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Last Updated: December 22, 2024

BUTALBITAL AND ACETAMINOPHEN Drug Patent Profile


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Which patents cover Butalbital And Acetaminophen, and what generic alternatives are available?

Butalbital And Acetaminophen is a drug marketed by Dr Reddys Labs Sa, Granules, Alvogen, Halsey, Larken Labs Inc, Lgm Pharma, Mikart, Ne Rx Pharma, Quagen, Senores Pharms, and Watson Labs. and is included in thirteen NDAs.

The generic ingredient in BUTALBITAL AND ACETAMINOPHEN 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 BUTALBITAL AND ACETAMINOPHEN
Drug patent expirations by year for BUTALBITAL AND ACETAMINOPHEN
Recent Clinical Trials for BUTALBITAL AND ACETAMINOPHEN

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SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
GlaxoSmithKlinePhase 3

See all BUTALBITAL AND ACETAMINOPHEN clinical trials

Pharmacology for BUTALBITAL AND ACETAMINOPHEN
Drug ClassBarbiturate

US Patents and Regulatory Information for BUTALBITAL AND ACETAMINOPHEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Sa BUTALBITAL AND ACETAMINOPHEN acetaminophen; butalbital CAPSULE;ORAL 207313-001 Dec 27, 2017 AA RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lgm Pharma BUTALBITAL AND ACETAMINOPHEN acetaminophen; butalbital TABLET;ORAL 090956-001 Aug 23, 2011 AA RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alvogen BUTALBITAL AND ACETAMINOPHEN acetaminophen; butalbital TABLET;ORAL 205120-001 Oct 30, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Senores Pharms BUTALBITAL AND ACETAMINOPHEN acetaminophen; butalbital TABLET;ORAL 214088-001 Apr 7, 2022 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mikart BUTALBITAL AND ACETAMINOPHEN acetaminophen; butalbital TABLET;ORAL 207386-001 Nov 15, 2016 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Senores Pharms BUTALBITAL AND ACETAMINOPHEN acetaminophen; butalbital TABLET;ORAL 214088-003 Apr 7, 2022 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Granules BUTALBITAL AND ACETAMINOPHEN acetaminophen; butalbital CAPSULE;ORAL 213115-001 Nov 22, 2019 AA RX 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

BUTALBITAL AND ACETAMINOPHEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Butalbital and Acetaminophen

Introduction

Butalbital and acetaminophen, often combined with caffeine and marketed under names like Fioricet, are widely used for the treatment of tension headaches and pain. This combination drug has a complex market dynamics due to its therapeutic benefits, potential for abuse, and the evolving landscape of pain management.

Therapeutic Benefits and Indications

Butalbital and acetaminophen combination is a pain reliever and relaxant, primarily used to treat tension headaches. Butalbital, a barbiturate, acts on the central nervous system to produce its effects, while acetaminophen provides additional pain relief and fever reduction[5].

Market Size and Growth

The global acetaminophen market, which includes combinations like butalbital and acetaminophen, is substantial and growing. In 2022, the global acetaminophen market was valued at USD 9.8 billion and is expected to expand at a CAGR of 4.2% to reach USD 15.2 billion by 2033. This growth is driven by increasing chronic illnesses, such as cancer and chronic obstructive pulmonary disease (COPD), and the need for effective pain management[3].

Regional Market Share

The market for butalbital and acetaminophen combinations is significant in various regions. The United States leads in the development of drugs targeting similar receptors, indicating a strong market presence. In Asia, countries like China and India are experiencing rapid growth due to an increasing geriatric population and rising healthcare expenditures. China, for instance, is expected to grow at a CAGR of nearly 5.3% during the forecast period[3].

Competitive Landscape

The competitive landscape for drugs targeting the same receptors as butalbital and acetaminophen is intense. Companies like AbbVie, Inc. are at the forefront of research and development, with a strong focus on these targets. The United States is a hub for this R&D activity, with multiple small molecule drugs in various phases of development[1].

Potential for Abuse and Addiction

One of the critical challenges in the market dynamics of butalbital and acetaminophen is the potential for abuse and addiction. Butalbital, being a barbiturate, has sedative properties that can lead to psychological and physical dependence. This has significant implications for patient management and regulatory oversight[2].

Immediate and Short-term Health Risks

  • Overdose: Acetaminophen overdose can lead to severe liver damage, a potentially fatal condition.
  • Central Nervous System Effects: Butalbital can cause drowsiness, confusion, and impaired coordination, with severe cases leading to respiratory depression.
  • Gastrointestinal Issues: Abuse can result in nausea, vomiting, abdominal pain, and pancreatitis[2].

Impact of Alternative Treatments

The introduction of newer, more specific treatments like Nurtec ODT (rimegepant) has significantly impacted the use of butalbital-containing medications. A real-world administrative claims analysis showed that nearly 48.7% of patients discontinued butalbital use after initiating Nurtec ODT, highlighting a shift away from older, less specific remedies[4].

Expert Insights

  • "Butalbital containing compound prescriptions remain high despite longstanding questions of safety in other conditions, significant potential side effects, multiple drug interactions and risk of dependency and misuse," noted Dr. Noah Rosen, emphasizing the need for safer alternatives[4].
  • Dr. Katherine Standley added, "Butalbital has a high risk of leading to medication overuse headaches, and has led to the American Academy of Neurology (AAN) and the American Headache Society (AHS) to recommend avoiding its use as a first line agent in the treatment of headaches"[4].

Financial Trajectory

The financial trajectory of butalbital and acetaminophen combinations is influenced by several factors:

  • Market Demand: The increasing demand for pain management solutions, particularly in the context of rising chronic illnesses, drives the financial growth of this market.
  • Competition: The entry of new, more specific treatments like Nurtec ODT may reduce the market share of traditional butalbital and acetaminophen combinations.
  • Regulatory Environment: Strict regulations and guidelines on the use of barbiturates due to their abuse potential can impact sales and profitability.

Key Market Players

Major pharmaceutical companies such as Pfizer Inc., Sanofi, Janssen Pharmaceuticals, and others are key players in the acetaminophen market, which includes butalbital and acetaminophen combinations. These companies invest heavily in R&D and marketing, influencing the market dynamics and financial performance of these drugs[3].

Oral Route of Administration

The oral route of administration dominates the market, with approximately 92.4% of the market share in 2022. This is due to the non-invasive, practical, and economical nature of oral medication delivery[3].

Over-the-Counter (OTC) Segment

The OTC segment is significant, driven by the ease of access to affordable medications without a prescription in many countries. This segment is expected to continue holding a substantial market share due to consumer preference for convenient and accessible pain relief options[3].

Conclusion

The market dynamics and financial trajectory of butalbital and acetaminophen combinations are complex, influenced by therapeutic benefits, potential for abuse, and the evolving landscape of pain management. While the market is growing due to increasing chronic illnesses, it faces challenges from newer, safer treatments and strict regulatory environments.

Key Takeaways

  • Therapeutic Benefits: Effective in treating tension headaches and pain.
  • Market Growth: Driven by increasing chronic illnesses and demand for pain management.
  • Regional Presence: Strong in the United States, China, and India.
  • Abuse Potential: Significant risk of psychological and physical dependence.
  • Alternative Treatments: Newer treatments like Nurtec ODT are reducing the use of butalbital-containing medications.
  • Financial Trajectory: Influenced by market demand, competition, and regulatory environment.

FAQs

Q1: What are the primary therapeutic benefits of butalbital and acetaminophen combinations? Butalbital and acetaminophen combinations are primarily used to treat tension headaches and provide pain relief.

Q2: What are the risks associated with the use of butalbital and acetaminophen? The risks include potential for abuse and addiction, overdose leading to liver damage, central nervous system effects, and gastrointestinal issues.

Q3: How is the introduction of newer treatments affecting the market for butalbital and acetaminophen? Newer treatments like Nurtec ODT are reducing the use of butalbital-containing medications due to their safer profile and specific efficacy.

Q4: What drives the demand for butalbital and acetaminophen combinations? The demand is driven by increasing chronic illnesses, the need for effective pain management, and the ease of access to these medications.

Q5: Which regions are experiencing significant growth in the market for butalbital and acetaminophen combinations? The United States, China, and India are experiencing significant growth due to various demographic and healthcare-related factors.

Sources

  1. An In-depth Analysis of acetaminophen/butalbital/caffeine's R&D Progress - Synapse by Patsnap
  2. Fioricet Abuse and Addiction – Latest News - United Recovery Project
  3. Acetaminophen Market Size, Share, Trends & Outlook - 2033 - Future Market Insights
  4. Real-World Administrative Claims Analysis Demonstrates That Almost Half of Migraine Patients Discontinue Barbiturate Use After Initiation of Nurtec ODT - PR Newswire
  5. Butalbital and acetaminophen combination (oral route) - Mayo Clinic

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