BUTABARBITAL SODIUM - Generic Drug Details

What are the generic sources for butabarbital sodium and what is the scope of freedom to operate?

Butabarbital sodium is the generic ingredient in ten branded drugs marketed by Medpointe Pharm Hlc, Alpharma Us Pharms, Wockhardt, Lannett, Meda Pharms, Halsey, Bundy, Sandoz, Solvay, Teva, Watson Labs, Whiteworth Town Plsn, Pharmobedient, Hikma, Ivax Sub Teva Pharms, and Marshall Pharma, and is included in thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for BUTABARBITAL SODIUM

US Patents:	0
Tradenames:	10
Applicants:	16
NDAs:	32
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	1
Patent Applications:	2,003
DailyMed Link:	BUTABARBITAL SODIUM at DailyMed

Recent Clinical Trials for BUTABARBITAL SODIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all BUTABARBITAL SODIUM clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BUTABARBITAL SODIUM

N05CA	Barbiturates, plain
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for BUTABARBITAL SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lannett	SODIUM BUTABARBITAL	butabarbital sodium	TABLET;ORAL	085866-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bundy	BUTABARBITAL	butabarbital sodium	TABLET;ORAL	085550-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Hikma	SODIUM BUTABARBITAL	butabarbital sodium	TABLET;ORAL	085418-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ivax Sub Teva Pharms	SODIUM BUTABARBITAL	butabarbital sodium	TABLET;ORAL	083484-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Butabarbital Sodium Market Dynamics, Financial Outlook, Patent Status, and Generic Risk

Last updated: September 5, 2026

Butabarbital sodium is a mature barbiturate hypnotic with limited commercial scale, no meaningful new-product exclusivity, and declining strategic relevance in the U.S. market. Its market is constrained by substitution with benzodiazepines, nonbenzodiazepine sleep medicines, sedating antidepressants, and newer insomnia therapies. Public financial disclosures do not report standalone revenue for butabarbital sodium, indicating that any remaining sales are immaterial to the portfolios of major pharmaceutical companies.

What is the current FDA status of butabarbital sodium?

Butabarbital sodium is an oral barbiturate indicated for short-term treatment of insomnia and, in some labeling, for anxiety or daytime sedation. The drug is marketed in the United States under the historical brand name Butisol Sodium and as a generic product.

Attribute	Butabarbital sodium
Active ingredient	Butabarbital sodium
Drug class	Barbiturate sedative-hypnotic
Common dosage forms	Oral tablets; historical oral liquid products
Typical tablet strengths	30 mg and 50 mg
U.S. controlled-substance status	Schedule III
Primary historical brand	Butisol Sodium
U.S. regulatory pathway	Legacy NDA and generic abbreviated applications
Current innovation status	No meaningful new-molecule or formulation development
Biosimilar relevance	None
Main competitive substitutes	Benzodiazepines, zolpidem, eszopiclone, zaleplon, doxepin, suvorexant, lemborexant, ramelteon

The FDA has maintained legacy labeling for butabarbital products, including warnings concerning respiratory depression, dependence, tolerance, overdose, and interaction with alcohol or other central nervous system depressants (U.S. Food and Drug Administration [FDA], n.d.-a; National Library of Medicine, n.d.).

Availability can change by manufacturer, dosage strength, and wholesaler inventory. A product’s presence in DailyMed or historical FDA records does not guarantee continuous commercial supply.

How large is the butabarbital sodium market?

The U.S. market is a niche generic market rather than a growth pharmaceutical category. Public sources do not provide a reliable standalone revenue figure for butabarbital sodium. Major public pharmaceutical companies do not identify the product as a material reporting segment, and commercial prescription databases generally aggregate low-volume generic products or suppress data where prescription counts are small.

The market has four defining characteristics:

1. Low prescription volume relative to newer insomnia products.
2. Limited manufacturer participation.
3. Price competition when more than one supplier is active.
4. Supply risk when only one or two manufacturers maintain inventory.

A reasonable commercial classification is “legacy, low-volume, mature generic.” That classification is more useful than a point revenue estimate because public financial data do not support a defensible product-level forecast.

What drives demand?

Demand is primarily associated with:

• Longstanding physician familiarity.
• Low acquisition cost when inventory is available.
• Patients already stabilized on the medicine.
• Use in settings where a controlled sedative-hypnotic remains clinically accepted.
• Limited switching among patients who have used the product for many years.

Demand is reduced by safety concerns and the availability of therapies with more favorable prescribing profiles. Barbiturates have a narrower safety margin than many newer alternatives, particularly when combined with opioids, alcohol, benzodiazepines, or other sedatives.

What is the financial trajectory for butabarbital sodium?

The financial trajectory is likely flat to declining in nominal prescription revenue, with periodic supply-driven volatility. No public company reports butabarbital sodium as a material revenue contributor.

Financial factor	Likely market effect
Mature active ingredient	Limits pricing power and innovation value
Low prescription volume	Produces modest absolute revenue
Small supplier base	Increases shortage and inventory volatility
Generic competition	Compresses unit pricing
Controlled-substance handling	Raises compliance and distribution costs
Limited physician adoption	Restricts demand expansion
No major patent barrier	Permits generic competition
Replacement by newer therapies	Creates long-term volume pressure

For a generic manufacturer, the product may still have value as a portfolio-completion item if production costs are low and regulatory infrastructure already exists. It is unlikely to justify substantial standalone manufacturing investment unless the supplier can obtain a durable supply position or serve a contracted institutional market.

For a distributor, the main financial issue is inventory continuity rather than market expansion. Low-volume controlled substances can generate disproportionate operational costs because they require specialized ordering, monitoring, recordkeeping, and diversion controls under the Controlled Substances Act and Drug Enforcement Administration regulations (Drug Enforcement Administration, n.d.).

When does butabarbital sodium lose exclusivity?

Butabarbital sodium has no commercially meaningful remaining new-drug exclusivity. The molecule and its original formulations are decades old. Any historical FDA exclusivity associated with the original product expired long ago.

Exclusivity category	Current relevance
New chemical entity exclusivity	Expired
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	No current commercial significance
New formulation exclusivity	No material active protection identified
Marketed generic exclusivity	Depends on any specific ANDA approval, if applicable
Patent-based exclusivity	No material active U.S. patent barrier identified

The absence of a meaningful patent estate does not guarantee immediate generic entry. A manufacturer still needs an approved application, validated manufacturing capacity, controlled-substance compliance, commercial inventory, and acceptable economics.

What patents protect butabarbital sodium?

No significant active U.S. patent estate is publicly associated with the core butabarbital sodium molecule or its historical Butisol Sodium product. Original composition-of-matter and basic formulation rights would have expired many years ago.

The relevant intellectual-property position is therefore weak:

IP category	Assessment
Active ingredient patent	Expired historical rights
Salt-form patent	No meaningful current barrier identified
Tablet formulation patent	No material current barrier identified
Oral-solution patent	No material current barrier identified
Method-of-use patent	No material current barrier identified
Manufacturing patent	Potentially relevant only if a supplier uses a proprietary process
Trade secrets	Possible process and quality-control value, but not a market exclusivity right

Manufacturing know-how can still affect entry economics. Suppliers must control impurity profiles, assay, dissolution, content uniformity, stability, and controlled-substance security. Those requirements create operational barriers, not durable patent exclusivity.

What is the Orange Book status of butabarbital sodium?

The Orange Book is relevant for determining whether an approved reference product has listed patents or regulatory exclusivity. For an old barbiturate such as butabarbital sodium, the commercial question is generally abbreviated approval and supply availability rather than patent litigation.

No active Orange Book patent listing with material blocking effect is publicly evident for the historical Butisol Sodium product. Orange Book status can differ by product number, approval holder, and current marketing status. The Orange Book also distinguishes approved products from products that have been discontinued for commercial reasons.

A discontinued brand does not necessarily eliminate generic availability. An ANDA holder may continue marketing a generic product after the branded product has been withdrawn, provided the application remains approved and the manufacturer maintains supply.

Are there Paragraph IV challenges involving butabarbital sodium?

Paragraph IV litigation is not a material current market issue for butabarbital sodium. The relevant patent life ended long before the current generic market, and there is no prominent contemporary litigation campaign concerning an Orange Book-listed butabarbital sodium patent.

For this product, generic entry risk comes from:

• A new ANDA applicant entering without a patent barrier.
• Re-entry by a former supplier.
• Contract manufacturing or private-label supply.
• A manufacturer exploiting a temporary shortage.
• Substitution among existing suppliers.

Because the market is old and low volume, the primary competitive risk is not a large wave of patent-cleared entrants. It is the arrival of one additional supplier with sufficient capacity to compress prices or displace an incumbent.

Which companies are challenging or supplying butabarbital sodium?

Publicly visible supplier participation has historically been limited and may change over time. The Butisol Sodium brand has been associated with MedPointe Pharmaceuticals in legacy FDA labeling. Generic pharmaceutical companies have also held or marketed butabarbital sodium products at different times.

A definitive current supplier list cannot be inferred solely from historical labels. Drug directories, FDA approval records, DailyMed entries, and wholesaler inventories can show different statuses:

• Approved but not currently marketed.
• Listed but temporarily unavailable.
• Manufactured for institutional or contract customers.
• Available in one strength but not another.
• Distributed under a private-label arrangement.

The competitive landscape is therefore fragmented and supply-sensitive rather than dominated by a single high-growth company.

What generic entry risks exist for butabarbital sodium?

Generic entry risk is structurally high because patent protection is not the main barrier. Commercial entry remains constrained by low demand and controlled-substance compliance.

High-risk areas for incumbents

An incumbent faces volume and pricing pressure if:

• A second active manufacturer enters.
• A wholesaler secures an alternative supply channel.
• The FDA approves a dormant or newly filed ANDA.
• A shortage raises market visibility and attracts a niche supplier.
• Hospitals or pharmacies shift to another barbiturate or sedative.

Constraints on new entrants

A prospective entrant must address:

• Small addressable demand.
• Controlled-substance registration and recordkeeping.
• Forecasting difficulty.
• Minimum efficient batch size.
• Pharmacovigilance and labeling obligations.
• Commercial distribution costs.
• Risk that competitors respond with lower prices.

These factors make butabarbital sodium a low-revenue, low-barrier but operationally specialized product.

How does butabarbital sodium compare with competing insomnia drugs?

Butabarbital sodium competes primarily on legacy availability and price, not on clinical differentiation.

Product category	Commercial position versus butabarbital sodium
Zolpidem	Much broader prescribing and stronger generic supply
Eszopiclone	Broader modern insomnia use
Zaleplon	Alternative short-acting hypnotic
Benzodiazepines	Established sedative market, despite dependence concerns
Doxepin	Noncontrolled insomnia option at low doses
Ramelteon	Melatonin-receptor option with lower abuse concerns
Suvorexant and lemborexant	Branded or specialty insomnia products with newer mechanisms
Butabarbital sodium	Legacy, low-volume, controlled barbiturate

Butabarbital’s principal disadvantage is its risk-benefit profile. Modern prescribing increasingly favors agents with more predictable dosing, lower overdose risk, or lower abuse liability.

What manufacturing and regulatory barriers affect the market?

Manufacturing barriers are modest in technical complexity but meaningful in compliance burden. Butabarbital sodium is a small-molecule tablet product, so it does not require biologic manufacturing, cold-chain logistics, or complex delivery technology.

Key requirements include:

• Compliance with current good manufacturing practice.
• Controlled-substance security and inventory reconciliation.
• Validated analytical methods.
• Stability data for the marketed dosage strengths.
• Dissolution and content-uniformity control.
• FDA-approved labeling.
• DEA registration and applicable state licensing.
• Pharmacovigilance for dependence, overdose, and interactions.

There is no biosimilar risk. Butabarbital sodium is a conventional small molecule, so competition proceeds through generic-drug pathways rather than the biosimilar framework.

What litigation and settlement agreements affect butabarbital sodium?

No major current patent litigation or settlement agreement is associated with butabarbital sodium. The product’s commercial history predates the modern wave of branded-generic litigation that affects high-revenue medicines.

The absence of litigation is commercially significant. It means:

• No known litigation-based launch restriction.
• No settlement-controlled generic entry date.
• No at-risk launch controversy of material market importance.
• No major legal uncertainty affecting valuation.

What is the geographic coverage of butabarbital sodium?

The strongest documented commercial relevance is in the United States, where the product is regulated as a controlled substance and has legacy FDA-approved labeling. International availability is fragmented. Regulatory status, scheduling, reimbursement, and marketing authorization differ by country.

The product is unlikely to support a broad multinational growth strategy. Geographic expansion would require country-specific approvals, controlled-substance permissions, local pharmacovigilance, and commercial distribution arrangements. Those costs are difficult to justify for a low-volume medicine unless a local market has an established institutional demand.

Key Takeaways

• Butabarbital sodium is a mature, low-volume generic barbiturate with declining strategic relevance.
• Public companies do not report standalone butabarbital sodium revenue.
• The U.S. market is driven by legacy prescriptions and supply availability rather than clinical growth.
• Original molecule and formulation patents have expired; no material active patent barrier is evident.
• Paragraph IV litigation, biosimilar risk, and settlement-driven entry restrictions are not significant current issues.
• Generic entry is legally straightforward but commercially unattractive because demand is small and controlled-substance compliance adds cost.
• The main investment risk is supply interruption, not patent expiry.
• Newer insomnia therapies and safer sedative alternatives continue to reduce long-term demand.
• The product may have niche value for a low-cost generic supplier, but it is unlikely to create material revenue growth.

FAQs

Is butabarbital sodium still available in the United States?

Availability is intermittent and depends on the manufacturer, strength, pharmacy inventory, and wholesaler supply. Historical FDA approval or DailyMed presence does not guarantee continuous commercial distribution.

Is butabarbital sodium a controlled substance?

Yes. Butabarbital is regulated in the United States as a Schedule III controlled substance, creating additional prescribing, storage, distribution, and recordkeeping requirements.

Does butabarbital sodium have active patent protection?

No material active U.S. patent barrier is publicly associated with the historical molecule or standard tablet formulations. Any relevant original patents expired decades ago.

Can a generic company launch butabarbital sodium without a Paragraph IV challenge?

Yes. If no blocking patent is listed or enforceable, an applicant generally does not need to rely on a Paragraph IV certification. The primary requirements are FDA approval, manufacturing compliance, controlled-substance authorization, and commercial viability.

Is butabarbital sodium commercially attractive for pharmaceutical licensing?

Usually not as a standalone licensing asset. It may have value in a legacy generic portfolio, institutional supply contract, or specialty controlled-substance distribution platform, but its low demand and limited pricing power reduce licensing value.

References

1. Drug Enforcement Administration. (n.d.). Drug scheduling. U.S. Department of Justice. https://www.dea.gov/drug-information/drug-scheduling

2. National Library of Medicine. (n.d.). DailyMed: Butabarbital sodium tablet labeling. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

3. U.S. Food and Drug Administration. (n.d.-a). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/

4. U.S. Food and Drug Administration. (n.d.-b). 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

5. U.S. Food and Drug Administration. (n.d.-c). Abbreviated new drug application approvals. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda