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Last Updated: December 22, 2024

OXYCODONE AND ASPIRIN (HALF-STRENGTH) Drug Patent Profile


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When do Oxycodone And Aspirin (half-strength) patents expire, and what generic alternatives are available?

Oxycodone And Aspirin (half-strength) is a drug marketed by Roxane and is included in one NDA.

The generic ingredient in OXYCODONE AND ASPIRIN (HALF-STRENGTH) is aspirin; oxycodone hydrochloride; oxycodone terephthalate. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; oxycodone hydrochloride; oxycodone terephthalate profile page.

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Summary for OXYCODONE AND ASPIRIN (HALF-STRENGTH)
US Patents:0
Applicants:1
NDAs:1
Clinical Trials: 6
DailyMed Link:OXYCODONE AND ASPIRIN (HALF-STRENGTH) at DailyMed
Drug patent expirations by year for OXYCODONE AND ASPIRIN (HALF-STRENGTH)
Recent Clinical Trials for OXYCODONE AND ASPIRIN (HALF-STRENGTH)

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SponsorPhase
University of North Carolina, Chapel HillPhase 4
Albany Medical CollegePhase 4
John MascarenhasPhase 1

See all OXYCODONE AND ASPIRIN (HALF-STRENGTH) clinical trials

US Patents and Regulatory Information for OXYCODONE AND ASPIRIN (HALF-STRENGTH)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roxane OXYCODONE AND ASPIRIN (HALF-STRENGTH) aspirin; oxycodone hydrochloride; oxycodone terephthalate TABLET;ORAL 087742-001 Jun 4, 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

OXYCODONE AND ASPIRIN (HALF-STRENGTH) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Oxycodone and Aspirin (Half-Strength)

Introduction

Oxycodone, often combined with other analgesics like aspirin, has been a pivotal drug in the management of moderate to severe pain. The market dynamics and financial trajectory of oxycodone and aspirin (half-strength) formulations are influenced by several factors, including regulatory changes, market interventions, and economic conditions.

Historical Context of Oxycodone

Oxycodone, the active ingredient in medications like OxyContin, was first approved by the FDA in 1995. By 2001, it had become the most prescribed brand-name narcotic medication for treating moderate-to-severe pain, with sales exceeding $1 billion annually[4].

Rise and Abuse of OxyContin

The rapid growth in OxyContin prescriptions was accompanied by reports of abuse and diversion. Aggressive marketing by Purdue Pharma, particularly to primary care physicians who may not have been adequately trained in pain management, contributed to its widespread use and subsequent abuse[4].

Regulatory Interventions

Introduction of Abuse-Deterrent OxyContin

In August 2010, an abuse-deterrent formulation of OxyContin was introduced. This version was designed to be resistant to crushing or dissolving, making it harder to abuse. This change significantly impacted the market dynamics of oxycodone.

  • The introduction of abuse-deterrent OxyContin led to a substantial decrease in the dispensing of extended-release oxycodone. Two years after the introduction, the dispensing rate decreased by 11.3 milligrams of morphine-equivalent dose per member per quarter[1].
  • This intervention also resulted in a 20% decrease in the estimated overdose rate attributed to prescription opioids[1].

Withdrawal of Propoxyphene

In November 2010, propoxyphene was voluntarily withdrawn from the US market due to emerging data about its cardiac toxic effects. This withdrawal further altered the opioid market landscape.

  • The withdrawal of propoxyphene led to a decrease in its dispensing rate by 8.19 milligrams of morphine-equivalent dose per member per quarter. This change, combined with the introduction of abuse-deterrent OxyContin, affected the overall prescription opioid supply and overdose rates[1].

Economic Impact and Employment Factors

Economic Conditions and Opioid Demand

Economic conditions play a significant role in the demand for pain medications, including oxycodone. During local economic expansions, the demand for pain relief increases, particularly among workers in high-injury industries.

  • Better employment conditions can reduce opioid abuse by increasing the opportunity cost of using opioids, such as missed work opportunities and time spent under its effects. However, economic expansions can also increase physical pain due to new and less experienced hires and workers with existing health conditions joining the labor force[3].

Substitution Between Opioids and OTC Painkillers

The demand for opioids and over-the-counter (OTC) painkillers is interrelated. Economic expansions can lead to a substitution between these medications, with workers preferring OTC painkillers due to their lower opportunity costs.

  • Studies have shown that during economic expansions, the decline in opioid abuse is larger than the total effect on use, while the demand for OTC painkillers increases. This substitution is more pronounced in industries with higher injury rates[3].

Financial Trajectory

Sales and Revenue

The financial trajectory of oxycodone formulations has been significantly impacted by regulatory changes and market interventions.

  • The introduction of abuse-deterrent OxyContin led to a decrease in sales due to reduced dispensing rates. However, the overall revenue might not have decreased proportionally due to changes in pricing and insurance coverage. For instance, the out-of-pocket cost for OxyContin increased after the introduction of the abuse-deterrent formulation[1].

Pricing and Insurance Coverage

The cost of oxycodone formulations, including those combined with aspirin, can vary based on insurance coverage and out-of-pocket costs.

  • The annual mean out-of-pocket cost for OxyContin increased after the introduction of the abuse-deterrent formulation. This change could influence patient and prescriber behavior, potentially affecting the financial performance of the drug[1].

Market Alternatives and Competitors

Oxycodone is not the only option for pain management, and other opioids and analgesics compete in the market.

  • Alternatives like tramadol and hydromorphone (Dilaudid) are also prescribed for pain management. These drugs have different side effect profiles and user ratings, which can influence market share and financial performance[5].

Consumer and Prescriber Behavior

Patient Preferences and Reviews

Patient preferences and reviews can impact the market dynamics of oxycodone and aspirin formulations.

  • Oxycodone has a mixed review profile, with 63% of reviewers reporting a positive effect and 25% reporting a negative effect. This can influence prescriber decisions and patient adherence to treatment[5].

Prescriber Behavior

Prescriber behavior is crucial in the market dynamics of oxycodone. Regulatory changes and educational campaigns can influence how physicians prescribe these medications.

  • The introduction of abuse-deterrent OxyContin and the withdrawal of propoxyphene have led to changes in prescriber behavior, with a shift towards other long-acting opioids and a decrease in the prescribing of extended-release oxycodone[1].

Future Outlook

The future outlook for oxycodone and aspirin (half-strength) formulations is shaped by ongoing regulatory efforts, evolving patient needs, and economic conditions.

  • Continued efforts to address opioid abuse, such as improved prescribing practices and expanded access to addiction treatment, will likely influence the market dynamics of these drugs.
  • Economic conditions, particularly in industries with high injury rates, will continue to play a role in the demand for pain medications.

Key Takeaways

  • The introduction of abuse-deterrent OxyContin and the withdrawal of propoxyphene significantly reduced opioid dispensing and overdose rates.
  • Economic conditions impact the demand for pain medications, with better employment conditions reducing opioid abuse.
  • Patient and prescriber behavior, influenced by regulatory changes and market alternatives, shape the financial trajectory of oxycodone formulations.
  • Ongoing regulatory efforts and evolving patient needs will continue to influence the market dynamics of these drugs.

FAQs

What was the impact of introducing abuse-deterrent OxyContin on opioid dispensing rates?

The introduction of abuse-deterrent OxyContin led to a substantial decrease in the dispensing of extended-release oxycodone, with a reduction of 11.3 milligrams of morphine-equivalent dose per member per quarter two years after the introduction[1].

How did the withdrawal of propoxyphene affect the opioid market?

The withdrawal of propoxyphene resulted in a decrease in its dispensing rate by 8.19 milligrams of morphine-equivalent dose per member per quarter, contributing to a reduction in the overall prescription opioid supply and overdose rates[1].

What role do economic conditions play in the demand for oxycodone?

Economic conditions, particularly employment opportunities and industry injury rates, influence the demand for oxycodone. Better employment conditions can reduce opioid abuse by increasing the opportunity cost of using opioids[3].

How do patient reviews influence the market dynamics of oxycodone?

Patient reviews, which show mixed satisfaction with oxycodone, can influence prescriber decisions and patient adherence to treatment, thereby affecting the market dynamics of the drug[5].

What are some market alternatives to oxycodone for pain management?

Alternatives include tramadol and hydromorphone (Dilaudid), which have different side effect profiles and user ratings that can influence market share and financial performance[5].

Sources

  1. Larochelle MR, Zhang F, Ross-Degnan D, Wharam JF. Rates of Opioid Dispensing and Overdose After Introduction of Abuse-Deterrent Extended-Release Oxycodone and Withdrawal of Propoxyphene. JAMA Intern Med. 2015;175(6):978–987. doi:10.1001/jamainternmed.2015.0914
  2. Alina Lodge. How Long Does Oxycodone Stay in Your System? - Alina Lodge. 2022.
  3. Economics Department, University of Illinois at Urbana-Champaign. Employment Shocks and Demand for Pain Medication. 2019.
  4. GAO. OxyContin Abuse and Diversion and Efforts to Address the Problem. 2003.
  5. Drugs.com. Oxycodone Alternatives Compared - Drugs.com.

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