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Last Updated: December 22, 2024

OXYCODONE AND ACETAMINOPHEN Drug Patent Profile


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When do Oxycodone And Acetaminophen patents expire, and when can generic versions of Oxycodone And Acetaminophen launch?

Oxycodone And Acetaminophen is a drug marketed by Actavis Elizabeth, Barr, Duramed Pharms Barr, Halsey, Mallinckrodt, Mutual Pharm, Vintage Pharms, Vintage Pharms Llc, Watson Labs, Abhai Llc, Mikart, Nostrum Labs Inc, Specgx Llc, Alvogen, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell, Dr Reddys Labs Sa, Elite Labs Inc, Endo Operations, Epic Pharma Llc, Granules, Lannett Co Inc, Nesher Pharms, Novel Labs Inc, Rhodes Pharms, Sanaluz, Sun Pharm Inds Inc, and Wes Pharma Inc. and is included in fifty-one NDAs.

The generic ingredient in OXYCODONE AND ACETAMINOPHEN is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

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Summary for OXYCODONE AND ACETAMINOPHEN
Drug patent expirations by year for OXYCODONE AND ACETAMINOPHEN
Recent Clinical Trials for OXYCODONE AND ACETAMINOPHEN

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

SponsorPhase
Henry Ford Health SystemPhase 4
Jessyka LighthallPhase 3
Universidad Simón BolívarPhase 3

See all OXYCODONE AND ACETAMINOPHEN clinical trials

Pharmacology for OXYCODONE AND ACETAMINOPHEN
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for OXYCODONE AND ACETAMINOPHEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mikart OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040608-003 Dec 30, 2005 RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040371-002 Dec 29, 2000 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Barr OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 087406-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Amneal Pharms Ny OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040789-002 Nov 27, 2007 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 ACETAMINOPHEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Oxycodone and Acetaminophen

Introduction

Oxycodone and acetaminophen, often combined in formulations like Percocet, have been pivotal in the management of moderate-to-severe pain. This article delves into the market dynamics and financial trajectory of these drugs, highlighting their efficacy, safety, marketing strategies, and the impact of the opioid epidemic.

Efficacy and Safety of Oxycodone and Acetaminophen

Studies have consistently shown that oxycodone and acetaminophen combinations are effective in treating chronic pain conditions, such as lower back pain (LBP). A clinical trial demonstrated that these formulations significantly reduced pain intensity, improved pain relief, and enhanced quality of life for patients with LBP[1].

Market Introduction and Growth

OxyContin, a controlled-release formulation of oxycodone, was introduced in 1996 and quickly gained popularity. By 2001, it had become the most prescribed brand-name narcotic medication for treating moderate-to-severe pain, with annual sales exceeding $1 billion[3].

Marketing Strategies and Controversies

The aggressive marketing of oxycodone and other opioids by manufacturers like Purdue Pharma and Johnson & Johnson has been a significant factor in their widespread use. However, these marketing strategies have been criticized for overstating the effectiveness of these drugs for chronic pain and understating the risk of addiction. Johnson & Johnson, in particular, was accused of fueling the opioid epidemic through deceptive marketing campaigns[2].

Financial Impact

The financial success of oxycodone and acetaminophen formulations has been substantial. By 2001, OxyContin alone generated over $1 billion in annual sales. Johnson & Johnson, as a major supplier of raw materials for opioid production, made billions of dollars from these sales. However, the company has also faced significant legal and financial repercussions, including a $465 million judgment in Oklahoma for its role in the opioid epidemic[2].

Regulatory Actions and Litigations

Regulatory bodies and law enforcement agencies have taken various actions against opioid manufacturers. The FDA has cited Purdue Pharma for using potentially false or misleading medical journal advertisements for OxyContin. Attorney General Bob Ferguson of Washington state has sued Johnson & Johnson and other opioid manufacturers for their roles in the opioid epidemic, seeking civil penalties and damages[2][3].

Public Health Impact

The widespread use of oxycodone and other opioids has had devastating public health consequences. The opioid epidemic has led to increased mortality rates, higher incidence of hepatitis-C, and other related public health issues. Studies have shown that states with higher oxycodone exposure experienced significant declines in employment and labor force participation rates due to increased heroin use and other behavioral changes[4].

New Formulations and Safety Considerations

To address the safety concerns associated with high doses of acetaminophen, new formulations of oxycodone and acetaminophen have been developed with lower acetaminophen content. These formulations aim to maintain the analgesic effectiveness while reducing the risk of hepatotoxicity[1].

Economic Impact on Labor Markets

The oxycodone-heroin epidemic has had a profound impact on labor markets. States with higher oxycodone exposure prior to 2010 experienced larger relative declines in employment-to-population ratio (EPOP) and labor force participation rate (LFPR) after 2010. This decline is attributed to behavioral changes related to greater heroin use rather than compositional effects[4].

Industry Response and Future Directions

In response to the opioid epidemic, the pharmaceutical industry has been forced to reevaluate its marketing and distribution practices. There is a growing focus on developing safer alternatives and improving pain management strategies that minimize the risk of addiction. Regulatory bodies are also implementing stricter guidelines to monitor the prescription and distribution of opioids.

Key Takeaways

  • Oxycodone and acetaminophen combinations are effective for treating moderate-to-severe pain but come with significant risks of addiction.
  • Aggressive marketing strategies by manufacturers have contributed to the opioid epidemic.
  • The financial success of these drugs has been substantial, but it is overshadowed by the severe public health and economic consequences.
  • New formulations with reduced acetaminophen content aim to improve safety.
  • Regulatory actions and litigations are ongoing to address the opioid crisis.

FAQs

What are the primary uses of oxycodone and acetaminophen combinations?

Oxycodone and acetaminophen combinations are primarily used for the treatment of moderate-to-severe pain, including chronic pain conditions like lower back pain, postsurgical pain, and cancer pain[1][5].

How have marketing strategies impacted the use of oxycodone?

Aggressive marketing by manufacturers has led to the widespread use of oxycodone, often by overstating its effectiveness for chronic pain and understating the risk of addiction[2][3].

What are the public health consequences of the opioid epidemic?

The opioid epidemic has resulted in increased mortality rates, higher incidence of hepatitis-C, and other related public health issues. It has also led to significant declines in employment and labor force participation rates[4].

How have regulatory bodies responded to the opioid crisis?

Regulatory bodies have taken various actions, including lawsuits against manufacturers, stricter guidelines for prescription and distribution, and increased monitoring to prevent abuse and diversion[2][3].

What are the new safety considerations in oxycodone and acetaminophen formulations?

New formulations have been developed with lower acetaminophen content to reduce the risk of hepatotoxicity while maintaining analgesic effectiveness[1].

Sources

  1. Effectiveness and Safety of New Oxycodone/Acetaminophen Formulations - Academic.oup.com
  2. AG Ferguson sues opioid manufacturer Johnson & Johnson over state's opioid epidemic - Atg.wa.gov
  3. OxyContin Abuse and Diversion and Efforts to Address the Problem - Gao.gov
  4. Labor Market Effects of the Oxycodone-Heroin Epidemic - Federalreserve.gov
  5. Is oxycodone immediate release a good option for pain management? - Jag.journalagent.com

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