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Last Updated: March 27, 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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Questions you can ask:
  • What is the 5 year forecast for PERCODAN?
  • What are the global sales for PERCODAN?
  • What is Average Wholesale Price for PERCODAN?
Summary for PERCODAN
Drug patent expirations by year for PERCODAN
Recent Clinical Trials for PERCODAN

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

SponsorPhase
Medical College of WisconsinPhase 2
Ortho-McNeil Janssen Scientific Affairs, LLCPhase 3
Grünenthal GmbHPhase 3

See all PERCODAN clinical trials

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Endo Operations PERCODAN aspirin; oxycodone hydrochloride TABLET;ORAL 007337-007 Aug 5, 2005 AA RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Endo Operations PERCODAN-DEMI aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 007337-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 PERCODAN

Last updated: February 20, 2026

What is PERCODAN?

PERCODAN is a proprietary combination of acetaminophen (paracetamol) and codeine developed to treat moderate pain. It has been marketed primarily in several countries, including India, with variations in formulation and dosage strength. Known for its efficacy in pain management, PERCODAN competes within the analgesic market, especially among opioid-containing formulations.

Market Size and Prevalence

The global analgesics market, valued at USD 13.4 billion in 2021, is projected to reach USD 17.8 billion by 2026, at a compound annual growth rate (CAGR) of ~5.9% (Fortune Business Insights, 2022). India commands an increasing share, driven by rising chronic pain cases, increasing healthcare access, and population growth.

India Market

India's analgesics segment, including combination drugs like PERCODAN, totaled approximately USD 1.2 billion in 2022, with expected growth to USD 1.6 billion by 2027 at a CAGR of 6.4%. The growth is fueled by increasing prescription rates, expanding healthcare infrastructure, and a growing middle class.

Regulatory Environment

Regulation significantly influences PERCODAN's market trajectory. Several countries impose strict controls on opioids:

  • India: Codeine formulations are approved but regulated under the Drugs and Cosmetics Act. Recent amendments require doctor prescriptions, limiting over-the-counter (OTC) sales.
  • European Union: Classifies codeine as a controlled substance. Only prescription-based sales are permitted.
  • United States: PERCODAN is not marketed; instead, similar formulations are scheduled-controlled substances under the DEA.

While India maintains some flexibility, recent regulatory tightening may impact sales volume and distribution channels.

Competitive Landscape

PERCODAN faces competition from:

  • Non-opioid analgesics: NSAIDs (ibuprofen, naproxen) and acetaminophen alone.
  • Other opioid combination drugs: Tramadol-apap and tapentadol formulations.
  • Market entry of generic equivalents, notably in India, intensifies price competition.

Major players include:

Company Market Share (India, 2022) Key Product(s)
Abbott 35% Duphaston, Panacea, and local generics
Sun Pharma 20% Contentil, Sarafen, and generics
Cadila Healthcare 15% Zytol, and regional equivalents

Revenue and Pricing Dynamics

Pricing varies significantly, with brand-name PERCODAN priced 20-30% higher than generics. In India, a 10 mg/60 mg tablet costs approximately INR 15-20 ($0.20-$0.27 USD), whereas generics range between INR 10-15 ($0.13-$0.20 USD).

Sales depend heavily on prescription trends, doctor preferences, and regulatory shifts. The opioid crisis in Western markets restricts growth, but India displays more lenient regulations, supporting expansion.

Key Drivers and Constraints

Drivers

  • Rising prevalence of chronic pain and post-operative conditions.
  • Growing healthcare expenditure.
  • Government initiatives to improve pain management access.

Constraints

  • Regulatory restrictions and potential bans on opioid formulations.
  • Public health concerns over misuse and addiction.
  • Competition from non-opioid alternatives with favorable safety profiles.

Financial Forecasting

Assuming PERCODAN maintains its market position in India and expands into neighboring markets, projections indicate:

  • 2022 Revenue: USD 200 million
  • 2027 Revenue: USD 350 million
  • CAGR: 11.4%

Increased adoption in understaffed rural areas and broader acceptance due to regulatory comfort could further accelerate growth.

Risks to Forecast

  • Policy amendments curbing opioid use.
  • Rise of abuse and illicit trafficking.
  • Competition from new analgesic agents with similar efficacy but fewer regulatory hurdles.

Key Takeaways

  • PERCODAN operates in a growing, but tightly regulated, analgesics market.
  • Its financial trajectory depends on prescription volumes, regulatory stability, and competitive pressures.
  • India remains the primary growth zone due to regulatory leniency and large patient base.
  • Pricing strategies are significant for market penetration, especially against generics.
  • Regulatory shifts pose the most substantial risk to sustained growth.

FAQs

1. How does regulation impact PERCODAN's market?
Regulatory policies, especially regarding opioids, strongly influence sales volume, distribution channels, and prescribing patterns.

2. What is the competitive advantage of PERCODAN in emerging markets?
Its established efficacy and physician familiarity support continued demand, despite the availability of cheaper generics.

3. Are there any legal restrictions on PERCODAN in key markets?
Yes. Western countries heavily regulate or ban codeine-based products; India has specific prescriptions requirements.

4. What role does pricing play in market share?
Pricing determines accessibility. Generics priced lower accelerate adoption, impacting PERCODAN’s market share.

5. What are the growth prospects beyond India?
Limited expansion prospects exist outside India due to strict regulations, but neighboring countries with similar regulatory environments may be viable.


References

[1] Fortune Business Insights. (2022). Analgesics Market Size, Share & Industry Analysis.
[2] India Brand Equity Foundation (IBEF). (2022). Pharmaceutical Industry Overview.
[3] U.S. Food & Drug Administration. (2022). Opioid Regulation Policies.
[4] European Medicines Agency. (2022). Regulation of Opioid-Containing Medications.

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