United States Patent 12,076,403: Halobetasol Propionate Lotion Claims, Scope, and Patent Landscape

U.S. Patent 12,076,403 claims topical lotion compositions containing 0.01% to 0.03% halobetasol propionate, an aqueous phase, and a defined liquid-oil system designed to solubilize the corticosteroid at approximately 22°C. The patent is composition-focused. Its principal commercial relevance is to low-dose halobetasol propionate lotions, including formulations positioned as alternatives to 0.05% halobetasol products.

The strongest claim element is not halobetasol propionate alone. Halobetasol propionate is an established active pharmaceutical ingredient. The potentially distinguishing limitation is the quantitative relationship between the liquid oil and the amount required to completely solubilize the corticosteroid at room temperature.

What does U.S. Patent 12,076,403 claim?

Claim 1 requires all of the following elements:

Claim element	Requirement
Dosage form	Lotion for topical application to skin
Active ingredient	Halobetasol propionate
Active concentration	About 0.01% to about 0.03% w/w
Vehicle	Aqueous component plus liquid oil component
Oil characteristics	Water-insoluble or practically water-insoluble materials that are liquid at 22°C
Ester component	Dicarboxylic acid ester or monocarboxylic acid ester
Mineral oil component	Mineral oil or light mineral oil
Solubility relationship	Liquid oil concentration of 1.0 to 3.0 times the amount required to completely solubilize halobetasol propionate
Temperature	22°C ±2°C

The claim uses “comprising,” an open-ended transition. A competing product can contain additional excipients and remain within the literal scope if it satisfies every required limitation. The presence of an additional solvent, emulsifier, preservative, humectant, or thickener does not by itself avoid infringement.

The claim does not expressly require a particular package, application device, particle size, emulsion type, viscosity range, preservative system, or manufacturing process.

How broad is the independent composition claim?

Claim 1 has moderate breadth in excipient identity but narrow breadth in formulation architecture.

The claim is broad because it does not identify a single ester, mineral-oil grade, emulsifier, preservative, or thickener. It can potentially cover multiple oil systems, provided that the formulation contains the specified ester and mineral-oil components and meets the solubility ratio.

The claim is narrow because it requires:

Halobetasol propionate rather than a corticosteroid generally.
A concentration of approximately 0.01% to 0.03%.
A lotion rather than an ointment, cream, foam, gel, solution, spray, or shampoo.
A liquid oil system.
An oil amount tied to measured solubility at a defined temperature.
An ester/mineral-oil configuration.

A product containing 0.05% halobetasol propionate would fall outside the literal concentration range of claim 1. A product containing 0.01% halobetasol propionate in a cream or ointment would generally avoid claim 1’s “lotion” limitation unless the formulation is legally characterized as a lotion.

What do dependent claims 2 through 12 protect?

Claims	Subject matter	Commercial significance
2	Approximately 0.01% halobetasol propionate	Targets low-dose lotion products
3	Dicarboxylic acid ester	Covers one ester class
4	Monocarboxylic acid ester	Covers another ester class
5	Further mineral oil or light mineral oil	Reinforces mineral-oil embodiment
6	Oil sufficient to dissolve the corticosteroid	May cover the lower boundary of the solubility relationship
7	Oil at 1.0 to 1.5 times the solubilization amount	Narrower lower-ratio embodiment
8	Oil at 1.5 to 3.0 times the solubilization amount	Narrower higher-ratio embodiment
9	Humectants, preservatives, chelating agents, emulsifiers, or thickeners	Adds common formulation excipients
10	Emulsifying agent	Narrows claim 9
11	Sorbitan monooleate	Specific emulsifier
12	pH-adjusting agent	Adds pH control

Claims 3 and 4 are alternative ester pathways. A formulation containing both a dicarboxylic ester and a monocarboxylic ester could remain within both claim categories if all other limitations are satisfied.

Claim 11 is materially narrower than claim 1. A formulation that avoids sorbitan monooleate may still infringe claims 1, 9, or 10 if the remaining limitations are met.

What is the significance of the 1.0-to-3.0 solubility ratio?

The solubility-ratio limitation is the central technical restriction in the patent.

The claim does not merely require enough oil to dissolve halobetasol propionate. It requires the amount of liquid oil to be quantified relative to the amount needed for complete solubilization at approximately room temperature. This creates a formulation-specific test:

[ \text{Oil ratio} = \frac{\text{actual liquid oil concentration}} {\text{minimum oil concentration required for complete solubilization}} ]

A formulation is within claim 1 if this ratio is approximately 1.0 to 3.0 and all other limitations are met.

Infringement and testing implications

A patent holder would likely need evidence addressing:

The identity and concentration of each liquid oil.
The temperature at which solubility was measured.
The analytical method used to determine complete solubilization.
Whether halobetasol propionate is dissolved rather than dispersed or suspended.
The treatment of multiple oils in calculating the “liquid oil component.”
Whether the ratio is calculated from the total oil phase or only from the oil that solubilizes the active.
The reproducibility of the result at 20°C to 24°C.

The claims supplied do not specify a single analytical method for “completely solubilize.” That omission may create claim-construction and proof issues. The patent specification and prosecution history would be important in determining whether the phrase requires visual clarity, chemical assay, equilibrium testing, or another standard.

Which formulations are protected by the patent?

The most commercially relevant protected configuration is a low-dose halobetasol propionate lotion containing:

0.01%, 0.02%, or 0.03% halobetasol propionate;
water or another aqueous phase;
one or more liquid ester oils;
mineral oil or light mineral oil;
sufficient oil to dissolve the corticosteroid at room temperature; and
optionally, an emulsifier, preservative, humectant, chelating agent, thickener, or pH adjuster.

The dependent claims specifically identify sorbitan monooleate as an emulsifier. The claims do not require the comparator ingredients recited in claims 13 and 14, including cetyl alcohol, glycerin, isopropyl isostearate, isopropyl palmitate, steareth-21, diazolidinyl urea, methylchloroisothiazolinone, or methylisothiazolinone.

Those ingredients appear in the comparator formulation used to define the claimed performance relationship, not as mandatory ingredients of the patented composition.

What do claims 13 through 15 protect?

Claims 13 through 15 add functional performance limitations.

Claim 13 requires a VasoConstrictor Assay score “similar to” the score obtained by a specified 0.05% halobetasol formulation. Claim 14 requires equivalent or better efficacy in treating a dermatological disorder compared with that comparator. Claim 15 limits claim 14 to psoriasis.

These claims raise several legal and technical questions:

What numerical VCA range qualifies as “similar”?
Does “equivalent or better efficacy” require a statistical equivalence design?
Which clinical endpoint controls?
Is the comparison based on drug concentration, dose applied, treatment duration, or lesion response?
Must the comparator contain the exact listed ingredients and concentrations?
Does a product need to satisfy both the compositional limitations of claim 1 and the functional performance limitation?

Because claims 13 through 15 depend on claim 1, a formulation that achieves comparable efficacy but lacks the required oil-solubility relationship would not literally satisfy those claims.

Functional limitations can provide useful fallback protection, but terms such as “similar” and “equivalent or better” can create indefiniteness, enablement, written-description, and evidentiary issues. The prosecution record would show whether the applicant defined these terms through assay data or amendments.

How does the patent compare with 0.05% halobetasol products?

Attribute	Patent 12,076,403	Conventional 0.05% halobetasol product
Active concentration	Approximately 0.01% to 0.03%	Typically 0.05%
Primary dosage form	Lotion	Lotion, cream, ointment, foam, or other topical form
Required oil system	Ester plus mineral-oil architecture	Product-specific
Solubility ratio	1.0 to 3.0 times required amount	Not necessarily required
Comparator role	Claims 13 and 14 use a 0.05% formulation as benchmark	Benchmark formulation
Main patent risk	Low-dose composition and vehicle	Depends on separate composition, use, and formulation patents

The claims are designed around a lower-concentration product that seeks performance comparable to a higher-concentration halobetasol formulation. That structure may support product differentiation, but it does not automatically extend protection to all low-dose halobetasol products.

What is the Orange Book and FDA status relevance?

The Orange Book lists patents submitted for approved drug products, generally including patents claiming the drug substance, drug product, or approved method of use. FDA Orange Book listing does not itself determine whether a patent is valid or infringed. It affects abbreviated new drug application certification and potential 30-month litigation stays under the Hatch-Waxman framework.[2][3]

For a halobetasol lotion, the relevant questions are:

Issue	Relevance
Approved product	Identifies the reference listed drug
Listed patent	Determines whether an ANDA applicant may need a Paragraph IV certification
Use code	Defines the method-of-use scope, if any
Patent expiration	Affects earliest ANDA approval and launch timing
Pediatric exclusivity	Can add six months to qualifying listed patents
Litigation	May trigger a 30-month stay if statutory conditions are met

The claims supplied describe a composition patent. They do not establish whether U.S. Patent 12,076,403 is listed in the Orange Book, which approved product it covers, whether an FDA use code applies, or whether an ANDA applicant has filed a Paragraph IV certification.

When does U.S. Patent 12,076,403 lose exclusivity?

The exact expiration date cannot be determined from the claims alone. U.S. patent term ordinarily runs 20 years from the earliest effective nonprovisional filing date, subject to patent-term adjustment, terminal disclaimers, patent-term extension, and other statutory adjustments.[4]

For this patent, the relevant term analysis requires:

Earliest effective priority date.
Filing date of the relevant nonprovisional application.
Continuation or divisional relationships.
Patent-term adjustment.
Any terminal disclaimer.
Any patent-term extension.
Whether the patent claims an approved product eligible for extension.

The issue date, September 2024, does not establish the expiration date. Patent term is generally measured from the relevant filing history, not from issuance.

What generic entry risks exist?

A generic or follow-on topical product could pursue several design-around strategies:

Use 0.05% halobetasol propionate instead of 0.01% to 0.03%.
Use a cream, ointment, foam, gel, or solution rather than a lotion.
Use an aqueous formulation without the claimed ester/mineral-oil combination.
Use a non-ester solvent system.
Use an oil concentration below or above the 1.0-to-3.0 solubility ratio.
Use a suspension rather than a fully solubilized system.
Avoid sorbitan monooleate.
Use a different corticosteroid.
Challenge the claim construction or validity of the solubility limitation.
File an ANDA with a Paragraph IV certification if the patent is listed for the reference product.

The principal risk is for a low-dose halobetasol lotion that reproduces the same vehicle architecture. A formulation that merely contains halobetasol propionate at 0.01% is not necessarily within the patent.

How strong is the patent estate based on the claims?

The claims indicate a focused rather than comprehensive estate.

Strength	Assessment
Active ingredient protection	Low, because halobetasol propionate is specifically claimed and already established
Low-dose protection	Moderate to strong for 0.01% to 0.03% lotions
Vehicle protection	Moderate, depending on the construction of the ester and mineral-oil limitations
Solubility limitation	Potentially strong if reproducible and technically distinctive
Formulation breadth	Moderate because many excipients are permitted
Use protection	Narrow and dependent on claims 14 and 15
Manufacturing protection	Not shown in the supplied claims
Device or packaging protection	Not shown in the supplied claims
Geographic scope	United States only for this patent

The estate may be supplemented by related patents covering specific excipient combinations, manufacturing processes, pharmaceutical uses, or alternative dosage forms. Those rights cannot be inferred from U.S. Patent 12,076,403’s claims alone.

What patent litigation, settlements, or licensing deals affect the product?

The supplied claim text does not establish any infringement action, Paragraph IV litigation, settlement agreement, license, assignment, or commercial partnership involving U.S. Patent 12,076,403.

A complete competitive review would ordinarily examine:

USPTO assignment and maintenance records.
FDA Orange Book patent listings.
FDA Paragraph IV litigation notices.
PACER complaints and docket entries.
ANDA litigation under 21 U.S.C. § 355(j).
Securities filings by the product sponsor.
Patent-family members in Europe, Canada, Australia, and other markets.
License agreements involving the formulation or halobetasol product.

No litigation or licensing conclusion follows from the claim language itself.

Key Takeaways

U.S. Patent 12,076,403 is directed to low-dose halobetasol propionate lotions.
Claim 1 requires 0.01% to 0.03% halobetasol propionate, an aqueous phase, a liquid ester/mineral-oil system, and an oil-to-solubility ratio of 1.0 to 3.0 at approximately 22°C.
The patent does not broadly cover all halobetasol products or all 0.01% halobetasol formulations.
The solubility-ratio limitation is the main technical and enforcement issue.
Claims 13 through 15 add VCA and efficacy comparisons against a 0.05% halobetasol comparator.
A 0.05% product ordinarily falls outside the concentration range of claim 1.
Exact patent expiration, Orange Book listing, Paragraph IV activity, litigation, settlements, licensing, and revenue exposure are not established by the claims provided.
Generic risk is highest for a low-dose halobetasol lotion that reproduces the claimed ester/mineral-oil vehicle and room-temperature solubility relationship.

FAQs

Does U.S. Patent 12,076,403 cover halobetasol propionate cream?

Not on the supplied claims. Claim 1 requires a lotion. A cream could create infringement risk only if it is legally characterized as a lotion or if another related patent contains broader dosage-form claims.

Does a 0.01% halobetasol lotion automatically infringe?

No. It must also contain the claimed aqueous and liquid-oil system, the required ester and mineral-oil components, and the 1.0-to-3.0 solubility ratio at approximately 22°C.

Can a generic avoid the patent by using a different ester?

Possibly. Claims 3 and 4 cover dicarboxylic and monocarboxylic ester pathways, but the complete formulation must be assessed. A different ester may still fall within the broader language of claim 1 depending on its classification and role in the liquid-oil component.

Does the patent protect the use of halobetasol for psoriasis generally?

No. Claim 15 is limited to psoriasis treatment in a composition that already satisfies claim 1 and claim 14. It is not a standalone claim to all psoriasis treatment with halobetasol.

Is U.S. Patent 12,076,403 necessarily listed in the Orange Book?

No. Patent issuance and Orange Book listing are separate events. Listing depends on FDA regulatory submissions and the relationship between the patent claims and an approved drug product or method of use.

References

United States Patent and Trademark Office. (2024). U.S. Patent No. 12,076,403.
U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations (Orange Book).
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j).
United States Patent and Trademark Office. (2024). Patent term adjustment and patent term extension guidance.

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	12,076,403	⤷ Start Trial	Y				⤷ Start Trial
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	AB	RX	Yes	Yes	12,076,403	⤷ Start Trial	Y				⤷ 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
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 12,076,403

Which drugs does patent 12,076,403 protect, and when does it expire?

Summary for Patent: 12,076,403