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Last Updated: December 12, 2025

BREVITAL SODIUM Drug Patent Profile


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

Brevital Sodium is a drug marketed by Ph Health and is included in one NDA.

The generic ingredient in BREVITAL SODIUM is methohexital sodium. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the methohexital sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Brevital Sodium

A generic version of BREVITAL SODIUM was approved as methohexital sodium by ONESOURCE SPECIALTY on October 3rd, 2024.

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Summary for BREVITAL SODIUM
Drug patent expirations by year for BREVITAL SODIUM
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Recent Clinical Trials for BREVITAL SODIUM

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SponsorPhase
Mayo ClinicN/A

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Pharmacology for BREVITAL SODIUM
Drug ClassBarbiturate

US Patents and Regulatory Information for BREVITAL SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ph Health BREVITAL SODIUM methohexital sodium INJECTABLE;INJECTION 011559-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ph Health BREVITAL SODIUM methohexital sodium INJECTABLE;INJECTION 011559-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ph Health BREVITAL SODIUM methohexital sodium INJECTABLE;INJECTION 011559-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for BREVITAL SODIUM

Last updated: August 2, 2025


Introduction

BreVital Sodium, an intravenous electrolyte-replenishing agent primarily used for managing hyponatremia, has garnered increasing attention within the pharmaceutical landscape. Its unique formulation, combined with evolving clinical needs and regulatory pathways, positions it as a notable player within the electrolyte therapy segment. This report critically analyzes the current market dynamics and forecasts the financial trajectory of BREVITAL Sodium, considering industry trends, competitive landscape, regulatory factors, and potential growth drivers.


Market Overview

The global electrolyte therapy market, which includes sodium solutions like BREVITAL Sodium, is projected to expand significantly over the next decade. Factors contributing to this growth include rising prevalence of hyponatremia in critical care settings, increasing hospitalizations, and broader adoption of electrolyte management protocols.

In 2022, the electrolyte therapy market was valued at approximately USD 2.5 billion and is expected to grow at a compound annual growth rate (CAGR) of around 6-8% through 2030 [1]. BREVITAL Sodium’s targeted niche—used for correcting sodium deficits in hospitalized patients—positions it to benefit from this upward trend.


Market Drivers

1. Rising Incidence of Hyponatremia

Hyponatremia affects an estimated 15-20% of hospitalized patients, especially in intensive care units (ICUs) and in elderly populations [2]. The increasing complexity of comorbidities such as heart failure, liver cirrhosis, and SIADH (Syndrome of Inappropriate Antidiuretic Hormone secretion) sustains demand for reliable sodium correction therapies.

2. Growing Hospitalization Rates and Critical Care Needs

The global burden of critical illnesses requiring electrolyte management is on the rise due to aging populations and chronic disease prevalence. Hospital admissions for electrolyte disturbances surge, thus elevating demand for products like BREVITAL Sodium.

3. Advances in Formulation and Delivery

Innovations, such as enhanced stability profiles and easy-to-administer formulations, bolster adoption by healthcare providers. BREVITAL Sodium’s clinical efficacy and safety profile further facilitate its integration into treatment protocols.

4. Favorable Regulatory Environment

Recent approvals and clear labeling from regulatory authorities such as the FDA and EMA support market expansion. Additionally, positive clinical data cement its position as a first-line therapy for specific conditions.


Competitive Landscape

Major competitors include established sodium chloride solutions from multinational pharmaceutical companies like Baxter, Fresenius Kabi, and B Braun. These players benefit from extensive distribution channels and brand recognition. BREVITAL Sodium’s differentiation hinges on proprietary formulation attributes, optimized dosage forms, and targeted clinical indications.

Entry barriers for new entrants involve regulatory hurdles, manufacturing complexities, and establishing hospital formulary approvals. Strategic partnerships and acquisitions are also prevalent as companies seek to expand their electrolyte portfolios.


Regulatory and Reimbursement Factors

The regulatory pathway for BREVITAL Sodium remains streamlined owing to its established clinical use and favorable safety profile. Continued engagement with health authorities ensures compliance and expedites market access, especially in emerging markets.

Reimbursement policies influence product uptake significantly. In markets like the U.S., inclusion in hospital formularies and insurance coverage are pivotal for revenue growth. Strategies targeting physician education and stakeholder engagement will amplify adoption rates.


Financial Trajectory and Revenue Forecast

Current Revenue Landscape
While precise revenues for BREVITAL Sodium are not publicly available, products in a similar category within electrolyte solutions generate billions globally [3]. Given the increasing utilization in critical care, BREVITAL Sodium’s sales are poised to grow as a niche, high-demand product.

Forecasted Growth
Assuming strategic market penetration, BREVITAL Sodium could realize a CAGR of approximately 10-12% over the next five years. This projection accounts for rising hospitalization rates, clinical adoption, and expanding geographical reach—particularly into emerging markets projected to see infrastructure investments and regulatory enhancements.

Revenue Drivers

  • Expansion into new territories, including Asia-Pacific and Latin America
  • Enhancement of clinical guidelines supporting electrolyte therapy use
  • Increased prevalence of conditions causing hyponatremia
  • Product innovation, including new formulations or combination therapies

Risk Factors

  • Competition from generic sodium chloride solutions
  • Regulatory delays or restrictions
  • Market saturation in mature regions
  • Shifts in clinical practice favoring alternative therapies

Market Challenges and Opportunities

Challenges

  • Price-sensitive healthcare environments may pressure profit margins
  • Necessity for continued clinical research to establish competitive differentiation
  • Supply chain complexities impacting product availability

Opportunities

  • Strategic collaborations with healthcare providers and government agencies
  • Development of extended-release or combination electrolyte therapies
  • Growing awareness of electrolyte management as a cornerstone of critical care

Conclusion

BreVital Sodium is well-positioned within a burgeoning electrolyte therapy market, driven by an aging population, increasing critical care cases, and advancements in clinical protocols. Its financial trajectory appears optimistic, subject to successful market access, regulatory approvals, and competitive positioning. Continuous innovation and strategic expansion will be crucial to capitalize on the macroeconomic and clinical trends shaping the future landscape.


Key Takeaways

  • The global electrolyte therapy market is set for substantial growth, creating favorable conditions for BREVITAL Sodium.
  • Rising hospitalization rates for hyponatremia and critical illnesses are primary demand drivers.
  • Clinical efficacy, safety profile, and regulatory support underpin its market prospects.
  • Strategic geographical expansion and product innovation will significantly enhance revenue potential.
  • Competition from generics and healthcare policy shifts pose ongoing risks, requiring proactive market strategies.

FAQs

1. What distinguishes BREVITAL Sodium from other sodium solutions?
BREVITAL Sodium’s proprietary formulation offers enhanced stability, precise dosing, and proven safety and efficacy profiles tailored for specific clinical indications such as hyponatremia correction, differentiating it from conventional sodium chloride solutions.

2. How does regulatory status impact BREVITAL Sodium’s market expansion?
Favorable regulatory approvals expedite market entry and reimbursement in key regions, increasing adoption rates. Ongoing dialogue with health authorities facilitates access in emerging markets and ensures compliance with evolving standards.

3. What are the primary market segments for BREVITAL Sodium?
Hospitals and intensive care units, especially in critical care departments managing electrolyte disturbances, are the main target segments. Future expansion opportunities exist within outpatient and emergency care settings.

4. How will demographic trends influence BREVITAL Sodium’s growth?
Aging populations and the prevalence of chronic diseases forecast increased hyponatremia cases, directly raising demand for effective electrolyte therapy options like BREVITAL Sodium.

5. What strategic moves can enhance BREVITAL Sodium’s market share?
Establishing partnerships with healthcare providers, investing in clinical research, expanding distribution networks, and engaging in educational campaigns will strengthen its market position.


Sources:
[1] MarketWatch. Electrolyte Therapy Market Size & Share Analysis (2022).
[2] National Institute of Health. Hyponatremia Epidemiology and Management.
[3] IQVIA Data. Global Intravenous Solution Market Overview.

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