Last Updated: August 9, 2026

Details for Patent: 7,741,374


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Which drugs does patent 7,741,374 protect, and when does it expire?

Patent 7,741,374 protects FIBRICOR and is included in one NDA.

Summary for Patent: 7,741,374
Title:Methods of use of fenofibric acid
Abstract:Fenofibric acid formulations comprising 105 mg of fenofibric acid are described as well as methods of use thereof. Dosage forms include, for example, immediate-release dosage forms.
Inventor(s):Kristin Anne Arnold, Hengsheng Feng
Assignee: Deerfield Management Company Lp As Administrative Agent , Rosemont Pharmaceuticals LLC
Application Number:US12/556,644
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

United States Patent 7,741,374 (Fenofibric Acid IR 105 mg, Meal-Independent “Immediate Release”): Scope, Claim Construction, and US Patent Landscape

US Patent 7,741,374 claims methods of treating dyslipidemia using a specific immediate-release fenofibric acid 105 mg dosing approach that is defined by a quantitative dissolution-style release metric at 2 hours in a single pH buffer and is administered “without regard to meals.” The estate’s practical value is the ability to deter generic or “authorized” competition for the fenofibric acid IR 105 mg product profile that matches the claimed release/administration constraints, including potential litigation leverage against formulations whose dissolution behavior or dosing instructions differ.

What does US 7,741,374 claim, and how broad is the “immediate release” limitation?

US 7,741,374 has two method claims with identical core technical limitations and different therapeutic framing. Both require:

  • Drug and dose: administering an immediate-release 105 mg fenofibric acid dosage form
  • Administration timing:without regard to meals
  • Immediate release definition (technical metric): immediate release means “release of 90% or greater of the fenofibric acid in the dosage form at 2 hours measured in a single pH buffer

Claim 1 vs claim 2: indication scope

  • Claim 1: “increased cholesterol and/or lipid levels” (broad lipid/cholesterol umbrella).
  • Claim 2: “mixed dyslipidemia” (a subset within Claim 1’s general language).

Because Claim 2 is narrower clinically but shares the same drug/product and release/meal limitations, the real scope hinge is the formulation definition and dosing instruction, not the clinical wording.

How a court is likely to construe the “immediate release” metric

The “immediate release” term is anchored by objective performance criteria:

  • 90% or greater release
  • at 2 hours
  • measured in a single pH buffer These features typically narrow claim coverage in a way that is more enforceable than a purely functional “immediate release” label in drug product patents.

Key scope effect: even if a competitor markets “immediate release,” infringement depends on whether its fenofibric acid 105 mg product meets the same dissolution/release threshold using the same measurement concept (single pH buffer).

How “without regard to meals” changes the infringement surface

“Without regard to meals” can cut both ways:

  • If the claimed labeling or standard of use permits dosing independent of meals, the method is easier to map to real-world administration and to argue infringement.
  • If a generic’s label requires administration with food (or specifies timing that materially conflicts with “without regard to meals”), that can become a non-infringement argument if the method claim requires the meal-independent instruction as a claim element.

Practical litigation point: in method-of-treatment claims, proving “administering without regard to meals” can become evidence-heavy, but the label language and prescribing instructions are usually central.


How do the claim elements map to a generic design-around?

A generic (or formulation change) generally tries to avoid one of the three claim pillars: dose, release profile, or meal-independent administration.

Generic entry risk buckets against the 7,741,374 method claims

  1. Dose mismatch

    • Claim is limited to 105 mg fenofibric acid immediate-release dosage form.
    • A product that is not 105 mg (or uses a different strength as the claimed dosage form) may avoid literal coverage, though doctrine-of-equivalents arguments can still be raised if the overall treatment regimen is effectively the same.
  2. Release-profile mismatch at 2 hours

    • The “90% at 2 hours” requirement is the strongest, most objective limitation.
    • A formulation that releases less than 90% by 2 hours in the relevant “single pH buffer” concept may reduce or eliminate infringement risk.
  3. Meal instruction mismatch

    • If administration is “with meals” or under a protocol that contradicts “without regard to meals,” infringement arguments weaken.
    • If a competitor instructs meal-independent dosing but has different dissolution performance, the dissolution metric remains the primary infringement battleground.

Formulation design paths that typically reduce claim exposure

  • Modifying excipients or coating so the release curve crosses the 90% threshold later than 2 hours.
  • Using a different release mechanism that changes dissolution kinetics.
  • Changing product labeling so administration is tied to meals, where permissible.

What is the therapeutic scope of the method claims for dyslipidemia?

Claim 1: “increased cholesterol and/or lipid levels”

This language is broad and can encompass:

  • elevated LDL-C
  • elevated triglycerides
  • mixed cholesterol/lipid elevations
  • other lipid-related dyslipidemic states that fall under “increased cholesterol and/or lipid levels”

Claim 2: “mixed dyslipidemia”

This is more specific and maps to mixed hyperlipidemia diagnoses and related clinical conditions.

Key practical point for enforcement

Even if clinical labeling is narrower than Claim 1’s text, the primary technical limitations (105 mg IR; meal-independent administration; 90% release at 2 hours) remain the main drivers. A competitor’s FDA label for indications can still matter in proving the “in need of treatment for” element, but the technical product match often dominates infringement analysis.


What “immediate-release” and dissolution standards are implicated by the “single pH buffer” limitation?

US 7,741,374 embeds a single pH buffer measurement concept. The claim does not state which pH value, but the language still creates a measurement-defined boundary.

Scope implications

  • If a competitor uses a different dissolution medium (or uses multiple pH conditions and still claims immediate release), the question becomes whether its product satisfies the 7,741,374 “single pH buffer” criterion as tested/accepted by the relevant standard.
  • If test conditions can vary, claim construction may require attention to what “single pH buffer” means in the patent’s specification and prosecution history. The numeric “90% at 2 hours” is the key enforceable component either way.

Litigation posture

Because the threshold is numeric and time-bound, infringement and non-infringement can pivot on:

  • competitor dissolution test data under the relevant medium concept
  • expert analysis matching the patent’s test setup to FDA or pharmacopeial methods

How does the patent fit into fenofibric acid US product patent families and Orange Book-style exclusivity risk?

US 7,741,374 is not a composition claim in the language you provided. It is a method of treatment claim built around a product performance profile. That places it closer to:

  • enforcement against use/administration of a marketed dosing regimen, and
  • enforcement against manufacturer-labeling + prescribing behavior

Exclusivity vs patent coverage

  • Patent coverage can outlast marketing exclusivity depending on expiration dates and the number of enforceable claims.
  • Orange Book listing is a separate question that depends on whether this patent is listed to cover a specific approved NDA/ANDA and its strengths. The enforceable risk is highest when the listed patent aligns with the method described in actual label instructions.

When does US 7,741,374 lose exclusivity: expiration timing and patent term mechanics?

A claims-only analysis does not include the application filing date, priority, jurisdictional term adjustments, or maintenance status. Those data determine the actual expiration under US law, including:

  • 20-year from earliest effective filing date (typical base)
  • any patent term adjustment (PTA)
  • any patent term extension (PTE), generally rare for this category
  • any terminal disclaimers

Because those term mechanics depend on the patent’s bibliographic data that are not provided here, no expiration date can be stated from the claim text alone.


What patents typically surround IR fenofibric acid 105 mg: likely adjacent claim categories?

Even without listing specific numbers, the landscape around fenofibric acid IR 105 mg methods typically clusters into these technical buckets:

1) Composition of matter or formulation patents

  • core fenofibric acid formulations
  • excipient systems that tune dissolution
  • coating or granulation methods to achieve immediate release behavior

2) Method-of-treatment patents

  • lipid-indication-based dosing regimens
  • meal-independent or dosing instruction-focused method claims
  • patient-selection methods

3) Dissolution and release-profile patents

  • patents that define “immediate release” using numeric release curves
  • patents specifying release in defined media conditions

4) Manufacturing process patents

  • methods of making the immediate-release dosage form
  • process conditions to maintain dissolution behavior reproducibility

US 7,741,374 sits squarely in bucket (2), but its claim is defined by a product performance metric, making it overlap functionally with (1) and (3) enforcement strategies.


Which companies are likely exposed in a fenofibric acid IR 105 mg method-of-use scenario?

Exposure generally tracks who markets or distributes an IR fenofibric acid 105 mg product that matches:

  • meal-independent administration
  • 90%+ release at 2 hours in a single-pH concept

In practice, exposure includes:

  • originator and branded label holders with meal-independent “without regard to meals” instructions
  • ANDA filers whose formulations meet the dissolution thresholds
  • distributors whose packaging/instructions drive the “without regard to meals” element

A company-level mapping requires bibliographic and Orange Book listing ties that are not included in the claim text.


What generic entry risks exist for fenofibric acid 105 mg “without regard to meals” IR dosing?

High infringement risk when all three match

  • If a generic’s 105 mg IR fenofibric acid product meets 90% at 2 hours in the relevant single-pH buffer concept
  • and labeling instructs dosing “without regard to meals,”
  • infringement risk is concentrated and can support method claim assertions.

Lower infringement risk when any element is materially different

  • If dissolution release crosses 90% at a later time, it can be used to argue non-infringement.
  • If dosing is directed “with meals,” method claims become harder to map to prescribing and administration.

Paragraph IV and litigation posture (conceptual)

A typical Paragraph IV strategy for method-of-use patents is to challenge:

  • invalidity (anticipation/obviousness)
  • non-infringement by design-around dissolution or labeling
  • claim construction of “immediate release” test parameters

Without filing dates, prior art citations, and prosecution history, the exact viability can’t be stated from the claim text.


What patent litigation issues typically arise for this claim type?

Method-of-treatment claims with dissolution-defined product performance usually drive disputes over:

1) Infringement proof: labeling + use patterns

  • whether prescribing instructions match “without regard to meals”
  • whether patients in the real world follow meal-independent dosing consistent with label
  • whether off-label use expands exposure beyond the label

2) Technical infringement: dissolution/release measurement replication

  • matching “single pH buffer” conditions to the patent’s test definition
  • establishing whether 90% release at 2 hours is reproducible
  • controlling variability between lots

3) Validity: prior art dissolution and dosing instructions

The strongest validity attacks often cite earlier disclosures of:

  • fenofibric acid immediate-release dosing
  • dissolution/release metrics for IR formulations
  • meal-independent administration

The claim text alone does not identify which prior art is relevant, so litigation outcomes can’t be mapped.


How does US 7,741,374 compare with other fenofibric acid patent scopes?

US 7,741,374’s distinguishing feature is that it turns “immediate release” into a measurable and threshold-defined characteristic:

  • “90% or greater at 2 hours”
  • “single pH buffer”
  • plus the dosing instruction “without regard to meals” That combination reduces the vagueness typical of generic “immediate release” language.

Compared with broader method-of-use patents that only recite patient indication and dosing, this one has a narrower technical perimeter. Compared with pure composition claims, it shifts enforcement toward:

  • use and administration conditions, and
  • the performance of the dosage form.

Key Takeaways

  • US 7,741,374 claims method-of-treatment use of immediate-release 105 mg fenofibric acid with meal-independent dosing and an objective definition of immediate release: ≥90% fenofibric acid release at 2 hours in a single pH buffer.
  • Claim 1 covers broad “increased cholesterol and/or lipid levels”; claim 2 targets mixed dyslipidemia. Core infringement risk is driven by the formulation performance metric and dosing instruction, not the clinical wording.
  • Generic design-around focus is straightforward: avoid 105 mg IR match, avoid meeting the 90% at 2 hours release threshold under the “single pH buffer” concept, and/or change labeling so dosing is not “without regard to meals.”
  • The claim’s numeric release constraint makes technical evidence (dissolution/release data) the central pivot in infringement and non-infringement disputes.

FAQs

1) Does US 7,741,374 cover fenofibric acid formulations that release less than 90% at 2 hours?
If the product does not meet the “90% or greater at 2 hours in a single pH buffer” criterion, the immediate-release limitation is not satisfied.

2) Can a company avoid infringement by dosing fenofibric acid 105 mg only with meals?
If “without regard to meals” is treated as a required method element, meal-dependent labeling and administration can be a non-infringement strategy.

3) Are the method claims limited to specific FDA-approved indications?
The claims use broad dyslipidemia language (“increased cholesterol and/or lipid levels” and “mixed dyslipidemia”), but infringement still depends on proving the method is used for a patient “in need of treatment” for the claimed indication.

4) How important is the “single pH buffer” element to claim scope?
It is part of the objective “immediate release” definition. Measuring release under different pH concepts can materially affect whether the 90% threshold is met for infringement analysis.

5) What is the main evidentiary focus in a dispute over these method claims?
Two items dominate: dosing instructions and administration (“without regard to meals”), and dissolution/release test evidence demonstrating whether ≥90% releases at 2 hours in a single pH buffer.

More… ↓

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Drugs Protected by US Patent 7,741,374

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Rosemont FIBRICOR fenofibric acid TABLET;ORAL 022418-001 Aug 14, 2009 DISCN Yes No 7,741,374 ⤷  Start Trial ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA ⤷  Start Trial
Rosemont FIBRICOR fenofibric acid TABLET;ORAL 022418-001 Aug 14, 2009 DISCN Yes No 7,741,374 ⤷  Start Trial ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH ELEVATED CHOLESTEROL AND/OR LIPID LEVELS ⤷  Start Trial
Rosemont FIBRICOR fenofibric acid TABLET;ORAL 022418-002 Aug 14, 2009 DISCN Yes No 7,741,374 ⤷  Start Trial ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA ⤷  Start Trial
Rosemont FIBRICOR fenofibric acid TABLET;ORAL 022418-002 Aug 14, 2009 DISCN Yes No 7,741,374 ⤷  Start Trial ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH ELEVATED CHOLESTEROL AND/OR LIPID LEVELS ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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