Last Updated: August 24, 2026

NEMBUTAL Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Nembutal

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

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Summary for NEMBUTAL
US Patents:0
Applicants:3
NDAs:6
Raw Ingredient (Bulk) Api Vendors: 37
Clinical Trials: 1
DailyMed Link:NEMBUTAL at DailyMed
Recent Clinical Trials for NEMBUTAL

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US Patents and Regulatory Information for NEMBUTAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sciegen Pharms NEMBUTAL pentobarbital ELIXIR;ORAL 083244-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Epic Pharma Llc NEMBUTAL SODIUM pentobarbital sodium CAPSULE;ORAL 084093-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sciegen Pharms NEMBUTAL pentobarbital sodium SUPPOSITORY;RECTAL 083247-003 Jan 25, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Epic Pharma Llc NEMBUTAL SODIUM pentobarbital sodium CAPSULE;ORAL 083245-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sciegen Pharms NEMBUTAL pentobarbital sodium SUPPOSITORY;RECTAL 083247-001 Jan 25, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sciegen Pharms NEMBUTAL pentobarbital sodium SUPPOSITORY;RECTAL 083247-002 Jan 25, 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
Last updated: July 13, 2026

Nembutal (Pentobarbital) Market Dynamics and Financial Trajectory: Exclusivity, Competition, Supply, and Revenue Outlook

Nembutal (pentobarbital) is a legacy barbiturate with a highly constrained modern market driven by controlled-substance status, narrow prescribing, formulation/channel volatility, and steady but limited demand in veterinary euthanasia and select human uses. Financial trajectory is typically characterized by small commercial scale, episodic supply availability, and pricing that moves primarily with regulatory and distribution bottlenecks rather than broad payer-driven utilization growth. Because Nembutal is not a blockbuster and remains a controlled substance, valuation and revenue sensitivity skew toward supply continuity, enforcement risk, and generic or alternative barbiturate substitution dynamics rather than patent-driven exclusivity.

What is Nembutal (pentobarbital) and what drives demand today?

Short answer: Demand is driven by (1) its role in specific clinical and procedural settings where barbiturates remain used, (2) veterinary euthanasia workflows, and (3) supply/distribution continuity under controlled-substance constraints.

Primary commercial end markets

  • Veterinary euthanasia and sedation: One of the more stable demand pockets for pentobarbital products in certain regions.
  • Human use in limited indications: Uses have narrowed over time due to safety profiles and availability of alternative therapies.
  • Institutional and compounding-adjacent utilization: In some markets, pentobarbital demand can be partially met through alternative formulations or controlled distribution routes, depending on local regulatory frameworks.

Key demand determinants

  • Controlled substance scheduling and enforcement: Tight distribution governs inventory turns and order sizes.
  • Prescriber base size: Barbiturate utilization is not scaled like modern specialty products.
  • Substitution risk: Where alternatives are accessible (other barbiturates, sedatives, procedural agents), pentobarbital faces substitution pressure.
  • Supply reliability: Shortages or manufacturing disruptions can dominate short-term sales.

How big is the Nembutal market and what revenue scale should investors assume?

Short answer: The market is small-to-moderate in revenue terms relative to modern branded products; financials tend to be dominated by volume constraints, pricing resets, and distribution availability rather than sustained unit growth.

Commercial scale realities

  • Nembutal is typically not modeled like a chronic-therapy franchise.
  • Sales are more consistent with institutional and niche channel economics: limited transaction counts, high regulatory friction, and inventory availability shaping fulfillment more than demand elasticity.

Where pricing power comes from

  • Pricing is often supported when:
    • supply is constrained,
    • there are limited alternative package sizes or channel-ready SKUs,
    • distribution is gated by controlled-substance protocols.
  • Pricing weakens when:
    • alternative barbiturate products are available through the same channels,
    • wholesalers and institutions shift to substitutes to reduce risk or procurement friction.

When does Nembutal revenue spike or drop, and what are the typical triggers?

Short answer: Revenue often shifts around controlled-substance supply changes, manufacturing disruptions, regulatory actions, and procurement cycles in institutions and veterinary networks.

Common spike drivers

  • Temporary supply tightness that increases allocation-driven demand for available inventory.
  • Procurement catch-up after a shortage period (institutions reorder to restore buffer stock).
  • Channel reactivation when a distributor regains sourcing and licenses compliance.

Common decline drivers

  • Manufacturing disruptions that restrict fulfillment.
  • Regulatory enforcement or distributor changes that reduce throughput.
  • Institutional protocol changes that shift euthanasia or sedation workflows to alternatives.

What is the competitive landscape for pentobarbital products like Nembutal?

Short answer: Competition is primarily among other pentobarbital formulations, alternative barbiturates, and substitute sedative/anesthetic agents, with the practical determinant being distribution accessibility and institutional procurement choice.

Competitor set (functional, not brand-by-brand)

  • Other pentobarbital products: Competing SKUs by strength, packaging, and channel readiness.
  • Alternative barbiturates: Where clinically acceptable, substitution reduces reliance on a specific branded product.
  • Non-barbiturate procedural sedatives/anesthetics: Where protocols evolve, pentobarbital share can decline.

Competitive factors that matter commercially

  • Availability: Institutions purchase what can be supplied reliably under controlled substance rules.
  • Package format: Packaging and concentration can determine formulary placement.
  • Price under constraints: When supply is constrained, price can rise even without patent protection.

How do controlled-substance rules affect Nembutal distribution economics?

Short answer: Controlled-substance status compresses market depth, increases compliance costs, and makes revenue sensitive to allocation and fulfillment capacity.

Distribution bottlenecks

  • Distributor onboarding and facility compliance standards.
  • Additional documentation steps for ordering, receiving, and inventory reporting.
  • Slower purchasing cycles for some institutions due to compliance workflows.

Net effect on financial trajectory

  • Revenue can remain “sticky” in certain channels, but growth is limited.
  • Shortages or compliance disruptions translate quickly into revenue volatility.

What patents protect Nembutal, and how does patent status influence market dynamics?

Short answer: Nembutal is a legacy product, and market dynamics for pentobarbital are driven less by active patent exclusivity and more by supply, controlled-substance logistics, and competition from generic or alternative barbiturate products.

Why patent-driven growth is limited

  • For older small-molecule barbiturates, most core IP typically predates modern branded-product commercialization.
  • Commercial scale is constrained, so even if formulation or method patents exist for certain variants, the market rarely behaves like modern high-value exclusivity landscapes.

What generic entry risks exist for Nembutal, and how do they change pricing?

Short answer: Generic and alternative barbiturate entry risks are less about “Hatch-Waxman timing” and more about whether manufacturers can supply and distribute at compliant volumes.

How generic competition shows up in practice

  • If multiple manufacturers supply pentobarbital at scale, pricing compresses toward competitive levels.
  • If supply consolidates among fewer suppliers, pricing can hold up despite generic availability because the binding constraint becomes availability.

How does FDA regulatory status influence supply and financial trajectory?

Short answer: For Nembutal, FDA drug approval and controlled-substance requirements influence manufacturing approvals, labeling, and distribution constraints; these factors typically determine supply continuity more than demand growth.

Regulatory mechanics that affect revenue

  • Changes in manufacturing site status, labeling, or operational compliance can trigger shortages.
  • Label updates or enforcement actions can shift procurement behavior.

What is the Orange Book status of Nembutal and what does it imply for exclusivity?

Short answer: For legacy barbiturates, Orange Book-driven exclusivity is typically limited and does not create broad, durable revenue protection.

Commercial implication

  • Even when a branded listing exists, revenue trajectory depends on whether regulated supply and distribution allow stable fulfillment.

How does Nembutal compare with other barbiturates on the market?

Short answer: Pentobarbital’s relative position is set by channel fit and procurement familiarity more than by differentiated clinical outcomes, since barbiturate class alternatives can substitute in many workflows.

Procurement-led comparison

  • Institutions often choose based on:
    • reliable supply,
    • inventory compatibility,
    • concentration and packaging,
    • willingness to stock under controlled-substance requirements.

What manufacturing and supply-chain factors most affect Nembutal financials?

Short answer: Nembutal financial trajectory is supply-led: manufacturing continuity and distribution authorization dominate unit availability and sales timing.

Supply-chain risk surface

  • Batch production constraints and quality system disruptions.
  • Regulatory or compliance issues at manufacturing or repackaging facilities.
  • Lead times for controlled-substance procurement.

How this drives quarterly earnings behavior

  • Sales can show stepwise moves tied to “in-stock” periods.
  • Revenue risk increases when a single supplier dominates.

What market dynamics shape revenue in veterinary euthanasia specifically?

Short answer: Veterinary demand is shaped by practitioner network concentration, local procurement policies, and availability of substitute euthanasia agents.

Veterinary channel dynamics

  • Pricing responds sharply during supply interruptions.
  • Adoption shifts can occur when alternative agents become preferred due to convenience, availability, or protocol updates.

Key Takeaways

  • Nembutal’s financial trajectory is primarily supply and distribution constrained, not patent-driven.
  • Revenue volatility is dominated by controlled-substance logistics, manufacturing continuity, and substitution among barbiturates or other procedural agents.
  • Competitive pressure tends to compress pricing when supply is abundant across multiple suppliers, while constrained supply can support higher realized prices.
  • Market growth is structurally limited by narrow end-market utilization and substitution behavior in both human and veterinary settings.

FAQs

  1. Why does pentobarbital pricing change abruptly even without brand-new product launches?
    Controlled distribution, supply interruptions, and institutional restocking cycles drive abrupt pricing shifts.

  2. Do controlled-substance compliance costs materially affect Nembutal sales velocity?
    Yes. Ordering and inventory controls slow purchasing and increase the cost of maintaining buffer stock.

  3. What substitution options most threaten Nembutal share in veterinary use?
    Other euthanasia agents and protocol-driven alternatives that fit institutional ordering and supply reliability.

  4. How do manufacturing site disruptions typically impact Nembutal quarterly revenue?
    They create stepwise sales drops that reverse when supply returns to “in-stock” status.

  5. Is Nembutal’s market more sensitive to demand or supply?
    Supply, because controlled distribution and manufacturing continuity determine fulfillment more than broad demand expansion.


References

  1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-07-13).
  2. DEA. Controlled Substances Regulations and scheduling resources for pentobarbital (and related controlled substance guidance). (Accessed 2026-07-13).

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