Last updated: August 29, 2026
Methohexital sodium is a mature, low-revenue injectable anesthetic with limited patent protection and concentrated supply. Its commercial value comes from recurring use in electroconvulsive therapy, short procedural anesthesia, and induction of general anesthesia rather than from product differentiation. Public filings do not report standalone methohexital revenue. The financial trajectory is therefore best assessed through demand stability, hospital purchasing, shortage frequency, supplier concentration, and generic injectable economics.
What is the current market position of methohexital sodium?
Methohexital sodium is a short-acting barbiturate anesthetic marketed primarily as an intravenous injection. Its main clinical uses are:
- Induction of general anesthesia
- Short surgical or diagnostic procedures
- Electroconvulsive therapy, or ECT
- Selected emergency and procedural sedation applications
The product is commonly known by the former brand name Brevital. Most current commercial supply is generic or authorized-generic injectable product. The market is small compared with propofol, midazolam, ketamine, and other commonly used sedatives.
Methohexital retains a clinical niche because it has rapid onset, short duration, and long-established use in ECT. ECT providers may prefer it when rapid recovery and reliable seizure induction are priorities. Substitution is possible, but changes in anesthetic choice can affect seizure duration, recovery, workflow, and clinician familiarity.
Product characteristics
| Attribute |
Methohexital sodium |
| Therapeutic class |
Barbiturate anesthetic |
| Route |
Intravenous injection |
| Common strengths |
100 mg and 500 mg vials, depending on supplier |
| Primary settings |
Operating rooms, ECT suites, procedural areas |
| Controlled-substance status |
Schedule IV in the United States |
| Market maturity |
Mature generic injectable |
| Key competitors |
Propofol, etomidate, ketamine, midazolam |
| Principal commercial risk |
Supply interruption rather than patent loss |
The drug is not a biologic, complex drug-device combination, or specialty formulation. Biosimilar competition does not apply.
How large is the methohexital sodium market?
No major manufacturer publicly reports methohexital sodium revenue as a separate line item. Sales are generally included within broader generic injectables, hospital products, or U.S. pharmaceuticals segments.
The U.S. market is likely the most commercially important market because ECT use is established, hospital injectable purchasing is substantial, and regulatory documentation is more visible. Global demand exists, but country-level revenue is difficult to isolate because methohexital is often sold through institutional tenders and hospital distributors.
Revenue drivers
Methohexital revenue is determined by:
- Procedure volume, especially ECT and short-duration anesthesia.
- The number of active suppliers.
- Hospital contract pricing.
- Product availability during shortages.
- Conversion to propofol or other anesthetics.
- Vial size and wastage in institutional settings.
- Regulatory and manufacturing costs for sterile injectables.
The product has limited demand elasticity. Hospitals need reliable supply, but procurement departments also apply strong price pressure because several alternative anesthetics are available.
Financial trajectory
The most likely long-term trajectory is stable or modestly declining unit demand, offset by periodic price increases during shortages. The commercial pattern is not that of a growth pharmaceutical product. It is a low-volume, mature injectable in which margin performance can change sharply when one supplier exits or production is interrupted.
| Financial factor |
Expected effect |
| Stable ECT utilization |
Supports recurring baseline demand |
| Propofol substitution |
Limits long-term volume growth |
| Supplier shortages |
Can increase short-term price and revenue |
| Hospital tender pricing |
Compresses normal margins |
| Sterile manufacturing costs |
Reduce profitability |
| Small market size |
Limits scale economies |
| Patent expiry |
Prevents premium pricing |
| Supplier concentration |
Increases volatility |
Short-term revenue may rise during supply disruptions, but that does not necessarily indicate durable market expansion. Buyers may switch to alternatives once supply normalizes.
When does methohexital sodium lose exclusivity?
Methohexital sodium lost meaningful compound and product exclusivity decades ago. The active ingredient is an established small molecule, and the original branded product is no longer protected by a commercially relevant basic patent estate.
The practical exclusivity profile is:
| Exclusivity category |
Current position |
| New chemical entity exclusivity |
Expired |
| Compound patent |
Expired |
| Original formulation exclusivity |
Expired |
| Orphan-drug exclusivity |
Not applicable |
| Pediatric exclusivity |
No current relevance identified |
| Biosimilar exclusivity |
Not applicable |
| Generic exclusivity |
Not a material current barrier |
| Patent-based market protection |
Minimal or absent |
Methohexital therefore competes primarily on supply reliability, regulatory status, manufacturing quality, distribution, and contract pricing.
What patents protect methohexital sodium?
No commercially material, currently enforceable Orange Book patent estate is associated with the basic methohexital sodium injection product. The molecule and conventional injectable presentation are old technologies.
Patent protection by category
| Patent category |
Commercial status |
| Methohexital active ingredient |
Historical protection expired |
| Conventional injectable formulation |
Historical protection expired or not material |
| ECT method of use |
No meaningful current exclusivity identified |
| Manufacturing process |
Potential trade-secret or process know-how value, not a broad market barrier |
| Delivery device |
Not central to the standard product |
| Pediatric formulation |
No material current protection identified |
The main intellectual-property barrier is operational rather than legal. A manufacturer may hold confidential process controls, validated aseptic manufacturing procedures, supplier relationships, and regulatory know-how. Those assets can delay a new entrant even when patent protection is absent.
What is the Orange Book status of methohexital sodium?
The FDA Orange Book remains the principal U.S. reference for approved drug applications, therapeutic-equivalence evaluations, and listed patents. Methohexital sodium is associated with an old approved injectable product and generic competition. Current commercial products may be distributed under abbreviated new drug applications or older branded and authorized-generic arrangements.
For this product, Orange Book value is primarily regulatory rather than patent-related. The relevant questions are whether a product is actively marketed, whether it has a therapeutic-equivalence rating, and which sponsor maintains an approved sterile injectable application.
The FDA’s Orange Book does not create exclusivity where no unexpired patent or exclusivity period remains. Product discontinuation, application ownership changes, and supply status can also differ from the presence of an approval in FDA records. [1]
Which companies supply or compete with methohexital sodium?
The U.S. supplier base has included manufacturers and marketers of generic injectable anesthetics, including companies associated with the former Brevital product and hospital generic portfolios. Supplier identity can change through acquisition, contract manufacturing, application transfers, or discontinuation.
The relevant competitive groups are:
Direct methohexital suppliers
These include firms holding an approved methohexital sodium injection application or marketing a product manufactured by an affiliated or contract facility. The market has historically included Par Pharmaceutical-related operations and other generic injectable suppliers. Corporate ownership and active marketing status require confirmation against current FDA listings and manufacturer catalogs.
Therapeutic substitutes
| Product |
Competitive advantage |
| Propofol |
Broad use, rapid onset, extensive hospital familiarity |
| Etomidate |
Hemodynamic profile in selected induction cases |
| Ketamine |
Analgesia, dissociation, and utility in emergency settings |
| Midazolam |
Familiarity and broad procedural-sedation use |
| Thiopental |
Barbiturate alternative in selected markets |
Propofol is the most important commercial substitute in many procedural and anesthesia settings. Methohexital remains more defensible in ECT, where provider experience and treatment-specific protocols influence product selection.
Are there Paragraph IV challenges to methohexital sodium?
Paragraph IV litigation is unlikely to be a material issue for methohexital sodium. A Paragraph IV certification concerns an ANDA applicant’s assertion that a listed patent is invalid, unenforceable, or not infringed. Because the basic product has no meaningful current patent barrier, a new generic applicant would normally face an approval and manufacturing challenge rather than a patent challenge.
The practical entry risks are:
- FDA approval timing
- Sterile injectable facility capacity
- Validation and inspection findings
- Active pharmaceutical ingredient supply
- Drug-shortage allocation rules
- Hospital contracting
- Commercially viable production scale
A new applicant could still encounter litigation if a supplier asserted a narrow formulation, process, or device patent, but that would not be expected to protect the core methohexital sodium market.
What patent litigation and settlement agreements affect methohexital sodium?
No major current patent litigation or settlement agreement is broadly associated with the core methohexital sodium injection market. The absence of litigation is consistent with the product’s age, generic status, and lack of significant Orange Book patent protection.
Any commercial dispute is more likely to involve:
- Contract manufacturing
- Product liability
- Distribution rights
- Supply allocation
- Regulatory compliance
- Antitrust or procurement conduct
These issues can affect financial performance without changing formal patent exclusivity.
How does methohexital compare with propofol and ketamine?
| Factor |
Methohexital sodium |
Propofol |
Ketamine |
| Patent position |
Expired, generic |
Mature generic |
Mature generic |
| Primary use |
ECT and anesthesia induction |
General anesthesia and sedation |
Emergency, anesthesia, analgesia |
| Supply risk |
High when supplier base contracts |
Usually broader supply base |
Broad but demand can surge |
| Clinical differentiation |
Short-acting barbiturate, ECT familiarity |
Rapid recovery and broad adoption |
Analgesic and dissociative effects |
| Revenue potential |
Small, stable niche |
Large hospital market |
Larger and more diversified |
| Pricing power |
Low outside shortages |
Low to moderate |
Variable by presentation and setting |
| Biosimilar risk |
None |
None |
None |
Methohexital’s commercial defense is clinical workflow, not intellectual property. ECT centers may be less willing to switch than general procedural-sedation customers because anesthetic choice can affect treatment parameters.
What FDA regulatory issues affect methohexital sodium?
FDA oversight focuses on sterile injectable quality, labeling, controlled-substance requirements, and supply continuity. Important regulatory factors include:
- Current application approval and marketing status
- Facility inspection history
- Aseptic processing controls
- Container-closure integrity
- Sterility and particulate testing
- Stability data
- Controlled-substance distribution controls
- Shortage reporting and remediation
Methohexital products are vulnerable to the same manufacturing problems affecting other sterile injectables: limited filling capacity, component shortages, contamination events, quality investigations, and long facility-repair cycles. FDA drug-shortage records have historically identified methohexital sodium injection as a product exposed to intermittent availability constraints. [2]
What manufacturing and intellectual-property barriers exist?
The product has low patent barriers but meaningful manufacturing barriers. Injectable barbiturates require validated sterile production, controlled handling, reliable vial and stopper supply, and regulatory maintenance.
A new entrant would need to establish:
- A compliant sterile manufacturing site.
- A qualified methohexital active-ingredient supplier.
- Stable packaging and container-closure systems.
- Commercial-scale process validation.
- Controlled-substance distribution procedures.
- Hospital and wholesaler contracts.
- Adequate inventory to withstand allocation events.
These requirements favor established generic-injectable companies. A company with unused sterile capacity could enter without acquiring valuable patents, but the small market may not justify the regulatory and commercial investment.
What generic launch scenarios exist for methohexital sodium?
Base case: stable generic supply
Existing suppliers maintain production, ECT demand remains steady, and pricing follows hospital generic norms. Revenue is stable, with limited volume growth.
Upside case: supply-constrained pricing
A manufacturer exits or experiences a prolonged quality issue. Remaining suppliers capture incremental volume and may obtain higher net prices. The effect is temporary and depends on the duration of the shortage.
Downside case: substitution and supplier exit
Hospitals convert to propofol or other alternatives, while low margins discourage additional suppliers. Volume declines and the market becomes more concentrated.
Entry case: new sterile injectable supplier
A new entrant obtains FDA approval and secures hospital contracts. Entry would increase supply resilience but could reduce pricing for incumbent suppliers. The entrant’s economics would depend on securing sufficient volume to offset validation, manufacturing, and distribution costs.
What is the geographic coverage of methohexital sodium?
The United States is the clearest market for commercial analysis because FDA approval, Orange Book records, hospital purchasing data, and ECT utilization are comparatively transparent. European and other international markets may use methohexital or alternative barbiturates under different national approvals and procurement arrangements.
Geographic risks include:
- Country-specific registration requirements
- Controlled-substance rules
- Local tender pricing
- Limited approved manufacturers
- Import dependence
- National shortage policies
- Different clinical preference for propofol, thiopental, or ketamine
International revenue is likely more fragmented than U.S. revenue and may be less attractive where hospital tenders impose very low prices.
How strong is the methohexital sodium patent estate?
The patent estate is weak as a commercial defense. The product has no apparent current compound, formulation, method-of-use, or delivery-system patents capable of preventing generic competition.
The stronger assets are operational:
- Manufacturing validation
- Regulatory history
- Product availability
- ECT-provider familiarity
- Hospital contracts
- Distribution reach
- Shortage-management capability
For investors or licensees, methohexital is a supply-chain asset rather than a patent asset. Valuation should focus on manufacturing reliability, customer retention, pricing during shortages, and portfolio fit with other hospital injectables.
Key Takeaways
- Methohexital sodium is a mature generic injectable with a small but recurring clinical market.
- ECT is the most defensible demand segment.
- No meaningful current patent or biosimilar exclusivity protects the product.
- Paragraph IV litigation is not a central market risk.
- FDA regulatory and sterile-manufacturing execution are more important than intellectual property.
- Public companies do not generally disclose standalone methohexital revenue.
- Financial performance is likely stable in normal supply conditions and volatile during shortages.
- Propofol is the principal broad-market substitute.
- Supplier concentration can create temporary pricing power but also raises revenue and continuity risk.
- The most attractive commercial strategy is usually portfolio-based production alongside other hospital injectables.
FAQs About Methohexital Sodium Market Exclusivity and Commercial Risk
Is methohexital sodium still sold under the Brevital brand?
Brevital is the historical brand associated with methohexital sodium. Current U.S. supply may be marketed under generic or authorized-generic arrangements, depending on the active application holder and commercial status.
Can a generic manufacturer launch methohexital sodium without a patent license?
Yes. The core compound and conventional injectable product are long off patent. A new manufacturer would primarily need FDA approval, compliant sterile production, active pharmaceutical ingredient supply, and commercial distribution.
Is methohexital sodium affected by biosimilar competition?
No. Methohexital sodium is a chemically synthesized small molecule, not a biologic. Its competitors are generic manufacturers and therapeutic substitutes.
Why can an off-patent methohexital product experience shortages?
Sterile injectable manufacturing has limited capacity and high compliance costs. A facility shutdown, quality investigation, component shortage, or supplier exit can materially reduce supply in a small market.
Would a methohexital sodium acquisition create significant patent value?
No. Acquisition value would more likely come from an approved application, manufacturing capacity, hospital contracts, ECT market access, and reliable supply. Patent value is limited.
References
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U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
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U.S. Food and Drug Administration. (2024). Drug shortages: Methohexital sodium injection. https://www.accessdata.fda.gov/scripts/drugshortages/
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U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs database. https://www.accessdata.fda.gov/scripts/cder/daf/
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U.S. Drug Enforcement Administration. (2024). Controlled substance schedules. https://www.dea.gov/drug-information/drug-scheduling
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National Library of Medicine. (2024). DailyMed: Methohexital sodium injection prescribing information. https://dailymed.nlm.nih.gov/dailymed/
