ASPIRIN; OXYCODONE HYDROCHLORIDE - Generic Drug Details

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

Aspirin; oxycodone hydrochloride is the generic ingredient in six branded drugs marketed by Actavis Labs Fl Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Endo Operations, Halsey, Ani Pharms, Sun Pharm Industries, and Roxane, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

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

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 4
Albany Medical College	Phase 4
John Mascarenhas	Phase 1

See all ASPIRIN; OXYCODONE HYDROCHLORIDE clinical trials

Pharmacology for ASPIRIN; OXYCODONE HYDROCHLORIDE

Drug Class	Nonsteroidal Anti-inflammatory Drug Opioid Agonist Platelet Aggregation Inhibitor
Mechanism of Action	Cyclooxygenase Inhibitors Full Opioid Agonists
Physiological Effect	Decreased Platelet Aggregation Decreased Prostaglandin Production

Anatomical Therapeutic Chemical (ATC) Classes for ASPIRIN; OXYCODONE HYDROCHLORIDE

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

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
Sun Pharm Industries	OXYCODONE AND ASPIRIN	aspirin; oxycodone hydrochloride; oxycodone terephthalate	TABLET;ORAL	040260-001	Jul 17, 1998		DISCN	No	No
Endo Operations	PERCODAN	aspirin; oxycodone hydrochloride	TABLET;ORAL	007337-007	Aug 5, 2005	AA	RX	Yes	Yes
Roxane	ROXIPRIN	aspirin; oxycodone hydrochloride; oxycodone terephthalate	TABLET;ORAL	087743-001	Jun 4, 1982		DISCN	No	No
Epic Pharma Llc	OXYCODONE AND ASPIRIN	aspirin; oxycodone hydrochloride	TABLET;ORAL	040910-001	Jul 16, 2020	AA	RX	No	No
Actavis Labs Fl Inc	OXYCODONE AND ASPIRIN	aspirin; oxycodone hydrochloride	TABLET;ORAL	090084-001	Mar 22, 2011		DISCN	No	No

Market Dynamics and Financial Trajectory of Aspirin and Oxycodone Hydrochloride

Last updated: February 14, 2026

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What Is the Current Market Size for Aspirin and Oxycodone Hydrochloride?

Aspirin:

• Estimated global market size was approximately $2.3 billion in 2022.
• Key markets: United States, Europe, and Asia-Pacific.
• Main applications: cardiovascular prophylaxis, pain relief, antipyretic.

Oxycodone Hydrochloride:

• Estimated global market size was around $5.8 billion in 2022.
• Leading markets: United States holds roughly 85% of the oxycodone market.
• Main applications: management of moderate to severe pain, often in opioid prescription regimes.

How Do Market Trends Shift Due to Regulatory and Public Health Factors?

Aspirin:

• Market growth driven by aging populations and increased use in cardiovascular prevention.
• Facing competition from novel anticoagulants (e.g., rivaroxaban, apixaban).
• Regulatory warnings about bleeding risks have restrained some usage in primary prevention.

Oxycodone Hydrochloride:

• Subject to increased regulation due to opioid epidemic concerns.
• Stricter prescribing guidelines and prescription monitoring programs have reduced oxycodone sales in the US.
• Growth in markets outside the US is sluggish, constrained by stricter regulations.

What Are the Key Drivers and Challenges?

Aspirin:

• Drivers:
  • Widespread over-the-counter availability.
  • Evidence supporting secondary prevention of cardiovascular events.
  • Growing awareness of its benefits in low doses.
• Challenges:
  • Bleeding risk concerns.
  • Competition from other non-steroidal anti-inflammatory drugs (NSAIDs).

Oxycodone Hydrochloride:

• Drivers:
  • Ongoing need for pain management in surgical and chronic pain contexts.
  • Development of combination formulations (e.g., oxycodone with naloxone) to mitigate abuse potential.
• Challenges:
  • Legal and regulatory restrictions.
  • Rising prevalence of alternative pain management approaches.

What Are the Patent and Regulatory Factors Influencing Market Trajectory?

Aspirin:

• No recent patent protections; OTC formulations are generic.
• Patent expiries in the 1980s/1990s led to price pressures and generic proliferation.
• Regulatory stance increasingly cautious regarding primary prevention indications.

Oxycodone Hydrochloride:

• Several formulations are patented, including abuse-deterrent versions (e.g., Purdue’s OxyContin reformulations).
• Patent expiries in the late 2010s opened the market to generics.
• Ongoing regulatory scrutiny influences new product launches and formulations.

What Does the Financial Outlook Look Like?

Aspirin:

• Expected Compound Annual Growth Rate (CAGR) through 2030 is approximately 2-3%.
• Revenue declines in some markets due to competition but sustained demand in secondary prevention.

Oxycodone Hydrochloride:

• Market CAGR during 2022-2030 projected at around 3-4%, tempering traditional growth due to regulatory constraints.
• Growing segment: abuse-deterrent formulations, which command premium pricing.

Market Outlook and Future Trends

Aspirin:

• Growth will continue supported by aging demographics and secondary prevention applications.
• Innovations focus on safety improvements and formulations reducing gastrointestinal side effects.

Oxycodone Hydrochloride:

• Demand will stabilize or decline in key markets like the US due to regulatory challenges.
• Expansion in emerging markets is limited by local legal frameworks.
• Focus shifts toward abuse-deterrent formulations and new delivery systems.

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Key Takeaways

• Aspirin market remains steady mainly due to its established role in cardiovascular disease prevention, but faces competition and safety skepticism.
• Oxycodone's market is constrained by regulatory tightening but still benefits from its role in pain management with reformulations to address abuse risks.
• Patent expiries and generics significantly influence market pricing and revenue trajectories.
• Future growth for both drugs hinges on regulatory developments, safety improvements, and market expansion outside mature markets.

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FAQs

1. Will aspirin regain popularity for primary prevention of cardiovascular disease?
Potentially, but regulatory warnings and risk assessments have limited its primary prevention use. Current guidelines favor more targeted use, which limits market growth.

2. How has the opioid epidemic affected oxycodone market prospects?
Significantly. Stricter prescribing practices, prescription monitoring programs, and concerns over abuse have reduced sales in established markets like the US.

3. Are there innovative formulations of aspirin or oxycodone that will influence future market dynamics?
Yes. Aspirin formulations with gastrointestinal side effect mitigation are under development. Abuse-deterrent oxycodone formulations continue to command premium prices but face regulatory challenges.

4. What geographical markets are emerging for oxycodone?
Markets like China and parts of Europe show initial adoption but are hindered by local regulatory restrictions.

5. What impact will regulatory changes have on the generics market for these drugs?
For aspirin, no significant impact as it is generic and over-the-counter. For oxycodone, tighter regulations may limit market entry, impact pricing, or delay new formulations.

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References

1. MarketsandMarkets, "Aspirin Market by Application, Dosage Form, and Region," 2022.
2. IQVIA, "Global Pain Management Market Analysis," 2022.
3. U.S. Food and Drug Administration, "Opioids: Controlling Pain and Preventing Abuse," 2021.
4. Statista, "Global Aspirin Market Revenue Forecast," 2023.
5. Deloitte Insights, "Pharmaceutical Patent Expiry Trends," 2022.