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Last Updated: December 22, 2024

REPREXAIN Drug Patent Profile


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When do Reprexain patents expire, and what generic alternatives are available?

Reprexain is a drug marketed by Amneal Pharms Ny and is included in one NDA.

The generic ingredient in REPREXAIN is hydrocodone bitartrate; ibuprofen. There are twenty-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate; ibuprofen profile page.

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Summary for REPREXAIN
Drug patent expirations by year for REPREXAIN
Pharmacology for REPREXAIN

US Patents and Regulatory Information for REPREXAIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms Ny REPREXAIN hydrocodone bitartrate; ibuprofen TABLET;ORAL 076642-003 Oct 19, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Amneal Pharms Ny REPREXAIN hydrocodone bitartrate; ibuprofen TABLET;ORAL 076642-004 Oct 19, 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

REPREXAIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for REPREXAIN

Introduction

REPREXAIN, a combination drug containing hydrocodone bitartrate and ibuprofen, is used for the short-term management of acute pain. To understand its market dynamics and financial trajectory, it is essential to analyze various factors including market trends, regulatory environments, and consumer behavior.

Market Size and Growth

The opioids market, within which REPREXAIN operates, is significant and continues to grow, albeit at a moderate pace. As of 2023, the global opioids market size was estimated at USD 22.74 billion, and it is projected to reach USD 26.78 billion by 2034, growing at a Compound Annual Growth Rate (CAGR) of 1.5% from 2024 to 2034[3].

Segment Analysis

REPREXAIN falls under the category of Immediate Release (IR) or short-acting opioids, which is the dominant segment in the opioids market. This segment is expected to expand at a CAGR of 1.9% during the projected period due to its rapid onset of pain relief, making it suitable for acute pain management in surgeries, injuries, and medical procedures[3].

Route of Administration

The oral segment, which includes REPREXAIN, is anticipated to grow at a CAGR of 2.5% over the predicted period. Oral opioid medications are preferred due to their convenience and ease of administration, contributing significantly to their market dominance[3].

Regulatory Environment

The regulatory landscape plays a crucial role in shaping the market dynamics of opioids like REPREXAIN. Regulatory authorities have implemented various measures to curb opioid misuse, including prescription monitoring initiatives and the development of abuse-deterrent formulations. These measures have both positive and negative impacts on the market. While they reduce the risk of abuse, they also introduce new costs and complexities for pharmaceutical firms[3].

Impact of COVID-19

The COVID-19 pandemic had a multifaceted impact on the opioids market. Initially, there was a surge in demand for opioids to manage pain associated with COVID-19 infections. However, lockdowns and disruptions in healthcare services led to reduced prescriptions. The pandemic also amplified mental health issues and substance abuse disorders, potentially increasing opioid misuse. Despite these challenges, the market for opioids, including REPREXAIN, rebounded and continued to grow[3].

Prescribing Practices

Prescribing practices have evolved significantly in response to public health imperatives. The transformation of prescription guidelines and the incorporation of prescription monitoring initiatives have directly impacted the volume of opioid prescriptions. For REPREXAIN, this means that while the drug remains a viable option for acute pain management, prescribers are more cautious and selective in their prescribing, which can affect sales volumes[3].

Competition and Alternatives

The opioids market is highly competitive, with various products available for pain management. The development of non-opioid alternatives and abuse-deterrent formulations introduces competition and challenges for traditional opioids like REPREXAIN. However, the established history and patient familiarity with short-acting opioids continue to support their market presence[3].

Financial Performance

Given the overall growth of the opioids market and the specific segment in which REPREXAIN operates, the financial performance of this drug is likely to remain stable. The U.S. opioids market, a significant segment, was estimated at USD 7.18 billion in 2023 and is predicted to be worth around USD 8.92 billion by 2034, growing at a CAGR of 2% from 2024 to 2034[3].

Challenges and Opportunities

Challenges

  • Regulatory Scrutiny: Increased regulatory oversight and stricter prescribing guidelines can reduce the number of prescriptions for opioids like REPREXAIN.
  • Abuse and Misuse: The potential for abuse and misuse of opioids remains a significant concern, affecting both the market and public perception.
  • Competition from Alternatives: The development of non-opioid pain management options and abuse-deterrent formulations poses a competitive threat[3].

Opportunities

  • Established Market Presence: REPREXAIN’s long history and patient familiarity provide a strong foundation in the market.
  • Continued Need for Acute Pain Management: The ongoing need for effective acute pain management ensures a steady demand for short-acting opioids like REPREXAIN.
  • Innovative Formulations: Investing in abuse-deterrent technologies can help REPREXAIN maintain market share and contribute to a safer healthcare landscape[3].

Consumer Behavior and Healthcare Trends

Consumer behavior and healthcare trends also influence the market dynamics of REPREXAIN. The increased use of telemedicine, for instance, has changed how prescriptions are managed. While telemedicine initially saw a surge in use during the COVID-19 pandemic, its impact on opioid prescriptions has been mixed, with some regions showing continued use above pre-pandemic levels[1].

Key Takeaways

  • Market Growth: The opioids market, including REPREXAIN, is expected to grow at a moderate pace.
  • Regulatory Impact: Stricter regulations and prescribing guidelines affect the market but also drive innovation in abuse-deterrent formulations.
  • Competition: Non-opioid alternatives and new formulations pose competitive challenges.
  • Established Presence: REPREXAIN’s history and patient familiarity maintain its market position.
  • Consumer Trends: Telemedicine and changing healthcare practices influence prescription patterns.

FAQs

What is the projected growth rate of the opioids market from 2024 to 2034?

The global opioids market is expected to grow at a CAGR of 1.5% from 2024 to 2034[3].

How does REPREXAIN fit into the broader opioids market?

REPREXAIN is a short-acting opioid, part of the dominant IR opioids segment, which is expected to expand at a CAGR of 1.9% during the projected period[3].

What impact did the COVID-19 pandemic have on the opioids market?

The pandemic led to an initial surge in demand, followed by reduced prescriptions due to lockdowns, and later rebounded with continued growth[3].

What are the main challenges facing REPREXAIN in the market?

Challenges include regulatory scrutiny, potential for abuse and misuse, and competition from non-opioid alternatives and abuse-deterrent formulations[3].

How has telemedicine affected the prescribing of opioids like REPREXAIN?

Telemedicine initially saw a surge in use during the pandemic, with some regions maintaining higher usage levels, but its overall impact on opioid prescriptions has been mixed[1].

Sources

  1. IQVIA Report on Stimulant Trends from 2012 - 2022. U.S. Department of Justice, Drug Enforcement Administration.
  2. BMJ Open. For peer review only.
  3. Opioids Market Size To Reach Around USD 26.78 Billion By 2034. Precedence Research.
  4. Reprexain Tablets (hydrocodone bitartrate and ibuprofen) - RxList. RxList.
  5. Update to national guideline - CMAJ. Canadian Medical Association Journal.

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