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Last Updated: December 15, 2025

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
Raw Ingredient (Bulk) Api Vendors: 24
Clinical Trials: 2
DailyMed Link:PERCODAN at DailyMed
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 ⤷  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

Market Dynamics and Financial Trajectory for PERCODAN

Last updated: July 29, 2025

Introduction

PERCODAN, a branded formulation of the potent opioid analgesic, contains Pentazocine as its active ingredient. Widely prescribed for moderate to severe pain management, PERCODAN has historically held a significant position within analgesic markets. However, evolving regulatory landscapes, rising concerns over opioid misuse, and shifting healthcare paradigms have profoundly influenced its market dynamics. This analysis provides an in-depth examination of PERCODAN’s current market status, factors shaping its financial trajectory, and future outlooks.

Pharmacological Profile and Therapeutic Use

PERCODAN’s active component, Pentazocine, acts as a mixed agonist-antagonist at opioid receptors, providing analgesia while purportedly reducing the risk of respiratory depression compared to full agonists like morphine. Its therapeutic application spans acute pain, postoperative pain, and certain chronic pain scenarios. Despite its efficacy, concerns related to dependency and abuse potential have prompted stricter usage regulations globally.

Market Landscape and Key Players

Global Market Overview

The demand for opioid analgesics, including PERCODAN, remains substantial, driven by increasing prevalence of acute and chronic pain conditions and expanding surgical procedures. In 2022, the global opioid analgesics market was valued at approximately USD 15 billion, with a compound annual growth rate (CAGR) forecasted around 3-4% through 2030 [1].

Regional Dynamics

  • North America: The largest market, driven by high opioid prescription rates, sizable healthcare infrastructure, but concurrently facing regulatory pressures and opioid epidemic challenges.
  • Europe: Growth influenced by evolving analgesic guidelines and stringent control measures.
  • Asia-Pacific: Rapidly expanding due to rising healthcare access, increasing pain management needs, and commercialization efforts by pharmaceutical firms.

Competitive Environment

PERCODAN faces competition from other opioid formulations (e.g., codeine, tramadol) and non-opioid alternatives (NSAIDs, antidepressants). Key pharmaceutical entities, including Mylan, Teva, and local generic manufacturers, dominate the market, often offering formulations with similar efficacy at lower prices. Patent expirations, when applicable, boost generic entry, intensifying market competition and impacting revenue streams for proprietary brands.

Regulatory and Legal Factors

Evolving Regulations

Stringent regulations aimed at mitigating opioid abuse have affected PERCODAN’s market dynamics. Several countries have restricted prescribing, implemented tamper-resistant formulations, and increased monitoring of opioid distribution. These measures have directly impacted sales volume and distribution channels.

Litigation Risks

Legal actions related to opioid misuse and addiction liabilities have led to substantial financial settlements and heightened compliance costs. Companies producing PERCODAN must navigate these complexities, impacting profit margins and market access strategies.

Demand Drivers and Constraints

Demand Drivers

  • Increasing global incidence of pain-related conditions.
  • Expansion of surgical and outpatient procedures.
  • Growing awareness and acceptance among clinicians regarding pain management options.

Constraints

  • Growing concerns over dependency, misuse, and diversion.
  • Regulatory restrictions limiting prescribing and distribution.
  • Competition from non-opioid analgesics with better safety profiles.
  • Public and government campaigns against opioid proliferation.

Pharmacovigilance and Safety Profile

Enhanced surveillance has led to stricter controls, pushing manufacturers to develop tamper-resistant formulations or alternative delivery pathways. The safety profile directly influences prescribing practices and, consequently, sales volumes.

Financial Trajectory and Market Projections

Revenue Trends

Historically, PERCODAN generated significant revenues within its primary markets, with sales peaks correlating to favorable prescribing practices and regulatory environments. However, recent years demonstrate a plateau or decline in certain regions due to regulatory restrictions and public health interventions.

Future Outlook

The outlook indicates a potential decline in PERCODAN’s market share unless strategic adaptations occur. Innovations such as abuse-deterrent formulations (ADFs), geographic expansion into emerging markets, and repositioning within pain management protocols are vital.

Strategic Opportunities

  • Formulation Innovations: Development of formulations with lower abuse potential.
  • Market Diversification: Expanding into regions with less restrictive regimes.
  • Partnerships: Collaborations with healthcare providers to promote appropriate use.

Risks and Uncertainties

  • Political and regulatory turbulence.
  • Increasing litigation costs and potential bans.
  • Competition from emerging non-opioid analgesics.
  • Public health campaigns diminishing acceptance.

Conclusion

The market dynamics for PERCODAN are characterized by a complex interplay of pharmacological efficacy, regulatory scrutiny, societal concerns, and competitive forces. While demand remains significant, especially in regions with high pain management needs, the financial trajectory faces headwinds rooted in regulatory constraints, public health initiatives, and shifting clinician preferences. Companies invested in PERCODAN must proactively innovate and adapt strategies aligned with evolving market realities to sustain profitability and market relevance.


Key Takeaways

  • Regulatory Evolution: Increased restrictions and safety concerns have moderated PERCODAN's market growth, necessitating strategic innovation.
  • Market Competition: Generic competition and alternative therapies challenge profit margins, emphasizing the need for formulation enhancements.
  • Regional Variability: North American markets remain sizable but are hampered by abuse mitigation policies; emerging markets offer growth opportunities.
  • Innovation Imperative: Abuse-deterrent formulations and alternative delivery systems are critical to maintaining market share.
  • Strategic Adaptability: Diversification, partnerships, and compliance investments are essential for future financial resilience.

FAQs

1. How are regulatory changes impacting PERCODAN’s sales globally?
Regulatory measures, such as prescription monitoring and restrictions on opioid prescribing, have reduced PERCODAN’s demand in certain regions, especially North America. These policies aim to curb misuse but have led manufacturers to reassess market strategies, often resulting in sales decline or reformulation efforts.

2. What are the key factors influencing PERCODAN’s future market growth?
Factors include regulatory acceptance, ability to develop abuse-deterrent formulations, demand from pain management sectors, competition from non-opioid analgesics, and expansion into emerging markets with less restrictive environments.

3. Are there any ongoing developments to reduce the abuse potential of PERCODAN?
Yes, pharmaceutical companies are investing in reformulations incorporating tamper-resistant and abuse-deterrent features, aligning with regulatory expectations and societal demands to minimize misuse.

4. How significant is the competition from non-opioid analgesics for PERCODAN?
Non-opioid options like NSAIDs, antidepressants, and anticonvulsants are increasingly preferred for pain management due to favorable safety profiles, thus constraining PERCODAN’s market share, especially for mild to moderate pain.

5. What prospects exist for PERCODAN in emerging markets?
Emerging markets present growth opportunities driven by increasing healthcare infrastructure and rising pain management needs. However, challenges include regulatory uncertainties and competition from low-cost generics.


References

[1] MarketWatch, “Global Opioid Analgesics Market Size, Share & Trends Report, 2022-2030,” 2022.

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