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Last Updated: December 22, 2024

BUTAPAP Drug Patent Profile


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

Butapap is a drug marketed by Mikart and is included in two NDAs.

The generic ingredient in BUTAPAP is acetaminophen; butalbital. There are sixty-six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.

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Summary for BUTAPAP
Drug patent expirations by year for BUTAPAP
Pharmacology for BUTAPAP
Drug ClassBarbiturate

US Patents and Regulatory Information for BUTAPAP

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mikart BUTAPAP acetaminophen; butalbital TABLET;ORAL 089987-001 Oct 26, 1992 AA RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mikart BUTAPAP acetaminophen; butalbital TABLET;ORAL 089988-001 Oct 26, 1992 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

BUTAPAP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Butapap

Introduction

Butapap, a combination drug containing acetaminophen, butalbital, and caffeine, has been a staple in the treatment of tension-type headaches and pain for decades. However, its market dynamics and financial trajectory are influenced by several factors, including regulatory scrutiny, competition from newer therapies, and public perception of drug pricing.

Historical Context and Indications

Butapap is indicated for the relief of tension-type headaches and pain. It combines the analgesic properties of acetaminophen, the sedative effects of butalbital, and the stimulant properties of caffeine. Despite its efficacy, the drug has faced criticism due to the potential for addiction and medication overuse headaches associated with butalbital[1].

Regulatory and Clinical Landscape

The regulatory landscape for Butapap has become increasingly complex. Regulatory bodies and healthcare organizations have been scrutinizing the use of barbiturates like butalbital due to their addiction potential and side effects. For instance, the initiation of newer migraine therapies like Nurtec ODT (rimegepant) has shown significant reductions in butalbital use among migraine patients, highlighting a shift towards safer and more specific treatments[1].

Competition from Newer Therapies

The introduction of newer migraine therapies has significantly impacted the market dynamics of Butapap. Drugs like Nurtec ODT have demonstrated robust reductions in barbiturate use, offering an alternative that is not associated with addiction potential. A real-world administrative claims analysis showed that almost half of migraine patients discontinued butalbital use after starting Nurtec ODT, indicating a preference for safer and more effective treatments[1].

Research and Development (R&D) Progress

The R&D landscape for drugs targeting similar receptors as Butapap is competitive. Companies like AbbVie are focusing on developing drugs that target multiple receptors, including A1R, A2aR, COX, and GABAA receptors. These developments suggest intense competition in the pain and headache treatment market, potentially threatening the market share of older drugs like Butapap[4].

Public Perception and Media Coverage

Public perception and media coverage play a crucial role in the financial trajectory of pharmaceutical companies. High drug prices and the associated media scrutiny can negatively impact a company's financial performance. The case of Butapap is no exception, as the public and media have criticized the continued use of barbiturates despite their known risks. Media coverage of drug price issues can lead to reduced stock value and public trust, affecting the overall financial health of the company[3].

Financial Performance and Capitalization

The financial performance of pharmaceutical companies is closely tied to the public's perception of their pricing strategies. Significant media coverage of drug price increases can lead to a reduction in net margin, return on research capital, and market capitalization. For Butapap, the financial trajectory is likely to be affected by the increasing scrutiny on drug prices and the availability of alternative treatments[3].

Impact of Generic Substitution Policies

Generic substitution policies also influence the financial trajectory of branded drugs like Butapap. Many healthcare organizations and Medicaid programs have high generic dispensing rates, which can reduce the market share of branded drugs. For example, Nevada Medicaid reported a generic dispensing rate of almost 82%, indicating a preference for generic alternatives that could impact the sales of Butapap[5].

Clinical Evaluations and Utilization Reviews

Healthcare organizations are increasingly focusing on clinical evaluations and utilization reviews to ensure the safe and effective use of medications. Programs like the Drug Use Review Board (DUR) monitor and manage the use of high-risk medications, including those containing butalbital. These reviews can lead to reduced prescriptions and a shift towards safer alternatives, further impacting the market dynamics of Butapap[5].

Patient Adherence and Safety

Patient adherence and safety are critical factors in the long-term financial success of any medication. However, the potential for addiction and medication overuse headaches associated with Butapap can lead to reduced patient adherence and increased healthcare costs in the long run. Newer therapies that address these concerns are likely to gain preference, affecting the financial trajectory of Butapap negatively[1].

Market Share and Revenue

The market share and revenue of Butapap are expected to decline as newer, safer therapies gain traction. The reduction in butalbital prescriptions following the initiation of Nurtec ODT is a clear indicator of this trend. As more patients and healthcare providers opt for alternative treatments, the revenue generated by Butapap is likely to decrease[1].

Conclusion

The market dynamics and financial trajectory of Butapap are complex and influenced by multiple factors. The rise of newer, safer therapies, increased regulatory scrutiny, and public perception of drug pricing are all contributing to a decline in the use and revenue of Butapap.

Key Takeaways

  • Shift to Newer Therapies: The introduction of safer and more effective migraine therapies like Nurtec ODT is reducing the use of Butapap.
  • Regulatory Scrutiny: Regulatory bodies are increasingly scrutinizing the use of barbiturates due to their addiction potential and side effects.
  • Public Perception: Media coverage of drug price issues and safety concerns can negatively impact the financial performance of pharmaceutical companies.
  • Generic Substitution: High generic dispensing rates can reduce the market share of branded drugs like Butapap.
  • Clinical Evaluations: Healthcare organizations are focusing on clinical evaluations and utilization reviews to ensure safe and effective medication use.

FAQs

Q: What are the main components of Butapap? A: Butapap is a combination drug containing acetaminophen, butalbital, and caffeine.

Q: Why is Butapap facing criticism? A: Butapap is facing criticism due to the potential for addiction and medication overuse headaches associated with butalbital.

Q: How has the introduction of Nurtec ODT affected Butapap? A: The introduction of Nurtec ODT has led to a significant reduction in butalbital use among migraine patients, indicating a shift towards safer and more specific treatments.

Q: What role does media coverage play in the financial trajectory of pharmaceutical companies? A: Media coverage of drug price issues and safety concerns can negatively impact the financial performance of pharmaceutical companies by reducing public trust and stock value.

Q: How do generic substitution policies affect branded drugs like Butapap? A: Generic substitution policies can reduce the market share of branded drugs like Butapap by promoting the use of generic alternatives.

Sources

  1. PR Newswire: Real-World Administrative Claims Analysis Demonstrates That Almost Half of Migraine Patients Discontinue Barbiturate Use After Initiation of Nurtec ODT.
  2. Oklahoma.gov: Print Annual Reviews for Fiscal Year 2020.
  3. ScholarWorks at Walden University: Relationship Over Time Between Drug Price News and U.S. Pharmaceutical Companies’ Financial Results.
  4. Patsnap Synapse: An In-depth Analysis of Acetaminophen/Butalbital/Caffeine's R&D Progress.
  5. Nevada Medicaid: Nevada Medicaid Drug Use Review Board Meeting.

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