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Last Updated: December 22, 2024

PENTOBARBITAL SODIUM Drug Patent Profile


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

Pentobarbital Sodium is a drug marketed by Lannett, Vitarine, Whiteworth Town Plsn, Bpi Labs, Elkins Sinn, Hikma, and Sagent Pharms Inc. and is included in nine NDAs.

The generic ingredient in PENTOBARBITAL SODIUM 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 Pentobarbital Sodium

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

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

US Patents and Regulatory Information for PENTOBARBITAL SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lannett PENTOBARBITAL SODIUM pentobarbital sodium CAPSULE;ORAL 085937-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma PENTOBARBITAL SODIUM pentobarbital sodium INJECTABLE;INJECTION 203619-001 Nov 13, 2017 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Whiteworth Town Plsn PENTOBARBITAL SODIUM pentobarbital sodium CAPSULE;ORAL 083338-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sagent Pharms Inc PENTOBARBITAL SODIUM pentobarbital sodium INJECTABLE;INJECTION 206404-001 May 23, 2016 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lannett PENTOBARBITAL SODIUM pentobarbital sodium CAPSULE;ORAL 085915-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Vitarine PENTOBARBITAL SODIUM pentobarbital sodium CAPSULE;ORAL 083284-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Elkins Sinn PENTOBARBITAL SODIUM pentobarbital sodium INJECTABLE;INJECTION 083270-001 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

PENTOBARBITAL SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pentobarbital Sodium

Introduction

Pentobarbital sodium, a barbiturate medication, has a diverse range of medical and non-medical applications. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare professionals.

Market Size and Growth

The global pentobarbital sodium market has experienced significant growth over recent years. From 2014 to 2019, the market saw an increase from USD XX million to USD XX million, with a Compound Annual Growth Rate (CAGR) of X.X%[1].

Forecast

The market is projected to continue growing, with estimates suggesting it will reach USD XX million by 2026. This growth is driven by increasing demand in various medical applications, technological innovations, and expanding use in downstream sectors[1].

Applications and Uses

Pentobarbital sodium is approved by the US FDA for several medical conditions, including:

Medical Indications

  • Status epilepticus
  • Pre-anesthesia or sedation
  • Short-term treatment of insomnia
  • Inducing medically induced comas[2].

Veterinary Use

It is also widely used in veterinary medicine for humane euthanasia of animals, particularly dogs[5].

Geographical Distribution

The market is geographically segmented into several regions, including:

United States

  • The US market is a significant contributor to the global pentobarbital sodium market, driven by its approved medical uses and stringent regulatory framework[1].

Europe

  • Countries such as Germany, the UK, France, Italy, Spain, Russia, and Poland also show substantial demand and growth potential[1].

Asia-Pacific

  • China, Japan, and India are emerging markets with increasing demand due to growing healthcare needs and expanding pharmaceutical industries[1].

Other Regions

  • Central and South America, Middle East and Africa, and other regions also contribute to the global market, albeit with varying growth rates[1].

Competitive Landscape

The pentobarbital sodium market is characterized by a competitive landscape involving multiple major players. These companies are engaged in continuous research and development to enhance product performance and expand market share.

Major Players

  • The market includes several key players, each with their own market strategies and product offerings. These companies are focused on technological innovation and compliance with regulatory standards[1].

Market Dynamics

Drivers

  • Technological Advancements: Innovations in pharmaceutical technology are optimizing the performance of pentobarbital sodium, making it more effective and widely used in various applications[1].
  • Increasing Demand: Growing demand for effective treatments for conditions like status epilepticus and insomnia drives the market forward[2].

Restraints

  • Regulatory Challenges: Pentobarbital sodium is a Schedule II controlled substance, which imposes strict regulatory requirements and limits its availability and use[2].
  • Illicit Use: The drug's potential for illicit use and its appearance in counterfeit pills pose significant challenges to its legitimate market[3].

Opportunities

  • Expanding Applications: The drug's versatility in medical and veterinary fields presents opportunities for growth in new markets and applications[1][5].
  • Emerging Markets: Growing healthcare needs in emerging economies offer potential for market expansion[1].

Financial Performance

Revenue Forecast

  • The global pentobarbital sodium market is expected to generate significant revenue, with forecasts indicating continued growth through 2026[1].

Production and Consumption

  • The report forecasts production, consumption, export, and import trends by region, highlighting areas of high demand and supply chain dynamics[1].

Pricing Trends

  • The price of pentobarbital sodium is expected to stabilize or increase slightly due to technological advancements and regulatory compliance costs[1].

Supply Chain and Distribution

The supply chain for pentobarbital sodium involves complex logistics due to its controlled substance status. Manufacturers must adhere to strict regulations, and distribution channels are closely monitored to prevent diversion for illicit use.

Porter's Five Forces Analysis

  • This analysis provides insights into the competitive forces shaping the market, including potential entrants, suppliers, substitutes, buyers, and industry competitors[1].

Challenges and Risks

Illicit Use and Counterfeit Pills

  • Pentobarbital sodium's presence in the illicit market, particularly in counterfeit pills, poses a significant risk to public health and the legitimate market[3].

Regulatory Compliance

  • The drug's Schedule II status requires stringent regulatory compliance, which can be a challenge for manufacturers and distributors[2].

Monitoring and Safety

Given the drug's potential for abuse and its high-risk profile, monitoring and safety measures are crucial.

Toxicity and Dependence

  • Pentobarbital sodium can lead to tolerance, physical dependence, and psychological effects with long-term use. Monitoring parameters include EEG and serum drug levels[2].

Environmental Precautions

  • The drug is harmful to aquatic life and wildlife, necessitating proper disposal and environmental precautions[5].

Key Takeaways

  • The pentobarbital sodium market is growing due to increasing medical demand and technological advancements.
  • The market is geographically diverse, with significant contributions from the US, Europe, and Asia-Pacific regions.
  • Regulatory challenges and illicit use pose significant risks to the market.
  • Continuous monitoring and safety measures are essential due to the drug's high-risk profile.

FAQs

What are the primary medical uses of pentobarbital sodium?

Pentobarbital sodium is primarily used for managing status epilepticus, pre-anesthesia or sedation, and short-term treatment of insomnia. It is also used to induce medically induced comas[2].

Why is pentobarbital sodium classified as a controlled substance?

Pentobarbital sodium is classified as a Schedule II controlled substance due to its high potential for abuse, leading to physical dependence and psychological effects[2].

What are the risks associated with illicit use of pentobarbital sodium?

Illicit use of pentobarbital sodium can lead to acute intoxication, chronic dependence, and even fatal exposures. It is often mixed with other drugs, increasing the risk of unknown exposure and adverse effects[3].

How does the veterinary use of pentobarbital sodium differ from its medical use?

In veterinary medicine, pentobarbital sodium is used for humane euthanasia of animals, particularly dogs. This use is strictly regulated and differs significantly from its medical applications in humans[5].

What are the environmental precautions for handling pentobarbital sodium?

Pentobarbital sodium is harmful to aquatic life and wildlife. Proper disposal methods such as deep burial, incineration, or other compliant methods are necessary to prevent environmental harm[5].

Cited Sources:

  1. Global Pentobarbital Sodium Market Report 2019, Competitive Landscape, Trends and Opportunities - Market Publishers.
  2. Pentobarbital - StatPearls - NCBI Bookshelf - NCBI.
  3. Monitoring illicit pentobarbital availability in the United States - PubMed.
  4. Pentobarbital Sodium Injection - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030 - Market Research Reports.
  5. HAZARD(S) IDENTIFICATION - Dechra Veterinary Products - Dechra-US.

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