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Last Updated: December 22, 2024

NEMBUTAL SODIUM Drug Patent Profile


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

Nembutal Sodium is a drug marketed by Epic Pharma Llc and Rising and is included in four NDAs.

The generic ingredient in NEMBUTAL 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 Nembutal Sodium

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

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

US Patents and Regulatory Information for NEMBUTAL SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Epic Pharma Llc NEMBUTAL SODIUM pentobarbital sodium CAPSULE;ORAL 084095-001 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
Epic Pharma Llc NEMBUTAL SODIUM pentobarbital sodium CAPSULE;ORAL 084093-001 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

NEMBUTAL SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Nembutal Sodium (Pentobarbital Sodium)

Overview of Nembutal Sodium

Nembutal Sodium, also known as pentobarbital sodium, is a barbiturate drug commonly used for sedation, status epilepticus, and in some cases, for animal euthanasia. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth Projections

The market for pentobarbital sodium injection has witnessed significant growth in recent years and is expected to continue this trend. By 2023, the market had reached a substantial value, and it is anticipated to grow further, reaching a projected value by 2031[1].

Global Barbiturate Drugs Market Context

The broader barbiturate drugs market, which includes pentobarbital sodium, was valued at USD 483 million in 2023. This market is expected to grow at a compound annual growth rate (CAGR) of 3.12% from 2024 to 2030. This growth is driven by the rising prevalence of conditions such as insomnia, epilepsy, and anxiety, as well as the growing geriatric population[3].

Segmentation of the Market

The pentobarbital sodium injection market is segmented based on several key factors:

By Type

  • The market is categorized into different concentrations such as 1000mg/20mL and 2500mg/50mL. These variations cater to different medical needs and applications[1].

By Application

  • The drug is used for both adult and pediatric applications. Adult use is more prevalent due to the management of conditions like epilepsy and insomnia, while pediatric use is also significant due to the need for sedation and anticonvulsant treatments[1].

By Geography

  • The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America dominates the market due to significant product launches, cooperative agreements between manufacturers, and favorable reimbursement policies[1][3].

Market Dynamics

Drivers

  • The growing prevalence of neurological disorders such as epilepsy and insomnia drives the demand for pentobarbital sodium. According to the World Health Organization, epilepsy affects approximately 50 million individuals worldwide, with varying diagnosis rates across different regions[3].
  • The increasing geriatric population also contributes to the market growth, as older adults are more likely to suffer from conditions that require sedation and anticonvulsant treatments.

Restraints

  • Despite its efficacy, the use of barbiturates, including pentobarbital sodium, has declined in some areas due to concerns about side effects and the development of newer, safer antiepileptic drugs[3].
  • The COVID-19 pandemic negatively impacted the market by disrupting healthcare services and global supply chains, affecting the availability of medications[3].

Opportunities

  • Emerging markets in Asia-Pacific, particularly in countries like India and China, offer significant growth opportunities due to the increasing burden of neurological disorders in these regions[3].
  • Advancements in healthcare infrastructure and favorable reimbursement policies in developed markets also present opportunities for growth.

Challenges

  • Regulatory challenges and strict control over the use of barbiturates due to their potential for abuse can hinder market growth.
  • Competition from newer antiepileptic and sedative drugs that have fewer side effects is another challenge the market faces.

Financial Trajectory

Pricing

  • The cost of Nembutal Sodium injectable solution varies, with a supply of 20 milliliters costing around $1,337, depending on the pharmacy. Generic versions are also available, which can be more affordable, starting from $1,243.96 for 20 milliliters[2].

Revenue Projections

  • The pentobarbital sodium injection market is expected to see robust growth rates throughout the forecast period from 2023 to 2031. This growth is driven by the increasing demand for sedatives and anticonvulsants, as well as the expanding geriatric population[1].

Distribution Channels

Retail Pharmacies

  • The retail pharmacy segment holds a dominant revenue share due to the ongoing use of long-acting barbiturates like pentobarbital sodium for chronic conditions such as epilepsy. Patients often obtain their prescriptions from retail pharmacies, driving the segment’s growth[3].

Hospital Pharmacies

  • Hospital pharmacies also play a significant role, especially for acute care and emergency treatments where pentobarbital sodium is used for sedation and status epilepticus.

Key Players

  • The market is characterized by the presence of several key players, including Leucadia Pharmaceuticals, SAGENT Pharmaceuticals, Martindale Pharma, Bioveta, and Akorn Pharmaceuticals. These companies are involved in the production and distribution of pentobarbital sodium injections and play a crucial role in shaping the market dynamics[1].

Conclusion

The market for Nembutal Sodium (pentobarbital sodium) is poised for significant growth driven by increasing demand for sedatives and anticonvulsants, the growing geriatric population, and expanding healthcare infrastructure in emerging markets. However, the market also faces challenges such as regulatory scrutiny, competition from newer drugs, and the impact of global health crises.

Key Takeaways

  • Market Growth: The pentobarbital sodium injection market is expected to grow significantly from 2023 to 2031.
  • Segmentation: The market is segmented by type, application, and geography.
  • Drivers: Growing prevalence of neurological disorders and the increasing geriatric population drive market growth.
  • Restraints: Concerns about side effects and competition from newer drugs are significant restraints.
  • Opportunities: Emerging markets and advancements in healthcare infrastructure offer growth opportunities.
  • Financial Trajectory: The market is expected to see robust revenue growth driven by increasing demand.

FAQs

What is Nembutal Sodium used for?

Nembutal Sodium (pentobarbital sodium) is used for sedation, status epilepticus, and in some cases, for animal euthanasia.

How is the market for Nembutal Sodium segmented?

The market is segmented by type (1000mg/20mL, 2500mg/50mL), application (adult use, pediatric use), and geography (North America, Europe, Asia-Pacific, etc.).

What are the key drivers of the Nembutal Sodium market?

The growing prevalence of neurological disorders like epilepsy and insomnia, and the increasing geriatric population are key drivers.

Which region dominates the Nembutal Sodium market?

North America dominates the market due to significant product launches, cooperative agreements between manufacturers, and favorable reimbursement policies.

What are the challenges faced by the Nembutal Sodium market?

Concerns about side effects, competition from newer drugs, and regulatory challenges are significant challenges.

How much does Nembutal Sodium cost?

The cost of Nembutal Sodium injectable solution can range from $1,243.96 to $1,337 for a supply of 20 milliliters, depending on the pharmacy and whether a generic version is used.

Sources

  1. Market Research Intellect: "Pentobarbital Sodium Injection Market Size, Scope And Forecast"
  2. Drugs.com: "Nembutal Sodium Prices, Coupons, Copay Cards & Patient Assistance"
  3. Grand View Research: "Barbiturate Drugs Market Size, Share & Growth Report, 2030"
  4. Market Research Intellect: "Pentobarbital Sodium Injection for Animal Euthanasia Market Size"
  5. Wikipedia: "Pentobarbital"

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