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Last Updated: December 22, 2024

PERCODAN-DEMI Drug Patent Profile


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Summary for PERCODAN-DEMI
US Patents:0
Applicants:1
NDAs:1
Clinical Trials: 2
DailyMed Link:PERCODAN-DEMI at DailyMed
Drug patent expirations by year for PERCODAN-DEMI
Recent Clinical Trials for PERCODAN-DEMI

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

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US Patents and Regulatory Information for PERCODAN-DEMI

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-DEMI aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 007337-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

PERCODAN-DEMI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PERCODAN-DEMI

Introduction

PERCODAN-DEMI, a combination of oxycodone and aspirin, is a potent opioid analgesic used to manage moderate to moderately severe pain. This article delves into the market dynamics and financial trajectory of PERCODAN-DEMI, highlighting its usage, regulatory environment, market trends, and the financial implications of its sales.

Market Context: Opioid Pain Relievers

The opioid pain reliever market has been marked by significant growth and controversy over the past few decades. The U.S. has seen a substantial increase in the prescription and consumption of opioid analgesics, driven by the need to manage chronic and acute pain. By 2007, the U.S. accounted for over 99% of the global consumption of hydrocodone and 83% of oxycodone, despite comprising only 4.6% of the global population[4].

Regulatory Environment

The regulatory environment for opioid analgesics like PERCODAN-DEMI is stringent due to the risks associated with addiction, abuse, and misuse. The FDA has mandated strong safety warnings on the labels of these drugs, emphasizing the risks of life-threatening respiratory depression, accidental ingestion, and neonatal opioid withdrawal syndrome[1].

Marketing and Promotion

The marketing and promotion strategies for opioid analgesics have been under scrutiny. For example, Purdue Pharma's aggressive marketing of OxyContin, another oxycodone-based drug, was criticized for targeting a wide range of conditions and physicians who may not have been adequately trained in pain management. Similar concerns could apply to PERCODAN-DEMI, necessitating careful and responsible marketing practices[3].

Sales and Financial Performance

The financial performance of PERCODAN-DEMI is closely tied to the broader opioid market. Sales of opioid analgesics have been robust, with OxyContin, for instance, exceeding $1 billion in annual sales by 2001. However, the financial trajectory is also influenced by the costs associated with addressing abuse and diversion, as well as regulatory compliance.

Sales Growth

The sales growth of opioid analgesics, including PERCODAN-DEMI, has been significant. From 1997 to 2007, sales of oxycodone increased by 866%, reflecting a growing demand for effective pain management solutions[4].

Revenue Impact

The revenue generated by PERCODAN-DEMI contributes to the overall financial health of its manufacturer. However, the revenue must be balanced against the costs of regulatory compliance, educational programs, and risk management plans aimed at preventing abuse and diversion.

Challenges and Risks

Abuse and Diversion

One of the major challenges facing PERCODAN-DEMI is the risk of abuse and diversion. The FDA and DEA have implemented various measures to combat these issues, including risk management plans and educational programs. These efforts, while necessary, add to the operational costs and can impact the financial trajectory of the drug[1][3].

Regulatory Actions

Regulatory actions, such as the imposition of stronger safety warnings and the requirement for risk management plans, can affect the sales and profitability of PERCODAN-DEMI. For example, Purdue Pharma faced regulatory actions for its marketing practices related to OxyContin, which could serve as a precedent for other opioid manufacturers[3].

Public Health Concerns

The opioid crisis in the U.S. has significant public health implications, with chronic pain affecting 50 million adults and resulting in economic costs estimated between $560 billion and $635 billion annually. This crisis can lead to increased scrutiny and regulatory pressure on opioid manufacturers, potentially impacting the market dynamics and financial performance of PERCODAN-DEMI[2].

Competitive Landscape

The competitive landscape for opioid analgesics is complex, with multiple players offering various formulations. PERCODAN-DEMI competes with other oxycodone-based products like OxyContin, as well as other opioid analgesics such as hydrocodone and methadone. The competitive environment is further complicated by the need for responsible prescribing practices and the ongoing efforts to address the opioid crisis[4].

Future Outlook

The future outlook for PERCODAN-DEMI is influenced by several factors:

Regulatory Changes

Any changes in regulatory policies or guidelines for opioid prescribing could impact the sales and financial performance of PERCODAN-DEMI. For instance, stricter guidelines for opioid prescribing could reduce the number of prescriptions written.

Public Health Initiatives

Public health initiatives aimed at addressing the opioid crisis may also affect the market dynamics. These initiatives could include increased funding for pain management education, stricter monitoring of opioid prescriptions, and the development of alternative pain management strategies.

Market Trends

The trend towards more responsible opioid prescribing and the development of non-opioid pain management alternatives could influence the long-term financial trajectory of PERCODAN-DEMI. As healthcare providers and patients seek safer and more effective pain management options, the demand for opioid analgesics may decrease.

Key Takeaways

  • Regulatory Environment: Strict regulations and safety warnings are in place due to the risks associated with opioid analgesics.
  • Market Growth: Significant sales growth has been observed in the opioid analgesic market, but this is balanced by the costs of addressing abuse and diversion.
  • Challenges: Abuse and diversion risks, regulatory actions, and public health concerns are major challenges.
  • Competitive Landscape: The market is competitive with multiple opioid analgesics available.
  • Future Outlook: Regulatory changes, public health initiatives, and market trends will shape the future financial trajectory of PERCODAN-DEMI.

FAQs

What are the primary risks associated with PERCODAN-DEMI?

The primary risks include addiction, abuse, and misuse, life-threatening respiratory depression, accidental ingestion, and neonatal opioid withdrawal syndrome.

How has the opioid crisis impacted the market for PERCODAN-DEMI?

The opioid crisis has led to increased regulatory scrutiny, public health initiatives, and a shift towards more responsible prescribing practices, all of which can impact the sales and financial performance of PERCODAN-DEMI.

What are the key factors influencing the financial trajectory of PERCODAN-DEMI?

Key factors include sales growth, regulatory compliance costs, the costs of addressing abuse and diversion, and the competitive landscape.

How does PERCODAN-DEMI compare to other opioid analgesics in the market?

PERCODAN-DEMI competes with other oxycodone-based products like OxyContin and other opioid analgesics such as hydrocodone and methadone, with its unique formulation and regulatory environment distinguishing it.

What are the potential future trends that could affect PERCODAN-DEMI?

Future trends include stricter regulatory guidelines, increased public health initiatives, and the development of non-opioid pain management alternatives, all of which could influence the demand for PERCODAN-DEMI.

Sources

  1. FDA Label for PERCODAN: "PERCODAN® (Oxycodone and Aspirin Tablets, USP) CII Rx only."
  2. Pain Management Best Practices Inter-Agency Task Force Report: "Pain Management Best Practices Inter-Agency Task Force Report."
  3. GAO Report on OxyContin Abuse and Diversion: "OxyContin Abuse and Diversion and Efforts to Address the Problem."
  4. Scholarly Commons on Cancer Pain: "Cancer Pain."
  5. WebMD on Percodan Demi: "Percodan Demi Tablet - Uses, Side Effects, and More."

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