Details for Patent: 7,179,475

Summary for Patent: 7,179,475

Title:	Anhydrous topical skin preparations
Abstract:	The present invention provides anhydrous compositions for topical delivery of a medicament comprising (A) a penetration enhancer/solvent selected from the group consisting of alcohol, propylene glycol, or a combination thereof; (B) a humectant/solvent selected from the group consisting of polyethylene glycol, glycerin, sorbitol, xylitol, or any combination of any of the foregoing; and (C) an anhydrous vehicle. In an alternate embodiment, the present invention provides anhydrous compositions for topical delivery of a medicament which comprise (A) a penetration enhancer/solvent selected from the group consisting of alcohol, propylene glycol, or a combination thereof; (B) a humectant/solvent selected from the group consisting of polyethylene glycol, glycerin, sorbitol, xylitol or any combination of any of the foregoing; (C) an anhydrous vehicle; and (D) a medicament. Also provided are methods for topically delivering a medicament to an animal, such as a mammal or a human patient, in need of the medicament by topically administering to the animal the compositions of the present invention.
Inventor(s):	Katherine M. Burnett, Ellen S. Kurtz
Assignee:	Kenvue Brands LLC
Application Number:	US09/562,376
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;

US Patent 7,179,475: Ketoconazole Gel Claims, Patent Scope, Expiration and Generic Entry Risk

US Patent 7,179,475 covers a narrow, anhydrous ketoconazole topical gel containing a defined combination of solvents, humectants, surfactant, polymer, antioxidants and acidulants. The patent is materially narrower than a patent covering ketoconazole itself or all ketoconazole topical formulations. Its ordinary 20-year patent term expired in 2022, eliminating current US exclusionary rights unless an unusual patent-term adjustment or extension applied. The claims remain relevant for historical Orange Book analysis, freedom-to-operate reviews and prosecution-history analysis, but they do not independently block a current generic launch.

What does US Patent 7,179,475 protect?

The patent protects a specific anhydrous gel composition and methods of using that composition for fungal skin disorders.

The independent composition claim requires every one of the following:

Required element	Claim limitation
Dosage form	Topical gel
Water status	Anhydrous
Antifungal	Ketoconazole
Solvents and humectants	Propylene glycol, polyethylene glycol and glycerin
Alcohol	1% to 50% by weight ethanol
Surfactant or emollient	PPG-15 stearyl ether
Gelling agent	Hydroxypropyl cellulose
Antioxidant or stabilizer	Ascorbic acid and butylated hydroxytoluene
Acidulant	Citric acid
Composition format	"Consisting of" the listed components

Claim 1 is the core composition claim. Claim 2 adds at least one colorant, fragrance, UV stabilizer or sunscreen. Claim 3 narrows claim 2 to at least one colorant.

The patent does not claim:

• Ketoconazole generally;
• All 2% ketoconazole gels;
• Ketoconazole creams, foams, shampoos, solutions or lotions;
• Aqueous ketoconazole formulations;
• Formulations using carbomer, poloxamer or another polymer instead of hydroxypropyl cellulose;
• Formulations using a different surfactant instead of PPG-15 stearyl ether;
• Oral, injectable or other non-topical dosage forms.

How narrow are the composition claims?

The claims are narrow because they combine a formulation architecture with multiple mandatory excipients.

A competing product would generally need to satisfy all limitations of claim 1, or all limitations of claim 2 or 3, to present a literal infringement issue. Removing or replacing a single required component can avoid literal infringement, subject to the construction of the claim and any doctrine-of-equivalents analysis.

The most commercially significant limitations are:

1. Anhydrous status. A formulation containing water is outside the ordinary literal scope of the anhydrous limitation.
2. Gel dosage form. A cream, foam, shampoo or liquid solution is not ordinarily a gel.
3. PPG-15 stearyl ether. This is a distinctive formulation limitation that narrows the claim substantially.
4. Hydroxypropyl cellulose. A different gelling polymer may avoid literal infringement.
5. Ascorbic acid, BHT and citric acid. Each is separately required in claim 1.
6. Closed claim format. The word "consisting of" generally excludes additional unrecited ingredients that materially alter the claimed composition.

The presence of a ketoconazole concentration within the claimed range is not enough. A product with 2% ketoconazole but without PPG-15 stearyl ether, hydroxypropyl cellulose, ascorbic acid, BHT or citric acid would not meet claim 1 as written.

What formulation ranges are protected?

Claims 5 through 20 create nested concentration limitations.

Ingredient	Claimed range or amount
Ketoconazole	About 0.5% to about 3%
Ketoconazole preferred amount	About 2.0%
Polyethylene glycol	About 10% to about 80%
Polyethylene glycol preferred amount	About 20%
Propylene glycol	About 1% to about 50%
Propylene glycol preferred amount	About 20%
Glycerin	About 10% to about 80%
Glycerin preferred amount	About 20%
PPG-15 stearyl ether	Greater than 0% to about 2%
PPG-15 stearyl ether preferred amount	About 2%
Hydroxypropyl cellulose	About 1.5% to about 2.0%
Ascorbic acid	Greater than 0% to about 0.3%
Ascorbic acid preferred amount	About 0.3%
Citric acid	Greater than 0% to about 0.5%
Citric acid preferred amount	About 0.1%
BHT	Greater than 0% to about 0.1%
Ethanol	About 1% to about 50%

The claims use "about," which creates a fact-dependent boundary rather than a rigid numerical cutoff. A court would evaluate the specification, prosecution history, analytical measurement method and the technical meaning of the term in the formulation field.

Claims 6, 8, 10, 12, 14, 17, 18 and 20 are narrower species claims. A formulation falling within a dependent claim also falls within the broader claim from which it depends, assuming the broader claim is valid and enforceable.

What is the scope of the method-of-use claims?

Claims 21 through 30 cover topical administration of the claimed composition.

The method claims target:

• Treatment of skin fungal disorders;
• Human treatment;
• Seborrheic dermatitis;
• Infections associated with Trichophyton rubrum or Pityrosporum ovale;
• Tinea corporis;
• Tinea cruris;
• Tinea pedis.

The method claims are composition-dependent. They do not independently cover administering any ketoconazole product for seborrheic dermatitis. The administered product must first satisfy the composition limitations incorporated from claims 1, 2 or 3.

This structure limits enforcement against a generic product. A method claim may be relevant where the product label directs use for a patented indication, but the manufacturer must still establish that the product has the claimed formulation. A generic ketoconazole product with a different formulation does not meet the method claims merely because it treats the same disorder.

Does "consisting of" exclude additional excipients?

Generally, yes. "Consisting of" is a closed transitional phrase in a composition claim. It normally excludes additional ingredients that materially affect the basic and novel characteristics of the claimed composition.

That limitation creates design-around opportunities. A formulation containing a required preservative, penetration enhancer, fragrance, chelating agent or other excipient may fall outside the literal scope of claim 1 if the additional component is not permitted by the claim.

Claim 2 is also closed, but it expressly permits at least one member of a limited group: colorant, fragrance, UV stabilizer or sunscreen. It does not automatically authorize every conventional cosmetic or pharmaceutical excipient.

The analysis becomes fact-specific where an additional ingredient is present in a trace amount, is an impurity, is generated during manufacture or is inherent in a listed component. The patent's specification and prosecution record would control the interpretation.

When did US Patent 7,179,475 lose exclusivity?

The ordinary US patent term for a utility patent is 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, patent-term extension and terminal-disclaimer rules.[2]

The ordinary term for US 7,179,475 ended in 2022 based on the patent's filing chronology. No current commercial exclusivity should be attributed to the patent after that date absent a specific USPTO term-adjustment record establishing a later expiration.

Event	Timing
US patent application filing	2002
Patent issuance	March 20, 2007
Ordinary 20-year term endpoint	2022
Current status for launch analysis	Expired under ordinary term calculation

Patent expiration does not invalidate the patent's historical relevance. It removes the right to exclude future conduct after expiration. Claims may still matter in disputes concerning conduct before expiration, damages periods, license obligations or contractual covenants.

What was the FDA and Orange Book significance?

The patent is a formulation patent, not an active-ingredient patent. Its FDA relevance depends on whether it was listed against a specific approved drug application.

FDA Orange Book listings are tied to approved drug products and generally include patents claiming the drug substance, drug product or approved method of use under the applicable listing rules.[3] A formulation patent does not automatically appear in the Orange Book merely because it concerns an FDA-approved topical product.

The commercially relevant ketoconazole topical product associated with this field is Xolegel, a 2% ketoconazole gel approved for seborrheic dermatitis under NDA 21-613.[4] FDA labeling and Drugs@FDA records should be distinguished from the patent claims:

• FDA approval establishes safety, efficacy and quality for the approved product.
• The patent determines the claimed technical subject matter.
• Orange Book listing establishes the patent certification framework for an ANDA applicant.
• FDA approval does not establish that every approved ketoconazole gel infringes this patent.

For a Paragraph IV analysis, the applicant would evaluate each listed patent claim and certify that the patent is invalid, unenforceable or will not be infringed. A Paragraph IV notice can trigger patent litigation under the Hatch-Waxman framework, but an expired patent cannot support a current 30-month stay in the same manner as an unexpired listed patent.[5]

What Paragraph IV and generic entry risks existed?

During the patent term, a generic applicant targeting a listed ketoconazole gel could have pursued several noninfringement positions:

Design-around position	Relevance
Use an aqueous formulation	Challenges the anhydrous limitation
Use a cream, foam, shampoo or solution	Challenges the gel limitation
Replace hydroxypropyl cellulose	Removes a required polymer
Replace PPG-15 stearyl ether	Removes a distinctive required excipient
Omit ascorbic acid, BHT or citric acid	Removes mandatory claim elements
Use a different solvent or humectant system	Removes mandatory composition elements
Add unrecited excipients	Tests the closed "consisting of" language
Use a different ketoconazole concentration	May avoid dependent concentration claims, but not necessarily claim 1

A validity challenge could have focused on anticipation, obviousness, written description, enablement and claim construction. The dense combination of excipients makes anticipation more difficult if no single prior-art reference disclosed the complete formulation. Obviousness would turn on whether the prior art suggested combining the specific solvents, stabilizers, polymer and surfactant with a reasonable expectation of producing a stable anhydrous ketoconazole gel.

The patent's commercial strength was therefore narrower than its claim count might suggest. Thirty claims do not create thirty independent barriers. Claims 2 through 20 largely create fallback concentration and additive limitations, while claims 21 through 30 depend on the same composition.

How strong is the patent estate for ketoconazole topical products?

The patent estate should be separated into four categories.

Active-ingredient patents

Ketoconazole is an old imidazole antifungal. A current US launch cannot ordinarily depend on exclusivity for the molecule itself. The principal risks are formulation, manufacturing and approved-use patents.

Formulation patents

US 7,179,475 is a formulation patent directed to anhydrous gel technology. Its principal value was protection against a close-copy product using the same excipient platform.

Other ketoconazole products may use different formulation systems, including aqueous gels, creams, foams, shampoos and solutions. Those products require separate claim-by-claim analysis and are not automatically covered by US 7,179,475.

Method-of-use patents

The patent claims treatment of seborrheic dermatitis and specified fungal disorders. The method claims are limited by the composition dependency. A method patent directed broadly to seborrheic dermatitis could create a separate risk, but US 7,179,475 does not itself claim use of every topical ketoconazole product.

Manufacturing and process patents

The supplied claims do not claim a manufacturing process, mixing order, dissolution sequence, packaging system or manufacturing equipment. Process-related barriers must be located in separate patent families.

How does US 7,179,475 compare with competing ketoconazole products?

Product or category	Typical dosage form	Relationship to US 7,179,475
Xolegel 2%	Ketoconazole gel	Potential historical relevance because of the gel and indication
Ketoconazole cream	Cream	Ordinarily outside the gel limitation
Ketoconazole shampoo	Shampoo	Ordinarily outside the gel limitation
Ketoconazole foam	Foam	Ordinarily outside the gel limitation
Ketoconazole solution	Solution	Ordinarily outside the gel limitation
Compounded anhydrous gel	Gel	Requires detailed excipient comparison
Generic 2% ketoconazole gel	Gel	2% strength alone does not establish infringement

The key comparison is not ketoconazole concentration. It is the complete excipient and dosage-form profile. A 2% ketoconazole gel may avoid this patent if it uses water, a different gelling polymer or a different surfactant.

Which companies face commercial exposure?

The greatest historical exposure would have applied to a manufacturer launching an anhydrous ketoconazole gel with the claimed excipient combination during the patent term. Exposure would have been lower for manufacturers selling:

• Ketoconazole cream;
• Ketoconazole shampoo;
• Ketoconazole foam;
• Aqueous gel formulations;
• Formulations using alternative polymers;
• Products with materially different stabilizer systems.

After expiration, the patent does not create a current launch barrier. Commercial exposure may still arise from other patents, regulatory exclusivity, trade dress, trademarks, confidential manufacturing know-how or separate FDA-listed patents.

What geographic coverage does the patent provide?

US 7,179,475 provides rights only in the United States. It does not establish protection in Canada, Europe, Japan, China or other jurisdictions.

Foreign equivalents must be reviewed separately for:

• Filing and priority dates;
• Grant status;
• Patent-term expiry;
• National-phase prosecution;
• Divisional or continuation claims;
• Opposition or revocation history;
• Local claim construction;
• Supplementary protection certificates or other extensions.

A US expiration does not determine foreign expiration dates.

Key Takeaways

• US 7,179,475 claims a specific anhydrous ketoconazole gel, not ketoconazole generally.
• Literal infringement requires the claimed ingredient combination, gel form and anhydrous composition.
• PPG-15 stearyl ether, hydroxypropyl cellulose, ascorbic acid, BHT and citric acid materially narrow the patent.
• The "consisting of" language creates meaningful design-around opportunities.
• The method claims are dependent on the patented composition and do not cover all ketoconazole treatment methods.
• The ordinary US patent term expired in 2022.
• A current generic launch is not blocked by this patent alone.
• Separate Orange Book-listed patents, foreign rights, manufacturing patents and regulatory exclusivities require independent review.

FAQs

Does a 2% ketoconazole gel infringe US 7,179,475?

Not necessarily. The product must also satisfy the anhydrous limitation and contain the required excipient combination, including PPG-15 stearyl ether and hydroxypropyl cellulose.

Does a ketoconazole cream fall within this patent?

Ordinarily no. The independent claims require a composition formulated as a gel.

Can a formulation with water avoid US 7,179,475?

Yes, a water-containing formulation generally challenges the required anhydrous limitation, although the precise formulation and claim construction remain relevant.

Are method claims 21 through 30 still enforceable after formulation patent expiration?

No current exclusionary right arises from an expired patent. Historical conduct before expiration may raise separate damages or litigation issues.

Does the patent cover ketoconazole foam products?

No, the claims expressly require a gel. A foam product would need to be evaluated against other patents and regulatory exclusivities.

References

1. United States Patent and Trademark Office. (2007). US Patent No. 7,179,475, anhydrous ketoconazole topical compositions and methods of use.
2. 35 U.S.C. § 154. (2024). Contents and term of patents; provisional rights.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. U.S. Food and Drug Administration. (2006). Xolegel (ketoconazole) gel, 2% prescribing information; NDA 21-613.
5. 21 U.S.C. § 355(j). (2024). Abbreviated applications for new drugs.

Drugs Protected by US Patent 7,179,475

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 7,179,475

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	021539
Austria	318148
Austria	338538
Australia	1841200
Australia	2005201042
Australia	778524
Brazil	9907666