List of Excipients in Branded Drug BREVITAL SODIUM

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Par Health USA LLC	BREVITAL SODIUM	methohexital sodium	42023-105	SODIUM CARBONATE
Par Health USA LLC	BREVITAL SODIUM	methohexital sodium	42023-105	SODIUM HYDROXIDE

BREVITAL SODIUM Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: September 7, 2026

BREVITAL SODIUM is the branded injectable formulation of methohexital sodium, an ultra-short-acting barbiturate used primarily for induction of general anesthesia and short procedures. Its commercial opportunity is driven less by new-molecule exclusivity and more by dependable sterile manufacturing, rapid reconstitution, preservative-free presentation, hospital supply contracts, and differentiated dosage forms.

The core formulation is relatively simple: methohexital sodium is supplied as a sterile powder, with sodium carbonate used to maintain alkalinity and facilitate solubility. The main development risks are chemical degradation, precipitation during dilution, particulate control, vial-container compatibility, and operational handling in anesthesia departments.

What is BREVITAL SODIUM and how is it formulated?

BREVITAL SODIUM contains methohexital sodium, a short-acting intravenous anesthetic. The product is supplied as a sterile powder for reconstitution rather than as a ready-to-administer liquid.

Product attribute	Publicly documented position
Active ingredient	Methohexital sodium
Drug class	Barbiturate anesthetic
Primary use	Intravenous induction of anesthesia and short procedures
Dosage form	Sterile powder for injection
Common vial strengths	500 mg and 2.5 g presentations have been marketed
Reconstitution	Sterile water or another label-authorized diluent
Typical concentrations	0.5%, 1%, and 2% solutions, depending on clinical use
Key excipient	Sodium carbonate
Preservative profile	Product is generally positioned as preservative-free
Regulatory pathway	FDA-approved drug product, historically listed under NDA 008589
Commercial channel	Hospitals, ambulatory surgery centers, anesthesia providers, and distributors

The formulation’s alkaline pH is central to performance. Methohexital is supplied as a sodium salt, and sodium carbonate helps maintain the pH needed for solubility and product stability. The formulation is not a conventional ready-to-use aqueous injection because the active ingredient has stability and concentration-management challenges in solution.

The FDA prescribing information identifies methohexital sodium and sodium carbonate in the formulation. The label also provides reconstitution instructions, concentration options, storage requirements, and warnings related to administration and respiratory depression.[1]

What excipients are used in BREVITAL SODIUM?

The principal excipient is sodium carbonate. It acts as an alkalizing agent and supports formation of a soluble methohexital salt.

Excipient composition

Excipient or component	Functional role	Commercial significance
Sodium carbonate	pH adjustment, alkalinity, solubility support	Critical to product performance
Sterile water for injection	Reconstitution diluent	Usually supplied separately
Container closure system	Maintains sterility and protects the powder	Important for extractables, leachables, and moisture control
Nitrogen or headspace control, if used	May limit oxidative stress	Must be confirmed through product-specific CMC data
Label-authorized infusion diluents	Enable clinical administration after reconstitution	Compatibility must be demonstrated

The product’s limited excipient system creates both an advantage and a constraint. A short qualitative composition can simplify regulatory review and reduce excipient-related adverse-event concerns. It also leaves fewer conventional formulation levers for differentiation.

A competing developer should avoid adding excipients without a clear technical or commercial rationale. Surfactants, preservatives, complexing agents, and alternative buffers could alter injection tolerability, pH, osmolality, reconstitution time, precipitation risk, or container compatibility.

What formulation patents protect BREVITAL SODIUM?

Publicly available product information indicates that the commercial formulation relies on legacy methohexital chemistry and a conventional alkaline sterile-powder presentation. The principal commercial barriers are therefore unlikely to come from a currently enforceable compound patent.

Core patent position

Methohexital was developed and commercialized decades ago. Any original composition-of-matter protection would have expired long before the current generic market. The remaining intellectual-property issues are more likely to concern:

• Product-specific formulation claims
• Sterile manufacturing processes
• Lyophilization or drying conditions
• Container-closure systems
• Reconstitution procedures
• Stability improvements
• Premixed or ready-to-use presentations
• Method-of-use claims for particular anesthesia procedures

The Orange Book should be reviewed for current listed patents and regulatory exclusivities associated with the relevant NDA. A legacy drug may have no active Orange Book patent listings even when manufacturing know-how remains commercially valuable.[2]

Patent strength assessment

IP category	Estimated strategic value
Methohexital molecule	Low; legacy protection has expired
Sodium salt composition	Low to moderate, depending on claim scope and expiration
Powder-for-injection formulation	Moderate if supported by unexpected stability or reconstitution data
Ready-to-use liquid formulation	Potentially high if stability and compatibility are difficult to replicate
Device or administration system	Moderate to high for proprietary delivery formats
Manufacturing process	Moderate; difficult to enforce unless process evidence is accessible
Method of anesthesia	Low to moderate because clinical-use claims may face validity and infringement limits
Trade secrets	Moderate, particularly for sterile processing and stability controls

The strongest new patent opportunity would not be a broad claim to methohexital sodium. It would be a narrow formulation or presentation claim tied to a measurable performance benefit, such as improved room-temperature stability, reduced reconstitution time, lower particulate burden, or a stable ready-to-use concentration.

When does BREVITAL SODIUM lose exclusivity?

BREVITAL SODIUM has already lost the exclusivity associated with a new active ingredient. Methohexital is an established anesthetic, and generic competition has existed in the U.S. market.

Exclusivity category	Position
New chemical entity exclusivity	Expired
Original compound patent	Expired or no longer commercially relevant
Pediatric exclusivity	No current commercial significance identified
Orphan exclusivity	Not applicable to the primary anesthesia indication
Biologic exclusivity	Not applicable
Orange Book patent protection	Requires current listing review for the applicable NDA
Generic competition	Established or historically established

The commercial question is therefore not whether a generic can enter based on active-ingredient exclusivity. The question is whether a competitor can obtain approval, maintain sterile supply, meet hospital procurement requirements, and offer a formulation that improves workflow or reduces total acquisition cost.

What is the FDA regulatory status of BREVITAL SODIUM?

BREVITAL SODIUM is an FDA-approved prescription injectable anesthetic. The product’s regulatory risk profile is consistent with other sterile injectable products: manufacturing deficiencies, supply interruptions, sterility failures, particulate contamination, and drug-shortage exposure can have a greater commercial impact than ordinary tablet-market competition.

The relevant FDA pathways include:

1. An abbreviated new drug application for a conventional generic equivalent.
2. A 505(b)(2) application for a materially different formulation, concentration, delivery system, or reconstitution format.
3. A supplemental application for changes to an existing approved product.
4. A new drug application for a proprietary ready-to-use or differentiated formulation.

A conventional powder-for-injection product is more likely to fit an ANDA strategy if the reference product remains eligible and the applicant can demonstrate pharmaceutical equivalence and bioequivalence under applicable FDA requirements. A ready-to-use solution, extended-stability product, or novel container system may be better suited to a 505(b)(2) strategy.

What excipient strategies create commercial opportunities?

1. Ready-to-use liquid methohexital

A stable, ready-to-administer product would target the principal operational weakness of the current powder format: reconstitution before use.

Potential advantages include:

• Reduced preparation time
• Fewer compounding steps
• Lower risk of dilution error
• Simplified emergency or procedural use
• Improved pharmacy workflow
• More predictable concentration at administration

The major technical barrier is solution stability. A liquid formulation must control pH, degradation, precipitation, container interaction, sterilization method, and microbial risk. Sodium carbonate concentration, buffer selection, ionic strength, and headspace conditions would require systematic optimization.

A successful ready-to-use product could support 505(b)(2) positioning and potentially justify a premium over conventional generic powder.

2. Faster-reconstituting powder

A lower-risk development program would retain the powder format while improving reconstitution behavior.

Possible approaches include:

• Controlled particle engineering
• Spray drying or improved vacuum-drying conditions
• Optimized cake morphology
• Reduced vial fill mass
• More efficient sodium carbonate balance
• Improved stopper and vial geometry
• Validated rapid-mixing instructions

The relevant performance metrics would include dissolution time, absence of visible particles, pH after reconstitution, assay, impurities, and stability after dilution.

3. Concentrated anesthesia presentations

A high-concentration vial can reduce storage volume and support procedural settings with high patient turnover. The tradeoff is a greater risk of dosing or dilution error.

Commercial development would require clear labeling, standardized syringe preparation, and compatibility data with commonly used infusion or administration systems. Concentration differentiation may create a product line for hospitals while preserving a conventional strength for routine use.

4. Low-sodium or alternative-buffer formulations

Sodium carbonate is central to the existing product, but a developer could investigate alternative alkalizing systems or lower sodium content. Such a strategy would need a meaningful clinical or operational rationale.

Potential benefits could include:

• Lower sodium burden in selected patients
• Improved pH control
• Reduced precipitation after dilution
• Better compatibility with administration materials
• Longer post-reconstitution stability

The regulatory burden would be higher because the developer would need to establish that the revised excipient system does not change pharmacokinetics, tolerability, local irritation, or clinical performance.

5. Container-closure differentiation

A high-value formulation patent could focus on the container system rather than the active ingredient. Relevant opportunities include:

• Low-adsorption vial materials
• Improved moisture-barrier closures
• Dual-chamber systems
• Prefilled syringes
• Ready-to-mix presentations
• Unit-dose packaging
• Tamper-evident anesthesia trays

Container innovation can be commercially relevant if it reduces breakage, preparation time, contamination risk, or waste.

What generic entry risks exist for BREVITAL SODIUM?

Generic entry risk is high for a conventional powder equivalent because the active ingredient is established and the formulation is comparatively simple. The primary barriers are technical and operational rather than patent-based.

Paragraph IV risk

A Paragraph IV certification would be relevant only if the Orange Book lists an unexpired patent for the reference product. For a legacy methohexital product, a Paragraph IV challenge is more likely to target a later formulation, manufacturing, or use patent than the original active ingredient.

Potential challenge targets include:

• Claims covering a specified pH range
• Stability claims after reconstitution
• A particular sodium carbonate ratio
• A ready-to-use liquid
• A container-closure system
• A defined method of induction or procedural anesthesia

A generic applicant could also file with a Paragraph III certification if an applicable patent remains listed but has an expiration date that does not block near-term development planning.

What patent litigation affects BREVITAL SODIUM?

No major, widely recognized current patent litigation campaign is associated with the legacy methohexital active ingredient comparable to litigation involving newer branded anesthetics or specialty injectables. Litigation exposure would more likely arise from a new formulation or device patent introduced by a current sponsor.

The highest litigation risk would occur if a sponsor launched a differentiated product with claims covering:

• Stable aqueous methohexital
• A novel buffer system
• A prefilled syringe
• A dual-chamber reconstitution device
• A specific sterile manufacturing method

A conventional ANDA product would face a lower patent burden but could encounter regulatory, supply-chain, or quality-related barriers.

Which companies are challenging or competing with BREVITAL SODIUM?

Competition has historically come from generic injectable manufacturers and alternative anesthetic products rather than from a single branded rival.

Competitive products

Competitor category	Examples	Competitive effect
Generic methohexital sodium	Multiple injectable generic suppliers over time	Direct price competition
Propofol	Generic and branded formulations	Strong substitute for induction
Thiopental	Limited-market barbiturate alternative	Substitution where available
Etomidate	Generic injectable	Alternative induction agent
Ketamine	Generic injectable	Alternative for selected procedures
Sevoflurane and other inhaled anesthetics	Hospital and ambulatory use	Competes in induction and maintenance workflows

Propofol is the most important practical substitute in many operating-room settings. Methohexital retains relevance where clinicians value rapid onset, short duration, specific procedural performance, or established anesthesia protocols.

How strong is the BREVITAL SODIUM patent estate?

The patent estate is weak at the molecule level and potentially moderate at the formulation and presentation level.

Dimension	Assessment
Active ingredient protection	Weak or expired
Formulation complexity	Low to moderate
Freedom to develop a conventional generic	Relatively favorable
Freedom to develop a ready-to-use solution	Requires formulation and patent review
Manufacturing barrier	Moderate because sterile injectable production is demanding
Regulatory barrier	Moderate to high
Supply-chain barrier	Moderate, with potential shortage exposure
Commercial differentiation	Dependent on workflow and stability improvements

The most defensible investment thesis is a product that solves a specific hospital problem. A copy product would compete mainly on price and availability. A differentiated product could compete on preparation time, reduced waste, ready-to-use convenience, or supply reliability.

What licensing deals could support a BREVITAL SODIUM product?

Licensing opportunities are more likely to involve technology than the legacy BREVITAL brand itself.

Potential transaction structures include:

• Licensing a stable liquid methohexital formulation
• Acquiring rights to a dual-chamber vial or syringe platform
• Contract manufacturing with an established sterile injectable producer
• Regional commercialization rights for a generic equivalent
• Hospital-focused co-development with an anesthesia supplier
• In-licensing of a formulation patent with 505(b)(2) potential

A license has greater strategic value if it includes validated stability data, scale-up experience, an established container system, and a clear FDA regulatory path. A bare patent license without manufacturing evidence would have limited value.

What revenue exposure and commercial opportunities exist?

BREVITAL SODIUM is a hospital injectable rather than a high-volume retail prescription product. Revenue potential depends on account penetration, supply continuity, contract pricing, and differentiation.

Commercial opportunity ranking

Opportunity	Revenue potential	Development risk	Strategic rationale
Conventional generic powder	Low to moderate	Moderate	Entry based on price and reliable supply
Premium rapid-reconstitution powder	Moderate	Moderate	Workflow improvement without major clinical change
Ready-to-use liquid	Moderate to high	High	Reduces preparation burden
Prefilled syringe	Moderate	High	Supports procedural efficiency
Dual-chamber presentation	Moderate to high	High	Combines stability with rapid administration
Specialty concentration	Moderate	Moderate to high	Targets defined hospital protocols
Regional supply partnership	Low to moderate	Low to moderate	Limits development investment

The most attractive segment is a stable, ready-to-use or rapidly reconstituted presentation supported by hospital pharmacy economics. The product must demonstrate reduced preparation labor, lower waste, fewer medication errors, or improved availability.

What manufacturing and IP barriers apply to methohexital sodium?

The principal manufacturing barriers are:

• Sterile powder filling
• Moisture control
• Uniform sodium carbonate distribution
• Assay and impurity control
• Reconstitution performance
• Particulate limits
• Container-closure integrity
• Stability after dilution
• Validation of sterilization or aseptic processing
• Reliable supply of active pharmaceutical ingredient

Methohexital sodium is not difficult because of molecular complexity. It is difficult because injectable products tolerate little variation. A failed sterility test, container-closure defect, or out-of-specification pH result can interrupt supply and trigger regulatory action.

Geographic coverage also matters. U.S. approval does not establish market access in Europe, Japan, Canada, or emerging markets. Each region may impose different requirements for reference-product selection, bioequivalence, excipient justification, sterile manufacturing, and labeling. A global program should protect the formulation, container system, manufacturing process, and reconstitution method in major commercial jurisdictions.

Key Takeaways

• BREVITAL SODIUM is methohexital sodium supplied as a sterile powder for injection.
• Sodium carbonate is the principal formulation excipient and supports alkalinity and solubility.
• The active ingredient is legacy technology with limited strategic value from original molecule patents.
• Generic competition is primarily constrained by sterile manufacturing, regulatory execution, and reliable supply.
• The strongest commercial opportunity is a ready-to-use liquid, rapid-reconstitution powder, prefilled syringe, or dual-chamber presentation.
• A 505(b)(2) strategy may be appropriate for a materially differentiated formulation.
• A conventional generic would likely compete on price, availability, and hospital contracts.
• Formulation patents should focus on measurable stability, reconstitution, compatibility, or handling improvements.
• Propofol, etomidate, ketamine, thiopental, and inhaled anesthetics are the principal competitive alternatives.
• Licensing value is highest where formulation rights are paired with manufacturing data and a credible regulatory pathway.

FAQs About BREVITAL SODIUM Excipient and Commercial Strategy

Is sodium carbonate essential in BREVITAL SODIUM?

Sodium carbonate is a key formulation component because it maintains the alkaline environment required for methohexital sodium solubility and product performance.

Can methohexital sodium be developed as a ready-to-use injection?

Yes, but the formulation would require extensive stability, precipitation, container-compatibility, sterility, and post-dilution studies. A ready-to-use product could support a differentiated regulatory strategy.

Does BREVITAL SODIUM have biologic or biosimilar competition?

No. Methohexital sodium is a small-molecule drug. Competition comes from generic injectables and alternative anesthetic agents, not biosimilars.

What is the strongest patent angle for a new methohexital product?

The strongest patent angle is likely a formulation or delivery-system claim tied to improved stability, rapid reconstitution, ready-to-use storage, reduced particulate formation, or simplified administration.

Would a BREVITAL SODIUM generic need a Paragraph IV filing?

Only if the FDA Orange Book lists an unexpired patent covering the reference product and the applicant seeks approval before that patent expires. A conventional generic may not require Paragraph IV certification if no relevant unexpired patent is listed.

References

1. U.S. Food and Drug Administration. (n.d.). Brevital sodium prescribing information: Methohexital sodium for injection, USP.
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs database.
4. U.S. Food and Drug Administration. (2017). ANDA submissions: Content and format of an abbreviated new drug application.
5. U.S. Food and Drug Administration. (2022). 505(b)(2) applications.