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Last Updated: December 22, 2024

SODIUM PENTOBARBITAL Drug Patent Profile


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Which patents cover Sodium Pentobarbital, and when can generic versions of Sodium Pentobarbital launch?

Sodium Pentobarbital is a drug marketed by Anabolic, Elkins Sinn, Everylife, Halsey, Ivax Sub Teva Pharms, Parke Davis, Perrigo, Purepac Pharm, Valeant Pharm Intl, Watson Labs, Wyeth Ayerst, and Nexgen Pharma Inc. and is included in thirteen NDAs.

The generic ingredient in SODIUM PENTOBARBITAL is pentobarbital sodium. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the pentobarbital sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sodium Pentobarbital

A generic version of SODIUM PENTOBARBITAL was approved as pentobarbital sodium by SAGENT PHARMS INC on May 23rd, 2016.

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Summary for SODIUM PENTOBARBITAL
Drug patent expirations by year for SODIUM PENTOBARBITAL

US Patents and Regulatory Information for SODIUM PENTOBARBITAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Anabolic SODIUM PENTOBARBITAL pentobarbital sodium CAPSULE;ORAL 084590-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parke Davis SODIUM PENTOBARBITAL pentobarbital sodium CAPSULE;ORAL 084156-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Halsey SODIUM PENTOBARBITAL pentobarbital sodium CAPSULE;ORAL 084677-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wyeth Ayerst SODIUM PENTOBARBITAL pentobarbital sodium CAPSULE;ORAL 083239-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Perrigo SODIUM PENTOBARBITAL pentobarbital sodium CAPSULE;ORAL 084560-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Nexgen Pharma Inc SODIUM PENTOBARBITAL pentobarbital sodium TABLET;ORAL 084238-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Elkins Sinn SODIUM PENTOBARBITAL pentobarbital sodium CAPSULE;ORAL 083368-001 Approved Prior to Jan 1, 1982 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

SODIUM PENTOBARBITAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Sodium Pentobarbital

Introduction

Sodium pentobarbital, a short-acting barbiturate, is widely used in medical and veterinary fields for its sedative, preanesthetic, and euthanasia properties. Understanding the market dynamics and financial trajectory of this drug is crucial for stakeholders, including manufacturers, investors, and healthcare professionals.

Medical Applications and Market Segmentation

Medical Uses

Pentobarbital is approved by the US FDA for managing various medical conditions such as status epilepticus, pre-anesthesia, and controlling convulsions in emergencies. It is also used to treat insomnia, reduce intracranial pressure in Reye's syndrome, and induce coma in cerebral ischemia patients[2][5].

Market Segmentation

The market for sodium pentobarbital is segmented based on types and applications. In the medical sector, it is primarily categorized into different concentrations and forms (e.g., oral, intravenous, intramuscular, and rectal). Geographically, the market spans across regions including the United States, Europe, China, Japan, India, and Southeast Asia[1].

Veterinary Applications and Market Growth

Animal Euthanasia

In the veterinary sector, pentobarbital sodium injections are widely used for animal euthanasia. The market for these injections is categorized by type (50 mg/ml, 100 mg/ml, 200 mg/ml, etc.) and application (pet hospitals, veterinary clinics, zoos, biology laboratories, etc.)[3][4].

Market Growth

The market for pentobarbital sodium injections for animal euthanasia has experienced rapid growth and is projected to continue expanding significantly from 2023 to 2031. This growth is driven by positive market dynamics, including increasing demand for humane euthanasia methods and advancements in veterinary care[3][4].

Market Dynamics

Drivers

  • Technological Innovations: Advances in pharmaceutical technology are optimizing the performance of pentobarbital, making it more effective and widely used in various applications[1].
  • Increasing Demand: The need for sedatives and euthanasia agents in both medical and veterinary fields is driving the demand for sodium pentobarbital[2][3].
  • Government Policies: Regulatory frameworks that support the use of pentobarbital in medical and veterinary practices contribute to market growth[1].

Restraints

  • Regulatory Challenges: The use of pentobarbital in executions has led to legal and ethical controversies, affecting its supply and distribution in some regions[2].
  • Alternative Treatments: The rise of benzodiazepines and other sedatives has reduced the market share of barbiturates like pentobarbital in some medical applications[2].

Opportunities

  • Emerging Markets: Expanding healthcare and veterinary services in developing regions present opportunities for market expansion[1][3].
  • Research and Development: Continuous research into new applications and formulations of pentobarbital can open up new market segments[1].

Challenges

  • Dependence and Abuse: Pentobarbital is a high-risk habit-forming drug, which can lead to regulatory scrutiny and public health concerns[5].
  • Supply Chain Disruptions: Legal restrictions and public outcry can disrupt the supply chain, as seen in the case of Lundbeck's decision to stop selling pentobarbital to US states for executions[2].

Financial Trajectory

Historical Growth

The pentobarbital sodium market has witnessed significant growth from 2014 to 2019, with a notable CAGR. This growth is attributed to increasing demand and technological advancements[1].

Forecasted Growth

The market is expected to reach substantial revenue by 2026 and continue growing through 2031. The forecasted period indicates robust growth rates, particularly in the veterinary euthanasia segment[1][3][4].

Revenue and Production Forecast

  • Global Revenue: The global pentobarbital sodium market is projected to increase in revenue, driven by growing demand in both medical and veterinary sectors[1].
  • Production and Consumption: Production, consumption, export, and import forecasts indicate a balanced market with significant growth potential across various regions, including the United States, Europe, China, and India[1].

Competitive Landscape

Major Players

The market is dominated by several key players, including Leucadia Pharmaceuticals, SAGENT Pharmaceuticals, Hospira Healthcare Corporation, Bioveta, and others. These companies are investing in research and development to enhance product performance and expand market share[1][3].

Market Concentration

The competitive landscape is characterized by a mix of large pharmaceutical companies and specialized veterinary care providers. Market concentration is moderate, with several players competing for market share[1].

Regional Analysis

Global Market

The global pentobarbital sodium market is geographically diverse, with significant markets in North America, Europe, Asia-Pacific, and other regions. Each region has its own growth trajectory based on local healthcare and veterinary practices[1].

Key Regions

  • United States: A major market for pentobarbital sodium, driven by both medical and veterinary applications.
  • Europe: Significant growth is expected, particularly in countries like Germany, the UK, and France.
  • Asia-Pacific: Countries such as China, Japan, and India are experiencing rapid growth due to expanding healthcare and veterinary services[1].

Legal and Ethical Considerations

Regulatory Status

Pentobarbital is classified as a DEA Schedule II drug due to its high potential for abuse and dependence. Its use in executions has led to legal and ethical debates, affecting its distribution and supply[2][5].

Ethical Implications

The use of pentobarbital in executions and animal euthanasia raises ethical concerns. Companies like Lundbeck have faced public backlash and have subsequently altered their distribution policies[2].

Key Takeaways

  • Growing Demand: Increasing demand in both medical and veterinary sectors drives market growth.
  • Technological Advancements: Innovations in pharmaceutical technology enhance product performance.
  • Regulatory Challenges: Legal and ethical controversies impact supply and distribution.
  • Geographical Expansion: Emerging markets in developing regions offer growth opportunities.
  • Competitive Landscape: Moderate market concentration with several key players competing for market share.

FAQs

What are the primary medical applications of sodium pentobarbital?

Sodium pentobarbital is used as a sedative, preanesthetic, and to control convulsions in emergencies. It is also used to treat insomnia, reduce intracranial pressure in Reye's syndrome, and induce coma in cerebral ischemia patients[2][5].

How is the market for pentobarbital sodium injections for animal euthanasia segmented?

The market is segmented by type (50 mg/ml, 100 mg/ml, 200 mg/ml, etc.) and application (pet hospitals, veterinary clinics, zoos, biology laboratories, etc.)[3][4].

What are the key drivers of the pentobarbital sodium market?

Key drivers include technological innovations, increasing demand for sedatives and euthanasia agents, and supportive government policies[1][3].

What are the major challenges facing the pentobarbital sodium market?

Challenges include regulatory scrutiny, the rise of alternative treatments, dependence and abuse issues, and supply chain disruptions[1][2][5].

Who are the major players in the global pentobarbital sodium market?

Major players include Leucadia Pharmaceuticals, SAGENT Pharmaceuticals, Hospira Healthcare Corporation, Bioveta, and others[1][3].

Sources

  1. Global Pentobarbital Sodium Market Report 2019, Market Publishers.
  2. Pentobarbital, Wikipedia.
  3. Pentobarbital Sodium Injection for Animal Euthanasia Market, Market Research Intellect.
  4. Pentobarbital Sodium Injection for Animal Euthanasia Market Size, Market Research Intellect.
  5. Pentobarbital, StatPearls - NCBI Bookshelf.

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