SODIUM PENTOBARBITAL Drug Patent Profile

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

Sodium Pentobarbital is a drug marketed by Anabolic, Elkins Sinn, Everylife, Halsey, Ivax Sub Teva Pharms, Parke Davis, Perrigo, Purepac Pharm, Valeant Pharm Intl, Watson Labs, Wyeth Ayerst, and Nexgen Pharma Inc. and is included in thirteen NDAs.

The generic ingredient in SODIUM PENTOBARBITAL is pentobarbital sodium. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pentobarbital sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sodium Pentobarbital

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

Summary for SODIUM PENTOBARBITAL

US Patents:	0
Applicants:	12
NDAs:	13
Raw Ingredient (Bulk) Api Vendors:	25
Patent Applications:	3,908
DailyMed Link:	SODIUM PENTOBARBITAL at DailyMed

US Patents and Regulatory Information for SODIUM PENTOBARBITAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Anabolic	SODIUM PENTOBARBITAL	pentobarbital sodium	CAPSULE;ORAL	084590-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Parke Davis	SODIUM PENTOBARBITAL	pentobarbital sodium	CAPSULE;ORAL	084156-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Halsey	SODIUM PENTOBARBITAL	pentobarbital sodium	CAPSULE;ORAL	084677-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Wyeth Ayerst	SODIUM PENTOBARBITAL	pentobarbital sodium	CAPSULE;ORAL	083239-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Perrigo	SODIUM PENTOBARBITAL	pentobarbital sodium	CAPSULE;ORAL	084560-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Nexgen Pharma Inc	SODIUM PENTOBARBITAL	pentobarbital sodium	TABLET;ORAL	084238-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Sodium Pentobarbital Market Dynamics, Patent Status, Supply Risks, and Financial Trajectory

Last updated: August 6, 2026

Sodium pentobarbital is a mature, off-patent barbiturate with limited commercial scale and unusually fragmented demand. Its financial profile is driven by controlled-substance regulation, sterile injectable manufacturing, veterinary euthanasia, institutional procurement, and supply interruptions rather than by patent exclusivity. Public companies do not generally report sodium pentobarbital revenue separately, so market value and product-level revenue cannot be established from audited filings. The commercial outlook is stable to declining in routine human medicine, with persistent niche demand in veterinary, laboratory, and end-of-life applications.

What is sodium pentobarbital used for?

Sodium pentobarbital is the water-soluble sodium salt of pentobarbital, a short- to intermediate-acting barbiturate. It depresses central nervous system activity and has sedative, hypnotic, anticonvulsant, and anesthetic properties.

Market	Principal use	Commercial relevance
Human medicine	Sedation, seizure control, and anesthesia in limited settings	Small and declining
Veterinary medicine	Euthanasia and, less commonly, anesthesia	Core recurring market
Research	Animal anesthesia and laboratory protocols	Fragmented
Corrections	Execution protocols in certain U.S. jurisdictions	Irregular, politically and legally constrained
End-of-life care	Physician-assisted death in selected jurisdictions and formulations	Jurisdiction-specific and limited

The human market has contracted because newer anesthetics, anticonvulsants, sedatives, and intensive-care protocols have replaced barbiturates in many indications. Pentobarbital remains clinically useful where rapid CNS depression, established dosing, or institutional protocols support continued use. FDA labeling identifies pentobarbital sodium injection as a barbiturate with sedative, hypnotic, and anticonvulsant applications, although actual clinical use is narrower than the historical label footprint (U.S. Food and Drug Administration [FDA], n.d.-a).

How large is the sodium pentobarbital market?

No authoritative public source reports a global, product-specific market value for sodium pentobarbital. Manufacturer filings generally aggregate it with broader injectable generics, hospital products, animal-health products, or controlled substances.

The market is best characterized as a low-volume, high-friction generic market:

1. The underlying molecule is old and inexpensive to manufacture at the API level.
2. Finished sterile injectable supply is more difficult than ordinary solid-dose generic production.
3. Controlled-substance quotas and distribution rules restrict inventory flexibility.
4. Demand is divided among hospitals, veterinary clinics, government purchasers, laboratories, and correctional agencies.
5. Buyers may pay materially higher prices when only one or two qualified suppliers remain.

The absence of public revenue disclosure does not indicate commercial irrelevance. It indicates that sodium pentobarbital is generally too small to represent a reportable product line for diversified pharmaceutical companies.

Estimated market structure

Factor	Current market effect
Product maturity	Low pricing power under normal supply conditions
Patent status	No meaningful composition-patent barrier
Supplier count	Limited in some injectable presentations
Demand growth	Flat to declining in human medicine
Veterinary demand	More durable than hospital demand
Margin potential	Highest during shortages and constrained tenders
Revenue visibility	Low because suppliers rarely disclose product-level sales
Regulatory burden	High relative to product age
Substitution risk	Moderate to high in human medicine; lower in veterinary euthanasia

What is the financial trajectory for sodium pentobarbital?

The long-term financial trajectory is one of nominal price volatility around a structurally mature product.

Historical trajectory

Sodium pentobarbital entered the market during the barbiturate era and later became a generic product after the expiry of its original intellectual-property rights. During the second half of the 20th century, newer anesthetics and sedatives reduced its role in mainstream medicine.

By the 2000s, the product had moved into a fragmented market supported by:

• veterinary euthanasia;
• hospital and emergency-use protocols;
• seizure management in specialized settings;
• laboratory animal procedures;
• government procurement;
• limited execution-related demand.

During the 2010s, procurement became more difficult in some markets. Manufacturers and distributors faced tighter controls, shortages of injectable presentations, and reluctance by overseas suppliers to support executions. These factors produced sharp price movements without creating durable molecule-level market growth.

2020s trajectory

The 2020s market is likely to remain economically bifurcated:

• Routine human use continues to erode as alternatives expand.
• Veterinary demand remains relatively stable.
• Injectable shortages can create temporary price spikes.
• Oral and non-injectable products have smaller or more specialized demand.
• Government and institutional buyers may pay premiums for dependable supply.
• Revenue gains are more likely to come from price and mix than from volume.

The product does not have the profile of a growth pharmaceutical. Its value is tied to supply reliability, regulatory qualifications, and access to specific buyer groups.

What companies manufacture or distribute sodium pentobarbital?

Sodium pentobarbital has been supplied by multiple generic, specialty, and veterinary manufacturers over time. Product availability changes by country, dosage form, labeler, and manufacturing status.

In the United States, relevant supply channels have included:

• hospital injectable-drug manufacturers;
• specialty pharmaceutical companies;
• veterinary drug manufacturers;
• authorized distributors;
• government and institutional procurement contractors.

The FDA’s National Drug Code Directory and Drugs@FDA records are the appropriate sources for identifying currently listed products and labelers. Listing does not by itself establish uninterrupted commercial availability, current inventory, or meaningful market share (FDA, n.d.-b; FDA, n.d.-c).

Competitive positioning

Competition is less about branded differentiation than about regulatory and operational execution. The most defensible commercial capabilities are:

• DEA-controlled-substance authorization;
• FDA-compliant sterile manufacturing;
• validated fill-finish capacity;
• reliable pentobarbital API sourcing;
• qualified veterinary distribution;
• supply continuity during shortages;
• willingness to serve restricted or politically sensitive channels.

A supplier with a small product portfolio may obtain better economics than a broad generic company if it controls scarce injectable capacity or maintains qualified institutional contracts.

What patents protect sodium pentobarbital?

Sodium pentobarbital is not protected in the United States by a current composition-of-matter patent. The original intellectual-property position associated with pentobarbital and the historical Nembutal product expired many decades ago.

Patent category	Current relevance
Composition of matter	Expired
Basic sodium salt protection	Expired or not commercially limiting
Core formulation patents	No material current barrier identified
Method-of-use patents	No commercially significant active exclusivity identified
Manufacturing patents	Potentially process-specific, but not a barrier to ordinary generic entry
Orange Book-listed patents	No meaningful current patent barrier for standard products

The FDA Orange Book remains the controlling public source for patents and exclusivity associated with approved prescription products. Sodium pentobarbital’s commercial position is not analogous to a modern branded drug with listed formulation, method-of-use, or delivery-system patents (FDA, n.d.-d).

How strong is the patent estate for sodium pentobarbital?

The patent estate is commercially weak because the central molecule is long off patent and generic competition is legally permissible. Any remaining process or formulation know-how would be narrow, product-specific, and unlikely to prevent alternative manufacturing.

The relevant barriers are operational rather than intellectual-property based:

• controlled-substance registration;
• API qualification;
• sterile manufacturing;
• stability data;
• regulatory documentation;
• distribution controls;
• procurement qualification.

What is the Orange Book status of sodium pentobarbital?

Sodium pentobarbital has no Orange Book position comparable to an actively protected branded product. Any approved human products must be evaluated by specific NDA, ANDA, dosage form, and labeler because product status can change through discontinuation, transfer, withdrawal, or relabeling.

The practical conclusion is clear: an abbreviated new drug application can compete on the basis of pharmaceutical equivalence, bioequivalence where applicable, manufacturing compliance, and supply capability rather than by overcoming active patent claims.

When does sodium pentobarbital lose exclusivity?

Sodium pentobarbital lost meaningful exclusivity decades ago. There is no anticipated small-molecule patent cliff comparable to those affecting recently launched specialty drugs.

The relevant commercial timeline is therefore:

Period	Commercial event
1930s	Pentobarbital introduced during the barbiturate market era
Mid-20th century	Broad use in sedation, hypnosis, seizure control, and anesthesia
Late 20th century	Generic substitution and therapeutic displacement
2000s	Niche use persists; suppliers become more specialized
2010s	Injectable shortages and controlled-supply constraints become more visible
2020s	Mature, fragmented market with episodic pricing pressure

No future patent expiration date is expected to materially change the market.

Are there Paragraph IV challenges for sodium pentobarbital?

A meaningful current Paragraph IV litigation wave is unlikely because standard sodium pentobarbital products do not depend on an active Orange Book patent estate. Paragraph IV certifications are most relevant when a listed patent remains in force and an ANDA applicant seeks approval before patent expiry.

The current competitive risk is therefore not patent challenge risk. It is supply-entry risk:

• whether a new applicant can obtain controlled-substance approvals;
• whether it can qualify a sterile injectable facility;
• whether it can secure API;
• whether it can achieve commercial scale;
• whether hospital or veterinary buyers will qualify the product.

What formulation patents protect sodium pentobarbital?

No major active formulation-patent barrier is associated with ordinary sodium pentobarbital injection, capsules, or oral solutions. The principal technical issues are formulation compliance and manufacturing performance.

Injectable formulation

Sodium pentobarbital injection requires control of:

• concentration and dose uniformity;
• pH;
• sterility;
• particulate matter;
• container closure integrity;
• stability;
• preservative or excipient compatibility;
• controlled-substance handling.

These requirements increase development cost but do not create durable exclusivity by themselves.

Veterinary formulations

Veterinary products may be differentiated by:

• concentration;
• vial size;
• species labeling;
• euthanasia instructions;
• packaging;
• distributor contracts;
• state-level controlled-substance compliance.

The commercial value of veterinary formulations is higher than the patent value because purchasing decisions are often based on availability, dosing convenience, price, and regulatory status.

What FDA regulatory status applies to sodium pentobarbital?

Sodium pentobarbital is subject to FDA drug regulation in human products and FDA Center for Veterinary Medicine oversight for approved animal drugs. Human formulations are controlled substances, and distribution is subject to the federal Controlled Substances Act and DEA requirements.

The regulatory status differs by product:

Product type	Primary regulatory issue
Human injectable	NDA or ANDA status, sterile manufacturing, controlled-substance compliance
Veterinary injectable	New Animal Drug approval or applicable regulatory pathway
Compounded product	State and federal compounding rules
Imported API	FDA import requirements and DEA controls
Institutional supply	Procurement, chain-of-custody, and controlled-substance records

FDA drug-shortage records should be reviewed by presentation rather than by active ingredient alone. A shortage may affect one concentration or supplier while other presentations remain available (FDA, n.d.-e).

What manufacturing and supply barriers affect sodium pentobarbital?

Manufacturing barriers are the principal source of economic defensibility.

Controlled-substance controls

Pentobarbital is regulated under the U.S. Controlled Substances Act. Manufacturers, distributors, pharmacies, hospitals, and veterinary users must meet registration, recordkeeping, storage, ordering, and security requirements. DEA production quotas can constrain supply planning, particularly when demand changes unexpectedly (U.S. Drug Enforcement Administration [DEA], 2024).

Sterile injectable capacity

Sterile injectables are vulnerable to:

• plant shutdowns;
• contamination investigations;
• limited fill-finish slots;
• raw-material shortages;
• quality-system remediation;
• low-volume manufacturing decisions.

Because sodium pentobarbital is a mature generic, suppliers may have limited incentives to maintain redundant capacity unless contracts compensate for the operational burden.

Geographic coverage

The product is not uniformly available worldwide. Regulatory status, euthanasia rules, controlled-substance law, import restrictions, and local veterinary practice determine market access.

Region	Market characteristics
United States	Established veterinary and institutional demand; strict DEA controls
European Union	Country-specific authorization and controlled-drug rules
United Kingdom	Veterinary and controlled-drug regulation limits distribution
Canada	Controlled-substance and veterinary procurement restrictions
Australia and New Zealand	Veterinary demand with tightly regulated supply
Emerging markets	Variable approval, local sourcing, and limited transparency

What generic launch scenarios exist for sodium pentobarbital?

Because the market is already generic, a new entrant would not be responding to patent expiry. It would enter through one of four scenarios.

Scenario 1: Stable multi-supplier market

Several qualified suppliers maintain inventory. Prices remain competitive, margins are modest, and buyers prioritize contract reliability.

Scenario 2: Shortage-driven entry

A supplier enters after an incumbent shortage. The entrant may secure premium pricing and institutional contracts, but the opportunity depends on regulatory speed and available sterile capacity.

Scenario 3: Veterinary-focused launch

A company targets animal-health distributors with a concentrated injectable product, differentiated packaging, and reliable delivery. This is likely the clearest commercial route for a new entrant.

Scenario 4: Institutional or government supply

A supplier targets hospitals, correctional systems, laboratories, or public agencies. Volumes may be irregular, and legal or reputational issues can affect procurement continuity.

Which companies are challenging sodium pentobarbital?

No significant patent challengers define the current market. Competition comes from generic and veterinary suppliers that seek approval, maintain distribution, or replace disrupted manufacturers.

The relevant competitive set should be tracked through:

• FDA Drugs@FDA;
• FDA’s National Drug Code Directory;
• FDA drug-shortage records;
• FDA’s Green Book for animal drugs;
• DEA registrant and quota rules;
• public procurement records;
• company product catalogs and filings.

Supplier identity is presentation-specific. A company may appear in regulatory databases without maintaining active commercial inventory.

What patent litigation affects sodium pentobarbital?

No major current patent litigation is central to sodium pentobarbital’s market economics. Historical disputes have been more likely to involve:

• execution-protocol access;
• importation and distribution;
• prison or correctional procurement;
• pharmaceutical-company efforts to restrict use;
• state-level controlled-substance enforcement;
• product liability or professional-use issues.

These disputes can affect demand and supply but do not restore exclusivity to the molecule.

What is the revenue exposure for pharmaceutical companies?

Revenue exposure is generally immaterial at the consolidated-company level unless a supplier is highly concentrated in veterinary or institutional products. For diversified pharmaceutical companies, sodium pentobarbital is usually reported inside broader categories such as generic injectables, animal health, or hospital products.

The financial exposure is asymmetric:

• Volume exposure is limited because total demand is niche.
• Margin exposure can be high during supply interruptions.
• Compliance costs are significant relative to product revenue.
• Contract loss can eliminate a large share of a small supplier’s product revenue.
• Inventory and quota decisions can affect quarterly results more than underlying demand.

A company with a small specialty portfolio may have meaningful product-level exposure even when the broader market is small.

How does sodium pentobarbital compare with competing drugs?

Product	Primary role	Market position versus sodium pentobarbital
Propofol	IV anesthesia and sedation	Strong substitute in human procedural and ICU settings
Midazolam	Sedation and seizure-related use	Common alternative for sedation
Phenobarbital	Seizure control, veterinary use	Stronger chronic anticonvulsant position
Ketamine	Anesthesia and analgesia	Alternative in selected procedural settings
Alfaxalone	Veterinary anesthesia	Veterinary substitute, not a direct euthanasia equivalent
Secobarbital	Barbiturate use	Limited availability and narrower commercial footprint
Sodium pentobarbital	Sedation, seizure control, euthanasia	Niche product with durable veterinary demand

Pentobarbital retains an advantage where rapid, predictable CNS depression and established euthanasia protocols matter. It has weaker positioning in mainstream human anesthesia and procedural sedation, where newer agents offer more favorable recovery profiles and broader clinical adoption.

Key Takeaways

• Sodium pentobarbital is a mature, off-patent generic with no meaningful current composition-patent barrier.
• Its commercial market is niche and fragmented across veterinary, hospital, research, government, and institutional users.
• Public audited revenue data for the active ingredient are not generally available.
• Financial performance is driven by supply reliability, shortages, controlled-substance quotas, and sterile injectable capacity.
• Veterinary euthanasia is the most durable recurring demand segment.
• Human medical use is structurally declining because of therapeutic substitution.
• No major current Paragraph IV or patent-litigation event defines the market.
• Formulation and manufacturing requirements create operational barriers but not durable patent exclusivity.
• New entrants would compete through regulatory execution, supply continuity, and distribution rather than patent differentiation.
• The likely long-term trajectory is flat to declining volume with episodic price and margin spikes.

FAQs

Is sodium pentobarbital still commercially available?

Yes. Availability varies by country, formulation, supplier, controlled-substance authorization, and current manufacturing status. Veterinary and institutional products are generally more commercially persistent than routine human products.

Is sodium pentobarbital a branded or generic drug?

It is primarily a generic drug. Nembutal is the historical brand associated with pentobarbital, but current supply is dominated by generic, specialty, and veterinary products.

Does sodium pentobarbital have biosimilar risk?

No. Sodium pentobarbital is a chemically synthesized small molecule, not a biologic. Biosimilar regulation does not apply. Competition occurs through generic drug pathways.

Can a pharmaceutical company obtain exclusivity for a new sodium pentobarbital product?

A company could potentially obtain limited exclusivity for a qualifying new formulation, delivery system, indication, or regulatory pathway. Such exclusivity would not restore exclusivity to the underlying molecule and would need to provide clinically or commercially meaningful differentiation.

Why can an off-patent drug become expensive?

An off-patent drug can become expensive when few manufacturers remain, sterile injectable capacity is constrained, DEA quotas limit production, API supply is disrupted, or buyers require immediate delivery. Sodium pentobarbital is exposed to each of these factors.

References

1. U.S. Drug Enforcement Administration. (2024). Controlled substances quotas and regulatory requirements. https://www.dea.gov
2. U.S. Food and Drug Administration. (n.d.-a). Pentobarbital sodium injection prescribing information. https://dailymed.nlm.nih.gov
3. U.S. Food and Drug Administration. (n.d.-b). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
4. U.S. Food and Drug Administration. (n.d.-c). National Drug Code Directory. https://www.accessdata.fda.gov/scripts/cder/ndc/
5. U.S. Food and Drug Administration. (n.d.-d). 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
6. U.S. Food and Drug Administration. (n.d.-e). Drug shortages. https://www.accessdata.fda.gov/scripts/drugshortages/