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Last Updated: December 22, 2024

XTRELUS Drug Patent Profile


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

Xtrelus is a drug marketed by Eci Pharms Llc and is included in one NDA.

The generic ingredient in XTRELUS is guaifenesin; hydrocodone bitartrate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the guaifenesin; hydrocodone bitartrate profile page.

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Summary for XTRELUS
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:XTRELUS at DailyMed
Drug patent expirations by year for XTRELUS

US Patents and Regulatory Information for XTRELUS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eci Pharms Llc XTRELUS guaifenesin; hydrocodone bitartrate TABLET;ORAL 208085-001 Apr 25, 2018 DISCN Yes 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

XTRELUS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XTRELUS

Introduction

XTRELUS, a combination of hydrocodone bitartrate and guaifenesin, is a medication indicated for the symptomatic relief of cough in patients where the benefits of cough suppression are expected to outweigh the risks. Understanding the market dynamics and financial trajectory of XTRELUS involves analyzing broader trends in opioid prescriptions, healthcare spending, and the impact of regulatory and market factors.

Opioid Prescription Trends

The prescription landscape for opioids, including XTRELUS, has undergone significant changes in recent years. From 2019 to 2022, opioid prescriptions declined by 17.2%, with in-person visits accounting for the majority of these prescriptions, although telehealth prescriptions saw a notable increase, especially during the pandemic[1].

Telehealth Impact

The COVID-19 pandemic accelerated the adoption of telehealth services, which had a mixed impact on opioid prescriptions. While telehealth prescriptions for opioids increased, they still constituted a minority of total opioid prescriptions, leveling off at 8.4% in 2022. This shift indicates a growing acceptance of remote healthcare services but also highlights the ongoing need for in-person care in managing opioid prescriptions[1].

Gender and Demographic Trends

Female individuals have shown a higher rate of increase in telehealth prescriptions for opioids and other medications, including stimulants and antidepressants. This trend suggests sex differences in prescription needs or access preferences, which could influence the market dynamics of XTRELUS[1].

Financial Impact of Opioid Prescriptions

The financial aspect of opioid prescriptions is complex, influenced by factors such as pricing dynamics, insurance coverage, and the cost of adverse drug events. The overall spending on pharmaceuticals, including opioids, has seen significant fluctuations. For instance, in 2014, total drug spending in the U.S. increased by 13.1%, driven by innovation in treatments like hepatitis C and cancer, as well as changes in pricing and discount structures[3].

Cost of Adverse Drug Events

The economic burden of adverse drug events (ADEs) is substantial. Studies have shown that medication reviews by clinical pharmacists can significantly reduce healthcare costs associated with ADEs. For example, a study estimated that resolving drug-related problems detected by clinical pharmacists could result in annual net savings of €213,069, highlighting the importance of careful prescription management[2].

Pricing and Spending on Opioids

The pricing of opioid medications, including XTRELUS, is subject to various market forces. Price increases for protected brands have contributed to spending growth, but these increases are often offset by off-invoice discounts and rebates. In 2014, price increases for branded products rose by 13.5% on an invoice basis, but net price growth was substantially lower due to these discounts[3].

Regulatory and Safety Considerations

XTRELUS, like other opioids, carries significant risks such as addiction, abuse, and life-threatening respiratory depression. Regulatory measures and proper prescribing practices are crucial to mitigate these risks. The careful assessment of patient risk, proper prescribing, and periodic re-evaluation of therapy are essential to limit abuse and ensure safe use[5].

Market Competition and Innovation

The pharmaceutical market is highly competitive, with continuous innovation driving spending growth. Specialty medicines, which include many opioid formulations, have grown significantly, accounting for one-third of total medicine spending. New treatment options and advances in diseases like hepatitis C, cancer, and multiple sclerosis have driven this growth[3].

Patient and Prescriber Behavior

Changes in patient and prescriber behavior, influenced by factors such as insurance coverage and cost-sharing, impact the market dynamics of XTRELUS. The expansion of insurance coverage has led to increased prescription demand, while changes in patient cost-sharing through insurance design and coupons can influence treatment choices and outcomes[3].

Future Outlook

Given the declining trend in opioid prescriptions and the increasing focus on telehealth, the future market for XTRELUS will likely be shaped by these factors. The need for careful prescription management, the impact of regulatory measures, and the ongoing innovation in pharmaceuticals will continue to influence the financial trajectory of this medication.

Key Takeaways

  • Declining Opioid Prescriptions: Opioid prescriptions, including those for XTRELUS, have declined in recent years.
  • Telehealth Growth: Telehealth services have seen significant growth, but in-person visits remain dominant for opioid prescriptions.
  • Financial Impact: The financial burden of adverse drug events and the impact of pricing dynamics are critical factors.
  • Regulatory Considerations: Strict regulatory measures and proper prescribing practices are essential to mitigate risks associated with XTRELUS.
  • Market Competition: Continuous innovation and changes in patient and prescriber behavior influence the market dynamics.

FAQs

Q: What are the primary risks associated with XTRELUS? A: XTRELUS poses risks of addiction, abuse, and life-threatening respiratory depression, among other serious adverse reactions[5].

Q: How has the COVID-19 pandemic affected opioid prescriptions? A: The pandemic led to an increase in telehealth prescriptions, but in-person visits still account for the majority of opioid prescriptions[1].

Q: What is the financial impact of adverse drug events on healthcare costs? A: Adverse drug events can significantly increase healthcare costs, but medication reviews by clinical pharmacists can help reduce these costs[2].

Q: How does insurance coverage affect the prescription demand for medications like XTRELUS? A: Insurance coverage expansion has led to increased prescription demand, while changes in patient cost-sharing influence treatment choices and outcomes[3].

Q: What are the key factors influencing the market dynamics of XTRELUS? A: The market dynamics are influenced by declining opioid prescriptions, growth in telehealth, regulatory considerations, and ongoing innovation in pharmaceuticals.

Sources

  1. Stimulant, Antidepressant, and Opioid Telehealth Prescription Trends - JAMA Network Open
  2. Financial impact of medication reviews by clinical pharmacists - PubMed
  3. Medicines Use and Spending Shifts in the US in 2014 - IQVIA
  4. IQVIA Report on Stimulant Trends from 2012 - 2022 - DEA Diversion Control Division
  5. Xtrelus (Hydrocodone Bitartrate and Guaifenesin Tablets) - RxList

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