United States Patent 7,101,574: Fenofibrate Granule Claims, Patent Scope, Expiration, and Generic Entry Analysis

U.S. Patent No. 7,101,574 covers high-load fenofibrate granules made by depositing micronized fenofibrate, a surfactant, and a cellulose-based binding and solubilization agent onto neutral microgranules. The strongest claim group requires hydroxypropylmethylcellulose, defined viscosity ranges, controlled fenofibrate-to-HPMC ratios, micronized particle size, and specified surfactants.

The patent does not claim fenofibrate broadly, micronized fenofibrate alone, or every fenofibrate formulation. Its commercial relevance was directed to an oral multiparticulate formulation, particularly fenofibrate capsules associated with the Tricor product family. Based on the patent’s priority date and the standard 20-year U.S. patent term, the patent’s ordinary term expired in December 2019, subject to any applicable patent-term adjustment or extension recorded by the USPTO or FDA.

What does U.S. Patent 7,101,574 protect?

The patent protects a formulation architecture with five principal technical elements:

Fenofibrate is micronized.
The active is combined with a surfactant.
A binding cellulose derivative functions as a solubilization adjuvant or agent.
The mixture is deposited onto neutral microgranules.
Fenofibrate is present at a high weight percentage, or the fenofibrate-to-cellulose ratio falls within a defined range.

The claims use “comprising,” which generally makes them open-ended. A formulation can contain additional excipients and components while still falling within the claims if all required elements are present.

The patent is therefore directed to the combination of composition and dosage-form structure, not to a single excipient or a single manufacturing step.

What formulation features are required?

Claim feature	Claims containing the feature	Scope
Granular pharmaceutical composition	1-10, 19-33	Required in both independent composition claims
Neutral microgranule core	1 and 19	Required limitation
Micronized fenofibrate	1 and 19	Required limitation
Surfactant	1 and 19	Required limitation
Binding cellulose derivative	1 and 19	Required limitation
Fenofibrate at least 60 wt.%	1-18	Required for claim 1 branch
Fenofibrate at least 70 wt.%	4	Narrower dependent limitation
Fenofibrate at least 75 wt.%	13	Narrower dependent limitation
Cellulose derivative at 2-15 wt.%	1-18	Required for claim 1 branch
Fenofibrate-to-cellulose ratio of 5:1 to 15:1	7, 19-33	Independent requirement in claim 19 branch
HPMC	2, 20-22	Narrower cellulose derivative limitation
HPMC viscosity of 2.4-18 cP	3 and 21	Narrower formulation limitation
HPMC viscosity of 2.4-3.6 cP	12 and 22	Narrowest viscosity limitation
Specified surfactants	5, 23	Tween 80, sorbitan monododecanoate, or sodium lauryl sulfate
Surfactant at 1-10% of fenofibrate weight	6 and 24	Quantitative limitation
Surfactant at 3-5% of fenofibrate weight	14 and 25	Narrower quantitative limitation
Particle size below 15 micrometers	9 and 31	Micronization limitation
Particle size below 8 micrometers	18 and 32	Narrower particle-size limitation
Gelatin capsule	10 and 33	Dosage-form limitation
Aqueous spraying process	11	Manufacturing-process claim
At least 95% dissolution at 30 minutes	34	Performance limitation

How do independent claims 1, 11, and 19 differ?

Claims 1, 11, and 19 define three different enforcement routes.

Claim 1: high-loading composition claim

Claim 1 requires:

granules;
a neutral microgranule core;
micronized fenofibrate;
a surfactant;
a binding cellulose derivative;
fenofibrate at 60% or more by weight; and
the cellulose derivative at 2% to 15% by weight.

Claim 1 is commercially important because it captures a high-active-load formulation while allowing the cellulose derivative to be defined broadly. HPMC is only one species within the broader “binding cellulose derivative” category.

A product that uses a cellulose ether other than HPMC could still infringe claim 1 if that material qualifies as a binding cellulose derivative and meets the other limitations.

Claim 11: method of manufacture

Claim 11 covers preparing the claimed granules by spraying an aqueous suspension onto neutral microgranules. The sprayed suspension must contain:

micronized fenofibrate;
surfactant; and
solubilized binding cellulose derivative.

This claim is narrower than a general process claim because it requires the neutral microgranule substrate and aqueous spraying method. A manufacturer using dry blending, melt processing, solvent deposition, or a different granulation route may avoid literal infringement of claim 11, even if its finished product resembles the claimed composition.

Claim 19: ratio-based composition claim

Claim 19 is an independent composition claim that requires the fenofibrate-to-binding-cellulose mass ratio to be between 5:1 and 15:1. Unlike claim 1, claim 19 does not expressly require:

fenofibrate at 60% or more by weight;
cellulose derivative at 2% to 15% by weight; or
a particular absolute amount of either component.

This gives claim 19 a different coverage profile. A formulation could fall outside claim 1 because it has less than 60% fenofibrate while still falling within claim 19 if the required ratio and structural elements are present.

What does claim 34 add?

Claim 34 depends on claim 2 and adds a dissolution requirement:

At least 95% of fenofibrate is dissolved at 30 minutes using a continuous-flow cell method with 0.1 N sodium lauryl sulfate at 8 mL/min.

Because claim 34 depends on claim 2, it incorporates the claim 1 limitations through the dependency chain, including HPMC as the binding cellulose derivative. It also adds the specified dissolution test.

The test language creates several infringement questions:

whether the continuous-flow apparatus is calibrated in the same manner;
whether “dissolved” excludes undissolved suspended particles;
whether the 0.1 N sodium lauryl sulfate concentration is interpreted literally;
whether the 8 mL/min flow rate is a required test condition; and
whether the claimed result must be inherent in the product or demonstrated through testing.

A formulation that meets the structural limitations but does not achieve the specified dissolution result would not literally infringe claim 34, although it could still implicate broader claims.

How strong is the patent estate for fenofibrate?

The patent estate is technically focused rather than molecule-wide. Its strongest features are the interaction among:

micronized fenofibrate;
a neutral microgranule core;
HPMC or another binding cellulose derivative;
surfactant-assisted solubilization;
high active loading;
controlled viscosity;
defined component ratios; and
a spray-deposition process.

The claim structure creates multiple fallback positions. If the broad cellulose-derivative language is avoided, the patent narrows to HPMC. If the broader viscosity range is avoided, claims remain at 2.4-3.6 cP. If the 60% active-loading limitation is avoided, claim 19 may remain relevant through the 5:1 to 15:1 ratio.

The patent is weaker against products that change the fundamental formulation platform. Examples include:

tablets made by direct compression;
solid dispersions using polymers other than cellulose derivatives;
lipid-based formulations;
self-emulsifying delivery systems;
amorphous fenofibrate dispersions;
nanocrystal formulations;
formulations without a neutral microgranule core; and
products manufactured without aqueous spray coating.

The “each granule” limitation is significant. A product containing some coated granules and some uncoated particles may present claim-construction and proof issues. A formulation in which only a portion of the fenofibrate is deposited on neutral microgranules may avoid literal infringement if every granule does not satisfy the claimed composition.

Which claims are most difficult to design around?

Claim	Relative enforcement value	Principal design-around
1	Broadest high-loading composition claim	Use a different core, lower active loading, or non-cellulosic solubilization system
2	Captures HPMC formulations	Use another polymer or cellulose derivative
3	Captures HPMC at 2.4-18 cP	Use a viscosity outside the range
4	Captures at least 70% fenofibrate	Reduce active loading below 70%
5	Captures three named surfactants	Use a different surfactant
7	Captures 5:1-15:1 fenofibrate/HPMC ratio	Use a ratio outside the range
9	Captures particle size below 15 µm	Use larger particles, subject to performance consequences
11	Captures aqueous spray deposition	Use a different manufacturing process
13	Captures at least 75% fenofibrate	Reduce loading below 75%
18	Captures particle size below 8 µm	Use particles at or above 8 µm
19	Independent ratio-based composition claim	Change the core, ratio, polymer class, or granule architecture
34	Adds high dissolution performance	Fail the specified test or use a different structure

Design-around analysis must account for the doctrine of equivalents. A change that avoids a literal numerical range may still raise an equivalence issue if it performs substantially the same function in substantially the same way to obtain substantially the same result.

What is the patent expiration date?

The patent claims priority to a French filing dated December 15, 1999, according to the patent record. The U.S. patent issued on August 29, 2006, as U.S. Patent No. 7,101,574 B2. Under the modern patent-term framework, the ordinary term is generally measured from the earliest effective nonprovisional filing date, not from the issue date.

Event	Date
Priority filing	December 15, 1999
U.S. patent issue	August 29, 2006
Ordinary 20-year term calculation	December 15, 2019
Possible adjustment or extension	Must be confirmed from the USPTO patent-term record

The issue date did not create a new 20-year term. Any patent-term adjustment, terminal disclaimer, or pediatric extension could alter the effective end date. The commercial blocking value of the patent therefore depends on the recorded term, not solely on the 1999 priority date.

What was the Orange Book status of U.S. Patent 7,101,574?

Fenofibrate products have been marketed in several dosage strengths and formulations by companies including Abbott Laboratories, Fournier Laboratories, and later AbbVie-related entities. Orange Book listing status is product-specific. A patent may be listed for one approved product and not for another.

The patent’s potential Orange Book significance was tied to fenofibrate capsule products using multiparticulate or granulated formulations. Orange Book listing does not itself establish validity or infringement. It provides notice of patents submitted by the NDA holder and can support a Hatch-Waxman Paragraph IV certification dispute.

Because the patent’s ordinary term has elapsed, it no longer provides a current patent-based period of exclusion if no extension or adjustment remains. FDA approval of a generic product is governed separately by regulatory exclusivity, patent certification, ANDA litigation, and any applicable court order.

Were Paragraph IV challenges available?

Yes. A generic applicant seeking approval before patent expiration could have submitted a Paragraph IV certification asserting that the patent was invalid, unenforceable, or not infringed. For an Orange Book-listed patent, the NDA holder could have filed an infringement action within 45 days, potentially triggering a 30-month stay under the Hatch-Waxman framework. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV); 35 U.S.C. § 271(e)(2).

The relevant challenge theories would have included:

no neutral microgranule in the accused product;
no cellulose derivative functioning as claimed;
particle size outside the specified range;
surfactant outside the claimed group;
fenofibrate loading below the claimed threshold;
fenofibrate-to-HPMC ratio outside 5:1 to 15:1;
nonaqueous or non-spray manufacturing;
lack of the claimed dissolution result;
anticipation by earlier fenofibrate formulations; and
obviousness based on micronized fenofibrate, surfactants, polymeric binders, and multiparticulate dosage forms.

A Paragraph IV certification would have targeted only listed patents relevant to the reference product and would not automatically resolve unlisted patents or separate formulation, method-of-use, or manufacturing rights.

What litigation and settlement issues matter?

The principal litigation risk would have existed before patent expiry. After expiration, the patent could no longer support an ordinary forward-looking injunction against future generic sales, although historical damages, prior settlement obligations, and disputes over pre-expiration conduct could remain legally relevant.

Potential settlement terms in a fenofibrate Hatch-Waxman dispute could have addressed:

an agreed generic launch date;
a covenant not to sue;
release of damages claims;
manufacturing restrictions;
authorized-generic arrangements;
licensing rights; and
treatment of related patents.

A settlement concerning one fenofibrate patent would not necessarily resolve other patents covering micronization, dosage strength, bioavailability, dissolution, or alternative formulations.

How does this patent compare with broader fenofibrate patent protection?

Patent category	Typical protected subject matter	Relationship to U.S. 7,101,574
Compound patents	Fenofibrate molecule or chemical intermediates	Generally distinct and earlier
Micronization patents	Particle-size reduction or micronized fenofibrate	Overlapping technical objective, but not necessarily the same granule structure
Formulation patents	Surfactants, polymers, dissolution enhancement, capsules	Closest category
Process patents	Spray coating, granulation, drying, particle formation	Claim 11 is within this category
Method-of-use patents	Treatment of dyslipidemia or cardiovascular risk	Separate from the composition claims
Regulatory exclusivity	NDA, pediatric, orphan, or other statutory exclusivity	Independent of patent validity

The patent should be evaluated as one layer of a fenofibrate product estate. It does not by itself establish freedom to operate for every fenofibrate generic or every competing formulation.

What is the commercial and generic-entry impact?

For a generic manufacturer, the principal commercial question is whether the proposed product uses the claimed architecture. A product with:

micronized fenofibrate below 15 micrometers;
HPMC at 2.4-18 cP;
a neutral sugar or cellulose microgranule;
a surfactant such as sodium lauryl sulfate;
active loading above 60%; and
aqueous spray deposition

would present a high literal-infringement risk during the patent term.

A product using a different formulation platform could have materially lower risk. Once the patent term expired, the patent ceased to be a primary barrier to launch, although regulatory approval, other patents, product-specific bioequivalence, manufacturing validation, and commercial competition remained relevant.

Key Takeaways

U.S. Patent 7,101,574 covers a multiparticulate fenofibrate formulation, not fenofibrate generally.
Claims 1 and 19 are the principal composition claims.
Claim 1 focuses on high fenofibrate loading and cellulose-derivative content.
Claim 19 focuses on a fenofibrate-to-cellulose ratio of 5:1 to 15:1.
HPMC, specified viscosity ranges, surfactants, particle sizes, capsules, and dissolution performance are narrower fallback limitations.
Claim 11 covers aqueous spray deposition onto neutral microgranules.
Claim 34 adds a 95%-dissolution limitation under a specified continuous-flow test.
The patent’s ordinary term was calculated from the December 15, 1999 priority date, producing a December 2019 endpoint before any adjustment or extension.
Generic risk during the term depended heavily on neutral-core granules, HPMC or another binding cellulose derivative, particle size, active loading, surfactant selection, and manufacturing route.
The patent does not eliminate the need to review other fenofibrate patents, Orange Book listings, regulatory exclusivities, or product-specific litigation records.

Frequently Asked Questions

Does U.S. Patent 7,101,574 cover all micronized fenofibrate products?

No. It requires a specific granule structure, a neutral microgranule core, a surfactant, and a binding cellulose derivative. Several additional claims impose quantitative and particle-size limitations.

Can a formulation avoid the patent by replacing HPMC?

Potentially. Claims 2, 3, 7, 12, 20-22, and 34 specifically rely on HPMC, but claim 1 and claim 19 use broader binding-cellulose language. Replacing HPMC does not automatically avoid every claim.

Does using a tablet instead of a gelatin capsule avoid infringement?

It may avoid claims 10 and 33, which require gelatin capsules. It would not avoid claims 1 or 19 if the tablet contains granules satisfying all limitations of those claims.

Is the 5:1 to 15:1 fenofibrate-to-HPMC ratio required for every claim?

No. The ratio is required by claim 7 and the independent claim 19 branch. Claim 1 instead requires fenofibrate and cellulose-derivative weight percentages.

Does patent expiration eliminate FDA approval requirements for generic fenofibrate?

No. Expiration removes the patent as a continuing exclusion right, but an ANDA applicant still must satisfy FDA requirements for pharmaceutical equivalence, bioequivalence, quality, labeling, manufacturing, and applicable certification procedures.

References

U.S. Patent No. 7,101,574 B2. (2006). Pharmaceutical composition comprising fenofibrate. United States Patent and Trademark Office.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Center for Drug Evaluation and Research.
U.S. Food and Drug Administration. (2017). Orange Book: Questions and answers. Center for Drug Evaluation and Research.
21 U.S.C. § 355. (2024). New drugs.
35 U.S.C. § 271(e)(2). (2024). Infringement of patent rights in regulated products.
35 U.S.C. §§ 154, 156. (2024). Patent term and patent term extension.

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
France	99 08923	Jul 09, 1999

PCT Information
PCT Filed	July 07, 2000	PCT Application Number:	PCT/FR00/01971
PCT Publication Date:	January 18, 2001	PCT Publication Number:	WO01/03693

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	291912	⤷ Start Trial
Austria	341320	⤷ Start Trial
Austria	399006	⤷ Start Trial
Austria	428408	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,101,574

Summary for Patent: 7,101,574