Details for Patent: 10,086,080

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Which drugs does patent 10,086,080 protect, and when does it expire?

Patent 10,086,080 protects AMZEEQ and is included in one NDA.

This patent has twenty-two patent family members in ten countries.

Summary for Patent: 10,086,080

Title:	Topical tetracycline compositions
Abstract:	A topical therapeutic hydrophobic breakable composition includes a carrier comprising (a) about 60% to about 99% by weight of at least one hydrophobic oil; (b) at least one viscosity-modifying agents selected from the group consisting of a fatty alcohol, a fatty acid and a wax; and (c) a tetracycline antibiotic, characterized in that at least part of the tetracycline antibiotic is suspended in the composition; the viscosity of the composition is at least about 30% higher than the viscosity of the carrier without the tetracycline antibiotic; and is higher than the viscosity of the hydrophobic oil and the tetracycline antibiotic without the viscosity modifying agents; and the amount of viscosity modifying agents can optionally be reduced by at least an amount by weight that would have increased the viscosity of the carrier without the tetracycline antibiotic by at least 30%; wherein the tetracycline is chemically stable in the composition for at least six months; wherein more than about 90% of the tetracycline has not broken down; wherein when packaged in an aerosol container to which is added a liquefied or compressed gas propellant the composition affords upon release from the container a breakable foam of at least good quality that breaks easily upon application of shear force.
Inventor(s):	Dov Tamarkin, Elana Gazal, Irakliy PAPIASHVILI, Yohan HAZOT, David Schuz, Rita KEYNAN
Assignee:	Journey Medical Corp
Application Number:	US15/913,574
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,086,080
Patent Claim Types: see list of patent claims	Use; Composition;

US Patent 10,086,080: Claim Scope, Amzeeq Relevance, and Minocycline Foam Patent Landscape

US Patent 10,086,080 protects methods of treating acne vulgaris with a waterless, oil-based minocycline composition that excludes surfactants and polyols. The broadest independent claims cover both foam and non-foam compositions. Dependent claims narrow protection to a 4% minocycline hydrochloride formulation using soybean oil, coconut oil, cyclomethicone, mineral oil, fatty alcohols, stearic acid, hydrogenated castor oil, and beeswax.

The patent is closely aligned with the formulation platform used for Amzeeq, a 4% minocycline topical foam approved by the FDA for acne vulgaris. The principal commercial risk is therefore a product that reproduces the claimed oil-and-wax carrier architecture, even if it uses different inactive-ingredient percentages or a different propellant system.

What does US Patent 10,086,080 protect?

US 10,086,080 protects treatment methods rather than a bare composition claim. The required conduct is administration of a minocycline-containing composition to treat acne vulgaris.

The patent has two independent claim structures:

Claim	Independent subject matter	Principal limitations
1	Method of treating acne vulgaris with a waterless foam	Minocycline; foamable carrier; hydrophobic oil; fatty alcohol, fatty acid, wax, hydrogenated oil, or combinations; no listed incompatible substances; no surfactant; no polyol
19	Method of treating acne vulgaris with a waterless composition	1%-10% minocycline; hydrophobic oil; fatty alcohol, fatty acid, wax, hydrogenated oil, or combinations; no surfactant; no polyol

Claim 1 is directed to a foam composition and includes a lengthy negative limitation excluding solvents, penetration enhancers, preservatives or excipients identified as incompatible with minocycline. Claim 19 is broader in dosage-form terms because it does not initially require a foam.

The patent does not claim every topical minocycline product. A competing product must generally satisfy the specific carrier, exclusion, and therapeutic-use limitations to create a strong literal-infringement case.

How broad are the independent claims?

Claim 1: waterless minocycline foam

Claim 1 requires all of the following:

1. Treatment of acne vulgaris.
2. Administration of a waterless foam composition.
3. Minocycline in the composition.
4. A foamable carrier containing at least one hydrophobic oil.
5. An additional agent containing one of five structural alternatives:
   • fatty alcohol plus wax;
   • fatty acid plus wax;
   • fatty alcohol, fatty acid, and wax;
   • wax comprising a hydrogenated oil; or
   • two or more waxes.
6. No listed minocycline-incompatible substance.
7. No surfactant.
8. No polyol.

The claim is technically broad because the hydrophobic oil can be selected from a large group of mineral, vegetable, ester, silicone, triglyceride, hydrocarbon, and specialty oils. The wax and fatty-material limitation provides the principal formulation boundary.

The claim is commercially narrower than the ingredient list suggests. A product containing a conventional surfactant, glycerin, propylene glycol, ethanol, polyethylene glycol, or another excluded polyol may avoid literal infringement of claim 1 even if it is a waterless minocycline foam.

Claim 19: waterless minocycline composition

Claim 19 requires:

• acne treatment;
• a waterless composition;
• 1%-10% minocycline;
• a hydrophobic oil;
• a fatty alcohol, fatty acid, wax, hydrogenated oil, or combination;
• no surfactant; and
• no polyol.

Claim 19 does not initially require a foam or propellant. Claim 22 adds the foam requirement, while claim 23 adds the detailed Amzeeq-type carrier composition.

This creates two distinct enforcement pathways:

• Claim 1 targets waterless minocycline foam treatment.
• Claim 19 can reach a non-foaming waterless composition if the other limitations are met.

A product using 4% minocycline hydrochloride in an anhydrous oil-and-wax vehicle could fall within claim 19 even if it is packaged as a cream, gel, ointment, or non-aerosol topical preparation, provided the claim terms are satisfied.

What formulations are protected by the dependent claims?

The dependent claims create narrower but commercially important embodiments.

Claims	Protected feature
2, 18	Broad classes of hydrophobic oils, including mineral oil, coconut oil, soybean oil, cyclomethicone, triglycerides, ester oils, silicone oils, petrolatum, and botanical oils
3	Fatty alcohol or fatty acid with at least 12 carbon atoms
4	Fatty alcohol, fatty acid, and wax, with beeswax or hydrogenated oil
5, 6, 14	Less than 0.4% of specified solvents, gelling agents, or silicone thickening agents
7	Minocycline hydrochloride
8	Detailed soybean oil, coconut oil, cyclomethicone, mineral oil, fatty alcohol, stearic acid, hydrogenated castor oil, and beeswax formulation
9, 10	1%-10% minocycline, including approximately 4%
11	Additional active agent
12	No more than 10% petrolatum, or no petrolatum
13	Hydrophobic oil at approximately 60%-99%
15, 16	At least once-daily administration, including 4% minocycline
17, 22	Foam generated with liquefied or compressed gas
20	4% minocycline hydrochloride
21	Fatty alcohol, fatty acid, and wax
23	Detailed carrier percentages corresponding to claim 8

The most commercially significant narrowing limitation is claim 8 or claim 23. These claims require a specific composition window:

Ingredient	Claimed range
Soybean oil	45%-55%
Coconut oil	21.2%-26%
Cyclomethicone	4.5%-5.5%
Light mineral oil	0.85%-4.8%
Cetostearyl alcohol	3.2%-3.9%
Stearic acid	2.7%-3.3%
Myristyl alcohol	2.3%-2.8%
Hydrogenated castor oil	1.8%-2.2%
Beeswax	1.8%-2.2%
Stearyl alcohol	1.4%-1.7%
Behenyl alcohol	1%-1.2%

Because the ranges must be read together, a product that falls outside one or more of these percentages may avoid claims 8 and 23 while remaining exposed to claims 1 or 19.

How does the patent relate to Amzeeq?

Amzeeq contains minocycline hydrochloride equivalent to 4% minocycline and is approved as a topical foam for acne vulgaris. The FDA label identifies once-daily application to affected areas and describes the product as a topical foam formulation [1].

The disclosed Amzeeq profile corresponds closely to the central limitations of US 10,086,080:

Amzeeq-related characteristic	Relevance to US 10,086,080
Minocycline hydrochloride	Directly addressed by claims 7, 10, 16, and 20
Approximately 4% minocycline	Directly addressed by claims 10, 16, and 20
Topical acne treatment	Required by claims 1 and 19
Foam dosage form	Required by claim 1 and added by claim 22
Once-daily administration	Addressed by claims 15 and 16
Oil-based, waterless carrier	Central limitation of claims 1 and 19
Fatty alcohol, fatty acid, and wax system	Addressed by claims 4, 8, 21, and 23
Propellant-generated foam	Addressed by claims 17 and 22

The patent should therefore be treated as a formulation and method-of-use asset associated with the Amzeeq product platform. Its value is strongest where the commercial product retains the same waterless, surfactant-free, polyol-free oil-and-wax design.

What is the FDA and Orange Book status?

Amzeeq was approved by the FDA under NDA 213055 for the topical treatment of acne vulgaris in patients nine years of age and older [1, 2]. FDA approval establishes the regulatory status of the product, but it does not by itself establish that every patent covering the formulation is listed in the Orange Book.

The Orange Book listing must be checked at the NDA level and against the FDA’s patent-listing records. A patent may cover an approved product without appearing in the Orange Book if it is not submitted by the NDA holder, does not meet the statutory listing standard, or is directed primarily to a manufacturing process or a method not eligible for listing.

For US 10,086,080, three separate questions must be distinguished:

1. Whether the patent covers the Amzeeq formulation.
2. Whether the patent was submitted for Orange Book listing against NDA 213055.
3. Whether the patent remains enforceable after any terminal disclaimer, disclaimer filing, PTA adjustment, or other term event.

The claims supplied establish the first question as commercially relevant. They do not, by themselves, establish the second or third.

When does US 10,086,080 lose exclusivity?

The patent’s expiration date cannot be determined from the claims alone. US patent term depends on the earliest effective nonprovisional filing date in the continuity chain, any patent-term adjustment, any patent-term extension, and any terminal disclaimer.

For Hatch-Waxman analysis, the relevant dates are:

Event	Business significance
Patent grant	Creates enforceable patent rights subject to validity and term
Orange Book listing, if any	Can support a statutory stay after a Paragraph IV notice
Patent expiration	Removes ordinary patent-based exclusion after the effective term ends
FDA regulatory exclusivity expiration	Separate from patent rights
Paragraph IV certification	Can trigger litigation and a potential 30-month stay
First commercial marketing of a generic	Depends on patent, exclusivity, approval, and settlement restrictions

FDA generic approval is not necessarily blocked by an unlisted patent. Conversely, an Orange Book-listed patent can create substantial launch delay even if the underlying patent appears narrow, because litigation and the 30-month stay operate independently of the ultimate merits.

What Paragraph IV challenges and litigation affect the patent?

A Paragraph IV challenge is relevant only if the patent is listed in the Orange Book for the approved NDA and an ANDA applicant certifies that the patent is invalid, unenforceable, or not infringed.

The supplied patent information does not establish:

• an ANDA filer;
• a Paragraph IV notice;
• a district-court complaint;
• a 30-month stay;
• a settlement agreement; or
• a final judgment concerning US 10,086,080.

Accordingly, no litigation outcome should be attributed to this patent solely from the claim language. The relevant litigation review should cover the patent number, the NDA holder, related continuation patents, and any case involving Amzeeq or minocycline foam products.

A Paragraph IV defense would likely focus on four areas:

Lack of infringement

An ANDA or commercial product could avoid infringement by using:

• water or a substantial aqueous phase;
• a surfactant;
• a polyol such as glycerin or propylene glycol;
• a different carrier without the claimed wax or fatty-material structure;
• a dosage form that does not produce a foam, for claim 1; or
• minocycline outside the 1%-10% range, for claims 19-23.

Anticipation and obviousness

Prior-art attacks would target earlier topical minocycline formulations, waterless foam vehicles, oil-and-wax carriers, and acne-treatment methods. The most vulnerable limitations are likely the broad alternatives covering common cosmetic excipients. The stronger validity position would be associated with the narrow combination of:

• 4% minocycline hydrochloride;
• soybean oil and coconut oil;
• cyclomethicone;
• fatty alcohols;
• stearic acid;
• hydrogenated castor oil;
• beeswax; and
• propellant-generated foam.

Written description and enablement

The very broad lists of hydrophobic oils and excluded substances could be challenged if the specification does not provide adequate support across the full scope. Claims 1 and 19 cover numerous combinations, while claims 8 and 23 are much more formulation-specific.

Claim construction

Disputes may arise over:

• the meaning of "waterless";
• whether trace water is permitted;
• the scope of "surfactant";
• whether a material qualifies as a "polyol";
• the meaning of "wax";
• whether the listed incompatible substances must be entirely absent; and
• whether the claim requires the composition to be administered in the claimed form or merely capable of being formed into that form.

How strong is the patent estate?

US 10,086,080 has meaningful commercial coverage but is not a complete barrier to all topical minocycline competition.

Strength factor	Assessment
Product alignment	Strong for a 4% oil-based minocycline foam
Independent-claim breadth	Moderate to strong
Formulation specificity	Broad in claims 1 and 19; narrow but commercially precise in claims 8 and 23
Design-around potential	Material
Dependence on negative limitations	High
Method-of-use coverage	Limited to acne vulgaris treatment
Manufacturing protection	Not apparent from the supplied claims
Biosimilar relevance	None; minocycline is a small molecule
Orange Book significance	Requires confirmation from FDA listing records
Litigation leverage	Highest if the claims are Orange Book-listed and the reference product practices them

The patent’s weaknesses are the numerous exclusionary limitations and the absence of an expressly claimed manufacturing process. A competitor may be able to design around the patent through a surfactant-containing, polyol-containing, aqueous, or structurally different carrier.

Its strengths are the broad hydrophobic-oil alternatives, the explicit protection for minocycline hydrochloride at 4%, and the detailed claims covering the likely commercial carrier.

What generic launch scenarios exist?

Scenario 1: Exact or near-exact oil-and-wax foam

A generic using 4% minocycline hydrochloride in a substantially identical waterless oil-and-wax carrier would present the highest infringement risk. Claims 1, 7, 10, 16, 17, 20, 22, and potentially 23 would be relevant.

Scenario 2: Same active ingredient, different vehicle

A formulation containing minocycline in an aqueous gel, polymeric gel, surfactant system, or polyol-containing vehicle could avoid the principal claim architecture. It may still face other patents in the broader Amzeeq estate.

Scenario 3: Same carrier, different strength

A product outside the 1%-10% range could avoid claims 19-23, but claim 1 does not include an express minocycline concentration limitation. A strength change alone would therefore not necessarily avoid claim 1.

Scenario 4: Non-foam oil composition

A non-foam waterless composition could avoid claim 1 but remain exposed to claim 19, which does not initially require a foam.

Scenario 5: Alternative minocycline form

Use of a minocycline form other than minocycline hydrochloride may avoid the dependent claims directed to the hydrochloride salt, but claims 1 and 19 use the broader term "minocycline."

How does this patent compare with biosimilar and generic risk?

Biosimilar risk is not applicable. Minocycline is a small-molecule antibiotic, so competition proceeds through the ANDA pathway rather than the biosimilar pathway under the Biologics Price Competition and Innovation Act.

The relevant competitive set includes:

• generic oral minocycline products;
• generic topical minocycline formulations;
• other topical antibiotics;
• retinoid-antibiotic combinations;
• clindamycin and benzoyl peroxide products; and
• alternative foam or aerosol delivery systems.

Generic oral minocycline does not directly substitute for Amzeeq in the regulatory or formulation sense. A topical generic that matches the 4% foam dosage form presents the most direct threat.

What licensing and settlement issues matter?

No license, covenant not to sue, or settlement agreement can be inferred from the claim language. The commercial review should distinguish:

• patent ownership and assignment;
• product licensing;
• development or commercialization agreements;
• Orange Book patent-listing agreements;
• ANDA litigation settlements;
• launch-date licenses; and
• authorized-generic arrangements.

A settlement could permit a generic launch before patent expiration while preserving the patent’s formal validity. The existence of a settlement would materially change revenue exposure even if the patent remains unexpired.

What is the geographic scope?

US 10,086,080 is a United States patent. It can support infringement claims for conduct within the United States, including US manufacture, sale, offers for sale, importation, and potentially inducement or contributory infringement under applicable law.

Equivalent protection in Europe, Canada, Japan, China, or other markets must be assessed through related national applications and granted counterparts. The US claims do not establish foreign rights. Regulatory exclusivity and patent status also differ by jurisdiction.

Key Takeaways

• US 10,086,080 protects methods of treating acne vulgaris with waterless minocycline compositions.
• Claim 1 focuses on a foamable, oil-and-wax carrier that excludes surfactants, polyols, and specified incompatible substances.
• Claim 19 is broader in dosage-form terms and can cover non-foam waterless compositions.
• Claims 8 and 23 target a detailed carrier closely aligned with the commercial 4% minocycline foam platform.
• Claims 7, 10, 16, and 20 specifically strengthen coverage around minocycline hydrochloride and approximately 4% strength.
• A different strength does not necessarily avoid claim 1 because claim 1 has no express concentration limitation.
• A surfactant-containing, polyol-containing, aqueous, or structurally different formulation presents a potential design-around path.
• Minocycline is a small molecule, so biosimilar analysis is not applicable.
• Orange Book listing, Paragraph IV activity, litigation, settlement status, and patent expiration require review of the FDA and USPTO records beyond the claim text.
• The strongest commercial exposure is an Amzeeq-like 4% minocycline hydrochloride foam using the claimed oil, fatty-material, and wax system.

FAQs

Does US 10,086,080 cover all topical minocycline products?

No. The claims require a waterless composition with a hydrophobic oil and specified fatty-material or wax components. Products using aqueous, surfactant-based, polyol-containing, or materially different carriers may fall outside the claims.

Can a 4% minocycline gel avoid US 10,086,080?

Possibly, but not automatically. A non-foam waterless gel may avoid claim 1 while remaining within claim 19 if it contains the required hydrophobic oil, wax or fatty-material system, and no surfactant or polyol.

Does changing minocycline hydrochloride to another salt avoid the patent?

It may avoid claims limited to minocycline hydrochloride, but claims 1 and 19 use the broader term "minocycline." Salt substitution alone is not a complete design-around.

Is US 10,086,080 a manufacturing patent?

The supplied claims are method-of-treatment and formulation-related claims. They do not expressly claim a manufacturing process, equipment, filling operation, or propellant-charging process.

Are other patents likely to affect a generic Amzeeq launch?

Yes. A launch assessment must include related continuation patents, Orange Book-listed patents, formulation patents, method-of-use patents, regulatory exclusivity, and any Paragraph IV litigation or settlement affecting the approved NDA.

References

1. U.S. Food and Drug Administration. (2019). Amzeeq (minocycline) topical foam, 4%: Prescribing information. FDA.
2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: Amzeeq, NDA 213055. FDA.
3. U.S. Patent and Trademark Office. (2018). U.S. Patent No. 10,086,080: Foamable pharmaceutical compositions and methods of use thereof. USPTO.
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. FDA.
5. U.S. Food and Drug Administration. (n.d.). Orange Book patent and exclusivity information. FDA.

Drugs Protected by US Patent 10,086,080

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Journey	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379-001	Oct 18, 2019		RX	Yes	Yes	10,086,080					TREATMENT OF NON-NODULAR ACNE VULGARIS

International Family Members for US Patent 10,086,080

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010302350
Australia	2015224534
Brazil	112012007473
Canada	2776366