Details for Patent: 7,915,247

Which drugs does patent 7,915,247 protect, and when does it expire?

Patent 7,915,247 protects FIBRICOR and is included in one NDA.

Summary for Patent: 7,915,247

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:	US12/141,280
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

United States Patent 7,915,247 Scope, Claims Construction, and US Patent Landscape for 105 mg Immediate-Release Fenofibric Acid

US Patent 7,915,247 is a US method-of-treatment and product-comparator claim set focused on once-daily dosing of an immediate-release 105 mg fenofibric acid dose form with defined excipient ranges and explicit exclusions (no enteric binder, no surfactant). The claim is anchored to a bioequivalence requirement against a 145 mg fenofibrate reference dosage form characterized by sub-2 µm fenofibrate particles and specific surface stabilization ingredients (hypromellose, sodium lauryl sulfate, dioctyl sodium sulfosuccinate). The net effect is that the patent does not merely claim “fenofibric acid 105 mg.” It claims a very specific immediate-release tablet formulation and a cross-formulation equivalence to a particular fenofibrate particle/surface-stabilized composition.

What patents protect 105 mg immediate-release fenofibric acid for primary hypercholesterolemia and hypertriglyceridemia in the US?

Answer: US 7,915,247 protects (i) a specific immediate-release 105 mg fenofibric acid dosing regimen, (ii) a tablet/capsule excipient matrix within tight wt% bands, (iii) negative limitations that exclude enteric binders and surfactants, and (iv) a bioequivalence linkage to a defined 145 mg fenofibrate particle-and-surface-stabilized dosage form.

Core claim elements of US 7,915,247 (as provided)

Claim 1 requires all of the following, in combination:

1. Patient population / indication

   • “A human patient in need of treatment for primary hypercholesterolemia, hypertriglyceridemia, mixed dyslipidemia, or mixed hyperlipidemia.”

2. Method of administration

   • “Orally administering… once daily” the active dose form.

3. Active and dose

   • “Immediate-release 105 mg fenofibric acid dosage form.”

4. Excipient composition ranges

   • Disintegrant: 1 wt% to 30 wt%
   • Filler: 30 wt% to 90 wt%
   • Binder: 0.1 wt% to 20 wt%
   • Lubricant: 0.01 wt% to 10 wt%

5. Negative formulation limitations

   • The dosage form does not include an enteric binder
   • The dosage form does not include a surfactant

6. Bioequivalence requirement

   • The 105 mg fenofibric acid dosage form is bioequivalent to a 145 mg fenofibrate dosage form under:
     • “fasted”
     • “standard or low-fat meal non-fasted” conditions

7. Reference fenofibrate characterization

   • The 145 mg fenofibrate dosage form comprises:
     • fenofibrate particles with effective average particle size < ~2000 nm
     • surface stabilizer with hypromellose + sodium lauryl sulfate + dioctyl sodium sulfosuccinate

How to read the scope in practice

Broadest protection the claim captures

• Any once-daily oral immediate-release regimen using a 105 mg fenofibric acid dose form that meets the excipient wt% ranges and exclusions, and that is demonstrated as bioequivalent to the specific fenofibrate particle/surface-stabilized composition, under the specified feeding conditions.

Narrowest boundary the claim draws

• Any product that fails any one of the four excipient categories (disintegrant/filler/binder/lubricant wt% ranges), includes an enteric binder, includes a surfactant, is not bioequivalent under the defined conditions, or cannot truthfully match the defined comparator fenofibrate particle size/surface stabilizer profile falls outside the claim.

This combination structure is typical of claims meant to reduce “design-around by changing excipients” risk by forcing an equality-style excipient structure plus an equivalence to a defined comparator reference.

Claim construction pressure points (where infringement analysis often turns)

1. “Immediate-release”

   • The claim requires an immediate-release fenofibric acid dose form. Products with modified release or delayed release are excluded even if excipient bands align.

2. “Does not include an enteric binder”

   • Any binder designed to confer enteric protection (polymer systems used for enteric coatings) can become a binary infringement gate. Even trace inclusion questions may be litigated depending on measurement tolerance and prosecution history.

3. “Does not include a surfactant”

   • This is a hard exclusion. Many formulation approaches use surfactants (wetting agents, solubilizers). If a candidate formulation uses an excipient classified as a surfactant, the product likely avoids the claim.

4. Excipient wt% bands

   • The ranges are wide in some categories (filler 30–90 wt%, disintegrant 1–30 wt%), but binding categories like binder (0.1–20 wt%) and lubricant (0.01–10 wt%) still impose constraint.

5. Bioequivalence is an element

   • “Bioequivalent” can create an infringement evidentiary hurdle. A generic or reformulation would need testing data matching the defined feeding conditions. In litigation, pharmacokinetic study design and statistical criteria can become a focal point.

6. Comparator fenofibrate profile

   • The reference fenofibrate is not generic “145 mg fenofibrate.” It is defined by:
     • particle size (<2000 nm effective average)
     • specific surface stabilizer system (hypromellose + SLS + dioctyl sodium sulfosuccinate)
   • This makes the equivalence requirement tethered to a specific formulation archetype.

What formulations are protected by US Patent 7,915,247, and what excipient ranges matter?

Answer: The protected formulation is an immediate-release 105 mg fenofibric acid dosage form whose excipient makeup falls within the specified wt% ranges and which excludes enteric binders and surfactants.

Protected excipient bands (from Claim 1)

Component	Range (wt%)	Claim language
Disintegrant	1% to 30%	“comprises 1 wt % to 30 wt % of a disintegrant”
Filler	30% to 90%	“comprises 30 wt % to 90 wt % of a filler”
Binder	0.1% to 20%	“comprises 0.1 wt % to 20 wt % of a binder”
Lubricant	0.01% to 10%	“comprises 0.01 wt % to 10 wt % of a lubricant”

Exclusions that can enable design-arounds

Exclusion	Effect on scope
Enteric binder not included	Blocks enteric-coated or enteric-protection binder approaches
Surfactant not included	Blocks inclusion of typical wetting/solubilizing excipients labeled as surfactants

Immediate-release and dosing frequency

The claim locks the route (“orally”), dosing frequency (“once daily”), and release profile (“immediate-release”). Extended release, delayed release, or alternate dosing frequency would be outside.

Evidence needed to prove infringement for formulation similarity

Given the express exclusions and numeric bands, infringement analysis usually uses:

• formulation composition analysis (lab testing or manufacturing disclosure)
• release classification evidence (dissolution profiles, label claims)
• excipient identity evidence (whether an ingredient qualifies as a surfactant or enteric binder)
• PK study data supporting bioequivalence to the comparator fenofibrate formulation under fasted and low-fat/non-fasted conditions

How does US 7,915,247 require fenofibrate bioequivalence, and how tight is the particle-size/surface-stabilizer limitation?

Answer: The claim makes bioequivalence to a specific fenofibrate formulation an element. The comparator fenofibrate is defined by fenofibrate particles with effective average particle size < ~2000 nm and by a surface stabilizer comprising hypromellose, sodium lauryl sulfate, and dioctyl sodium sulfosuccinate.

Comparator definition embedded in Claim 1

The claim uses this language to define the comparator:

• “145 mg fenofibrate dosage form”
• comprises:
  • “particles of fenofibrate having an effective average particle size of less than about 2000 nm”
  • “surface stabilizer comprising hypromellose, sodium lauryl sulfate and dioctyl sodium sulfosuccinate”

Why the comparator is likely doing substantial claim-limiting work

Without the particle size and surface stabilizer definition, “bioequivalent to 145 mg fenofibrate” could be broad and cover multiple product lines. By anchoring to a specific particle/surface-stabilizer architecture, the claim constrains what “bioequivalent” can mean in practice.

Typical litigation focal points that follow from this structure

• Is the accused product bioequivalent to the specified comparator under fasted and fed low-fat/non-fasted conditions?
• Does the comparator fenofibrate product in question actually meet the <2000 nm effective average particle size and the exact stabilizer system?
• Are PK study designs comparable, and do they use the same or sufficiently similar reference product?

What patents could overlap with US 7,915,247 around fenofibric acid 105 mg immediate-release tablets?

Answer: Overlap risk typically comes from three patent “lanes” that usually coexist for this product space: (i) fenofibric acid formulation excipient/exclusion patents, (ii) particle-engineering and stabilizer-system patents for fenofibrate 145 mg formulations, and (iii) method-of-use claims for lipid disorders using fenofibric acid. The claim’s bioequivalence linkage also creates overlap with patents focused on PK/bioequivalence strategy.

Likely overlapping categories (based on claim architecture)

1. Formulation patents for fenofibric acid immediate-release dose forms

   • excipient ranges
   • release profile (immediate-release)
   • avoidance of enteric binder and surfactants
   • compression/granulation/manufacturing routes that yield those excipient distributions

2. Fenofibrate 145 mg particle-size and surface stabilization patents

   • nanoscale/submicron particle engineering (<2000 nm)
   • stabilizer system reciting hypromellose + SLS + dioctyl sodium sulfosuccinate
   • manufacturing methods to maintain particle stabilization

3. Method-of-treatment patents for lipid indications

   • hypercholesterolemia/hypertriglyceridemia/mixed dyslipidemia claims
   • “once daily oral” constraints

4. Bioequivalence-driven claims

   • dosing strength mapping (105 mg fenofibric acid vs 145 mg fenofibrate)
   • test condition limitations (fasted vs standard/low-fat meal non-fasted)

Landscape implications for infringement and freedom-to-operate

A product that changes excipient class to include a surfactant or an enteric binder can sometimes avoid the fenofibric-acid formulation limitation. But any attempt to use a compliant fenofibric formulation while still achieving bioequivalence can trigger the comparator-lane.

Conversely, products engineered to match bioequivalence but with excluded ingredients still avoid the claim.

The claim’s strength is the combination: formulation restrictions plus a bioequivalence tether to a constrained comparator.

When does US Patent 7,915,247 lose exclusivity, and what regulatory milestones drive generic risk?

Answer: Exclusivity timelines, expiration date, and regulatory trigger for US generic entry cannot be provided from the claim text alone. The claim does not contain filing date, priority, term adjustment, pediatric exclusivity, or patent listing status (Orange Book) needed to compute exclusivity end dates or to time Paragraph IV/TH segment risk.

What is the Orange Book status of US Patent 7,915,247 for fenofibric acid 105 mg?

Answer: Orange Book listing status and associated FDA references are not contained in the claim text provided. Without the specific FDA reference product, application number, and listing identifiers, an Orange Book status determination cannot be produced.

How strong is the patent estate for 105 mg fenofibric acid versus generic launch risk?

Answer: The enforceable strength of US 7,915,247, based on Claim 1 structure, is high at the element-combination level. It is hard for a would-be entrant to match all limitations simultaneously: immediate-release 105 mg strength, once-daily oral dosing, excipient wt% bands, no enteric binder, no surfactant, and demonstrated bioequivalence under fasted and standard/low-fat fed non-fasted conditions to a defined fenofibrate particle/surface-stabilized reference.

However, “hard” in infringement terms does not equate to “broad” in legal scope; the claim is product- and evidence-constrained. The practical risk to generics depends on whether their formulation includes excluded elements and whether their PK profile is engineered to meet the constrained bioequivalence requirement.

What patent litigation affects US 7,915,247 and its fenofibrate comparator bioequivalence?

Answer: Litigation posture, court rulings, claim construction outcomes, settlement agreements, and Paragraph IV triggers are not present in the provided claim text. Those items cannot be stated from the claim alone.

Which companies are challenging this patent, and what settlements exist?

Answer: Parties, defendants, or settlement terms are not identified in the provided claim text. This information cannot be produced.

How does US 7,915,247 compare with other fenofibric acid or fenofibrate patents in the US?

Answer: US 7,915,247 is distinguished by its explicit coupling of:

• a specific fenofibric acid immediate-release formulation parameter set (excipient wt% ranges + exclusions), and
• a fenofibrate bioequivalence comparator defined by particle size and surface stabilizers.

Many fenofibric acid formulation patents stop at excipients and release profile. Many fenofibrate patents stop at particle size and stabilizer systems. This claim links the two via bioequivalence and a mapped dose-strength relationship (105 mg fenofibric acid to 145 mg fenofibrate), making it structurally less common and more evidentiary in infringement.

Key Takeaways

• US 7,915,247 Claim 1 is a combination claim: immediate-release once-daily 105 mg fenofibric acid plus specific excipient wt% bands plus hard exclusions (no enteric binder, no surfactant) plus a bioequivalence requirement to a defined 145 mg fenofibrate formulation.
• The comparator is limited: fenofibrate particles with effective average particle size < ~2000 nm and a surface stabilizer comprising hypromellose, sodium lauryl sulfate, and dioctyl sodium sulfosuccinate.
• The claim’s practical infringement analysis is likely to hinge on formulation composition (including whether any ingredient qualifies as a surfactant or enteric binder) and PK bioequivalence evidence under fasted and standard/low-fat fed non-fasted conditions.
• Exclusivity timing, Orange Book status, litigation, and challengers cannot be derived from the claim text alone.

FAQs

1) Does Claim 1 cover extended-release or delayed-release fenofibric acid?
No. The claim requires an “immediate-release” 105 mg fenofibric acid dosage form.

2) Can a formulation include a surfactant and still infringe?
No. Claim 1 expressly excludes a surfactant from the 105 mg fenofibric acid dosage form.

3) Is bioequivalence to “any” 145 mg fenofibrate sufficient?
No. The claim ties bioequivalence to a 145 mg fenofibrate dosage form defined by <~2000 nm particle size and a specific surface stabilizer system (hypromellose, sodium lauryl sulfate, dioctyl sodium sulfosuccinate).

4) If the excipient ranges are met but dosing is not once daily, does it infringe?
No. Once-daily oral administration is an express claim limitation.

5) What is the tightest technical limitation in the comparator definition?
The effective average particle size (< about 2000 nm) and the exact surface stabilizer composition (hypromellose + sodium lauryl sulfate + dioctyl sodium sulfosuccinate) are the comparator’s defining constraints.

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References

1. United States Patent 7,915,247. (Claim 1 text provided in prompt).

Drugs Protected by US Patent 7,915,247

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						ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA
Rosemont	FIBRICOR	fenofibric acid	TABLET;ORAL	022418-001	Aug 14, 2009		DISCN	Yes	No						ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA
Rosemont	FIBRICOR	fenofibric acid	TABLET;ORAL	022418-001	Aug 14, 2009		DISCN	Yes	No						ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS
Rosemont	FIBRICOR	fenofibric acid	TABLET;ORAL	022418-002	Aug 14, 2009		DISCN	Yes	No						ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS
Rosemont	FIBRICOR	fenofibric acid	TABLET;ORAL	022418-002	Aug 14, 2009		DISCN	Yes	No						ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA