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Last Updated: December 22, 2024

Pentobarbital - Generic Drug Details


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What are the generic drug sources for pentobarbital and what is the scope of patent protection?

Pentobarbital is the generic ingredient in four branded drugs marketed by Sciegen Pharms Inc, Epic Pharma Llc, Lannett, Vitarine, Whiteworth Town Plsn, Anabolic, Elkins Sinn, Everylife, Halsey, Ivax Sub Teva Pharms, Parke Davis, Perrigo, Purepac Pharm, Valeant Pharm Intl, Watson Labs, Wyeth Ayerst, Rising, Bpi Labs, Hikma, Sagent Pharms Inc, and Nexgen Pharma Inc, and is included in twenty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for pentobarbital.

Drug Prices for pentobarbital

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Recent Clinical Trials for pentobarbital

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sohag UniversityPhase 2/Phase 3
Assiut UniversityN/A
Children's Hospital Medical Center, CincinnatiPhase 1

See all pentobarbital clinical trials

Medical Subject Heading (MeSH) Categories for pentobarbital
Anatomical Therapeutic Chemical (ATC) Classes for pentobarbital

US Patents and Regulatory Information for pentobarbital

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis SODIUM PENTOBARBITAL pentobarbital sodium CAPSULE;ORAL 084156-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ivax Sub Teva Pharms SODIUM PENTOBARBITAL pentobarbital sodium CAPSULE;ORAL 083461-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Epic Pharma Llc NEMBUTAL SODIUM pentobarbital sodium CAPSULE;ORAL 083245-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising NEMBUTAL SODIUM pentobarbital sodium INJECTABLE;INJECTION 083246-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  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

Pentobarbital Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pentobarbital

Introduction to Pentobarbital

Pentobarbital, a barbiturate, is widely used in medical settings for various indications, including the management of seizures, status epilepticus, pre-anesthesia, and short-term treatment of insomnia. Here, we delve into the market dynamics and financial trajectory of pentobarbital, highlighting its current status, future projections, and key factors influencing its market.

FDA-Approved Indications and Medical Use

Pentobarbital is approved by the US FDA for several medical conditions, including status epilepticus, pre-anesthesia or sedation, and short-term treatment of insomnia. Its efficacy in rapidly penetrating the brain and its shorter half-life make it a preferred treatment for refractory status epilepticus[5].

Market Segmentation

The pentobarbital market can be segmented by type, application, and geography.

By Type

  • Pentobarbital is available in various forms such as injections, tablets, and oral suspensions. The injection form, particularly pentobarbital sodium injection, is a significant segment due to its rapid action and use in emergency settings[1].

By Application

  • The primary applications include adult and pediatric use for conditions like seizures, status epilepticus, and as a pre-anesthetic agent. The drug's versatility in treating different neurological disorders contributes to its market demand[1].

By Geography

  • The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own growth trajectory based on healthcare infrastructure, regulatory environments, and disease prevalence[1][3].

Market Size and Growth Projections

Global Market

  • The global pentobarbital market, particularly the pentobarbital sodium injection segment, is expected to grow significantly. For instance, the North American market is projected to increase from a certain value in 2023 to a higher value by 2030, at a compound annual growth rate (CAGR) during the forecast period of 2024 through 2030. Similarly, the Asia-Pacific market is also anticipated to grow at a notable CAGR during the same period[1].

Regional Growth

  • In the Asia-Pacific region, countries like China, Japan, and India are expected to drive growth due to increasing healthcare needs and the prevalence of neurological disorders. Europe and North America will also see steady growth, driven by advanced healthcare systems and the continuous need for effective antiepileptic and sedative medications[1][3].

Key Players and Competitive Landscape

  • Major manufacturers of pentobarbital sodium injection include Leucadia Pharmaceuticals, SAGENT Pharmaceuticals, Martindale Pharma, Bioveta, and Akorn Pharmaceuticals. These companies dominate the market, with the top three vendors accounting for a significant percentage of the revenue in 2023[1].

Driving Factors

  • Increasing Prevalence of Neurological Disorders: The growing prevalence of epilepsy and other neurological disorders globally is a key driver for the pentobarbital market. Phenobarbital, another barbiturate, also sees increased demand due to similar factors, highlighting the broader trend in the antiepileptic drug market[3].

  • Affordability and Efficacy: Pentobarbital's affordability and proven efficacy, especially in regions with limited access to newer therapies, maintain its market relevance. Despite the availability of newer medications, pentobarbital remains a mainstay in the treatment of epilepsy and seizures[3][5].

  • Technological and Formulation Advancements: Ongoing research into new applications and formulations keeps pentobarbital relevant in therapeutic practices. This continuous innovation ensures the drug remains a viable option in the pharmaceutical landscape[3].

Restrictive Factors

  • Regulatory Challenges: Strict regulatory environments can pose challenges to the market growth. For instance, monitoring and control over the illicit use of pentobarbital can affect its legal and medical use[4].

  • Competition from Newer Medications: The emergence of newer antiepileptic and sedative medications can pose a threat to the market share of pentobarbital. However, its established use and cost-effectiveness help it maintain a significant market presence[3].

Financial Performance and Projections

  • The financial performance of the pentobarbital market is reflected in its revenue and sales volume. The global market for pentobarbital sodium injection is expected to see substantial revenue growth, with regional markets contributing significantly to this growth. For example, the North American and Asia-Pacific markets are forecasted to increase in revenue from 2023 to 2030[1].

Market Trends and Future Outlook

  • Growing Demand in Emerging Markets: The demand for pentobarbital is expected to rise in emerging markets due to increasing healthcare needs and the growing prevalence of neurological disorders.

  • Continuous Innovation: The market will continue to see innovations in formulations and applications, ensuring pentobarbital remains a relevant treatment option.

  • Regulatory Compliance: Manufacturers will need to comply with stringent regulatory requirements to ensure the safe and legal use of pentobarbital.

Key Takeaways

  • Market Growth: The pentobarbital market is expected to grow significantly, driven by the increasing prevalence of neurological disorders and the drug's affordability and efficacy.
  • Regional Dynamics: North America, Europe, and the Asia-Pacific region will be key drivers of market growth.
  • Competitive Landscape: Major manufacturers dominate the market, with a focus on innovation and regulatory compliance.
  • Driving Factors: Growing demand, affordability, and continuous innovation are key drivers.
  • Restrictive Factors: Regulatory challenges and competition from newer medications are potential barriers.

FAQs

Q: What are the primary medical uses of pentobarbital? A: Pentobarbital is used for managing status epilepticus, pre-anesthesia or sedation, and short-term treatment of insomnia. It also functions as an anticonvulsant for emergent seizure control and for inducing medically induced comas[5].

Q: Which regions are expected to drive the growth of the pentobarbital market? A: The North American, European, and Asia-Pacific regions are anticipated to be key drivers of market growth due to their healthcare infrastructure and the prevalence of neurological disorders[1][3].

Q: Who are the major manufacturers of pentobarbital sodium injection? A: Major manufacturers include Leucadia Pharmaceuticals, SAGENT Pharmaceuticals, Martindale Pharma, Bioveta, and Akorn Pharmaceuticals[1].

Q: What are the driving factors for the pentobarbital market? A: The increasing prevalence of neurological disorders, affordability, and continuous innovation in formulations and applications are key drivers[3].

Q: Are there any regulatory challenges affecting the pentobarbital market? A: Yes, strict regulatory environments and monitoring to control illicit use can pose challenges to the market growth[4].

Sources

  1. Global Pentobarbital Sodium Injection Market Research Report 2024 - QY Research
  2. Vertex Reports Third-Quarter 2017 Financial Results - Vertex
  3. Phenobarbital Market Size, Share & Trends | Growth, 2031 - Market Research Intellect
  4. Monitoring illicit pentobarbital availability in the United States - ScienceDirect
  5. Pentobarbital - StatPearls - NCBI Bookshelf - NCBI

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