Last Updated: September 24, 2026

SECONAL SODIUM Drug Patent Profile


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

Seconal Sodium is a drug marketed by Valeant Pharms North and Lilly and is included in three NDAs.

The generic ingredient in SECONAL SODIUM is secobarbital sodium. There is one drug master file entry for this compound. Additional details are available on the secobarbital sodium profile page.

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Summary for SECONAL SODIUM

US Patents and Regulatory Information for SECONAL SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms North SECONAL SODIUM secobarbital sodium CAPSULE;ORAL 086101-001 Oct 3, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly SECONAL SODIUM secobarbital sodium SUPPOSITORY;RECTAL 086530-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly SECONAL SODIUM secobarbital sodium SUPPOSITORY;RECTAL 086530-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Valeant Pharms North SECONAL SODIUM secobarbital sodium CAPSULE;ORAL 086101-002 Oct 3, 1983 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly SECONAL SODIUM secobarbital sodium INJECTABLE;INJECTION 007392-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly SECONAL SODIUM secobarbital sodium SUPPOSITORY;RECTAL 086530-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Lilly SECONAL SODIUM secobarbital sodium SUPPOSITORY;RECTAL 086530-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Seconal Sodium (secobarbital sodium) Market Dynamics & Financial Trajectory (US)

Last updated: July 20, 2026

Seconal Sodium is a legacy barbiturate marketed as secobarbital sodium for sedation and short-term management of insomnia. The US market is structurally constrained by controlled-substance scheduling, restricted prescribing, and a mature, low-growth competitive environment. Financial trajectory has been characterized by declining/flat unit demand over time, episodic procurement demand, and limited upside from new formulations because the drug is long established and largely exposed to substitution within the same therapeutic niche (benzodiazepines and non-barbiturate sedatives) and to prescriber risk controls.

What is Seconal Sodium’s commercial history and who sells it?

Seconal Sodium is the brand name for secobarbital sodium. It is part of the barbiturate class and has historically been marketed in the US under the Seconal brand for sleep and sedation indications.

Commercial model (typical for legacy controlled-substance brands)

  • Supply chain depends on controlled-substance manufacturing and distribution infrastructure.
  • Demand is influenced by prescriber behavior, payer controls, and formulary restrictions.
  • Sales durability tends to decline as non-barbiturate sedatives gain preference and as stewardship programs tighten.

Key market dynamic

  • Barbiturate prescribing has faced persistent headwinds due to safety profile concerns (narrow therapeutic index historically associated with misuse and overdose risk) and the shift toward benzodiazepines and newer hypnotics. This tends to cap long-term sales growth for barbiturate brands.

How do controlled-substance regulations shape Seconal Sodium market dynamics?

Seconal Sodium is a scheduled barbiturate in the US. Scheduling affects the commercial and operating economics through compliance, forecasting burden, and distribution constraints.

Regulatory and compliance effects on pricing and volume

  • Retail access is tightly managed through prescribing and dispensing controls.
  • Wholesaler purchasing can be more volatile, reflecting institutional and regional prescribing patterns.
  • Payer and pharmacy controls can reduce conversion to prescriptions where safer alternatives are preferred.

Business impact

  • Even where demand exists, sales often track stability rather than growth because compliance friction increases frictional time-to-demand.
  • Competitive substitution is typically faster within hypnotics and sedatives than in higher-differentiation specialty categories.

What market categories does Seconal Sodium compete in?

Seconal Sodium competes primarily in the broader sedative-hypnotic space, where substitution is common.

Competitive set (therapeutic substitution)

  • Benzodiazepines and benzodiazepine-like hypnotics for insomnia and anxiety-adjacent indications.
  • Non-benzodiazepine hypnotics for sleep initiation and maintenance.
  • Use cases where older barbiturates remain options due to clinician familiarity, specific patient histories, or formulary allowances.

Why substitution matters

  • Most prescribers have multiple pharmacologic options with broader current guideline support.
  • Controlled-substance controls can tilt prescribers toward agents with more established current use pathways and risk-management tools.

What do the financial trajectory drivers look like for a legacy barbiturate brand?

Financial outcomes for drugs like Seconal Sodium typically hinge on four drivers: (1) volume trend, (2) pricing pressure, (3) supply and compliance cost, and (4) inventory and channel fluctuations.

1) Volume trend

  • Long-established sedatives often experience mature market behavior.
  • Volume typically declines as prescribers move to alternatives, then stabilizes at a residual base.

2) Pricing pressure

  • Barbiturate brands face pricing pressure from:
    • generic substitution (where available for secobarbital sodium equivalents),
    • therapeutic alternatives with stronger payer support,
    • channel negotiations that compress net price versus list.

3) Supply and compliance cost

  • Manufacturing and distribution costs are structurally higher for controlled substances.
  • Any production disruptions can temporarily shift market allocation and distort quarterly sales, often followed by catch-up.

4) Channel inventory dynamics

  • Wholesaler ordering patterns can create quarterly volatility.
  • A stable but constrained prescribing base produces less predictable channel demand.

How does exclusivity and generic exposure affect Seconal Sodium’s sales ceiling?

Seconal Sodium has been marketed for decades, which places it in a category where most meaningful commercial exclusivity has already matured. With time, brand economics are typically dominated by:

  • generic penetration in the same active ingredient (secobarbital sodium),
  • erosion of share as prescribers and payers standardize on generics or alternative molecules.

Commercial consequence

  • New incremental value from patent-led exclusivity is unlikely for a legacy active ingredient unless specific formulation or manufacturing patents still provide barriers, which is uncommon at this stage for older barbiturate brands.

What is the typical net revenue path: flat vs declining?

For legacy controlled-substance hypnotics, the market often exhibits:

  • historical decline (as safer alternatives displace use),
  • subsequent stabilization at lower baseline,
  • episodic bumps tied to procurement cycles and institutional ordering.

Seconal Sodium fits this profile in general market mechanics:

  • residual demand driven by specific clinician practice patterns,
  • limited category-wide growth tailwinds,
  • ongoing cost and compliance burdens without new differentiation to expand share.

How do payer and formulary decisions impact Seconal Sodium profitability?

Formulary controls can reduce scripts even when the drug is available:

  • Preferred status for non-barbiturate hypnotics can limit formulary conversion.
  • Step edits, quantity limits, or restrictions can reduce patient starts and refill persistence.
  • Pharmacy-level controls can shift dispensing behavior toward alternatives.

Net effect

  • Lower utilization supports stable, not expanding, brand-scale revenue.
  • Margin performance depends on the ability to maintain net pricing after rebates and distribution terms.

What substitution trends matter most for secobarbital sodium vs modern hypnotics?

In sedative-hypnotics, modern prescribing patterns favor drugs with:

  • clearer safety messaging for typical outpatient sleep,
  • more standardized dosing guidance,
  • broader payer acceptance.

Substitution consequence for barbiturates

  • Barbiturate demand is typically narrower and more clinician-driven.
  • The category tends toward lower growth and higher switching probability if alternative agents are available on formulary.

How do supply, manufacturing reliability, and channel behavior affect quarterly sales?

For controlled substances, sales can show volatility from:

  • manufacturing batch scheduling,
  • regulatory releases and QA lot acceptance,
  • distributor allocation constraints.

Financial pattern

  • Quarterly revenue can swing based on distribution fill rates and wholesaler inventory turns.
  • Over time, the baseline stabilizes if supply is consistent and prescriber demand remains steady.

What does “brand vs generic” competition mean for Seconal Sodium economics?

If generics for secobarbital sodium exist and are widely substituted, the brand tends to:

  • lose market share through therapeutic and pricing substitution,
  • keep sales only where “brand name” prescribing persists or where generic availability and substitution are constrained.

Actionable commercial interpretation

  • Upside requires either reinstated brand preference, distinct product advantages (dose form, packaging, availability), or a regulatory supply scarcity event. For a legacy molecule, those levers are intermittent, not systematic.

What does the Seconal Sodium revenue exposure look like in an investment lens?

A legacy barbiturate brand usually has:

  • limited growth optionality,
  • risk concentration in regulatory and compliance costs,
  • dependence on steady low-to-mid baseline demand.

Investment-relevant risk factors

  • US controlled-substance enforcement and prescribing crackdowns.
  • Safety-related label perception and clinician risk management behavior.
  • Generic substitution and payer standardization.

Investment-relevant upside factors

  • Supply reliability that reduces stock-outs and preserves residual share.
  • Short procurement cycles by institutions that can temporarily lift volumes.

How does Seconal Sodium compare with other sedative-hypnotics’ market outcomes?

Compared with modern hypnotics, legacy barbiturates generally underperform on:

  • sustained category growth,
  • broad formulary access,
  • marketing differentiation.

Relative market positioning

  • Seconal Sodium is best viewed as a niche, controlled-substance residual product rather than a growth driver in a sedative-hypnotic portfolio.

Key Takeaways

  • Seconal Sodium is a legacy controlled-substance hypnotic where market dynamics are dominated by regulatory constraints, prescriber substitution, and mature competitive conditions.
  • The financial trajectory is consistent with decline or flat long-run growth after displacement by alternative sedative-hypnotics and generic secobarbital sodium equivalents.
  • Profitability is shaped by net price compression, channel inventory cycles, and higher compliance and manufacturing reliability costs typical for scheduled drugs.
  • Commercial upside is constrained without durable differentiation; the primary levers are supply continuity and residual demand stability.

FAQs

  1. Why do barbiturate brands like Seconal Sodium have limited long-term growth?
    Residual prescribing, substitution to benzodiazepines/non-benzodiazepines, and generic penetration constrain volume and share.

  2. What typically drives quarterly sales volatility for controlled-substance sedatives?
    Manufacturing lot release timing, distributor fill rates, and wholesaler inventory rebalancing.

  3. How does formulary restriction change patient conversion for legacy hypnotics?
    Preferred status for newer agents reduces starts and refill persistence; brand scripts shift to alternatives.

  4. What are the main financial risks for a scheduled legacy product?
    Net pricing compression, prescribing crackdowns, and supply/compliance operational disruptions.

  5. Is there meaningful upside from product lifecycle extensions for secobarbital sodium brands?
    Usually limited for long-established actives; meaningful upside requires new barriers to substitution or a distinct delivery/availability advantage.

References

  1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (secobarbital/Seconal). US Food and Drug Administration.
  2. DEA. Drug Scheduling Information. Drug Enforcement Administration.
  3. FDA. Controlled Substances Act and FDA oversight resources. US Food and Drug Administration.

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