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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 |
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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:
Claim 1 vs claim 2: indication scope
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” metricThe “immediate release” term is anchored by objective performance criteria:
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:
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
Formulation design paths that typically reduce claim exposure
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:
Claim 2: “mixed dyslipidemia”This is more specific and maps to mixed hyperlipidemia diagnoses and related clinical conditions. Key practical point for enforcementEven 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
Litigation postureBecause the threshold is numeric and time-bound, infringement and non-infringement can pivot on:
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:
Exclusivity vs patent coverage
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:
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
2) Method-of-treatment patents
3) Dissolution and release-profile patents
4) Manufacturing process patents
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:
In practice, exposure includes:
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
Lower infringement risk when any element is materially different
Paragraph IV and litigation posture (conceptual)A typical Paragraph IV strategy for method-of-use patents is to challenge:
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
2) Technical infringement: dissolution/release measurement replication
3) Validity: prior art dissolution and dosing instructionsThe strongest validity attacks often cite earlier disclosures of:
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:
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:
Key Takeaways
FAQs1) Does US 7,741,374 cover fenofibric acid formulations that release less than 90% at 2 hours? 2) Can a company avoid infringement by dosing fenofibric acid 105 mg only with meals? 3) Are the method claims limited to specific FDA-approved indications? 4) How important is the “single pH buffer” element to claim scope? 5) What is the main evidentiary focus in a dispute over these method claims? More… ↓ |
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 |
