Last Updated: May 10, 2026

Probucol - Generic Drug Details


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

Probucol is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for probucol.

Summary for probucol
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 6
Raw Ingredient (Bulk) Api Vendors: 108
Clinical Trials: 21
DailyMed Link:probucol at DailyMed
Recent Clinical Trials for probucol

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

SponsorPhase
Beijing Tiantan HospitalPHASE3
First Affiliated Hospital of Wannan Medical CollegePHASE3
General Hospital of Shenyang Military RegionPhase 4

See all probucol clinical trials

Medical Subject Heading (MeSH) Categories for probucol

US Patents and Regulatory Information for probucol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us LORELCO probucol TABLET;ORAL 017535-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us LORELCO probucol TABLET;ORAL 017535-002 Jul 6, 1988 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

Expired US Patents for probucol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us LORELCO probucol TABLET;ORAL 017535-002 Jul 6, 1988 3,862,332 ⤷  Start Trial
Sanofi Aventis Us LORELCO probucol TABLET;ORAL 017535-001 Approved Prior to Jan 1, 1982 3,576,883 ⤷  Start Trial
Sanofi Aventis Us LORELCO probucol TABLET;ORAL 017535-001 Approved Prior to Jan 1, 1982 3,862,332 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

PROBUCOL: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What is the commercial footprint of PROBUCOL?

PROBUCOL (brand names include Lorelco and Lomir) is a small-molecule drug with a long commercialization history and a narrower contemporary market profile than modern biologics and single-asset blockbusters. Its commercial trajectory has been constrained by three structural factors: (1) limited modern label breadth outside its best-established indications, (2) generic competition in multiple geographies, and (3) specialty prescribing patterns that reduced mainstream adoption versus large-scale lipid therapies.

Market structure

  • Likely payer position: specialty and formulary-dependent, with treatment decisions tied to LDL lowering and vasculopathy endpoints in the context of historical use.
  • Competitive landscape: dominant chronic-disease leaders in dyslipidemia (statins, ezetimibe, PCSK9 inhibitors) have structural pricing and guideline alignment advantages versus a niche bile/antioxidant mechanism asset.
  • Supply chain effect: the presence of generics for mature brands typically compresses price and reduces revenue volatility resistance.

Demand characteristics

  • Indication-driven demand: PROBUCOL’s sustained demand is dependent on clinician preference, historical treatment continuity, and geographic label availability.
  • Low expansion optionality: Unlike late-cycle assets with broad label extensions, PROBUCOL’s market growth has historically depended more on maintenance of existing use than on new blockbuster indications.

How do drug-level market dynamics translate into revenue behavior?

PROBUCOL’s financial trajectory is best understood as a mature, commoditizing product: revenue grows slowly or stays flat, then declines with generic penetration and competitor-led guideline shifts. In mature pharma economics, this creates a characteristic pattern: price compression outpacing unit stability, with near-term volatility driven by reimbursement rules and country-level generic mix.

Core market dynamics affecting revenue

  1. Guideline gravity in lipid disorders
    • First-line dyslipidemia care has shifted toward guideline-dominant classes, which reduces incremental demand for older agents unless they retain unique patient positioning.
  2. Generic substitution and margin erosion
    • Generic entry typically reduces the branded revenue pool even when total treated population does not collapse.
  3. Specialty prescribing and inertia
    • Niche lipid-related use can persist but does not scale quickly, limiting upside.
  4. Regulatory and manufacturing continuity
    • Mature products remain exposed to supply constraints, import decisions, and periodic regulatory renewals, each affecting continuity of supply and stable contracting.

What that means for the revenue curve

  • Branded peak: historically occurred before broad statin-era guideline consolidation and before the current wave of modern lipid agents.
  • Post-patent phase: tends toward a plateau followed by a gradual decline as generics take share and branded pricing becomes non-viable on most payer tiers.
  • Modern era equilibrium: product revenue is more sensitive to geography and label status than to new patient cohorts.

What is the financial trajectory implied by PROBUCOL’s maturity profile?

A “mature-niche” asset typically shows three financial signatures over time:

1) Revenue declines are driven more by pricing than volume

  • Generic competition reduces branded price realization.
  • Even if absolute patient use is stable, revenue declines because contracted pricing benchmarks reset at lower levels.

2) Operating income becomes a function of lifecycle cost control

  • Older assets can maintain modest profitability if manufacturing economics remain favorable and inventory risk is controlled.
  • In commoditization periods, gross margin often falls faster than overhead, tightening operating leverage.

3) Investor relevance shifts from growth to value retention

  • For investors or R&D planners, the asset’s role shifts from “growth engine” to “cash flow maintenance” or “compassionate/special population continuity,” depending on geography.

Where does PROBUCOL sit versus modern lipid competitors?

In lipid management, PROBUCOL competes in the same clinical space as multiple high-adoption classes, even when it does not replicate the same decision framework.

Competitive positioning summary

  • Statins (dominant baseline therapy): guideline-aligned, high adherence, strong payer coverage.
  • Ezetimibe (add-on): broad payer acceptance for combination use.
  • PCSK9 inhibitors (high-cost add-ons): payer-specific criteria but strong efficacy-driven use.
  • PROBUCOL (older molecule): niche usage patterns and lower guideline centrality.

Practical consequence for market dynamics

PROBUCOL’s market is less about capturing new guideline-driven cohorts and more about retaining residual demand where clinicians value historical experience, specific patient profiles, or label-specific use in a given geography.

How has the landscape likely changed for PROBUCOL’s economics over time?

The broad market shifts that have reshaped PROBUCOL economics include:

  • Escalation of lipid-treatment efficacy expectations: modern therapies created a higher bar for both absolute LDL reduction and tolerability.
  • Reimbursement tightening: payer policies increasingly gate therapies by risk thresholds and evidence packages, which tends to disadvantage older products with narrower modern evidence bundles.
  • International divergence: PROBUCOL’s market outcome in any year is strongly dependent on whether it is still marketed, covered, and manufactured locally.

What is the likely revenue risk profile going forward?

A mature, generic-exposed product typically carries:

  • High pricing risk: driven by generic market share and reimbursement resets.
  • Moderate volume risk: depends on persistent niche prescribing rather than broad guideline mainstreaming.
  • Operational risk: supply continuity and regulatory changes can cause abrupt localized disruptions.
  • Low innovation-driven upside: unless PROBUCOL gains label expansion or a new differentiated clinical niche, revenue remains constrained.

Market and financial indicators to watch (board-level checklist)

Even when revenue is not publicly reported at a single-asset level for PROBUCOL, the following proxies track the market trajectory in practice:

Indicator What it reveals about PROBUCOL economics
Branded-to-generic share in top markets Pace of branded revenue erosion and margin compression
Reimbursement tiering and prior authorization rules Coverage depth and net price realization
Net price vs wholesale price spread Real-world payer and contracting pressure
Import and local manufacturing availability Supply stability that affects sell-through
Prescribing prevalence in lipid clinics Volume stability and continuity of niche use
Margin trend for generic equivalents Industry pricing pressure and competitive intensity

Key Takeaways

  • PROBUCOL is a mature, niche lipid-related asset with market dynamics dominated by generic competition and guideline displacement rather than growth-driven uptake.
  • Its financial trajectory should follow a classic commoditization pattern: branded pricing compression drives most revenue decline, with volume stability constrained by specialty prescribing inertia.
  • Competitive pressure from guideline-dominant lipid therapies limits incremental market expansion and keeps upside dependent on geography-specific label and payer behavior.
  • Going forward, PROBUCOL’s risk profile is mainly price and reimbursement risk, with moderate dependence on supply continuity and niche prescribing persistence.

FAQs

  1. Is PROBUCOL a growth asset in current lipid markets?
    It behaves like a mature, niche product where incremental growth is structurally constrained by guideline centrality of newer lipid classes.

  2. What is the biggest driver of PROBUCOL revenue changes?
    Generic competition and reimbursement contracting typically drive price compression faster than any change in treated volume.

  3. Does PROBUCOL’s market size depend more on efficacy or coverage?
    For a mature product, coverage and payer rules determine realized net price and market access more than incremental efficacy perception alone.

  4. How do modern lipid competitors affect PROBUCOL’s trajectory?
    Statins, ezetimibe, and PCSK9 inhibitors capture the mainstream dyslipidemia decision path, reducing incremental demand for older agents.

  5. What operational factor most affects sell-through?
    Supply continuity and distribution stability matter because niche products can lose contracts or continuity if availability disrupts.


References

[1] FDA. Drug Approval Reports / Product Information for Lorelco (probu col), if applicable. U.S. Food and Drug Administration.
[2] EMA. European Medicines Agency product information and EPAR/legacy references for probucol-containing medicinal products. European Medicines Agency.
[3] WHO. WHO Model List of Essential Medicines and related historical context for probucol usage, where referenced. World Health Organization.
[4] DrugBank. Probucol (small molecule) product and indication summary. DrugBank Online.
[5] Company and market authorization records for probucol brands (e.g., Lorelco, Lomir) in key jurisdictions, including national regulatory databases.

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