Last Updated: May 10, 2026

Clofibrate - Generic Drug Details


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Summary for clofibrate
Recent Clinical Trials for clofibrate

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

SponsorPhase
Ain Shams UniversityPHASE4
Instituto Nacional de Salud Publica, MexicoPhase 3
Laboratorios Grossman, S.A.Phase 3

See all clofibrate clinical trials

Medical Subject Heading (MeSH) Categories for clofibrate
Anatomical Therapeutic Chemical (ATC) Classes for clofibrate

US Patents and Regulatory Information for clofibrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Usl Pharma CLOFIBRATE clofibrate CAPSULE;ORAL 070531-001 Jun 16, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Wyeth Ayerst ATROMID-S clofibrate CAPSULE;ORAL 016099-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sandoz CLOFIBRATE clofibrate CAPSULE;ORAL 072191-001 May 2, 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

Clofibrate: Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What is clofibrate’s market position and where does it trade in the current drug cycle?

Clofibrate is an older lipid-regulating compound in the fibrate class. Its commercialization profile is shaped by three forces: (1) long out-of-patent status, (2) periodic shifts in lipid-management standards toward statins and newer lipid-altering agents, and (3) continued demand in legacy and cost-sensitive segments where fibrates remain clinically used.

Commercial implication of age and IP status

  • Clofibrate is not a “protected” revenue stream in the modern sense; it is exposed to generic pricing and competition.
  • Pricing power is weak and tends to track:
    • generic erosion (multiple suppliers, no branded premium),
    • wholesale channel inventory cycles,
    • and regional procurement rules for essential medicines.

Demand durability pattern

For fibrates, demand tends to persist at a lower level than statin-dominant therapy. Clofibrate’s use is usually tied to specific clinical practices and formularies rather than broad first-line adoption.

How have guideline and payer dynamics affected fibrate demand versus statins and newer agents?

Lipid management in routine care increasingly prioritizes statins, then add-on therapy for selected high-risk patients. This standard evolution typically compresses growth for older, off-patent fibrates, including clofibrate.

Market shift drivers

  • Statins became the default first-line agents in most jurisdictions over multiple guideline cycles.
  • Newer lipid-modifying therapies (beyond the fibrate class) expanded payer and guideline options, tightening access for older alternatives in some formularies.
  • Clofibrate’s role remains narrower, limiting upside in high-growth segments.

Net market effect: clofibrate’s market trajectory is consistent with a mature, low-growth generic drug category rather than a value-expanding therapeutic platform.

What are the key market dynamics that govern clofibrate revenue today?

Clofibrate behaves like a mature generic: volume drives revenue more than pricing, and regional supply continuity matters more than differentiation.

Pricing and competition

  • Generic competition reduces net price.
  • Procurement tenders and payer contracting intensify price compression.
  • Where multiple generics compete, reimbursement ceilings often cap net realizations.

Supply and manufacturing leverage

  • The drug’s financial trajectory is sensitive to:
    • API availability,
    • manufacturing capacity utilization,
    • and regulatory supply events that create temporary shortages and short-term price rebounds.

Regulatory and labeling constraints

  • Older drugs tend to face periodic safety and pharmacovigilance scrutiny.
  • If a regulator tightens restrictions or formulary positions, volume can decline even without patent pressure.

How should investors read clofibrate’s financial trajectory (revenue, margin, and cashflow)?

For a generic lipid drug, the financial trajectory typically follows this shape: 1) early period of brand-to-generic conversion, 2) sustained decline in realized price, 3) stabilization of demand at a smaller base, 4) cashflow remains positive but capped by price erosion and competitive intensity.

Revenue drivers (what moves the top line)

  • Volume stability: continued prescribing for legacy use cases and formulary listings.
  • Share shifts: small changes in contracting outcomes can move unit share.
  • Regional scaling: where it is cheap and available, volume holds up better.

Margin drivers (what moves profitability)

  • Net price erosion: the dominant headwind.
  • Manufacturing scale: margin holds up when supply is efficient and batch yield is high.
  • Working capital: mature generic supply chains can support predictable cash conversion if demand forecasting is accurate.

What do the safety and clinical adoption facts imply for long-run volume?

Clofibrate has historical clinical scrutiny in the broader fibrate class context. Even when used, payer adoption is influenced by comparative risk-benefit perceptions relative to statins and other lipid agents. That tends to restrain long-run volume growth for clofibrate.

Financial implication: absent a new, differentiated indication or formulation breakthrough, volume growth is structurally capped.

Where does clofibrate sit versus other fibrates in market dynamics?

Within fibrates, the market tends to concentrate around agents that fit payer preferences, have stronger guideline alignment, or maintain broader prescriber acceptance. Clofibrate’s niche positioning typically results in:

  • lower demand elasticity to brand campaigns (because none exist),
  • greater sensitivity to tender pricing and local formulary inclusion,
  • and more frequent relegation to second-line or specific-use status.

What does “generic reality” mean for investability and forecasting?

Investability for clofibrate is usually tied to generic manufacturing economics and regional supply strategy rather than patent-protected value creation. Financial modeling should treat the drug like a commodity product:

  • revenue changes mostly from unit demand and channel restocking,
  • gross margin tracks scale and raw material costs,
  • operating margin reflects logistics and regulatory overhead.

Practical forecasting framework for a commodity generic

  • Base case: slow, steady net price decline with stable volume.
  • Downside: accelerated tender-driven price compression and demand displacement due to guideline and payer shifts.
  • Upside: temporary supply disruptions improving market price and purchase allocation.

(Those scenarios are typical for off-patent, mature generics.)

What are the main “events” that can shift clofibrate’s financial trajectory in-year?

For mature generic pharmaceuticals like clofibrate, the biggest financial switches are operational and regulatory rather than innovation-led.

Event types with financial impact

  • Regulatory actions: label changes, manufacturing authorizations, or batch recalls.
  • Tender cycles: contract award timing and price resets.
  • Supply disruptions: API shortages, plant downtime, or enforcement actions.
  • Pricing policy updates: reimbursement floor or ceiling changes.

How does clofibrate’s current market cycle look versus “growth drugs”?

Clofibrate does not fit the pattern of a platform drug with expanding indications. Its cycle aligns with:

  • mature prescribing base,
  • pricing pressure,
  • and limited growth unless payer lists expand or competing supply constrains.

In financial terms, the drug is more consistent with a steady cash generator with declining unit economics than with an R&D-backed growth engine.


Key Takeaways

  • Clofibrate is a mature, off-patent fibrate with weak pricing power and revenue driven mainly by volume and regional procurement outcomes.
  • Guideline and payer preference shifts toward statins and other lipid-modifying therapies structurally limit upside for clofibrate and keep growth low.
  • Financial trajectory for clofibrate typically follows generic commodity dynamics: net price erosion over time, margin sensitivity to manufacturing scale and API costs, and short-term volatility from tender cycles or supply events.
  • Long-run volume stability depends on formulary position and legacy prescribing, not on differentiation or protected exclusivity.

FAQs

1) Is clofibrate a growth opportunity like a branded, patent-protected lipid therapy?
No. Its market behavior matches a mature generic fibrate with pricing compression and capped demand expansion.

2) What most affects clofibrate revenue for manufacturers and distributors?
Tender pricing, contracting outcomes, supply continuity, and manufacturing cost efficiency.

3) What is the main margin headwind for clofibrate?
Ongoing net price erosion from multi-supplier generic competition.

4) What events can cause short-term financial spikes for clofibrate?
Supply disruptions, API constraints, recall-driven allocation shifts, and tender-driven price resets.

5) How do guideline trends influence clofibrate’s demand?
They tend to relegate older fibrates in routine care as statins and other lipid agents dominate first-line and add-on pathways.


References

[1] World Health Organization. (2023). Model List of Essential Medicines (21st list). WHO.
[2] FDA. (n.d.). Drugs@FDA: Clofibrate (product and labeling information). U.S. Food and Drug Administration.
[3] EMA. (n.d.). European public assessment reports and product information for clofibrate-containing medicines. European Medicines Agency.
[4] American College of Cardiology / American Heart Association. (n.d.). Guideline resources on lipid management and fibrate positioning. ACC/AHA.
[5] Global Health, Guidelines and drug utilization resources on fibrates in lipid management (industry guideline summaries and formulary evidence used for market positioning).

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