List of Excipients in Branded Drug FENOGLIDE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Shore Therapeutics Inc	FENOGLIDE	fenofibrate	52725-490	LACTOSE MONOHYDRATE
Shore Therapeutics Inc	FENOGLIDE	fenofibrate	52725-490	MAGNESIUM STEARATE
Shore Therapeutics Inc	FENOGLIDE	fenofibrate	52725-490	POLOXAMER 188
Shore Therapeutics Inc	FENOGLIDE	fenofibrate	52725-490	POLYETHYLENE GLYCOL 6000
Physicians Total Care Inc	FENOGLIDE	fenofibrate	54868-6118	LACTOSE MONOHYDRATE
Physicians Total Care Inc	FENOGLIDE	fenofibrate	54868-6118	MAGNESIUM STEARATE

Fenoglide Excipient Strategy and Commercial Opportunities for Fenofibrate

Last updated: August 7, 2026

Fenoglide is an immediate-release fenofibrate tablet developed to improve the oral performance of a poorly water-soluble lipid-lowering drug. Its core formulation strategy uses micronized fenofibrate with wetting, disintegration, binding, flow, and lubrication excipients. The largest commercial opportunities are in lower-cost generic substitution, food-independent dosing, differentiated bioequivalence, combination products, and lifecycle formulations that address tolerability, adherence, or administration burden.

What is Fenoglide and how does its formulation work?

Fenoglide contains micronized fenofibrate in 40 mg and 120 mg immediate-release tablets. The product is designed for oral administration without regard to meals, distinguishing it from older fenofibrate products whose absorption depended more heavily on dietary fat [1].

Fenofibrate is a highly lipophilic drug with low aqueous solubility. Its absorption depends on particle size, wetting, dispersion, dissolution, and gastrointestinal conditions. Micronization increases surface area and can improve dissolution, but particle-size reduction alone does not eliminate formulation risk. The excipient system must maintain uniform distribution of the hydrophobic active ingredient and promote rapid wetting and tablet disintegration.

Fenofibrate is hydrolyzed to fenofibric acid, the pharmacologically active moiety. It is used primarily for hypertriglyceridemia and mixed dyslipidemia. Treatment is generally combined with diet and may be used with statins when clinically appropriate [1].

Fenoglide product profile

Attribute	Fenoglide profile
Active ingredient	Fenofibrate
Dosage form	Immediate-release tablet
Strengths	40 mg and 120 mg
Primary formulation approach	Micronized fenofibrate
Administration	Without regard to meals, according to labeling
Therapeutic category	Lipid-modifying agent
Active metabolite	Fenofibric acid
Main formulation challenge	Low aqueous solubility and hydrophobicity
Primary competitive set	Generic fenofibrate tablets, capsules, and other micronized or engineered formulations

What excipients are used in Fenoglide tablets?

Fenoglide’s listed inactive ingredients include colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, and sodium starch glycolate [1].

The excipient architecture has distinct functional roles:

Excipient	Likely formulation function
Colloidal silicon dioxide	Glidant and moisture-control aid; improves powder flow
Crospovidone	Superdisintegrant; promotes rapid tablet breakup
Lactose monohydrate	Diluent and bulk-forming excipient
Magnesium stearate	Lubricant for tablet compression and ejection
Microcrystalline cellulose	Diluent, dry binder, and compression aid
Povidone	Binder that improves granule or tablet strength
Sodium lauryl sulfate	Surfactant and wetting agent for hydrophobic fenofibrate
Sodium starch glycolate	Superdisintegrant that supports water uptake and tablet breakup

The most strategically important excipients are sodium lauryl sulfate, crospovidone, sodium starch glycolate, microcrystalline cellulose, and povidone. These materials collectively address the main risks created by a hydrophobic, micronized drug: poor wetting, agglomeration, low bulk density, weak flow, and incomplete tablet disintegration.

Why is sodium lauryl sulfate important in Fenoglide?

Sodium lauryl sulfate is likely the principal wetting aid in the Fenoglide excipient system. Hydrophobic drug particles can resist water penetration and form aggregates during manufacture or dissolution. A surfactant lowers interfacial tension and supports more uniform wetting.

For a fenofibrate generic, sodium lauryl sulfate can improve dissolution performance, but it also creates development and regulatory risks:

• Excessive levels can affect dissolution through micellar solubilization.
• Surfactant concentration can alter bioavailability and food-effect behavior.
• Sodium lauryl sulfate may interact with other excipients or processing conditions.
• It can create sensitivity concerns for patients with gastrointestinal intolerance.
• Its use can complicate attempts to establish formulation sameness with a reference product.

A generic sponsor should not assume that reproducing the same excipient name will reproduce the same performance. Grade, particle size, residual moisture, supplier, blending order, and compression force can materially affect dissolution.

How do the disintegrants support Fenoglide performance?

Fenoglide uses both crospovidone and sodium starch glycolate. The combination can provide complementary disintegration mechanisms.

Crospovidone promotes rapid liquid uptake and wicking. Sodium starch glycolate hydrates and expands, producing tablet breakup. The combination can help compensate for the hydrophobic character of micronized fenofibrate and the compacting effect of compression.

The commercial advantage is a relatively simple immediate-release platform. The technical risk is over-disintegration or excessive sensitivity to lubricant and compression conditions. High magnesium stearate levels, prolonged lubrication, or excessive compaction can reduce wetting and delay dissolution.

A development program should control:

1. Fenofibrate particle-size distribution.
2. Surfactant concentration and distribution.
3. Disintegrant grade and swelling capacity.
4. Lubrication time.
5. Tablet porosity and hardness.
6. Dissolution across pH conditions.
7. Stability under humidity exposure.

What formulation patents protect Fenoglide?

Fenoglide’s principal product differentiation is formulation-based rather than based on a new chemical entity. The relevant intellectual-property categories include micronized fenofibrate compositions, dissolution-enhancing formulations, dosage forms with reduced food effect, and methods of treating dyslipidemia.

FDA labeling does not provide a complete patent-history analysis. A commercial patent review must distinguish among:

IP category	Relevance to Fenoglide
Compound patents	Limited relevance because fenofibrate is an established active ingredient
Micronized-drug patents	Potentially relevant to particle-size and dissolution architecture
Excipient-combination patents	May cover specific surfactant, binder, and disintegrant combinations
Dosage-form patents	May cover tablets, capsules, coatings, or release profiles
Method-of-use patents	May cover treatment of hypertriglyceridemia or mixed dyslipidemia
Manufacturing patents	May cover milling, blending, granulation, or particle engineering
Regulatory exclusivity	Separate from patent protection and generally limited for an established small molecule

Fenofibrate products have historically faced extensive generic competition. The practical barrier for a new entrant is therefore more likely to be formulation development, bioequivalence, manufacturing economics, and channel access than broad compound-level exclusivity.

When does Fenoglide lose exclusivity?

Fenoglide is not protected by the type of long remaining new chemical entity exclusivity associated with a recently approved drug. The product’s commercial protection depends on the status of formulation and method-of-use patents, FDA exclusivity, trademarks, and the ability of generic applicants to obtain approval.

A Paragraph IV applicant may challenge listed patents by asserting that the patents are invalid, unenforceable, or not infringed. A generic applicant may also use other pathways when it can avoid certification against patents that no longer block approval.

The key regulatory distinction is:

• Patent expiration controls whether a patent-based launch barrier remains.
• FDA exclusivity can delay approval independently of patent expiration.
• Orange Book listing determines which patents an applicant must address in an ANDA certification.
• A discontinued product may remain relevant to patent history and reference-product analysis even if commercial sales have declined [2].

Because fenofibrate has multiple approved dosage forms and manufacturers, patent analysis must be conducted by product, strength, dosage form, applicant, and listed patent. A conclusion based only on the active ingredient is unreliable.

What is the Orange Book status of Fenoglide?

The Orange Book is the principal FDA source for approved drug products, therapeutic-equivalence evaluations, patent listings, and exclusivity information [2]. Fenoglide should be reviewed by its specific application number and product presentation rather than by a general search for “fenofibrate.”

The commercial questions are:

• Is the relevant Fenoglide application active, discontinued, or moved to a discontinued section?
• Which patents, if any, are listed against the application?
• Are the listed patents drug-substance, drug-product, or method-of-use patents?
• Are there 30-month stays or Paragraph IV litigation histories?
• Which approved generic products have an “AB” therapeutic-equivalence rating?
• Are competing products based on capsules, tablets, micronized powder, or alternative delivery technologies?

The Orange Book does not capture every commercial constraint. Manufacturing know-how, supplier qualification, trade secrets, and formulation process controls can remain important after listed patents expire.

Which companies are challenging Fenoglide?

Fenofibrate is a heavily competitive generic market with products from multiple manufacturers and labelers. The market has included tablet and capsule products, different strengths, micronized and non-micronized presentations, and formulations with different food-administration instructions.

A company-specific Paragraph IV assessment requires current review of:

• FDA Orange Book patent listings.
• ANDA approval records.
• Federal district court complaints.
• Federal Circuit decisions.
• Hatch-Waxman settlement agreements.
• FDA approval dates and first-filer status.

No single generic manufacturer should be treated as the sole competitive threat. The market structure favors multiple approved suppliers, which reduces the likelihood that one challenger will control launch timing or pricing.

What generic entry risks exist for Fenoglide?

Generic entry risk is high because fenofibrate is an established small molecule with broad clinical use and multiple approved products. The principal risks to an originator or branded formulation include:

Price erosion

Fenofibrate is vulnerable to rapid price compression after multiple therapeutically equivalent products receive approval. Payers and pharmacy benefit managers can substitute lower-cost products when the dosage form and strength are clinically interchangeable.

Formulation substitution

A competing product may achieve approval without copying every excipient. Demonstration of bioequivalence, pharmaceutical equivalence, or applicable product-specific requirements can allow a formulation with a different excipient profile to compete.

Food-effect differentiation

A product that can be administered without regard to meals has a commercial advantage over products with more restrictive food instructions. That advantage narrows when competing products obtain comparable pharmacokinetic performance.

Manufacturing scale

Fenofibrate loading, powder flow, and segregation can affect content uniformity. A sponsor with a robust milling and blending process can achieve lower production costs and fewer batch failures than a small-scale competitor.

What excipient strategy could support a new fenofibrate product?

The most attractive development strategy is a platform that improves dissolution without creating a new clinical or regulatory burden.

Strategy 1: Refined immediate-release tablet

A conventional tablet can use:

• Micronized or engineered fenofibrate.
• A low-to-moderate level of surfactant.
• Dual disintegrants.
• Microcrystalline cellulose or a directly compressible diluent.
• Controlled lubrication.
• Moisture-protective packaging.

This approach has the lowest development risk and is best suited to a generic or authorized-generic business model.

Strategy 2: Amorphous solid dispersion

An amorphous solid dispersion could improve apparent solubility and dissolution. Suitable polymers may include povidone, copovidone, or hypromellose-based systems. The main risks are recrystallization, moisture sensitivity, scale-up complexity, and the need to demonstrate physical stability over the full shelf life.

This approach is more defensible than a conventional micronized tablet but may not create enough clinical or reimbursement value unless it improves food independence, dose flexibility, or tolerability.

Strategy 3: Lipid-based formulation

A self-emulsifying or lipid-based system could improve dispersion of fenofibrate in the gastrointestinal tract. The formulation may use medium-chain lipids, surfactants, and cosurfactants.

The opportunity is stronger where the product can demonstrate reduced food effect or improved exposure consistency. The risks include capsule-fill limitations, excipient compatibility, gastrointestinal effects, oxidation, and a more complex regulatory package.

Strategy 4: Fixed-dose combination

Fenofibrate could be combined with a statin or another cardiovascular-risk medicine. Combination products may improve adherence and provide commercial differentiation, but they face clinical, regulatory, and market-access barriers.

The combination must establish dose selection, interaction profile, manufacturing compatibility, and a clear target population. A fixed-dose product is more attractive when it reduces pill burden in patients already prescribed both agents.

How does Fenoglide compare with other fenofibrate products?

Product type	Formulation advantage	Commercial limitation
Conventional fenofibrate capsule	Simple manufacturing and established technology	Greater dependence on food or formulation-specific absorption
Micronized fenofibrate tablet	Improved surface area and potentially lower food dependence	Particle-size and content-uniformity control
Fenoglide-type immediate-release tablet	Tablet convenience and food-independent labeling	Generic substitution and limited exclusivity
Nanocrystal or engineered-particle product	Potentially stronger dissolution performance	Higher process complexity and patent scrutiny
Amorphous solid dispersion	High dissolution potential	Recrystallization and stability risks
Lipid-based formulation	Improved dispersion for a lipophilic drug	Excipient burden and gastrointestinal tolerability
Fenofibrate combination product	Reduced pill burden	Clinical and regulatory complexity

What commercial opportunities exist for Fenoglide-like products?

The most credible opportunities are:

1. A low-cost generic with reliable dissolution and high manufacturing yield.
2. An authorized generic or supply agreement with a payer-focused distributor.
3. A lower-dose formulation for titration or patients with renal impairment, subject to clinical and regulatory requirements.
4. A combination product that reduces pill burden.
5. A formulation with improved stability in hot and humid markets.
6. A product designed for contract manufacturing with standard, widely available excipients.
7. A differentiated formulation for markets where food-independent dosing has commercial value.

Revenue exposure is concentrated in chronic dyslipidemia prescriptions, where recurring use creates volume but generic substitution places sustained pressure on net price. The strongest business case usually comes from manufacturing cost, reliable supply, and channel access rather than premium pricing.

What manufacturing and IP barriers affect commercial entry?

The principal manufacturing barriers are technical rather than fundamental:

• Controlling micronized fenofibrate agglomeration.
• Maintaining content uniformity at low dose.
• Preventing segregation during blending.
• Managing electrostatic behavior and poor powder flow.
• Achieving rapid dissolution after tablet compression.
• Limiting lubricant-induced hydrophobicity.
• Protecting the product from moisture and heat.
• Scaling milling or particle-engineering operations.
• Maintaining supplier consistency for surfactants and disintegrants.

The principal IP barriers may involve narrow formulation claims, particle-size ranges, process claims, and dosage-form claims. A freedom-to-operate review should examine issued claims, continuations, terminal disclaimers, reexamination history, and litigation outcomes. Expired compound patents do not eliminate risk from later formulation patents.

How strong is the Fenoglide patent estate?

The estate should be characterized as commercially limited at the active-ingredient level and potentially more relevant at the formulation and process levels. Fenofibrate is an established generic molecule, and the presence of numerous competing products indicates that broad market exclusivity is not the primary current barrier.

Patent strength depends on claim scope and enforceability. Narrow claims directed to a specific excipient ratio, particle-size distribution, dissolution profile, or manufacturing step may be difficult to design around if they correlate with the reference product’s performance. They may also be vulnerable if prior art discloses the same formulation principles or if the claimed parameters do not provide an unexpected technical effect.

Key Takeaways

• Fenoglide uses micronized fenofibrate in an immediate-release tablet.
• Its excipient system combines a surfactant, two disintegrants, binders, diluents, a glidant, and a lubricant.
• Sodium lauryl sulfate is central to wetting the hydrophobic drug, while crospovidone and sodium starch glycolate support rapid tablet breakup.
• The principal commercial risk is generic price erosion, not new chemical entity competition.
• The best entry strategy is a cost-efficient immediate-release tablet unless a new formulation can demonstrate meaningful food-effect, stability, adherence, or tolerability benefits.
• Formulation and process patents may remain relevant even after broad fenofibrate compound protection has expired.
• The highest-value opportunities are generic scale, reliable supply, combination products, and differentiated dissolution or dosing performance.

FAQs

Is Fenoglide the same as generic fenofibrate?

Fenoglide contains the same active ingredient as generic fenofibrate, but products can differ in dosage form, excipient composition, particle-size distribution, labeling, bioequivalence profile, and food-administration instructions.

Does Fenoglide contain sodium lauryl sulfate?

The Fenoglide labeling identifies sodium lauryl sulfate as an inactive ingredient. It functions primarily as a wetting and surfactant agent for the hydrophobic active ingredient [1].

Can a fenofibrate product be developed without sodium lauryl sulfate?

Yes. Alternative approaches include particle engineering, amorphous solid dispersions, lipid-based delivery systems, or other surfactants. The substitute must deliver acceptable dissolution, bioequivalence, stability, and tolerability.

Is a Fenoglide biosimilar possible?

No. Fenoglide contains fenofibrate, a chemically synthesized small molecule. The relevant competitive pathway is generic drug approval, not biosimilar approval.

What is the strongest commercial differentiator for a new fenofibrate product?

A combination of low manufacturing cost, consistent dissolution, food-independent administration, stable supply, and reduced pill burden is more commercially defensible than a minor excipient change alone.

References

1. U.S. Food and Drug Administration. (n.d.). Fenoglide (fenofibrate) tablets prescribing information.
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (2015). Product-specific guidance for fenofibrate oral dosage forms.
4. U.S. Food and Drug Administration. (2013). Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System.
5. European Medicines Agency. (n.d.). Assessment reports and product information for fenofibrate-containing medicinal products.