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Last Updated: December 22, 2024

VICOPRIN Drug Patent Profile


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Which patents cover Vicoprin, and what generic alternatives are available?

Vicoprin is a drug marketed by Abbott and is included in one NDA.

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

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Summary for VICOPRIN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 2
Patent Applications: 10
DailyMed Link:VICOPRIN at DailyMed
Drug patent expirations by year for VICOPRIN

US Patents and Regulatory Information for VICOPRIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbott VICOPRIN aspirin; hydrocodone bitartrate TABLET;ORAL 086333-001 Sep 14, 1983 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

VICOPRIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Hydrocodone-Based Drugs: A Focus on Vicodin (Vicoprofen)

Introduction

Hydrocodone, a potent opioid, is widely used in various pharmaceutical products, including Vicodin (also known as Vicoprofen when combined with ibuprofen). This article delves into the market dynamics and financial trajectory of hydrocodone-based drugs, with a particular focus on Vicodin.

Historical Context and Market Presence

Hydrocodone has been available in FDA-approved products since 1943 and is one of the most frequently prescribed opioids in the United States. In 2013, over 136.7 million prescriptions for hydrocodone-containing products were dispensed, with this number decreasing to 83.6 million in 2017 due to revised clinical guidelines and efforts to combat the opioid crisis[1].

Product Variations and Market Share

Vicodin, a combination of hydrocodone and acetaminophen, is one of the most commonly prescribed hydrocodone products. Another variation, Vicoprofen, combines hydrocodone with ibuprofen. These products dominate the market due to their effectiveness in treating severe pain when other medications fail[5].

Regulatory Environment

The FDA has played a crucial role in shaping the market dynamics of hydrocodone-based drugs. The approval of Zohydro ER, an extended-release hydrocodone product, in 2013 marked a significant development. Despite initial controversies and calls for abuse-deterrent formulations, the FDA concluded that the benefits of Zohydro ER outweighed the risks, and it was approved with stringent labeling and monitoring requirements[2].

Impact of Opioid Crisis on Market Dynamics

The opioid crisis has significantly influenced the prescribing patterns and market trajectory of hydrocodone-based drugs. Efforts to reduce opioid prescriptions have led to a decline in the number of hydrocodone prescriptions. For instance, the number of prescriptions decreased from 6.9 million in 2017 to 5.5 million in 2018[1].

Financial Trajectory

The financial performance of hydrocodone-based drugs, including Vicodin, has been impacted by several factors:

Prescription Volume

The reduction in prescription volume due to the opioid crisis has directly affected the revenue generated from these drugs. Despite this, hydrocodone remains one of the most prescribed opioids, ensuring a substantial market presence[1].

Pricing and Cost Considerations

The cost of hydrocodone-based drugs can vary, but they generally remain affordable compared to other opioid alternatives. However, the financial burden on individuals misusing these drugs can be significant, leading to financial struggles and legal consequences[3].

Competition and Market Alternatives

The market for opioid pain relievers is competitive, with various products available, including extended-release formulations like Zohydro ER. The introduction of abuse-deterrent formulations and alternative pain management options has further diversified the market, affecting the financial trajectory of traditional hydrocodone-based drugs[2].

Safety and Efficacy Concerns

Safety concerns, such as the risk of tolerance, physical dependence, respiratory depression, and liver damage, have been significant factors influencing the market dynamics. These concerns have led to stricter prescribing guidelines and monitoring, which in turn affect the financial performance of these drugs[3].

Regulatory Measures and REMS Programs

The FDA has implemented various measures, including Risk Evaluation and Mitigation Strategies (REMS) programs, to ensure the safe use of extended-release and long-acting (ER/LA) opioids. These programs have added costs to the manufacturers and distributors but are crucial for maintaining market approval[4].

Impact on Patient Access and Healthcare System

The stringent regulations and REMS programs have ensured that these drugs are used more judiciously, reducing the risk of misuse and abuse. However, this has also led to challenges in patient access, particularly for those who genuinely need these medications for chronic pain management[2].

Future Outlook

The future of hydrocodone-based drugs, including Vicodin, is likely to be shaped by ongoing efforts to balance pain management with the need to combat opioid misuse. Innovations in abuse-deterrent formulations and alternative pain therapies will continue to influence the market dynamics and financial trajectory of these drugs.

Key Takeaways

  • Hydrocodone is one of the most frequently prescribed opioids in the U.S., with a significant market presence.
  • The opioid crisis has led to a decline in prescriptions but not a complete withdrawal from the market.
  • Regulatory measures, including REMS programs, have been crucial in ensuring safe use.
  • Safety concerns and competition from alternative pain management options continue to impact the financial trajectory.
  • Future innovations in abuse-deterrent formulations will shape the market dynamics.

FAQs

Q: What is the most common combination of hydrocodone prescribed in the U.S.? A: The most common combination is hydrocodone and acetaminophen, known by brand names such as Vicodin and Lortab[1].

Q: How has the opioid crisis affected the prescribing of hydrocodone-based drugs? A: The opioid crisis has led to a reduction in the number of prescriptions for hydrocodone-based drugs, with efforts to reduce opioid misuse and abuse[1].

Q: What regulatory measures have been implemented for hydrocodone-based drugs? A: The FDA has implemented REMS programs and other safety measures to ensure the safe use of these drugs, including prominent warnings and regular patient monitoring[2].

Q: What are the potential health risks associated with long-term use of Vicodin? A: Long-term use can lead to tolerance, physical dependence, respiratory depression, liver damage, and other health issues[3].

Q: How do abuse-deterrent formulations impact the market dynamics of hydrocodone-based drugs? A: Abuse-deterrent formulations are expected to reduce the risk of misuse and abuse, but they also add costs and complexity to the market, influencing the financial trajectory of these drugs[4].

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