CLOFIBRATE Drug Patent Profile

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When do Clofibrate patents expire, and what generic alternatives are available?

Clofibrate is a drug marketed by Banner Pharmacaps, Sandoz, Teva, Usl Pharma, and Watson Labs. and is included in five NDAs.

The generic ingredient in CLOFIBRATE is clofibrate. There is one drug master file entry for this compound. Additional details are available on the clofibrate profile page.

Summary for CLOFIBRATE

US Patents:	0
Applicants:	5
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	9
DailyMed Link:	CLOFIBRATE at DailyMed

Recent Clinical Trials for CLOFIBRATE

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

Sponsor	Phase
Ain Shams University	PHASE4
Instituto Nacional de Salud Publica, Mexico	Phase 3
Laboratorios Grossman, S.A.	Phase 3

See all CLOFIBRATE clinical trials

Medical Subject Heading (MeSH) Categories for CLOFIBRATE

Anticholesteremic Agents

Hypolipidemic Agents

Anatomical Therapeutic Chemical (ATC) Classes for CLOFIBRATE

C10AB	Fibrates
C10A	LIPID MODIFYING AGENTS, PLAIN
C10	LIPID MODIFYING AGENTS
C	Cardiovascular system

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
Banner Pharmacaps	CLOFIBRATE	clofibrate	CAPSULE;ORAL	073396-001	Mar 20, 1992		DISCN	No	No
Usl Pharma	CLOFIBRATE	clofibrate	CAPSULE;ORAL	070531-001	Jun 16, 1986		DISCN	No	No
Sandoz	CLOFIBRATE	clofibrate	CAPSULE;ORAL	072191-001	May 2, 1988		DISCN	No	No

Clofibrate Market Dynamics and Financial Trajectory

Last updated: November 7, 2026

Clofibrate is a legacy fibrate lipid-lowering drug with no meaningful current commercial market in major regulated jurisdictions. Its financial trajectory followed a sharp rise in the 1960s, loss of clinical confidence after large cardiovascular trials, withdrawal or discontinuation across major markets, and replacement by safer and more effective lipid therapies. Clofibrate has no current U.S. exclusivity, no material Orange Book position, and no credible basis for a modern revenue forecast.

What is clofibrate and how was it used?

Clofibrate is an oral fibric-acid derivative that lowers serum triglycerides and cholesterol by activating pathways associated with lipid metabolism. It was developed before the modern statin era and marketed internationally under names including Atromid-S, Arteroclor and Lipavlon.

The drug was used primarily for:

• Hypertriglyceridemia
• Mixed dyslipidemia
• Hypercholesterolemia
• Certain rare lipid disorders before more selective treatments became available

Clofibrate was one of the first widely used fibrates. Its commercial positioning depended on its ability to reduce serum lipid measurements at a time when treatment options were limited.

The drug’s limitations included gastrointestinal adverse effects, gallstone risk, liver and muscle toxicity concerns, and an unfavorable long-term clinical benefit-risk profile. Later fibrates, including gemfibrozil and fenofibrate, achieved greater commercial acceptance because of improved positioning, dosing, tolerability or evidence packages.

When did clofibrate lose market exclusivity?

Clofibrate lost practical market exclusivity decades ago. Its original patent and regulatory exclusivity periods expired long before the current pharmaceutical market framework became relevant.

Market factor	Clofibrate status
Original innovation period	1950s and early 1960s
U.S. commercial period	Primarily 1960s through later 20th century
Current U.S. exclusivity	None
Current Orange Book exclusivity	None identified
Active branded franchise	None of commercial significance
Generic availability	Historically available in multiple countries
Current major-market status	Discontinued, withdrawn or commercially obsolete in many markets

Clofibrate does not have a surviving patent-based revenue protection strategy. Any remaining commercial use would depend on local registration, manufacturing economics and clinical acceptance rather than intellectual-property exclusivity.

What FDA regulatory status does clofibrate have?

Clofibrate has no material current FDA commercial position. The drug is generally regarded as a discontinued or obsolete lipid-lowering therapy in the United States.

Its regulatory history reflects the transition from surrogate lipid endpoints to cardiovascular-outcome evidence. Although clofibrate lowered serum cholesterol, the WHO Cooperative Trial found no meaningful reduction in coronary mortality and reported an increase in noncardiovascular mortality among treated participants. The findings materially weakened the case for continued broad use.[1]

The drug’s U.S. regulatory relevance is therefore historical:

1. It was marketed before modern statins.
2. It became associated with unfavorable long-term outcome data.
3. It lost clinical share to newer lipid-lowering drugs.
4. It has no current branded U.S. growth platform.

What did the major clofibrate clinical trials show?

The principal commercial damage came from outcome evidence rather than from patent expiration alone.

WHO Cooperative Trial

The World Health Organization conducted a large primary-prevention study involving middle-aged men with elevated serum cholesterol. Clofibrate reduced serum cholesterol but did not produce the expected reduction in coronary mortality. The trial also reported excess noncoronary mortality in the treatment group.[1]

The result exposed a critical weakness in the early lipid-lowering market: biochemical improvement did not necessarily translate into better survival.

Coronary Drug Project

The Coronary Drug Project evaluated several lipid-lowering agents in men with prior myocardial infarction. Clofibrate did not establish a compelling long-term cardiovascular benefit that could support continued broad use.[2]

Commercial implication

These trials changed the basis of competition. Physicians, regulators and payers increasingly demanded evidence of reduced cardiovascular events, not merely lower cholesterol readings. Clofibrate could not compete effectively once statins demonstrated stronger outcome data and better market access.

How did clofibrate compare with later fibrates?

Clofibrate was commercially displaced by later fibrates and then by statins.

Drug	Drug class	Main commercial advantage over clofibrate	Current market position
Clofibrate	First-generation fibrate	Early lipid-lowering availability	Obsolete or discontinued in many markets
Gemfibrozil	Fibrate	Stronger modern clinical positioning and established generic supply	Generic, limited by interaction concerns
Fenofibrate	Fibrate	Broad triglyceride and mixed-dyslipidemia use; multiple formulations	Generic and commercially active
Statins	HMG-CoA reductase inhibitors	Strong cardiovascular-outcome evidence and broad guideline adoption	Large global generic market
Ezetimibe	Cholesterol absorption inhibitor	LDL reduction with statin-combination use	Generic and active
PCSK9 inhibitors	Biologic lipid-lowering agents	High-potency LDL reduction for selected patients	Branded and specialty-market products

The key comparison is not price. Clofibrate became commercially irrelevant because it lost on clinical evidence, therapeutic positioning and physician confidence.

What was the financial trajectory of clofibrate?

Clofibrate’s financial trajectory can be divided into four stages.

1. Early adoption and market formation

During the 1960s, clofibrate benefited from limited competition and rising interest in treating hypercholesterolemia. The product addressed a growing medical concern with few established alternatives.

Revenue growth was driven by:

• Broad prescribing for elevated cholesterol
• Limited competition
• Physician interest in preventive lipid therapy
• Commercial availability through established pharmaceutical companies

Public financial reporting from the period did not consistently isolate clofibrate sales by product, geography or formulation. A reliable global peak-revenue figure is therefore not established.

2. Evidence-driven slowdown

The WHO and Coronary Drug Project findings weakened demand. The product’s ability to lower cholesterol no longer provided sufficient commercial support when outcome evidence failed to demonstrate a favorable benefit.

Prescribing declined as physicians shifted toward therapies with stronger cardiovascular data.

3. Generic erosion and portfolio deprioritization

Once patent protection expired, clofibrate became exposed to generic competition. The resulting price erosion was compounded by declining demand. Manufacturers had little incentive to maintain large branded sales organizations for a product with deteriorating clinical relevance.

Commercial decline likely reflected three simultaneous forces:

• Loss of exclusivity
• Reduced prescription volume
• Therapeutic substitution

4. Market exit and residual use

By the late 20th century, clofibrate had largely disappeared from mainstream lipid management in major pharmaceutical markets. Any remaining sales were likely concentrated in small geographic markets, legacy registrations or low-volume generic channels.

There is no credible basis for treating clofibrate as a current growth product. Its financial value is historical rather than prospective.

How many patents protect clofibrate?

No active patent estate materially protects clofibrate as a current commercial product.

The relevant intellectual-property position is:

Patent category	Current commercial relevance
Composition-of-matter patents	Expired
Original formulation patents	Expired
Manufacturing patents	Expired or commercially immaterial
Method-of-use patents	No material current exclusivity identified
Combination patents	No material current clofibrate franchise identified
Regulatory exclusivity	None
Orange Book-listed protection	None of commercial significance

Clofibrate was developed several decades ago. Any original compound, formulation and manufacturing patents would have expired under the patent terms applicable to their filing periods.

What formulations are protected by clofibrate patents?

Historical clofibrate products were generally oral formulations, including capsules and tablets. No current formulation patent appears to create a commercially meaningful barrier.

Potential historical formulation categories included:

• Immediate-release oral dosage forms
• Solid oral capsules
• Tablet presentations
• Legacy brand-specific excipient systems

These formulation distinctions do not support a modern exclusivity strategy. A generic manufacturer would face regulatory, quality and manufacturing requirements, but not a meaningful patent barrier in the ordinary course.

Are there method-of-use patents for clofibrate?

No commercially significant active method-of-use exclusivity is associated with clofibrate in the current market.

Historical use centered on dyslipidemia and hyperlipidemia. Those indications are broad, longstanding and unsuitable as a durable patent moat today. Any surviving claims would also face substantial validity, written-description, enablement and obviousness issues because of the drug’s age and extensive public clinical record.

Which companies challenged clofibrate patents?

No current Paragraph IV litigation landscape exists for clofibrate. The drug is too old to support a meaningful modern U.S. abbreviated-new-drug-application patent challenge.

Paragraph IV status

A Paragraph IV certification is relevant when an ANDA applicant challenges patents listed for an approved reference drug. Clofibrate has no active branded Orange Book strategy comparable to modern products.

Litigation issue	Clofibrate status
Active Orange Book patents	None of significance
Recent Paragraph IV filings	None of significance
Active patent litigation	None of significance
Patent settlements	No material current settlements identified
Generic launch blocking strategy	None

Historical competition was governed primarily by patent expiry, product discontinuation and clinical substitution rather than by contemporary Hatch-Waxman litigation.

What generic entry risks exist for clofibrate?

Generic entry risk is effectively complete because the product has no meaningful remaining exclusivity. The commercial constraint is demand, not access.

A manufacturer evaluating clofibrate would need to consider:

• Whether the product remains registered in the target jurisdiction
• Availability of an approved reference product
• Current pharmacopoeial and bioequivalence requirements
• Supply of active pharmaceutical ingredient
• Pharmacovigilance obligations
• Reimbursement and prescribing restrictions
• Physician acceptance
• Competition from fenofibrate, gemfibrozil and statins

The principal risk is that a successful regulatory filing would not generate sufficient volume to justify manufacturing, distribution and compliance costs.

What manufacturing and supply-chain barriers affect clofibrate?

Clofibrate does not appear to face a significant intellectual-property manufacturing barrier. The more relevant obstacles are commercial and regulatory.

Active pharmaceutical ingredient

The API is a mature small molecule, so chemical synthesis is unlikely to present a fundamental technical barrier. However, demand is probably too limited to support a broad supplier base.

Quality control

A manufacturer would need to manage:

• API purity
• Residual solvents
• Impurity specifications
• Content uniformity
• Dissolution performance
• Stability
• Batch-to-batch consistency

Regulatory maintenance

In markets where the product remains registered, the sponsor may need to maintain legacy technical files, manufacturing-site compliance and pharmacovigilance systems. These fixed costs can exceed the value of a low-volume generic product.

What licensing deals involve clofibrate?

No current high-value licensing transaction or active strategic alliance is associated with clofibrate.

Historical commercialization likely involved branded distribution and regional marketing arrangements, but those arrangements do not represent a current asset class. Clofibrate lacks the characteristics that usually support modern licensing:

• No patent runway
• No differentiated formulation
• No active clinical-development program
• No specialty indication with pricing power
• No biologic manufacturing platform
• No credible regulatory expansion opportunity

A transaction involving clofibrate today would more likely concern a legacy registration, dormant brand, regional product file or generic supply arrangement than an innovative pharmaceutical license.

What patent litigation affects clofibrate?

No material current patent litigation affects clofibrate. The product has no active litigation profile comparable to protected branded drugs such as PCSK9 inhibitors, anticoagulants or oncology medicines.

The historical disputes most relevant to clofibrate were commercial and regulatory rather than patent-centered:

• Product discontinuation
• Market withdrawal
• Clinical safety concerns
• Substitution by newer therapies
• Generic erosion

Is clofibrate a biosimilar risk?

No. Clofibrate is a chemically synthesized small molecule, not a biologic. Biosimilar regulation does not apply.

The relevant competitive categories are:

• Generic clofibrate
• Other fibrates
• Statins
• Ezetimibe
• Prescription omega-3 products
• PCSK9 inhibitors
• Lifestyle and dietary interventions

Any residual clofibrate demand is therefore exposed to conventional generic and therapeutic substitution risk rather than biosimilar competition.

How does clofibrate compare with fenofibrate and gemfibrozil?

Fenofibrate and gemfibrozil have stronger residual commercial positions because they remain recognized options for hypertriglyceridemia and mixed dyslipidemia.

Commercial metric	Clofibrate	Gemfibrozil	Fenofibrate
Current clinical use	Minimal	Established but selective	Established and broader
Generic availability	Historical or limited	Broad	Broad
Cardiovascular positioning	Weak	Limited by evidence and interactions	Used mainly for triglyceride management
Statin-combination suitability	Poor	Significant interaction concerns	More commonly used
Patent value	None	None of significance	Mostly expired
Revenue potential	Negligible	Mature generic	Mature generic

Clofibrate’s commercial failure was not caused solely by cheaper generics. It was displaced by better-positioned therapies with stronger clinical and regulatory support.

What is the revenue exposure from clofibrate today?

Current revenue exposure is negligible for major pharmaceutical companies. Clofibrate is not a meaningful contributor to the financial results of leading drug manufacturers.

The economic profile is best described as:

• No material branded revenue
• No meaningful royalty stream
• No active exclusivity premium
• Low potential gross margin at scale
• High relative regulatory overhead for small-volume sales
• Minimal strategic value in large pharmaceutical portfolios

There is no defensible basis for projecting significant future revenue growth without a new clinical indication, reformulation or regulatory repositioning. Such a strategy would require new evidence and investment disproportionate to the drug’s current market status.

What is the geographic coverage of clofibrate?

Clofibrate’s historical geographic footprint was international, particularly in markets where fibrates were used before statin therapy became dominant. Its current geographic presence is fragmented and likely limited to jurisdictions retaining legacy approvals or local generic supply.

The commercial outlook differs by region:

Region	Current outlook
United States	No meaningful commercial opportunity
European Union	Broadly obsolete relative to modern lipid therapies
Japan	Limited relevance; local lipid-treatment standards dominate
Emerging markets	Possible legacy or low-cost use, but demand is uncertain
Low-regulation markets	Potential availability without material brand value

Geographic fragmentation does not create a patent opportunity. It creates regulatory-maintenance costs and uncertain demand.

What is the investment outlook for clofibrate?

Clofibrate is not an attractive conventional pharmaceutical investment. The product has no patent runway, no meaningful current exclusivity and no identifiable growth driver.

The only plausible value sources are narrow:

1. Acquisition of a legacy registration in a low-cost market.
2. Contract manufacturing for a small regional product.
3. Portfolio rationalization involving an existing generic infrastructure.
4. Historical data or clinical knowledge relevant to lipid-drug development.

For commercial investors, clofibrate is a declining or dormant asset rather than a growth platform. For generic manufacturers, the product may be technically simple but economically unattractive unless manufacturing and distribution costs are exceptionally low.

Key Takeaways

• Clofibrate is a first-generation fibrate with no meaningful current U.S. commercial position.
• Its original patent and regulatory exclusivity expired decades ago.
• No material active Orange Book patents, Paragraph IV disputes or current patent settlements define the product.
• The WHO Cooperative Trial and other outcome evidence damaged the drug’s clinical and commercial position.
• Statins, fenofibrate and gemfibrozil displaced clofibrate in mainstream lipid management.
• Current revenue is negligible or unreported at major-company scale.
• Generic manufacturing is technically feasible, but limited demand and regulatory overhead weaken the business case.
• Clofibrate has no biosimilar risk because it is a small-molecule drug.
• The asset has historical pharmaceutical importance but little current strategic or financial value.

FAQs About Clofibrate Market Value and Exclusivity

Is clofibrate still prescribed?

Clofibrate is rarely prescribed in major regulated markets. Modern lipid management generally favors statins and, where appropriate, newer fibrates or other lipid-lowering agents.

Does clofibrate have an active U.S. patent?

No material active U.S. patent protects clofibrate as a commercial product. Any original composition, formulation and manufacturing patents expired long ago.

Can a company launch a generic clofibrate product?

A company could potentially pursue a local generic or legacy registration where regulatory requirements are satisfied. The main obstacle is weak commercial demand rather than patent protection.

Why did clofibrate fail commercially despite lowering cholesterol?

Clinical trials showed that reducing serum cholesterol did not deliver the expected reduction in coronary mortality and raised concerns about noncardiovascular mortality. Physicians subsequently favored therapies with stronger cardiovascular-outcome evidence.

Is clofibrate more profitable than fenofibrate?

No. Fenofibrate has substantially stronger current market relevance. Clofibrate has little meaningful revenue potential, while fenofibrate remains available as a generic therapy for selected patients with elevated triglycerides or mixed dyslipidemia.

References

1. World Health Organization Cooperative Trial Committee. (1978). Clofibrate and mortality: A randomized trial in men with hypercholesterolemia. The Lancet, 2(8105), 379-385.

2. Coronary Drug Project Research Group. (1975). Clofibrate and niacin in coronary heart disease. JAMA, 231(4), 360-381.

3. National Heart, Lung, and Blood Institute. (1976). The Coronary Drug Project: Findings leading to discontinuation of the clofibrate arm. U.S. Department of Health and Human Services.

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.

5. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. FDA.

6. Goodman, L. S., Brunton, L. L., Chabner, B., & Knollmann, B. C. (Eds.). (2011). Goodman & Gilman’s the pharmacological basis of therapeutics (12th ed.). McGraw-Hill.