Details for Patent: 11,865,100

Which drugs does patent 11,865,100 protect, and when does it expire?

Patent 11,865,100 protects EPSOLAY and is included in one NDA.

This patent has twelve patent family members in two countries.

Summary for Patent: 11,865,100

Title:	Method for treatment of rosacea in patients aged 65 years and older
Abstract:	A regimen for the therapeutic treatment of rosacea in subjects aged 65 years and older, the regimen comprising topically applying to the skin of a subject aged 65 years and older in need of said treatment a pharmaceutical composition, the pharmaceutical composition comprising about 1% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient, wherein the benzoyl peroxide is the only active ingredient in said pharmaceutical composition, wherein said pharmaceutical composition is applied once daily for a period of at least about 2 weeks, to achieve, in a group of such subjects, a success rate of at least about 15%, wherein the success rate is defined as the number of subjects achieving clear or almost clear skin on the investor global assessment (IGA) scale after treatment with the pharmaceutical composition.
Inventor(s):	Ofer Toledano, Ofra Levy-Hacham, Ori NOV, Vered RAM
Assignee:	Mayne Pharma LLC
Application Number:	US17/154,689
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Delivery;

United States Patent 11,865,100: Benzoyl Peroxide Treatment of Rosacea in Patients Aged 65 and Older

U.S. Patent No. 11,865,100 protects age-specific, once-daily topical benzoyl peroxide treatment for rosacea, with claims focused on clinical outcomes rather than a narrowly defined formulation. The independent claims require patients aged 65 years or older, benzoyl peroxide as the only active ingredient, a concentration of about 2.5% to about 10% w/w, and treatment for at least two weeks. Dependent claims add the 5% concentration, cream or emulsion dosage forms, extended-release technologies, fatty or oily phases, first-line use, rosacea subtypes, and specified efficacy thresholds.

The patent is potentially relevant to products such as Epsolay, a 5% benzoyl peroxide cream approved by the FDA for inflammatory lesions of rosacea. Its commercial value depends on whether the marketed product is prescribed for the claimed elderly population and whether the product label, clinical data, or prescribing practices support the claimed treatment regimen.

What does U.S. Patent 11,865,100 protect?

The patent protects a method-of-treatment and product-for-use concept with five cumulative limitations in the main independent claims:

Limitation	Claims affected	Scope
Patient age	1, 15, 17, 27	Subject or patient group must be aged 65 years or older
Disease	1, 15, 17, 27	Rosacea, including severe rosacea in claims 15 and 27
Active ingredient	All independent claims	Benzoyl peroxide must be the only active ingredient
Concentration	All independent claims	About 2.5% to about 10% w/w benzoyl peroxide
Dosing	All independent claims	Topical application once daily for at least two, four, eight, or 12 weeks
Clinical result	1, 15, 17, 27	IGA success rate or reduction in inflammatory lesions
Vehicle comparison	Claims 2, 4, 6, 8, 17-20, 27-28	Specified superiority to vehicle treatment

The claims do not require a particular brand, trade name, container, preservative system, particle size, encapsulation material, or excipient. That makes the claims broader than a conventional formulation patent in some respects. Their principal narrowing features are patient age, monotherapy, dosing duration, and clinical performance.

How many independent claims does U.S. Patent 11,865,100 have?

The patent has four independent claims: claims 1, 15, 17, and 27.

Claim 1: IGA success-rate regimen

Claim 1 covers once-daily topical treatment for at least two weeks in patients aged 65 or older. The composition must contain 2.5% to 10% benzoyl peroxide as the only active ingredient. The regimen must achieve an IGA success rate of at least 15% in a group of such subjects.

The claim is not limited to a particular rosacea subtype or dosage form. It can therefore reach a 5% benzoyl peroxide cream, emulsion, suspension, solution, or other composition if the remaining limitations are satisfied.

Claim 15: Composition for severe rosacea

Claim 15 is drafted as a pharmaceutical composition for use in treating severe rosacea in patients aged 65 or older. It incorporates alternative treatment periods and success-rate thresholds:

Treatment period	Minimum IGA success rate
At least 2 weeks	About 15%
At least 4 weeks	About 25%
At least 8 weeks	About 45%
At least 12 weeks	About 50%

This claim has a severe-rosacea limitation absent from claim 1. The claim also requires the composition to be applied once daily and to use benzoyl peroxide as the sole active ingredient.

Claim 17: Inflammatory-lesion reduction regimen

Claim 17 covers the same age, concentration, monotherapy, and once-daily requirements but uses inflammatory-lesion reduction as the efficacy endpoint. At two weeks, the claimed regimen produces an approximately 40% mean reduction from baseline, compared with approximately 25% for vehicle.

The claim does not merely require that benzoyl peroxide be statistically superior to vehicle. It recites specific approximate reductions for both the active treatment and control groups.

Claim 27: Composition for inflammatory-lesion reduction

Claim 27 is the composition-for-use counterpart to claim 17. It applies to subjects aged 65 years or older and specifies efficacy levels at two, four, eight, and 12 weeks:

Treatment period	Benzoyl peroxide reduction	Vehicle reduction
At least 2 weeks	About 40%	About 25%
At least 4 weeks	About 55%	About 35%
At least 8 weeks	About 60%	About 35%
At least 12 weeks	About 65%	About 35%

Claim 28 adds a second set of higher reported reductions: approximately 45%, 60%, 69%, and 70% for benzoyl peroxide, compared with approximately 29%, 42%, 41%, and 41% for vehicle.

What formulations are protected by U.S. Patent 11,865,100?

The formulation scope covers multiple physical and dosage-form categories.

Benzoyl peroxide concentration

Claims 1, 15, 17, and 27 require about 2.5% to about 10% w/w benzoyl peroxide. Dependent claims 10, 16, 22, and 29 narrow the concentration to about 5.0% w/w.

The 5% limitation is commercially significant because Epsolay is a 5% benzoyl peroxide cream. A competing product containing 2.5%, 5%, 7.5%, or 10% benzoyl peroxide could fall within the concentration range, subject to the age, monotherapy, dosing, and efficacy requirements.

Dosage forms

Claims 13 and 25 cover a cream or emulsion. Claims 11 and 23 cover benzoyl peroxide in solid, solution, or suspension form. Claims 14 and 26 cover extended-release formulations using:

• Encapsulation
• Microencapsulation
• Microspheres
• Coating

Claims 30-33 add a fatty phase and/or oily phase to the formulation categories in the relevant independent claim families.

The claims therefore cover both conventional topical dosage forms and delivery systems intended to control benzoyl peroxide release or improve tolerability. They do not appear limited to a specific encapsulation polymer or carrier composition.

Does the patent require benzoyl peroxide monotherapy?

Yes. The monotherapy requirement is central to the independent claims.

Claims 1, 15, 17, and 27 each state that benzoyl peroxide is the only active ingredient in the pharmaceutical composition. Claims 9 and 21 further state that benzoyl peroxide is the sole active ingredient administered during the duration of the regimen.

This limitation reduces the patent's reach over fixed-combination products containing metronidazole, ivermectin, azelaic acid, antibiotics, corticosteroids, or other active ingredients. A combination product may avoid literal infringement of the composition limitation because benzoyl peroxide would not be the only active ingredient. The separate administration of another active ingredient during the treatment period may also be relevant under claims 9 and 21.

The limitation does not require benzoyl peroxide to be the only topical product used by the patient for every unrelated dermatologic condition. The infringement analysis would focus on the claim language, the prescribed regimen, and the role of other active ingredients during treatment.

How do the efficacy limitations affect infringement risk?

The efficacy limitations create a significant proof issue for patent enforcement.

A product does not necessarily infringe merely because it contains 5% benzoyl peroxide and is used once daily in a patient aged 65 or older. The patentee would also need to establish the claimed treatment outcome, depending on the asserted claim.

For claims 1 and 15, the relevant endpoint is the percentage of subjects achieving clear or almost clear skin under the IGA scale. For claims 17 and 27, the endpoint is mean percentage reduction in inflammatory lesions compared with baseline and, in several claims, compared with vehicle.

Group-level versus individual outcomes

The claims use group-level efficacy language. They refer to “a group of such subjects” and define success as the number of subjects achieving the specified IGA result. This creates different enforcement questions from claims that require a particular outcome in every treated patient.

Potential evidence could include:

• Clinical trial protocols
• Statistical analysis plans
• Product labeling
• Promotional materials
• Investigator instructions
• Postmarketing studies
• Prescriber-directed dosing information
• Internal clinical or regulatory documents

The claim language does not require the physician to guarantee the result. It requires a regimen that achieves the stated result in the specified group.

“About” and approximate values

The repeated use of “about” creates potential claim-construction disputes around concentration and efficacy. The scope may depend on intrinsic evidence in the patent specification, prosecution history, examples, and the technical meaning of the terms to a person skilled in dermatology and pharmaceutical formulation.

A product with a concentration slightly outside 2.5% to 10% may still require analysis under the doctrine of equivalents, although the prosecution record could limit that theory. The same issue applies to efficacy results near the recited thresholds.

What rosacea types are covered?

Claim 12 and claim 24 expressly identify:

• Erythematotelangiectatic rosacea
• Papulopustular rosacea
• Phymatous rosacea
• Ocular rosacea

These claims are narrower than the independent claims because they require the regimen to be first-line therapy and identify one of the listed subtypes.

Claims 1, 15, 17, and 27 do not expressly limit rosacea to those four categories. A broader rosacea treatment may therefore fall within an independent claim even if it is not characterized as one of the listed subtypes, assuming the other limitations are met.

When does U.S. Patent 11,865,100 lose exclusivity?

The patent issued on January 9, 2024. Its ordinary patent term should be calculated from the relevant earliest nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers, patent-term extension, and other statutory adjustments. Patent No. 11,865,100 itself must be reviewed for the official expiration date and any terminal disclaimer.

Event	Date or status
Patent	U.S. Patent 11,865,100
Issue date	January 9, 2024
Patent term basis	20 years from the applicable earliest nonprovisional filing date
Patent-term adjustment	Must be confirmed in USPTO records
Patent-term extension	No extension is established by the supplied claims
Regulatory exclusivity	Separate from patent term
Orange Book listing	Must be confirmed against the relevant NDA and current FDA publication

The patent's expiration date cannot be calculated accurately from the claims alone. The issue date is known, but the earliest effective nonprovisional filing date, continuation status, terminal disclaimer, and patent-term adjustment determine the enforceable term. The claims supplied do not include those data.

What is the FDA and Orange Book relevance?

Benzoyl peroxide is an established topical active ingredient, but the relevant product-specific regulatory question is whether the marketed product is approved under an NDA and whether the patent is listed for that NDA.

Epsolay, a 5% benzoyl peroxide cream marketed by Galderma, received FDA approval for the treatment of inflammatory lesions of rosacea. The FDA prescribing information identifies benzoyl peroxide as the active ingredient and describes once-daily topical use. Those characteristics overlap materially with the concentration, dosage, and disease limitations in Patent 11,865,100. [1]

The patent's elderly-patient limitation is narrower than the general FDA indication. An FDA label that covers adults generally does not by itself establish that the product is approved specifically for patients aged 65 years and older. The relevant issue is whether the label, clinical evidence, or marketing instructions direct or support the claimed elderly-patient regimen.

For an ANDA applicant, patent exposure may arise through:

• Paragraph IV certification against a listed patent
• A section viii statement carving out a patented method of use
• A label that omits the elderly-patient use
• A non-infringement position based on failure to satisfy the efficacy limitations
• An invalidity position directed to written description, enablement, anticipation, or obviousness

An ANDA carve-out could be difficult if the proposed label still instructs once-daily benzoyl peroxide treatment for rosacea in a way that includes patients aged 65 or older.

Which companies are most relevant to the patent landscape?

Galderma

Galderma is the principal commercial entity associated with Epsolay, the leading branded product aligned with the claimed 5% benzoyl peroxide topical therapy. Galderma is therefore the most likely commercial beneficiary of the patent family if it owns or licenses the relevant rights.

Generic manufacturers

Generic dermatology companies could challenge the patent through an ANDA Paragraph IV filing if the patent is listed against the relevant NDA. A generic applicant would likely focus on the following positions:

1. The product label does not direct treatment specifically in patients aged 65 or older.
2. The product does not require benzoyl peroxide monotherapy.
3. The efficacy thresholds are not inherent in the proposed use.
4. The claims are invalid for lack of written description or enablement.
5. The age-specific regimen would have been obvious from general rosacea treatment and elderly-patient clinical data.
6. The claims impermissibly rely on functional or result-based limitations.

The claims supplied do not identify any Paragraph IV challenger, ANDA filer, district court action, PTAB proceeding, settlement, or license.

How strong is the patent estate?

The patent has meaningful commercial relevance but a narrower enforcement profile than a composition-of-matter or tightly specified formulation patent.

Strength	Assessment
Age-specific protection	Strong narrowing feature; may distinguish general rosacea patents
5% benzoyl peroxide coverage	Commercially relevant to Epsolay-type products
Monotherapy limitation	Helps distinguish combination regimens but creates a design-around route
Once-daily dosing	Common regimen; may be easier to challenge
Clinical efficacy limitations	Can support patentability but create proof and claim-construction issues
Formulation breadth	Broad across creams, emulsions, suspensions, and release systems
Defined excipient system	Limited; no narrow proprietary excipient combination appears in the claims
Disease scope	Broad in independent claims, narrower in first-line subtype claims
Generic design-around potential	Material

The patent's strongest practical position is against a 5% benzoyl peroxide monotherapy product labeled for once-daily rosacea treatment in elderly patients, where the sponsor's clinical data support the claimed IGA or lesion-reduction outcomes.

Its weaker position is against products with combination active ingredients, different dosing schedules, labels that omit the elderly population, or formulations whose clinical performance does not meet the recited thresholds.

What invalidity issues could affect the patent?

Written description and enablement

The claims cover a wide range of benzoyl peroxide concentrations, physical forms, carriers, emulsions, creams, extended-release systems, and rosacea subtypes. A challenger could argue that the specification does not adequately support the full breadth of these combinations, particularly if the examples focus on a narrower formulation or patient population.

Claims 15 and 27 also refer to severe rosacea in elderly patients. The sufficiency of disclosure may depend on the number of elderly subjects studied and whether the clinical data support severe disease as opposed to rosacea generally.

Obviousness

Benzoyl peroxide was known as a topical dermatologic active ingredient, and rosacea treatment was an established field. A challenger could combine prior art on benzoyl peroxide formulations, rosacea treatment, once-daily dosing, and elderly-patient dermatologic care.

The patentee's counterargument would likely focus on the specific clinical response in patients aged 65 and older, the claimed monotherapy regimen, and the reported superiority over vehicle.

Anticipation

Anticipation would require a single prior-art reference to disclose all limitations of the asserted claim, including the age group, benzoyl peroxide concentration, monotherapy, dosing schedule, and efficacy result. A prior art reference describing benzoyl peroxide for rosacea generally may not anticipate the age-specific and outcome-based claims unless it discloses those features expressly or inherently.

Claim construction

The following terms are likely to attract dispute:

• “About 2.5% w/w to about 10% w/w”
• “Only active ingredient”
• “Sole active ingredient administered”
• “Severe rosacea”
• “Once daily”
• “At least about”
• “Clear or almost clear skin”
• “Investor global assessment”

The word “investor” appears in the supplied claims, although the standard dermatology term is generally “investigator global assessment.” The prosecution history and specification may clarify whether this is a typographical issue, a defined term, or a potential indefiniteness argument.

What generic launch scenarios exist?

Scenario 1: Paragraph IV challenge

A generic applicant files an ANDA with a Paragraph IV certification and asserts that Patent 11,865,100 is invalid, not infringed, or unenforceable. A timely patent-holder lawsuit could trigger a 30-month stay under the Hatch-Waxman framework, subject to statutory exceptions and court developments. [2]

Scenario 2: Section viii carve-out

The applicant removes the patented elderly-patient indication from its label. This strategy may reduce infringement risk, but it is vulnerable if the remaining label still directs use that necessarily includes patients aged 65 and older.

Scenario 3: Formulation design-around

The applicant uses a different concentration, a combination active ingredient, a non-topical route, or a dosing schedule outside once daily. This approach may avoid literal infringement but could sacrifice clinical or commercial similarity to the reference product.

Scenario 4: At-risk launch

The applicant launches after receiving tentative or final approval while litigation remains unresolved. This exposes the company to damages, injunctive relief, and commercial disruption.

Is there biosimilar risk?

No conventional biosimilar pathway applies. Benzoyl peroxide is a small-molecule active ingredient, and an equivalent product would generally proceed through an ANDA or another small-molecule regulatory pathway rather than a section 351(k) biosimilar application.

The relevant competitive risks are generic topical products, authorized generics, pharmacy-compounded products, and alternative branded rosacea therapies.

Key Takeaways

• U.S. Patent 11,865,100 is directed to once-daily benzoyl peroxide monotherapy for rosacea in patients aged 65 years and older.
• The core concentration range is about 2.5% to about 10% w/w, with dependent claims targeting about 5%.
• The claims cover creams, emulsions, suspensions, solutions, and specified extended-release systems.
• Claims 1 and 15 use IGA success rates; claims 17 and 27 use inflammatory-lesion reductions.
• The efficacy thresholds are group-level limitations and may complicate infringement proof.
• Epsolay's 5% benzoyl peroxide cream is commercially aligned with several claim elements, but the elderly-patient and outcome limitations require separate analysis.
• Combination products may avoid the “only active ingredient” limitation.
• The patent's exact expiration date cannot be determined from the claims supplied because the relevant filing and patent-term data are not included.
• No Paragraph IV challenge, litigation, settlement, license, or Orange Book listing is identified in the supplied material.
• The patent is more vulnerable to design-around and validity attacks than a narrow composition-of-matter patent, but it may create a meaningful barrier for an Epsolay-equivalent generic label.

FAQs About U.S. Patent 11,865,100

Does Patent 11,865,100 cover all benzoyl peroxide rosacea products?

No. The claims require patient age of at least 65 years, benzoyl peroxide monotherapy, specified concentration and dosing limitations, and in several claims particular clinical outcomes.

Does a 5% benzoyl peroxide cream automatically infringe?

No. A 5% cream satisfies only one potential limitation. Age, rosacea treatment, once-daily use, monotherapy, treatment duration, formulation, and efficacy requirements must also be assessed.

Can a metronidazole and benzoyl peroxide product fall within the claims?

The combination may avoid the claims' requirement that benzoyl peroxide be the only active ingredient. The result depends on the exact product, label, and asserted claim.

Is the patent relevant to an over-the-counter benzoyl peroxide product?

Potentially, but an over-the-counter product may not direct the claimed elderly-patient rosacea regimen or provide the claimed clinical outcomes. The label and intended use would be central.

Does the patent protect treatment of ocular rosacea?

Claims 12 and 24 expressly list ocular rosacea as a covered subtype when the first-line-therapy limitations are met. The independent claims are broader but do not expressly enumerate that subtype.

References

1. U.S. Food and Drug Administration. (2022). Epsolay (benzoyl peroxide) cream, 5%: Prescribing information.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
3. United States Patent and Trademark Office. (2024). U.S. Patent No. 11,865,100: Treatment of rosacea.

Drugs Protected by US Patent 11,865,100

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mayne Pharma	EPSOLAY	benzoyl peroxide	CREAM;TOPICAL	214510-001	Apr 22, 2022		RX	Yes	Yes	11,865,100					TOPICAL TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA IN ADULTS 65 YEARS OF AGE AND OLDER

International Family Members for US Patent 11,865,100

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	3130362
Canada	3130437
Canada	3130439
Canada	3130441
World Intellectual Property Organization (WIPO)	2020170029
World Intellectual Property Organization (WIPO)	2020170030
World Intellectual Property Organization (WIPO)	2020170031