Last Updated: August 9, 2026

THORAZINE Drug Patent Profile


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Which patents cover Thorazine, and what generic alternatives are available?

Thorazine is a drug marketed by Glaxosmithkline and is included in two NDAs.

The generic ingredient in THORAZINE is chlorpromazine. There are twenty-four drug master file entries for this compound. Additional details are available on the chlorpromazine profile page.

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Summary for THORAZINE
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US Patents and Regulatory Information for THORAZINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline THORAZINE chlorpromazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 011120-016 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline THORAZINE chlorpromazine hydrochloride CONCENTRATE;ORAL 009149-043 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline THORAZINE chlorpromazine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 011120-019 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline THORAZINE chlorpromazine hydrochloride TABLET;ORAL 009149-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline THORAZINE chlorpromazine hydrochloride INJECTABLE;INJECTION 009149-011 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline THORAZINE chlorpromazine hydrochloride TABLET;ORAL 009149-020 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline THORAZINE chlorpromazine hydrochloride TABLET;ORAL 009149-013 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
Last updated: July 12, 2026

Thorazine (chlorpromazine) market dynamics and financial trajectory: sales trends, generics pressure, and pricing outlook

Executive summary: Thorazine (chlorpromazine) is a legacy, first-generation antipsychotic whose US market dynamics are dominated by generic substitution, periodic supply-demand swings, and mix shifts within antipsychotic formularies. Because it is off-patent in key jurisdictions, the revenue trajectory tracks primarily with pricing erosion, manufacturer share changes, and wholesale pipeline restocking cycles rather than brand exclusivity. Financial performance is constrained by low unit pricing, sustained generic availability in multiple dosage forms, and limited new-label expansion. Near-term upside is tied to supply stability and formulary positioning for specific strengths and routes (oral tablets and solution; injectable in certain settings), not new regulatory exclusivity.


What is Thorazine (chlorpromazine) and what role does it play in antipsychotic markets?

Thorazine is chlorpromazine, a phenothiazine antipsychotic used for schizophrenia and other indications (including agitation), and historically for nausea/vomiting and hiccups in clinical practice depending on jurisdictional labeling and standards. Market demand is driven by:

  • Institutional use in acute-care settings where short-term symptom control is needed.
  • Behavioral health and inpatient psychiatry where low-cost dopamine blockade options are favored.
  • Fallback prescribing when newer agents are contraindicated due to cost, formulary rules, or tolerability considerations.

Because Thorazine is an older molecule with entrenched prescriber familiarity, it can maintain baseline demand even as overall antipsychotic usage migrates toward newer options.

Which dosage forms drive US demand

Market behavior differs by route and strength:

  • Oral tablets and oral solution: most consistent volume base; sensitive to generic price competition and pharmacy substitution.
  • Injectable formulations: lower overall share than oral but can show sharper short-term swings tied to hospital purchasing, stocking behavior, and supply continuity.

How has Thorazine’s market evolved with generic substitution and what does that mean for pricing?

Thorazine’s brand revenue is structurally limited because chlorpromazine products are widely available as generics. The result is:

  • Rapid price erosion after brand exclusivity periods ended (US) and after generic entry in other markets.
  • Contracted pricing compression for wholesalers, group purchasing organizations (GPOs), and hospital formularies.
  • Switching behavior driven by pharmacy claims data: patients typically receive the lowest-cost equivalent under reimbursement rules unless a specific brand is required.

Featured snippet answer: what drives Thorazine sales despite generic dominance?

Thorazine sales persist mainly where brand retention is incentivized (administering workflow, hospital procurement contracts, or specific packaging/supply preferences), and where clinicians use chlorpromazine as a low-cost “workhorse” for acute control.


When does Thorazine lose exclusivity and how does that timing shape current market structure?

Chlorpromazine has long since exited effective exclusivity in major markets. Today’s structure is defined by:

  • Generic portfolio breadth across strengths and routes.
  • Multiple manufacturers competing at wholesale.
  • Low differentiation, so competitive intensity is primarily pricing, availability, and packaging.

Why exclusivity timelines matter less for Thorazine than for newer brands

For legacy generics, the practical determinant is not brand exclusivity but:

  • Whether any product is temporarily constrained (supply).
  • Whether specific presentations are scarce (e.g., certain strengths of injection).
  • Whether payer contracts favor particular labelers.

What patents protect chlorpromazine products and how strong is the residual IP estate for Thorazine?

For Thorazine as a brand name product, the active ingredient chlorpromazine is off-patent in most contexts. The enforceable IP landscape typically shifts to:

  • Process and formulation patents (if any active ones exist by jurisdiction, which is rare at this age).
  • Method-of-use patents only where there is a distinguishable, novel clinical regimen.
  • Device or administration-related patents if any connected product exists.

Market implication: even where minor secondary patents exist, generic manufacturers generally design around process/formulation claims, and the molecule’s long-standing therapeutic use limits scope for broad method-of-use protection.

Patent estate impact on market dynamics

  • Pricing stays low because primary composition protection does not block generic chlorpromazine.
  • Brand differentiation is limited, so marketing and distribution efficiency matter more than litigation outcomes.

What generic entry risks exist for Thorazine and which companies typically compete?

For an off-patent drug, the risk shifts from “will generics enter?” to “which manufacturer will maintain supply and competitive pricing?”

Generic entry risk remains but is usually lower in the near term because:

  • Many generics already exist.
  • Regulatory and manufacturing line transitions are the main operational risks.
  • Shortages become the dominant variable.

Competitive landscape drivers

  • ANDA portfolio breadth across oral and injectable strengths.
  • Manufacturing capacity and site reliability.
  • FDA inspections and site qualification affecting continuity of supply.
  • Distribution relationships with wholesalers and GPOs.

How do FDA status and Orange Book listings affect Thorazine commercialization?

Thorazine’s commercialization is governed by the availability of approved generic equivalents rather than by brand exclusivity. On the FDA Orange Book, the operative concept is whether:

  • Brand listings still exist as reference.
  • Generic ANDA products are listed for relevant dosage forms and routes.
  • Any patents are still listed that could limit generic competition (rare for older actives).

Regulatory pathway reality

For chlorpromazine products, most supply is carried by ANDA-labeled generics. The practical market consequence is that regulatory milestones mainly affect:

  • Supply resumption after interruptions,
  • Site approval for manufacturing scale,
  • Labeling consistency for substitution policies.

What formulation or route-specific patents could affect Thorazine substitution?

Substitution risk can vary by:

  • Oral solution concentration and excipient systems (stability and dosing accuracy).
  • Injectable formulation compatibility (concentration, solvent system, and stability).
  • Manufacturing process that changes impurities or shelf life.

In practice, these are more likely to influence product availability and quality perception than pricing across the entire category.

Route-specific market behavior

  • Oral: stable category volume with price pressure.
  • Injectable: fewer competitive SKUs in some strengths can create short-term discontinuities.

How does Thorazine compare with newer antipsychotics on commercial trajectory and payer preference?

Newer antipsychotics (second-generation agents) typically dominate outpatient and long-term schizophrenia treatment due to tolerability and guideline preference. Thorazine’s commercial role tends to concentrate in:

  • Acute settings where immediate symptom control is prioritized.
  • Cost-driven formulary tiers.
  • Specific clinical use cases where clinicians prefer phenothiazines.

Commercial implication

Even if absolute demand remains, share shifts against newer agents reduce growth. Revenue is mostly limited to maintaining coverage for legacy use rather than expanding into high-growth segments.


What market dynamics explain Thorazine revenue volatility: supply constraints, tenders, and wholesaler pipeline?

Thorazine category revenue can show periodic volatility due to:

  • Wholesale destocking and restocking cycles.
  • Tender outcomes in institutional procurement (GPO contracts, state purchasing schedules).
  • Manufacturing outages at specific sites.
  • Shipping and allocation policies during shortages.

Because generics dominate, the revenue is distributed across labelers. The brand name “Thorazine” can be more sensitive to brand-retention dynamics in specific contracts than the molecule’s total market.


What is Thorazine’s financial trajectory: growth vs decline and what drives revenue per unit?

Directionally, Thorazine brand revenue trends are typically:

  • Downward/flat after generics establish sustained market share,
  • With episodic rebounds only when supply issues temporarily improve net pricing or reduce competition for certain presentations.

Core financial drivers

  • Net price per unit: compressed by generic undercutting and rebate/contract economics.
  • Volume: tied to substitution policies and prescribing practice for acute control.
  • Mix: oral vs injectable proportions, and strength-specific demand.

Key conclusion for forecasting

Revenue trajectory is best modeled as:

  • Baseline molecule demand (stable)
    minus
  • Brand share erosion (structural)
    plus
  • Occasional supply or contract-driven uplift (cyclical)

What patent litigation or settlements affect Thorazine, if any?

For widely available off-patent molecules like chlorpromazine, litigation risk typically concentrates on:

  • Narrow formulation or process claims (if asserted),
  • Method-of-use claims (less common for legacy antipsychotics),
  • Orange Book listing disputes (rare when patents are absent or non-blocking).

Market implication: litigation is less likely to be a primary driver of commercial trajectory for Thorazine compared with contract and supply factors.


Key takeaway: how to underwrite Thorazine’s commercial outlook

A credible commercial underwriting for Thorazine requires treating it as a generic-dominated legacy commodity within antipsychotic care, where:

  • pricing compression is structural,
  • volume is stable but not growing strongly,
  • brand-specific revenue depends on select contract retention and supply continuity.

Key Takeaways

  • Thorazine’s market is dominated by generic substitution, leaving brand revenue sensitive to contracting and supply stability, not exclusivity.
  • Pricing is structurally constrained by multiple ANDA-labeled equivalents; net price varies mainly with supply-demand and tender dynamics.
  • Injectable presentations can create short-term volatility due to narrower SKU availability and higher allocation risk.
  • Long-term demand persists due to acute-care and cost-driven prescribing, but share growth is limited versus newer antipsychotics.
  • Patent and litigation impacts are typically secondary for chlorpromazine; market dynamics are primarily operational and commercial.

FAQs

  1. Does Thorazine have any remaining exclusivity for specific dosage forms (oral solution vs injection)?
  2. How does Medicare Part D or Medicaid formulary positioning typically affect Thorazine brand vs generic uptake?
  3. What are the most common causes of Thorazine shortages, and how do they translate into net price changes?
  4. Can a generic supplier’s FDA manufacturing status materially change Thorazine category market share?
  5. How do clinician preferences for first-generation antipsychotics influence Thorazine prescribing during inpatient episodes?

References

No sources were provided in the prompt, and no in-text citations are included.

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