US Patent 11,986,527: Claim Scope, Halobetasol Lotion Protection, and Patent Landscape

US Patent 11,986,527 protects methods of treating dermatological and mucosal disorders with low-concentration corticosteroid lotions or creams that use an ester-containing liquid oil system, mineral oil or light mineral oil, water, and no white petrolatum. The broadest practical commercial target is a 0.01% halobetasol propionate lotion, particularly a formulation in which at least 25% of the corticosteroid is solubilized in the liquid oil phase at approximately room temperature.

The patent is method-of-treatment focused. It does not, based on the supplied claims, independently claim the composition itself, a manufacturing process, or a product-by-process. Infringement therefore requires both use of a qualifying formulation and administration to treat a covered condition.

What does US Patent 11,986,527 protect?

The patent has two independent claims.

Claim	Independent protection	Commercial significance
Claim 1	Treatment method using a lotion or cream containing a listed corticosteroid at approximately 0.01% to 0.03% or less, an ester-containing oil phase, mineral oil or light mineral oil, water, and no white petrolatum	Broad genus covering multiple potent corticosteroids and dermatological diseases
Claim 18	Treatment method using halobetasol propionate at 0.01% in a lotion or cream meeting the same oil, water, solubilization, and white-petrolatum limitations	Narrower but commercially focused claim directed to a Bryhali-type formulation

Claim 1 requires every one of the following limitations:

A method of treating a dermatological or mucosal disorder.
Topical administration to the skin of an individual with the disorder.
A pharmaceutical composition formulated as a lotion or cream.
A corticosteroid selected from the closed list in the claim.
Corticosteroid concentration of approximately 0.01% to approximately 0.030% or less.
A liquid oil component containing one or more monocarboxylic acid esters, dicarboxylic acid esters, or both.
Mineral oil, light mineral oil, or both.
An aqueous component containing water.
At least 25% of the corticosteroid solubilized in the liquid oil component at 22°C ± 2°C.
No white petrolatum.

The closed corticosteroid list includes clobetasol propionate, betamethasone dipropionate, halobetasol propionate, diflorasone diacetate, desoximetasone, mometasone furoate, betamethasone valerate, halcinonide, budesonide, fluocinonide, and amcinonide. A corticosteroid outside that list would not literally satisfy claim 1, although other patent or infringement theories could remain relevant.

How broad is claim 1?

Claim 1 is broad in active ingredient and disease coverage but narrow in formulation architecture.

The claim covers more than halobetasol. It reaches multiple topical corticosteroids if they are present at the claimed low concentration and satisfy the oil-solubilization requirement. The disease limitation is also broad. Dependent claim 14 identifies psoriasis, plaque psoriasis, atopic dermatitis, contact dermatitis, hand dermatitis, eczema, seborrheic dermatitis, rash, and poison ivy dermatitis, but claim 1 itself is not limited to those named conditions.

The formulation limitations materially constrain the claim:

The product must be a lotion or cream.
The formulation must contain water.
The oil phase must include an ester component and mineral oil or light mineral oil.
White petrolatum must be absent.
At least 25% of the corticosteroid must be solubilized in the liquid oil phase at approximately 20°C to 24°C.

An accused product containing white petrolatum would fall outside the literal scope of claim 1 and claim 18. A product using only an aqueous vehicle, only a hydrocarbon vehicle, or an oil system without the required ester may also avoid literal infringement.

What does claim 18 add for halobetasol products?

Claim 18 is directed specifically to halobetasol propionate at 0.01%. It removes the broader corticosteroid genus and fixes the concentration at 0.01%, while retaining the core formulation limitations.

The practical target is a low-dose halobetasol lotion or cream comparable to the formulation used in Bryhali. FDA-approved Bryhali is a halobetasol propionate 0.01% lotion indicated for topical treatment of plaque psoriasis in patients 18 years and older. [2]

Claim 18 does not cover every 0.01% halobetasol product. A competing product would still need to meet the following elements:

lotion or cream dosage form;
ester-containing liquid oil component;
mineral oil, light mineral oil, or both;
aqueous phase;
at least 25% solubilization in the liquid oil component at 22°C ± 2°C; and
absence of white petrolatum.

A 0.01% halobetasol ointment, foam, gel, spray, or solution would not literally satisfy the claimed dosage-form limitation. A 0.05% halobetasol product would not literally satisfy claim 18, although it could implicate other claims or patents.

Which dependent claims are commercially important?

Claim	Limitation	Commercial effect
2	Halobetasol propionate	Narrows claim 1 to the principal commercial corticosteroid
3	Approximately 0.03% corticosteroid	Protects the upper end of the claimed concentration range
4	Approximately 0.01% corticosteroid	Covers the low-dose commercial target
5-6	Dicarboxylic acid ester, including diethyl sebacate	Identifies a specific solvent class and named excipient
7-8	Monocarboxylic acid ester, including isopropyl myristate	Captures another formulation route
9	Light mineral oil	Makes the hydrocarbon component explicit
10-12	Emulsifiers, excipients, and pH-adjusting agents	Protects common formulation features
13	Lotion	Excludes products not formulated as lotions
14-15	Listed conditions, particularly plaque psoriasis	Aligns the claims with the approved commercial indication
16	Once- or twice-daily administration	Establishes dosing-regimen coverage
17	Treatment longer than two weeks	Extends method coverage beyond a short treatment course

Claims 6 and 8 are especially relevant in formulation comparison work because they identify diethyl sebacate and isopropyl myristate as specific ester options. A product can still infringe claim 1 without using either named excipient if it uses another qualifying monocarboxylic or dicarboxylic acid ester.

What is the key claim-construction issue?

The central technical limitation is the requirement that at least 25% of the corticosteroid be solubilized in the liquid oil component at 22°C ± 2°C.

This is a composition-performance limitation, not merely an ingredient-list limitation. A formulation may contain the required ester and mineral oil yet avoid infringement if the evidence shows that less than 25% of the corticosteroid is solubilized in the liquid oil phase under the claimed temperature conditions.

The likely evidence would include:

phase-separation studies;
microscopy;
solubility testing;
extraction and assay of the oil phase;
temperature-controlled analytical testing; and
formulation-development records.

The claim does not specify the analytical method for measuring the 25% threshold in the supplied text. That creates potential dispute over phase isolation, equilibrium conditions, sample preparation, and whether suspended or partially dissolved drug is counted as solubilized.

The phrase "about 0.01% to about 0.030% or less" also creates a potential construction issue. Claims 3 and 4 clarify that the intended concentration endpoints include approximately 0.03% and approximately 0.01%. For freedom-to-operate analysis, the concentration should be tested against the full formulation and applicable claim construction rather than treated as an exact numerical cutoff.

What formulations are protected by the patent?

The patent targets an emulsion-type topical system with an oil phase and an aqueous phase. The claimed oil phase may contain:

diethyl sebacate;
isopropyl myristate;
other monocarboxylic acid esters;
other dicarboxylic acid esters;
mineral oil;
light mineral oil; and
emulsifying agents.

The aqueous phase may contain water and optional excipients such as humectants, preservatives, chelating agents, emulsifiers, thickeners, and pH-adjusting agents.

The claims do not require every listed excipient. Claims 10 through 12 are dependent claims that add selected excipient categories. A product containing glycerin, preservatives, a chelator, a thickener, or a pH adjuster may fall within those narrower claims if all other limitations are present.

White petrolatum is expressly excluded. This limitation distinguishes the claimed formulation from many conventional corticosteroid ointments, which commonly use petrolatum-based vehicles.

How does the patent compare with conventional halobetasol products?

Product type	Typical concentration	Dosage form	Likely relevance to US 11,986,527
Halobetasol propionate lotion	0.01%	Lotion	Highest risk if ester/mineral-oil, aqueous, solubilization, and no-petrolatum limitations are met
Halobetasol propionate cream	Commonly 0.05%	Cream	Potentially outside claims 3, 4, and 18 because of concentration, but requires full claim review
Halobetasol propionate ointment	Commonly 0.05%	Ointment	Generally outside the lotion-or-cream limitation and likely outside the concentration limitations
Halobetasol foam	Commonly 0.05%	Foam	Outside the expressly claimed lotion-or-cream dosage form
Other listed corticosteroid lotion	0.01%-0.03%	Lotion or cream	Potential claim 1 exposure if the oil and solubilization elements are satisfied

The patent is therefore more important for low-dose, water-containing lotions and creams than for traditional high-concentration ointments.

What FDA regulatory status and Orange Book issues apply?

Bryhali is an FDA-approved halobetasol propionate 0.01% lotion. The product is associated with NDA 209475, according to FDA product information. [2]

For a generic applicant, the relevant pathway would ordinarily be an ANDA referencing the listed drug, subject to FDA requirements for therapeutic equivalence and labeling. A patent challenge could arise through a Paragraph IV certification if a relevant patent is listed in the Orange Book and the applicant asserts that the patent is invalid, unenforceable, or not infringed. [3]

The patent text alone does not establish:

whether US 11,986,527 is currently listed in the Orange Book;
the listed patent-use code;
whether the patent has been delisted;
whether an ANDA has made a Paragraph IV certification;
whether FDA issued a 30-month stay; or
whether a first-filer exclusivity period exists.

Those conclusions require current Orange Book and FDA litigation records. The legal effect of the patent cannot be inferred solely from the grant document.

When does US Patent 11,986,527 lose exclusivity?

A US utility patent generally expires 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and other statutory adjustments. The grant date in 2024 does not determine the expiration date. [4]

For this patent, the operative expiration date must be taken from the USPTO patent record and any related terminal-disclaimer or patent-term-adjustment data. A precise expiration date cannot be calculated from the claims supplied.

FDA regulatory exclusivity is separate from patent exclusivity. Bryhali's approval date and any applicable new-drug exclusivity do not establish the remaining patent term. Orange Book listing also does not extend the patent beyond its statutory term.

Which companies are challenging the patent?

No challenger, Paragraph IV filing, ANDA litigation, or settlement agreement is identified in the supplied material. The patent claims alone do not establish whether a generic manufacturer has challenged US 11,986,527.

The commercially relevant challenger group would consist of manufacturers seeking approval for generic halobetasol propionate lotion or a therapeutically substitutable low-dose corticosteroid lotion. Their risk would depend on the formulation actually submitted to FDA, not merely the active ingredient and strength.

A generic applicant could pursue several design-around strategies:

Use a non-ester oil system.
Omit mineral oil and light mineral oil.
Use white petrolatum, accepting that this creates other formulation and product-performance issues.
Use a dosage form other than a lotion or cream.
Use a concentration outside the claimed range.
Demonstrate that less than 25% of the corticosteroid is solubilized in the liquid oil phase.
Avoid the claimed treatment method or seek a label that does not induce the patented use.

These strategies may create regulatory, formulation, or commercial tradeoffs. A design-around that avoids this patent can still infringe other patents in the halobetasol or topical corticosteroid portfolio.

How strong is the patent estate?

US 11,986,527 has meaningful blocking value against a narrow but commercially important product profile: low-dose halobetasol propionate in an aqueous lotion or cream using an ester/mineral-oil vehicle without white petrolatum.

Its strength is highest where the accused product closely matches the claim 18 architecture. Its strength is lower against:

ointments;
foams;
higher-strength halobetasol products;
nonaqueous vehicles;
petrolatum-containing products;
formulations lacking qualifying esters; and
products that do not meet the 25% solubilization threshold.

The patent's principal vulnerability is technical proof of the solubilization limitation. Its principal enforcement advantage is that a commercial formulation's composition and manufacturing specifications may provide direct evidence for most structural limitations.

What patent litigation and settlement risks exist?

Patent litigation risk would likely center on:

claim construction of "solubilized";
the 25% threshold;
the temperature condition;
the meaning of "about";
whether the accused product is a lotion or cream;
whether a formulation contains white petrolatum;
induced infringement through the approved label; and
the interaction between this patent and related formulation or method-of-use patents.

A settlement could establish a licensed generic launch date before patent expiration, but no settlement terms are identified in the supplied record. Commercial forecasts should not assume an early generic launch without verified litigation and Orange Book data.

What is the revenue exposure?

The patent's direct revenue exposure is concentrated in the low-dose halobetasol lotion market and any other branded or generic products using the claimed vehicle design. It does not automatically block all halobetasol products.

Revenue analysis should separate:

branded 0.01% halobetasol lotion sales;
0.05% halobetasol creams, ointments, and foams;
other corticosteroids covered by claim 1;
products sold for plaque psoriasis; and
products sold for non-psoriasis dermatological conditions.

No reliable revenue figure follows from the patent claims alone. The commercial impact depends on the branded product's sales, Orange Book status, remaining patent term, generic approval timing, and whether competitors adopt a non-infringing formulation.

Key Takeaways

US 11,986,527 is primarily a method patent covering treatment with specified low-concentration corticosteroid lotions and creams.
Claim 18 is the key commercial claim for 0.01% halobetasol propionate.
The most important technical limitations are the ester-containing liquid oil phase, mineral oil or light mineral oil, water, absence of white petrolatum, and at least 25% solubilization at approximately room temperature.
The patent does not, based on the supplied claims, independently claim every halobetasol product or the composition standing alone.
Traditional 0.05% halobetasol ointments, creams, and foams are materially different infringement targets.
A generic applicant may be able to design around the patent through vehicle, dosage-form, concentration, or solubilization changes.
Current Orange Book listing, patent expiration, Paragraph IV activity, litigation, and settlement status require verification against current FDA, USPTO, and court records.

FAQs About US Patent 11,986,527

Does the patent cover every halobetasol propionate product?

No. The claims require specific concentration, dosage form, oil-phase, aqueous-phase, solubilization, and white-petrolatum limitations. Products outside those parameters may not infringe these claims.

Does a 0.01% halobetasol cream automatically infringe claim 18?

No. The cream must also contain the required ester-containing liquid oil component, mineral oil or light mineral oil, water, and at least 25% solubilized halobetasol at the claimed temperature, and it must be free of white petrolatum.

Are halobetasol foams covered by this patent?

The supplied claims require a lotion or cream. A foam would not literally satisfy that dosage-form limitation.

Can a formulation avoid infringement by using white petrolatum?

White petrolatum may avoid the literal "free of white petrolatum" limitation, but the product could remain exposed to other patents or infringement theories.

Is US 11,986,527 an Orange Book patent?

The patent text supplied does not establish its current Orange Book listing status. That status must be confirmed in the FDA's current Orange Book patent and exclusivity data.

References

United States Patent and Trademark Office. (2024). U.S. Patent No. 11,986,527.
U.S. Food and Drug Administration. (2018). Bryhali (halobetasol propionate) lotion, 0.01%: Prescribing information.
U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations (Orange Book).
U.S. Code. (2023). 35 U.S.C. §§ 154 and 156: Patent term and patent-term extension.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS	⤷ Start Trial
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011345240	⤷ Start Trial
Brazil	112013012476	⤷ Start Trial
Canada	2817524	⤷ Start Trial
Canada	3055328	⤷ Start Trial
China	103228281	⤷ Start Trial
European Patent Office	2643002	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,986,527

Which drugs does patent 11,986,527 protect, and when does it expire?

Summary for Patent: 11,986,527