication range encompassing postoperative pain, cancer-related pain, and palliative care [4].

Market Dynamics

Oxycodone's global market size was valued at approximately USD 7–9 billion in recent years, with North America accounting for nearly 75% of sales, indicating regional concentration [5]. The drug’s financial trajectory is driven by rising opioid prescriptions in markets like the U.S., propelled by aging populations and increased chronic pain prevalence.

However, the market faces significant headwinds rooted in the opioid epidemic, regulatory crackdowns, and legal constraints. Ongoing litigation, tighter prescribing guidelines, and increased monitoring depress sales growth and heighten compliance costs [6].

Market Challenges and Opportunities

  • Challenges: Heightened regulatory oversight, litigation risks, and societal concerns over addiction.
  • Opportunities: Development of abuse-deterrent formulations (ADFs), novel delivery systems, and expansion into emerging markets with less regulatory saturation.

Financial Trajectory

In developed markets, growth is expected to plateau or decline owing to regulatory challenges and public health concerns. Conversely, emerging markets such as Asia-Pacific offer potential for growth, driven by increasing healthcare infrastructure and evolving pain management practices. Industry players investing in ADFs and alternative dosing forms can sustain profitability amid market constraints.


Oxycodone Terephthalate: A Niche Formulation with Limited But Notable Potential

Overview and Market Position

Oxycodone terephthalate, a salt form of oxycodone, is utilized in pharmaceutical formulations to enhance stability, bioavailability, or as part of specific sustained-release products. Compared to oxycodone hydrochloride, its market share remains niche, primarily confined to certain formulations and regions.

Market Dynamics

Due to limited commercial production and regulatory approval, oxycodone terephthalate's market footprint is restricted. Its attractiveness lies in formulation advantages such as reduced solubility and altered pharmacokinetics, which could benefit specific therapeutic areas.

Market Challenges and Opportunities

  • Challenges: Scarcity of market data, limited clinical trials, and regulatory hurdles.
  • Opportunities: Innovation in formulation science, potential for patent extensions, and niche market application for controlled-release mechanisms.

Financial Trajectory

Oxycodone terephthalate's prospects hinge on successful regulatory approval and clinician acceptance. Its niche application limits large-scale revenue expectations but may promise higher margins given proprietary advantages. Strategic partnerships and investment in formulation innovation can unlock its potential in pain management therapy.


Regulatory Environment and its Impact on Market Dynamics

Regulatory changes significantly influence the market trajectories of these drugs. Aspirin, facing safety reevaluations, may experience demand shifts, whereas opioids like oxycodone are subject to intense scrutiny following the opioid epidemic. The future landscape will be shaped by stricter prescribing guidelines, increased monitoring, and efforts to develop abuse-deterrent technologies.

Emerging Trends and Innovation

Innovation in formulation science, especially for oxycodone derivatives, offers pathways to extend patent protection, improve safety profiles, and meet regulatory standards. Digital health integration, such as electronic prescribing and patient monitoring, aligns with the broader trend towards safer opioid use.


Key Takeaways

  • Aspirin’s mature market faces stagnation, but opportunities in new formulations, targeted indications, and emerging markets remain.
  • Oxycodone hydrochloride’s growth potential is tempered by regulatory and societal concerns but can be sustained through abuse-deterrent formulations and geographic expansion.
  • Oxycodone terephthalate’s niche role requires strategic investment in formulation research and regulatory navigation to unlock financial value.
  • Regulatory shifts globally will continue to influence demand, prescribing practices, and innovation avenues for all three drugs.
  • Collaboration between pharma companies and regulators, alongside technological innovation, will be critical in shaping the financial trajectories of these pharmaceuticals.

FAQs

  1. What are the primary factors influencing aspirin’s market stability?
    Market stability is driven by its established safety profile, widespread OTC availability, and ongoing use in cardiovascular disease prevention—in tandem with patent expirations and generic competition.

  2. How are regulatory changes affecting oxycodone hydrochloride?
    Stricter prescribing restrictions, increased oversight, and legal actions have generally suppressed growth, prompting industry focus on abuse-deterrent formulations and alternative pain management solutions.

  3. What potential does oxycodone terephthalate hold in the pharmaceutical industry?
    Its niche role in advanced formulations presents opportunities for differentiation but requires significant investment in clinical validation and regulatory approval to realize economic benefits.

  4. Are emerging markets likely to adopt oxycodone-based therapies?
    Yes. As healthcare infrastructure improves, growth in pain management demand in regions like Asia-Pacific may enhance market opportunities for oxycodone products.

  5. What strategies can pharmaceutical companies adopt to navigate future regulatory and market challenges?
    Diversification into alternative formulations, investment in safety and abuse-deterrent technologies, and tailored regional strategies are vital to maintaining competitiveness and financial stability.


Sources:

  1. [1] "Aspirin Market Analysis," GlobalData, 2022.
  2. [2] "Over-the-counter (OTC) Drugs Market," MarketWatch, 2022.
  3. [3] "American Heart Association Guidelines on Aspirin Use," Circulation, 2021.
  4. [4] "Oxycodone Market Overview," IQVIA Institute, 2022.
  5. [5] "Opioid Market Insights," Deloitte, 2021.
  6. [6] "Regulatory Trends in Opioid Prescriptions," FDA Reports, 2023.

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