US Patent 9,173,847 Fenofibrate Patent Scope, Claims, Expiration, and Competitive Landscape

US Patent 9,173,847 protects fenofibrate tablets designed to reduce or eliminate the conventional food effect associated with fenofibrate. Its core requirements are a hydrophilic vehicle containing poloxamer and a hydrophilic polymer, combined with a pharmacokinetic performance threshold: the fasted-to-fed AUC ratio must be at least about 0.85, with a lower 90% confidence limit of at least 0.75.

The strongest claim groups cover:

Specified fenofibrate tablet strengths, including 40 mg, 100 mg, 110 mg, 120 mg, 130 mg and 145 mg.
PEG-poloxamer solid dispersions or solid solutions.
PEG 6000 and poloxamer 188 combinations.
Fenofibrate-to-polymer ratios of approximately 1:1 to 1:3.
Tablets with less than a 15% bioavailability difference between fasting and fed administration.
A 120 mg tablet with fasted exposure at least 1.1 times that of Antara 130 mg capsules.
Tablets bioequivalent to an Orange Book-listed fenofibrate product.

The patent is technically significant because it claims both composition structure and clinical performance. A competing product could avoid some structural limitations yet still face infringement risk if it uses the same hydrophilic vehicle and achieves the claimed food-effect profile.

What does US Patent 9,173,847 protect?

The patent protects oral fenofibrate tablets using a hydrophilic formulation platform intended to provide food-independent absorption.

The independent claims are claims 1, 18 and 20.

Claim	Protected subject matter	Principal limitations
1	Fenofibrate tablet	Specified dose; hydrophilic vehicle; poloxamer; hydrophilic polymer; fasted/fed AUC ratio
18	Solid dispersion or solid solution tablet	PEG 3000-35000 Da; poloxamer; PEG-poloxamer weight ratio; fasted/fed AUC ratio
20	Fenofibrate tablet on a solid carrier	40 mg or 120 mg; poloxamer; hydrophilic polymer; fasted/fed AUC ratio
21	Dependent formulation	Fenofibrate-to-polymer ratio of about 1:1 to 1:3

The claims do not cover every fenofibrate formulation. They require a combination of:

Fenofibrate in a tablet.
A hydrophilic vehicle.
Poloxamer in an effective amount.
A hydrophilic polymer.
A defined pharmacokinetic result.

A conventional micronized fenofibrate capsule, a formulation using only a lipid vehicle, or a tablet without the claimed food-effect performance would not satisfy the literal requirements of claim 1.

How broad is claim 1 of US 9,173,847?

Claim 1 is broad in formulation architecture but narrower in dosage and performance requirements.

Dosage-strength coverage

Claim 1 lists the following amounts:

33 mg
37 mg
40 mg
43 mg
48 mg
87 mg
100 mg
110 mg
120 mg
130 mg
145 mg
160 mg

The claim therefore reaches multiple historical and commercial fenofibrate strengths. Claims 2 through 6 narrow the scope to 145 mg, 130 mg, 120 mg, 110 mg and 100 mg. Claim 19 separately narrows the scope to 40 mg.

The unusual dose list creates a potential claim-construction issue. The claim covers exact stated amounts, but the legal treatment of manufacturing tolerances, assay variation and labeling conventions would depend on the specification, prosecution history and ordinary pharmaceutical claim interpretation.

Hydrophilic vehicle requirement

The vehicle must include poloxamer and a hydrophilic polymer. The claim does not limit the hydrophilic polymer in claim 1 to PEG. Claim 9 introduces PEG with an average molecular weight of at least 3,000, while claim 18 independently requires PEG in the 3,000 to 35,000 dalton range.

Potential hydrophilic polymers may include PEG and other water-compatible polymers, but the actual scope depends on the patent specification and prosecution history. The claim language should not be read as automatically covering every polymer that increases fenofibrate dissolution.

Pharmacokinetic limitation

The tablet must produce an AUCfasted/AUCfed ratio of:

At least about 0.85; and
A lower 90% confidence limit of at least 0.75.

This is a material limitation, not merely an intended use statement. The claim links the composition to a measured clinical or bioavailability outcome.

Claims 7 and 8 narrow the result further:

Claim 7 requires an AUCfasted/AUCfed ratio of at least about 0.9.
Claim 8 requires fasted-state bioavailability to be less than about 15% below fed-state bioavailability.

A product can therefore fall within the structural formulation language but outside the claim if it fails the specified pharmacokinetic test.

What formulations are protected by claims 9 through 15?

Claims 9 through 15 establish a detailed formulation subgenus.

Claim	Limitation
9	PEG with average molecular weight of at least 3,000
10	PEG and poloxamer in a weight proportion between 1:3 and 10:1
11	Poloxamer 188
12	PEG 6000
13	At least 90% w/w of fenofibrate dissolved in the vehicle
14	Conventional pharmaceutical excipients
15	Film, modified-release, enteric, protective or anti-adhesive coating

The commercially important combination is likely claim 10 combined with claims 11 and 12: PEG 6000 plus poloxamer 188 within the specified ratio.

Claim 13 is directed to the physical state of the fenofibrate in the vehicle. It requires at least 90% w/w of fenofibrate to be dissolved in the vehicle. That limitation may distinguish a true solid solution or molecular dispersion from a formulation containing predominantly suspended or crystalline drug.

Claim 15 confirms that coating does not necessarily remove a product from the claim scope. Immediate-release, modified-release, enteric and protective coatings may all remain covered if the underlying tablet satisfies the independent claim.

How do claims 18 and 20 differ from claim 1?

Claims 18 and 20 provide alternative infringement routes.

Claim 18: PEG-poloxamer solid dispersion

Claim 18 requires:

A tablet.
A solid dispersion or solid solution of fenofibrate.
PEG with molecular weight from 3,000 to 35,000 daltons.
Poloxamer.
A PEG-to-poloxamer weight proportion between 1:3 and 10:1.
The same fasted-to-fed AUC threshold.

Claim 18 is more structurally specific than claim 1 because it expressly requires a solid dispersion or solid solution and defines the PEG molecular-weight range. It may be more difficult to satisfy through a formulation in which fenofibrate remains primarily crystalline.

Claim 20: solid carrier and 40 mg or 120 mg dose

Claim 20 requires:

40 mg or 120 mg fenofibrate.
A hydrophilic vehicle on a solid carrier.
Poloxamer and a hydrophilic polymer.
The claimed fasted-to-fed AUC result.

Claim 21 narrows this group to a fenofibrate-to-polymer weight ratio of about 1:1 to about 1:3.

For a 40 mg or 120 mg product, claims 20 and 21 may provide additional coverage even if a challenger disputes the applicability of claim 1 or claim 18.

Does the patent cover bioequivalent fenofibrate products?

Claim 16 covers a tablet that is bioequivalent to an Orange Book-listed commercially available fenofibrate product containing the same active ingredient amount in the same solid dosage form.

This is a particularly important claim because it connects patent scope to approved-product equivalence. The claim does not cover bioequivalence alone. The product must also satisfy the formulation and food-effect limitations incorporated from claim 1.

An ANDA applicant could therefore face two separate questions:

Whether the proposed product is bioequivalent to the relevant reference product.
Whether the proposed product contains the claimed hydrophilic poloxamer formulation and meets the claimed pharmacokinetic profile.

FDA bioequivalence does not itself establish patent infringement, but the same comparative pharmacokinetic studies may become relevant evidence in litigation. FDA approval and patent validity are separate legal determinations.

What is the significance of claim 17 and the Antara comparison?

Claim 17 covers a 120 mg fenofibrate tablet that produces, in the fasted state, an AUC at least about 1.1 times the AUC of Antara 130 mg capsules under similar conditions.

This claim is narrower than claim 1 because it requires:

120 mg fenofibrate.
A comparison against Antara 130 mg capsules.
A fasted-state AUC ratio of at least approximately 1.1.
Similar testing conditions.

The Antara comparison is a formulation-performance limitation. It may be relevant to validity and infringement disputes because the comparator, study design, statistical analysis and “similar conditions” language could become central issues.

The claim also creates a potential vulnerability if Antara is no longer commercially available or if the original comparator formulation cannot be reproduced. The legal effect depends on whether the claim requires current commercial availability or simply a comparison to the identified product and its relevant formulation.

When does US Patent 9,173,847 lose exclusivity?

The patent’s expiration date cannot be determined from the claims alone. The issue date, November 3, 2015, does not establish the expiration date.

For a utility patent, the ordinary term is generally 20 years from the earliest effective nonprovisional filing date, subject to:

Patent term adjustment.
Patent term extension.
Terminal disclaimers.
Continuation or divisional relationships.
Any applicable prosecution-history limitations. (35 U.S.C. § 154)

The controlling expiration date should be taken from the USPTO patent record and the relevant family’s earliest effective filing date. A continuation patent generally shares the parent application’s term framework rather than receiving a new 20-year term from its continuation filing date.

Patent expiration must also be distinguished from FDA exclusivity. A fenofibrate product may lose patent protection before or after any applicable regulatory exclusivity period. FDA approval does not extend ordinary patent term unless a statutory patent-term extension applies.

Is US 9,173,847 an Orange Book-listed patent?

A formulation patent can be listed in the Orange Book if it claims an approved drug product or an approved method of using that product and satisfies FDA listing requirements. Not every patent owned by an NDA holder is eligible for listing.

The relevant questions are:

Whether the patent is listed against a specific fenofibrate NDA.
Which product, strength and dosage form are identified.
Whether the listing covers the formulation, method of use or both.
Whether the patent has been delisted, expired or remained active.
Whether an ANDA applicant must make a Paragraph IV certification.

Claim 16’s express reference to Orange Book-listed fenofibrate products suggests a regulatory strategy aimed at approved solid dosage forms. The claim language alone, however, does not establish that US 9,173,847 was actually listed in the Orange Book or identify a particular NDA.

What Paragraph IV risks exist for generic fenofibrate products?

A generic applicant could challenge the patent through a Paragraph IV certification asserting that the patent is invalid, unenforceable or not infringed. The principal technical arguments would likely focus on the following issues:

Issue	Potential generic position
Food-effect limitation	Proposed product does not meet the AUCfasted/AUCfed threshold
Poloxamer limitation	Formulation lacks poloxamer or uses a non-equivalent excipient
Hydrophilic polymer	Polymer does not fall within the claim construction
Solid dispersion	Fenofibrate is not dissolved or dispersed as required
PEG ratio	PEG-poloxamer ratio falls outside the claimed range
Dose limitation	Product strength is outside the listed amounts
Bioequivalence limitation	Product is not bioequivalent to the specified Orange Book product
Antara comparison	Claim 17’s comparator or testing condition is not satisfied
Validity	Prior art discloses the formulation, food-effect result or obvious combination

The patent’s strongest enforcement position would generally arise against a product using PEG and poloxamer in a solid dispersion at one of the expressly claimed strengths, particularly 40 mg or 120 mg, while demonstrating food-independent exposure.

Which companies are challenging US 9,173,847?

The claims supplied do not identify any Paragraph IV filer, district-court defendant, settlement agreement or licensee. A definitive list of challengers cannot be derived from the claim text.

A complete litigation review would require matching the patent against:

FDA Paragraph IV notice records.
ANDA litigation complaints under 21 U.S.C. § 355(j).
PACER and district-court dockets.
Federal Circuit decisions.
Orange Book patent-listing records.
Patent assignment and licensing records.

No biosimilar challenge is relevant. Fenofibrate is a chemically synthesized small molecule, so competitors use the ANDA pathway rather than the biosimilar pathway under the Public Health Service Act.

How strong is the patent estate for fenofibrate food-independent formulations?

The disclosed claim set is strongest where the accused product has all of the following characteristics:

Fenofibrate is incorporated in a tablet.
The formulation uses a hydrophilic vehicle.
The vehicle contains poloxamer and PEG or another hydrophilic polymer.
The dose is 40 mg, 120 mg or another expressly listed amount.
Fenofibrate is substantially dissolved in the vehicle.
The formulation is a solid dispersion or solid solution.
Clinical data show a fasted-to-fed AUC ratio of at least 0.85.
The product is bioequivalent to an Orange Book-listed fenofibrate tablet.

The estate is weaker against:

Lipid-based formulations without poloxamer.
Capsules rather than tablets.
Products using a different absorption technology.
Products with no PEG or hydrophilic polymer.
Products that fail the claimed food-effect threshold.
Products using doses outside the listed ranges.
Products in which fenofibrate remains predominantly crystalline and undissolved.

The functional pharmacokinetic limitations may improve commercial relevance but can create litigation complexity. Reproducibility, study population, fed and fasted protocols, AUC calculation, confidence intervals and statistical treatment may all affect infringement analysis.

How does the patent compare with other fenofibrate formulation patents?

Fenofibrate patent protection generally falls into four categories:

Patent category	Typical subject matter	Relevance to US 9,173,847
Particle-size patents	Micronized or nanosized fenofibrate	Different technical route
Lipid or self-emulsifying systems	Improved dissolution through oils and surfactants	Usually outside the PEG-poloxamer focus
Solid-dispersion patents	Fenofibrate dispersed in PEG, poloxamer or related carriers	Closest overlap
Food-effect patents	Reduced difference between fed and fasted exposure	Directly aligned

US 9,173,847 is not a basic fenofibrate composition patent. It is a formulation and pharmacokinetic patent directed to a particular strategy for overcoming fenofibrate’s food dependence.

What generic launch scenarios exist?

Launch after confirmed patent expiry

This is the lowest-risk pathway if no unexpired patent, regulatory exclusivity or enforceable continuation remains.

Paragraph IV launch

A generic applicant may launch after providing a Paragraph IV notice, subject to litigation risk and any 30-month stay triggered by timely patent litigation under the Hatch-Waxman framework.

Section viii carve-out

A method-of-use carve-out is less central here because the supplied claims are primarily formulation and product claims. A section viii strategy would not remove infringement exposure for a product claim covering the tablet itself.

Non-infringing formulation launch

A competitor could use a different formulation technology, such as a lipid-based system, a different polymer platform or a dosage form outside the claimed tablet limitations. The product would still need to satisfy FDA pharmaceutical-equivalence and bioequivalence requirements.

What commercial products are most exposed?

The most exposed products are solid oral fenofibrate tablets containing 40 mg or 120 mg and using PEG-poloxamer hydrophilic vehicles. Products positioned as food-independent or having minimal food effect present the clearest overlap with the patent’s functional limitations.

Traditional fenofibrate capsules, including products based on micronized fenofibrate without the claimed hydrophilic vehicle, present a lower literal infringement risk under the supplied claims. Commercial exposure depends on whether a marketed product’s actual formulation, rather than its label description alone, satisfies the structural limitations.

Key Takeaways

US 9,173,847 is directed to food-independent fenofibrate tablets.
Its central requirement is a hydrophilic vehicle containing poloxamer and a hydrophilic polymer.
The claims impose a pharmacokinetic threshold of at least about 0.85 for fasted-to-fed AUC, with a lower 90% confidence limit of at least 0.75.
PEG 6000, poloxamer 188, solid dispersions and 40 mg or 120 mg tablets receive particularly detailed coverage.
Claim 16 links the formulation to bioequivalence with an Orange Book-listed fenofibrate product.
Claim 17 specifically addresses a 120 mg tablet compared with Antara 130 mg capsules.
A biosimilar pathway does not apply because fenofibrate is a small-molecule drug.
Patent expiration, Orange Book listing, Paragraph IV challenges, litigation and settlement status require review of the USPTO, FDA and court records rather than the claim text alone.
The strongest design-around options involve avoiding poloxamer, avoiding the claimed PEG-poloxamer architecture, using a non-tablet dosage form or failing to meet the claimed food-effect performance.

FAQs About US Patent 9,173,847

Does US 9,173,847 cover all 120 mg fenofibrate tablets?

No. The tablet must also include the claimed hydrophilic vehicle with poloxamer and a hydrophilic polymer and meet the specified fasted-to-fed pharmacokinetic result.

Does using PEG 6000 automatically infringe the patent?

No. PEG 6000 is only one limitation within the dependent claims. Infringement would require satisfaction of all limitations of at least one asserted claim, including the poloxamer requirement and applicable pharmacokinetic threshold.

Can a fenofibrate capsule infringe US 9,173,847?

The supplied claims require a tablet. A capsule would not literally satisfy that dosage-form limitation, although other patents or an infringement theory based on equivalent structures could create separate issues.

Does FDA bioequivalence prove infringement?

No. Bioequivalence is an FDA regulatory determination. Patent infringement requires satisfaction of every limitation of an asserted claim under the applicable legal standard.

Is a product with a 15% food effect outside the patent?

Not necessarily. Claim 8 requires fasted-state bioavailability to be less than about 15% below fed-state bioavailability, but the independent claims use an AUC ratio and confidence-limit test. A product must be evaluated against the precise limitation of each asserted claim.

References

United States Patent and Trademark Office. (2015). U.S. Patent No. 9,173,847, fenofibrate tablet formulations. U.S. Department of Commerce.
U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.
U.S. Food and Drug Administration. (2009). Guidance for industry: Bioavailability and bioequivalence studies for orally administered drug products. U.S. Department of Health and Human Services.
Hatch, W. E. (1984). Drug Price Competition and Patent Term Restoration Act, Pub. L. No. 98-417, 98 Stat. 1585.
21 U.S.C. § 355(j).
35 U.S.C. § 154.

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Denmark	2005 00527	Apr 13, 2005

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004279661	⤷ Start Trial
Australia	2009201881	⤷ Start Trial
Brazil	PI0415121	⤷ Start Trial
Canada	2540984	⤷ Start Trial
Canada	2541382	⤷ Start Trial
Canada	2582403	⤷ Start Trial
Canada	2582405	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,173,847

Summary for Patent: 9,173,847