Details for Patent: 9,265,725

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Which drugs does patent 9,265,725 protect, and when does it expire?

Patent 9,265,725 protects FINACEA and is included in one NDA.

This patent has one hundred and thirty-seven patent family members in twenty countries.

Summary for Patent: 9,265,725

Title:	Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
Abstract:	The present invention teaches a foamable pharmaceutical carrier comprising a benefit agent, selected from the group consisting of a dicarboxylic acid and a dicarboxylic acid ester; a stabilizer selected from the group consisting of at least one surface-active agent; at least one polymeric agent and mixtures thereof; a solvent selected from the group consisting of water, a hydrophilic solvent, a hydrophobic solvent, a potent solvent, a polar solvent, a silicone, an emollient, and mixtures thereof, wherein the benefit agent, stabilizer and solvent are selected to provide a composition that is substantially resistant to aging and to phase separation and or can substantially stabilize other active ingredients. The invention further relates to a foamable composition further containing a liquefied hydrocarbon gas propellant.
Inventor(s):	Dov Tamarkin, Doron Friedman, Tal Berman, Enbal Ziv, David Schuz
Assignee:	Vyne Therapeutics Inc
Application Number:	US11/825,406
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,265,725
Patent Claim Types: see list of patent claims	Composition; Compound;

US Patent 9,265,725: Azelaic Acid Foam Composition Scope, Claims, Expiration and Competitive Patent Landscape

US Patent 9,265,725 protects a narrowly defined azelaic-acid foam platform associated with Finacea Foam. Its independent claims require a specific excipient system, approximate concentrations, a carrier pH of 4.5 to 5.3, and, for the composition claim, a propellant concentration of 3% to 25% by weight. The patent does not claim azelaic acid treatment generally. It targets the formulation architecture and its foamable delivery system.

The principal commercial risk is composition infringement by a product that reproduces the claimed excipient profile within the legally operative meaning of “about.” A product using the same active ingredient but a materially different vehicle, pH, propellant system, or excipient concentration may avoid literal infringement, although the doctrine of equivalents remains relevant.

What does US Patent 9,265,725 protect?

US 9,265,725 protects two related categories:

1. A propellant-containing foamable composition.
2. A propellant-free foamable carrier capable of forming the composition when combined with a propellant.

The core formulation contains:

Component	Claimed amount or limitation
Azelaic acid	About 15% by weight
Medium-chain triglycerides	About 11%
Propylene glycol	About 11%
Dimethyl isosorbide	About 5%
PEG-40 stearate	About 3%
Cetostearyl alcohol	About 1%
Polysorbate 80	About 1%
Monoglyceride, diglyceride, or combination	About 0.5%
Xanthan gum	About 0.3%
Methylcellulose	About 0.1%
Benzoic acid	About 0.1%
Water	Required, quantity not numerically fixed
Sodium hydroxide	Required, quantity not numerically fixed
Carrier pH	About 4.5 to 5.3
Propellant, claim 1 only	About 3% to 25% of total composition

The claims identify caprylic/capric triglycerides as a preferred medium-chain triglyceride and glyceryl stearate as a preferred monoglyceride.

How are the independent claims structured?

Claim 1: propellant-containing foamable composition

Claim 1 requires all of the following:

• A foamable composition.
• A formable carrier.
• A propellant.
• The specified azelaic acid formulation.
• A carrier pH of approximately 4.5 to 5.3.
• A propellant level of approximately 3% to 25% by weight of the total composition.

The claim is a closed practical recipe only in part. It recites each listed ingredient but does not expressly exclude additional ingredients. A competing formulation could therefore contain preservatives, fragrances, stabilizers, or other excipients and still fall within the claim if it retains the required elements and ranges.

The claim does not require a particular foam density, collapse time, particle size, spray pattern, viscosity, or clinical result. Those omitted performance limitations generally cannot be imported into the claim from the specification.

Claim 5: propellant-free foamable carrier

Claim 5 covers the same carrier without requiring a propellant. This is strategically important because it can reach:

• A bulk carrier manufactured before propellant filling.
• A pharmaceutical intermediate supplied to a contract manufacturer.
• A carrier packaged in a separate propellant system.
• A formulation that is later converted into a finished foam.

Claim 5 requires the same ingredient set and pH range as claim 1 but does not impose the 3% to 25% propellant limitation.

How narrow are the dependent claims?

Claims 2 through 4 narrow claim 1. Claims 6 through 8 narrow claim 5.

Claim	Narrowing limitation
1	Full propellant-containing composition
2	Medium-chain triglycerides specified as caprylic/capric triglycerides
3	Monoglyceride specified as glyceryl stearate
4	Both caprylic/capric triglycerides and glyceryl stearate
5	Propellant-free carrier
6	Caprylic/capric triglycerides
7	Glyceryl stearate
8	Both caprylic/capric triglycerides and glyceryl stearate

Claims 4 and 8 are the narrowest disclosed combinations. They may have greater technical distinctiveness but cover fewer commercial formulations.

What is the likely meaning of “about” in the patent claims?

“About” gives the patentee some tolerance around the stated numerical values, but the claims do not establish a single universal percentage margin. The scope depends on intrinsic evidence, including:

• The specification’s examples.
• Manufacturing tolerances.
• Measurement precision.
• Whether the formulation performs as the disclosed foam system.
• The prosecution history.
• The way a skilled formulation scientist would understand the range.

A formulation containing 14.8% azelaic acid is a strong literal-infringement candidate. A formulation containing 12% or 18% azelaic acid presents a more substantial claim-construction dispute. The same analysis applies to the excipient concentrations and pH.

The presence of “about” does not convert each limitation into an unlimited range. Courts generally interpret the term in context rather than as a blank check for substantial variation.

Which formulation elements create the principal infringement risk?

The highest-risk formulation is one that reproduces the full combination:

• 15% azelaic acid;
• approximately 11% caprylic/capric triglycerides;
• approximately 11% propylene glycol;
• approximately 5% dimethyl isosorbide;
• approximately 3% PEG-40 stearate;
• approximately 1% cetostearyl alcohol;
• approximately 1% polysorbate 80;
• approximately 0.5% glyceryl stearate;
• approximately 0.3% xanthan gum;
• approximately 0.1% methylcellulose;
• approximately 0.1% benzoic acid;
• water and sodium hydroxide;
• carrier pH of approximately 4.5 to 5.3; and
• a qualifying propellant concentration.

The claim uses functional and generic ingredient categories in several places. “Medium-chain triglycerides” is broader than caprylic/capric triglycerides. “A monoglyceride, a diglyceride, or a combination” is broader than glyceryl stearate. “A cetostearyl alcohol” covers the specified alcohol category without limiting the claim to a particular commercial grade.

What are the principal design-around strategies?

A design-around program would normally focus on changing claim limitations rather than merely changing trade names or suppliers.

Design-around lever	Potential effect
Replace or materially reduce medium-chain triglycerides	May remove a required claim element or move outside the “about 11%” range
Replace dimethyl isosorbide	Removes a specifically recited carrier component
Use a different surfactant system	May avoid PEG-40 stearate, polysorbate 80, or both
Remove the monoglyceride/diglyceride component	Eliminates a required element
Use a different thickener system	May avoid xanthan gum and methylcellulose limitations
Change pH outside 4.5 to 5.3	Potentially avoids the pH limitation
Use a propellant level below 3% or above 25%	Potentially avoids claim 1, but not claim 5
Deliver a non-foam formulation	May avoid both composition categories if no foamable carrier exists
Use a different active concentration	May move outside the claimed azelaic-acid range
Formulate a different carrier and use a separate delivery technology	May reduce overlap with claims 1 through 8

Changes should be evaluated against literal infringement and equivalents. Merely replacing a raw-material supplier, adjusting water content, or adding an unclaimed excipient is unlikely to create a reliable design-around if the required formulation remains materially unchanged.

What is the relationship between US 9,265,725 and azelaic acid foam products?

The patent is directed to the formulation technology used for a 15% azelaic acid foam product, commercially associated with Finacea Foam. FDA approved Finacea Foam under NDA 208351 for topical treatment of mild-to-moderate rosacea in adults. The product contains azelaic acid at 15% in a foam vehicle. FDA approval records identify the drug, sponsor, dosage form, strength, and approval history; the patent analysis must be performed separately from the labeling record because FDA approval does not determine infringement. (U.S. Food and Drug Administration, n.d.-a)

The patent claims are formulation claims. They do not expressly claim:

• Treatment of rosacea.
• Treatment of acne.
• Treatment of hyperpigmentation.
• A method of applying azelaic acid to skin.
• A particular dosing schedule.
• A particular disease population.

A separate patent or regulatory exclusivity right could cover method of use, but those rights are not present in the text of claims 1 through 8 supplied here.

What is the Orange Book status of US 9,265,725?

Finacea Foam is an FDA-approved drug product eligible for Orange Book analysis. Orange Book listings identify patents submitted by the NDA holder and categorize them by patent type, including formulation, drug substance, method of use, and product-by-process categories. The current Orange Book entry, not the patent claims alone, controls whether a patent is formally listed against a specific NDA product. (U.S. Food and Drug Administration, n.d.-b)

US 9,265,725 is associated with the azelaic acid foam formulation and has been treated in the commercial patent landscape as a product or formulation patent relevant to Finacea Foam. The exact current listing status, expiration field, and any delisting or correction should be checked against the current electronic Orange Book and the FDA patent listing data.

The Orange Book issue is commercially significant because a generic applicant filing an ANDA for a product referencing Finacea Foam may have to address listed patents through:

• Paragraph I certification, if the patent is not listed as relevant;
• Paragraph II certification, if the patent has expired;
• Paragraph III certification, if the applicant will wait until expiry; or
• Paragraph IV certification, if the applicant asserts that the patent is invalid, unenforceable, or not infringed.

When does US 9,265,725 lose exclusivity?

The patent’s nominal expiration is expected to fall in 2027 based on the patent family’s earliest priority date, subject to any patent-term adjustment or patent-term extension reflected in USPTO records. A precise expiration date should be taken from the USPTO Patent Center term data and the Orange Book patent listing.

Patent expiration is distinct from FDA regulatory exclusivity. Finacea Foam received three-year new-drug exclusivity associated with the approval of a new dosage form or formulation. That period does not extend the patent term and does not prevent all later products in the broader azelaic acid market. It can, however, affect the timing of certain ANDA approvals. (U.S. Food and Drug Administration, n.d.-a)

The relevant exclusivity layers are therefore:

Right	Scope	Commercial effect
Patent term	Claimed formulation and carrier	Can block infringing products until expiration
New-drug exclusivity	FDA approval-specific	Can delay certain abbreviated approvals
Orange Book listing	NDA-linked patent notice	Triggers certification and possible litigation
Trade secret or manufacturing know-how	Process and scale-up information	May increase development cost without creating a public patent barrier

Which companies are challenging the patent?

The supplied record does not identify a Paragraph IV filer, ANDA sponsor, district-court case, or settlement agreement directed specifically to US 9,265,725. No challenge should be attributed to a particular generic company without a verified FDA, court, or Orange Book record.

A Paragraph IV challenge would likely attack the patent on several grounds:

1. Anticipation by an earlier azelaic acid foam formulation.
2. Obviousness based on known topical excipients and aerosol vehicles.
3. Lack of written description for the full combination or claimed ranges.
4. Enablement of the full scope of the “about” ranges.
5. Indefiniteness of numerical terms such as “about.”
6. Noninfringement based on a changed excipient, concentration, pH, or propellant level.

The strongest patentee position is likely the full combination of ingredients and pH. The strongest challenger position is likely obviousness, because many individual ingredients are conventional in topical pharmaceutical formulation. The outcome would turn on whether the combination produced an unexpected formulation benefit supported by the specification and prosecution record.

How strong is the patent estate?

US 9,265,725 has a focused but commercially meaningful claim set.

Strength factor	Assessment
Claim specificity	High; numerous required ingredients and numerical limitations
Breadth	Moderate to narrow
Design-around exposure	Material
Product relevance	High for a matching 15% azelaic acid foam
Process protection	Limited in the supplied claims
Method-of-use protection	None in claims 1 through 8
Carrier protection	Stronger because claim 5 omits the propellant limitation
Obviousness exposure	Potentially significant because excipients are known
Biosimilar relevance	None; azelaic acid is a small-molecule active
Generic relevance	High for an ANDA referencing the foam product

The separate carrier claim is the most important structural element. It prevents a competitor from avoiding claim 1 solely by arguing that its manufacturing or packaging process adds the propellant later. A competitor still may avoid claim 5 by materially changing the carrier composition or pH.

What patent litigation and settlement risks affect generic entry?

A Paragraph IV notice concerning a listed patent can trigger a 45-day period for the NDA holder to bring an infringement action. A timely action generally creates a 30-month stay of ANDA approval, subject to statutory exceptions and court developments. (U.S. Food and Drug Administration, n.d.-b)

Potential settlement structures include:

• A licensed generic launch date before patent expiration.
• A delayed-entry agreement.
• A formulation-specific covenant not to sue.
• A settlement limited to a non-infringing product design.
• A supply or authorized-generic arrangement.

No settlement should be assumed for US 9,265,725 without a filed court document, FTC review record, or public company disclosure.

How does US 9,265,725 compare with broader azelaic acid patent coverage?

The patent is narrower than a patent claiming azelaic acid as an active ingredient or a method of treating rosacea. Its commercial value comes from covering a particular foam vehicle that may be difficult to replicate while maintaining stability, feel, spreadability, and aerosol performance.

A competitor could potentially enter the azelaic acid market through:

• A cream, gel, lotion, suspension, or non-foam dosage form.
• A foam with a materially different carrier.
• A different azelaic acid concentration.
• A different propellant or propellant level.
• A different pH and buffering system.
• A product approved through a pathway other than an ANDA, depending on product classification and regulatory equivalence.

The patent therefore creates a product-specific barrier rather than a market-wide barrier to azelaic acid.

What manufacturing and intellectual-property barriers remain after patent expiry?

Patent expiry would remove the principal statutory exclusion right for the claimed formulation, but technical barriers may remain:

• Reproducing foam texture and collapse behavior.
• Maintaining azelaic acid uniformity.
• Controlling pH while avoiding irritation.
• Managing propellant compatibility.
• Achieving commercial-scale filling consistency.
• Matching container-valve performance.
• Demonstrating pharmaceutical equivalence and product quality.
• Obtaining FDA approval for the proposed generic or follow-on product.

Manufacturing know-how may remain valuable after patent expiry, but it cannot extend the patent term. A generic applicant must also assess any other unexpired formulation, container, method-of-use, or manufacturing patents listed against the reference product.

What is the revenue exposure from this patent?

The patent’s revenue exposure is concentrated in the branded azelaic acid foam franchise rather than the entire azelaic acid market. Exposure depends on:

• Net sales of Finacea Foam.
• The share of sales attributable to the patented foam formulation.
• The timing of generic filings.
• The number of viable non-infringing designs.
• The remaining patent term.
• Any authorized-generic or settlement arrangement.
• Payer substitution after generic approval.

The patent does not block generic azelaic acid creams or gels that do not practice the claimed foam carrier. Its financial importance is therefore linked to substitution for the specific foam product.

Key Takeaways

• US 9,265,725 is a formulation patent, not a broad azelaic acid or rosacea-treatment patent.
• Claims 1 and 5 are the commercial anchors.
• Claim 1 requires a propellant; claim 5 protects the carrier without one.
• The formulation is defined by a dense combination of excipients, approximate percentages, sodium hydroxide, water, and pH 4.5 to 5.3.
• Claims 4 and 8 narrow the formulation to caprylic/capric triglycerides and glyceryl stearate.
• A product with the same active ingredient but a materially different vehicle may avoid literal infringement.
• A product that reproduces the full excipient profile within the operative meaning of “about” presents substantial infringement risk.
• The nominal patent term is expected to end in 2027, subject to USPTO term adjustments.
• FDA exclusivity and patent term are separate rights.
• No biosimilar pathway is relevant because azelaic acid is a small molecule.
• The principal competitive threat is an ANDA applicant using a Paragraph IV certification or developing a non-infringing foam vehicle.
• Current Orange Book listing and litigation status must be verified against FDA and court records before making a launch or freedom-to-operate decision.

FAQs

Does US 9,265,725 cover all 15% azelaic acid foams?

No. It covers a foam formulation containing the specified carrier components, approximate concentrations, pH, and, under claim 1, propellant concentration. A different 15% azelaic acid foam may avoid the claims.

Can a company avoid claim 1 by adding a different preservative?

Usually not by addition alone. The claims do not exclude additional ingredients. The competing product would need to remove or materially alter a required limitation.

Does claim 5 cover a finished aerosol can?

It can, if the finished product contains the claimed carrier. Claim 5 does not require a propellant, so it may reach the carrier before or after propellant incorporation.

Is glyceryl stearate required in every asserted claim?

No. Claims 1, 2, 5, and 6 permit the broader monoglyceride, diglyceride, or combination language. Glyceryl stearate is required only by claims 3, 4, 7, and 8.

Can patent expiry eliminate all barriers to a generic Finacea Foam product?

No. Expiry removes the patent exclusion right for the expired claims. FDA approval, pharmaceutical equivalence, manufacturing validation, container performance, and any other unexpired listed patents remain separate issues.

References

1. U.S. Patent and Trademark Office. (2016). U.S. Patent No. 9,265,725, Foamable compositions and methods of use thereof. U.S. Department of Commerce.

2. U.S. Food and Drug Administration. (n.d.-a). Drugs@FDA: Finacea Foam, NDA 208351. U.S. Department of Health and Human Services.

3. U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.

4. U.S. Code, 35 U.S.C. § 154. Patent term.

5. U.S. Code, 21 U.S.C. § 355. New drug applications and abbreviated applications.

Drugs Protected by US Patent 9,265,725

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 9,265,725

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Israel	152486	Oct 25, 2002

International Family Members for US Patent 9,265,725

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003279493
Australia	2004261063
Australia	2004266502