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Last Updated: March 19, 2026

PERCODAN Drug Patent Profile


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Which patents cover Percodan, and what generic alternatives are available?

Percodan is a drug marketed by Endo Operations and is included in one NDA.

The generic ingredient in PERCODAN is aspirin; oxycodone hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin; oxycodone hydrochloride profile page.

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Summary for PERCODAN
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for PERCODAN

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 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
Endo Operations PERCODAN aspirin; oxycodone hydrochloride TABLET;ORAL 007337-007 Aug 5, 2005 AA RX Yes Yes ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PERCODAN Market Analysis and Financial Projection

Last updated: February 8, 2026

What Is the Investment Potential of PERCODAN?

PERCODAN, a combination of acetaminophen and codeine, is used primarily for pain management. Its market penetration, regulatory status, and competitive landscape influence its investment viability. The drug's sales depend on prescriber preferences, regulatory restrictions on opioids, and generic competition.

What Are the Market Fundamentals of PERCODAN?

Market Size and Demand

  • The global analgesics market was valued at $8.83 billion in 2020 and is projected to grow at a CAGR of 4-6% through 2028 [1].
  • Opioids like PERCODAN account for a significant share in prescription pain treatments, especially in North America and parts of Europe.
  • The decline in opioid prescription rates due to regulatory controls impacts sales, but demand persists where opioid usage remains permitted.

Geographical Markets

  • Major markets include Canada, Australia, and some European countries.
  • In the U.S., PERCODAN contains codeine, which faces increased regulation and scheduling restrictions, limiting sales growth.
  • Emerging markets show growth potential for opioid-based analgesics, but regulatory environments are evolving.

Competitive Landscape

  • PERCODAN faces competition from:
    • Non-opioid analgesics (NSAIDs, acetaminophen alone).
    • Other combination drugs with similar efficacy.
    • Rising use of abuse-deterrent formulations seeks to mitigate opioid misuse concerns.

Regulatory Environment

  • Regulatory agencies like the FDA and EMA have tightened controls over opioids, including scheduling restrictions.
  • PERCODAN's regulatory status varies by country, affecting marketability.
  • Prescription limits and abuse-deterrent formulation mandates impact sales volume.

Patent and Regulatory Exclusivity

  • Original formulations of PERCODAN lack recent patent protection.
  • Generic versions are available in several markets, exerting price and volume pressure.
  • No recent regulatory exclusivity periods are apparent from available data.

What Are the Investment Risks and Opportunities?

Risks

  • Regulatory constraints reduce prescribing and sales volume.
  • Rising public health concerns and legal actions against opioids diminish market access.
  • Patent expiry and generic entry suppress pricing and margins.
  • Competition from non-opioid analgesics limits overall market growth.

Opportunities

  • Potential reformulation with abuse-deterrent features could prolong market relevance.
  • Expansion into emerging markets with less restrictive opioid policies.
  • Growth in chronic pain management could sustain demand if regulatory hurdles are managed.

What Are the Key Financial Considerations?

  • No recent licensing or patent revenue reported for PERCODAN.
  • Sales depend on incumbent producers' market strategies.
  • Margins are under pressure from generic competition.
  • Investment returns hinge on regulatory status and market expansion success.

Conclusion

PERCODAN's investment profile is limited by regulatory risks, patent uncertainties, and competitive pressures. Its current market is mature and declining in regions with strict opioid regulations. Growth prospects exist primarily in select emerging markets and through formulation reformulations. Financial viability depends heavily on regulatory developments, market access, and the ability to differentiate from generic competition.

Key Takeaways

  • Market size is significant but declining in mature regions due to regulation.
  • Competition from generics and non-opioid alternatives limits revenue potential.
  • Regulatory restrictions pose major risks, especially in North America and Europe.
  • Growth in emerging markets and reformulation options offer some upside.
  • Financial performance remains uncertain without new patent protections or innovative formulations.

FAQs

1. What regulatory challenges does PERCODAN face?
Codeine-containing products like PERCODAN face increasing restrictions globally. The U.S. FDA reclassified codeine for certain pediatric populations and imposed prescription limits, impacting sales.

2. How does patent expiration affect PERCODAN?
Patent expiry and the availability of generic versions have led to price erosion and reduced profit margins for brand-name formulations.

3. Are there opportunities for reformulating PERCODAN?
Yes, reformulations with abuse-deterrent features could sustain interest and compliance with new regulations, but development costs and regulatory approval timelines are obstacles.

4. What is the outlook for PERCODAN in emerging markets?
Emerging markets may offer growth potential due to laxer regulations, but healthcare infrastructure and opioid misuse controls vary.

5. How do public health initiatives impact the PERCODAN market?
Efforts to curb opioid misuse restrict prescribing practices, decreasing sales volume and revenue opportunities for formulations like PERCODAN.

References

[1] Grand View Research, "Analgesics Market Size, Share & Trends Analysis Report," 2021.

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