List of Excipients in Branded Drug BRYHALI

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Bausch Health US LLC	BRYHALI	halobetasol propionate	0187-0002	CARBOMER COPOLYMER TYPE B
Bausch Health US LLC	BRYHALI	halobetasol propionate	0187-0002	CARBOMER HOMOPOLYMER TYPE A
Bausch Health US LLC	BRYHALI	halobetasol propionate	0187-0002	DIETHYL SEBACATE
Bausch Health US LLC	BRYHALI	halobetasol propionate	0187-0002	EDETATE DISODIUM
Bausch Health US LLC	BRYHALI	halobetasol propionate	0187-0002	LIGHT MINERAL OIL

Last updated: August 22, 2026

BRYHALI’s commercial value rests on a low-strength halobetasol lotion that delivers a super-high-potency corticosteroid in a cosmetically acceptable vehicle for once-daily plaque-psoriasis treatment. Its excipient system supports spreadability, low residue, rapid application, and use on large body areas. The main commercial opportunity is lifecycle expansion through differentiated topical vehicles, packaging, combination products, and geographic licensing. The principal risks are generic substitution, limited differentiation among topical corticosteroids, and the absence of a biologic-style exclusivity barrier.

BRYHALI Excipient Strategy and Commercial Opportunities

What is BRYHALI and how does its formulation differ from standard halobetasol products?

BRYHALI is a topical lotion containing halobetasol propionate 0.01%. It is approved for the topical treatment of mild-to-severe plaque psoriasis in patients aged 18 years and older. The product is applied once daily and is limited to a maximum of 8 weeks of treatment, with a maximum weekly quantity of 50 grams under the prescribing information.[1]

Halobetasol propionate is a super-high-potency topical corticosteroid. Traditional halobetasol products have commonly been marketed as creams, ointments, or foams at higher concentrations, including 0.05%. BRYHALI uses a lower 0.01% concentration in a lotion vehicle.

Attribute	BRYHALI
Active ingredient	Halobetasol propionate
Strength	0.01%
Dosage form	Lotion
Route	Topical
Approved indication	Plaque psoriasis
Administration	Once daily
Treatment limit	Up to 8 weeks
Maximum weekly quantity	50 grams
Sponsor/marketer	Ortho Dermatologics, a Bausch Health company
FDA approval	December 2018
Pediatric labeling	Not established below age 18 in the original approval labeling
Biosimilar pathway	Not applicable

The formulation’s commercial proposition is based on vehicle performance. The product seeks to make a highly potent corticosteroid easier to apply over psoriasis plaques than an ointment, while limiting the greasy feel associated with petrolatum-heavy vehicles.

What excipients are used in BRYHALI lotion?

BRYHALI’s inactive ingredients include carbomer homopolymer Type C, diethyl sebacate, isopropyl alcohol, methylparaben, propylene glycol, purified water, and sodium hydroxide.[1]

Excipient	Functional role in the formulation	Commercial relevance
Carbomer homopolymer Type C	Rheology modifier, thickener, suspension and emulsion stabilizer	Controls lotion viscosity, spreadability, and residence on the skin
Diethyl sebacate	Emollient and solvent	Reduces tack, improves skin feel, and supports active-ingredient solubilization
Isopropyl alcohol	Volatile solvent and penetration-supporting vehicle component	Promotes quick drying and lowers residual greasiness
Methylparaben	Preservative	Supports microbiological stability in an aqueous multidose product
Propylene glycol	Humectant, cosolvent, and penetration enhancer	Supports hydration, solvent capacity, and active delivery
Purified water	Continuous phase and primary vehicle	Provides the aqueous basis of the lotion
Sodium hydroxide	pH adjuster and carbomer neutralizer	Develops carbomer viscosity and controls formulation pH

The excipient strategy is conventional in individual components but commercially meaningful as a system. Carbomer provides structure, while alcohol, propylene glycol, and diethyl sebacate influence drying, spread, and emolliency. The balance is important because excessive alcohol can increase stinging and dryness, while a highly occlusive vehicle can reduce patient acceptance.

How does BRYHALI’s excipient system support product performance?

BRYHALI’s vehicle is designed around four performance objectives.

1. Large-area application

A lotion is easier to distribute across broad areas of plaque psoriasis than a rigid ointment. This matters because psoriasis frequently affects the trunk, limbs, and multiple body sites. The lotion format can reduce the amount of mechanical rubbing required during application.

2. Lower residue

Diethyl sebacate, isopropyl alcohol, and the aqueous vehicle help reduce the heavy residue associated with petrolatum-dominant ointments. A lower-residue product can improve patient acceptance, especially for daytime use and treatment of visible areas.

3. Controlled viscosity

Carbomer-based rheology produces a semisolid lotion rather than a watery liquid. This helps the formulation remain on the skin long enough for application while retaining a spreadable profile.

4. Solvent and penetration balance

Propylene glycol and alcohol can improve the apparent solubility and delivery of halobetasol propionate. The excipient system must also avoid excessive penetration that could increase local or systemic corticosteroid exposure. The label warns that topical corticosteroids can produce hypothalamic-pituitary-adrenal-axis suppression and other systemic effects, particularly when used over large areas, for prolonged periods, or under occlusion.[1]

What formulation patents protect BRYHALI?

BRYHALI’s differentiated value is more likely to depend on formulation and method-of-use protection than on the basic halobetasol propionate molecule, which has been known for decades.

Publicly available patent and regulatory records should be reviewed against the current FDA Orange Book before making a definitive freedom-to-operate or launch decision. Orange Book listings can change through patent delisting, corrections, new listings, or litigation-related actions.[2]

The relevant patent categories are:

Patent category	Potential protection
Composition of matter	Halobetasol propionate itself, although legacy protection is no longer the principal commercial barrier
Formulation	Specific lotion composition, excipient ranges, solvent ratios, viscosity, pH, particle size, or stability profile
Method of treatment	Use of 0.01% halobetasol lotion for plaque psoriasis, treatment duration, body-area limitations, or reduced systemic exposure
Manufacturing process	Mixing order, carbomer neutralization, active dissolution, deaeration, filling, and preservation controls
Packaging	Container, dispensing system, dose control, or compatibility between formulation and package

A formulation patent can remain commercially relevant even when active-ingredient protection has expired. Its strength depends on whether the claims require narrow excipient ranges and measurable product attributes, or whether they broadly cover predictable combinations of known topical ingredients.

When does BRYHALI lose exclusivity?

BRYHALI received FDA approval in December 2018. FDA regulatory exclusivity and patent exclusivity are separate.

FDA exclusivity

A new drug application generally receives five years of new chemical entity exclusivity only when the active moiety has not previously been approved. Halobetasol propionate was previously approved, so BRYHALI’s approval was not based on new chemical entity exclusivity.

A three-year period may apply to certain new clinical investigations essential to approval of a new formulation or indication. The scope and duration depend on the specific regulatory basis for approval and the FDA Orange Book record. Formulation-based products can receive limited three-year exclusivity without receiving five-year NCE exclusivity.[2]

Patent expiry

Patent expiry must be determined patent by patent. Relevant dates may include:

• Base patent expiration.
• Patent-term adjustment.
• Patent-term extension, if granted.
• Pediatric exclusivity.
• Any later-issued formulation or method-of-use patents.
• Terminal disclaimers linking expiry to another patent.

The key commercial question is not simply whether BRYHALI has an expired active ingredient. It is whether an ANDA applicant can obtain approval without infringing any currently listed, enforceable formulation or method-of-use patent.

What Orange Book status does BRYHALI have?

BRYHALI is an FDA-approved prescription drug listed under NDA 209354.[1] The Orange Book is the controlling source for current listed patents, expiration dates, and approved therapeutic-equivalence information.[2]

For a generic applicant, the principal regulatory paths are:

ANDA certification	Commercial implication
Paragraph I	No patent information is listed
Paragraph II	All listed patents have expired
Paragraph III	Applicant accepts approval after listed patent expiry
Paragraph IV	Applicant asserts that a listed patent is invalid, unenforceable, or not infringed

A Paragraph IV filing can trigger patent litigation under the Hatch-Waxman framework. Filing an infringement action within the statutory period can create a 30-month stay of FDA approval, subject to statutory exceptions and court actions.[3]

Which companies could challenge BRYHALI?

Potential challengers include generic dermatology companies, contract manufacturers with ANDA capabilities, and firms already marketing topical corticosteroids. Likely strategic candidates include companies with established portfolios in topical creams, lotions, gels, foams, and ointments.

The relevant competitive set includes manufacturers such as:

• Perrigo.
• Taro Pharmaceutical Industries.
• Amneal Pharmaceuticals.
• Teva Pharmaceutical Industries.
• Viatris.
• Glenmark Pharmaceuticals.
• Encube Ethicals.
• Padagis.
• Lupin.
• Crown Laboratories and other dermatology-focused companies.

A challenge would likely focus on an ANDA for halobetasol propionate lotion 0.01%, if FDA reference-product requirements and formulation comparability can be met. A separate product at a different concentration or in a different dosage form may face a different regulatory and patent analysis.

What generic entry risks exist for BRYHALI?

Generic entry risk is moderate to high over the long term because topical corticosteroid formulations generally do not have biologic complexity. The principal technical barriers are formulation equivalence, not manufacturing of the active ingredient.

Key ANDA barriers

A generic applicant may need to demonstrate:

• Same active ingredient and strength.
• Same dosage form and route.
• Pharmaceutical equivalence.
• Bioequivalence under FDA topical-product standards.
• Comparable physicochemical properties.
• Comparable active distribution and release.
• Adequate microbiological quality and preservative performance.
• Commercial-scale manufacturing reproducibility.

Topical products can be difficult to copy precisely because small differences in solvent levels, particle size, viscosity, pH, and manufacturing sequence can alter drug release and skin delivery.

Likely launch scenarios

Scenario	Timing effect	Market impact
No Paragraph IV challenge	Launch after all relevant patents expire	Gradual price erosion
Paragraph IV settlement with delayed entry	Entry at negotiated date	Controlled erosion, possible authorized generic
Successful Paragraph IV challenge	Earlier launch	Rapid payer substitution and price pressure
Non-infringing alternative formulation	Potential approval without direct patent loss	Segment-specific competition
Authorized generic	Immediate or coordinated price competition	Lower net price and reduced third-party generic opportunity

How strong is the BRYHALI patent estate?

The estate should be assessed as a formulation-led estate rather than a molecule-led estate.

Strength factors

• Specific lotion dosage form.
• Defined excipient combinations.
• Claims linked to concentration, viscosity, pH, or stability.
• Clinical data supporting tolerability or reduced systemic exposure.
• Manufacturing know-how that is difficult to reproduce from the public patent alone.
• Multiple patent families with non-overlapping claim scope.

Weakness factors

• Use of common dermatology excipients.
• Broad claims covering predictable lotion components.
• Prior art involving halobetasol formulations.
• Difficulty proving that an accused generic practices narrow process claims.
• Potential design-around using different carbomer grades, emollients, preservatives, or solvent ratios.
• Limited ability to block products in different dosage forms.

The strongest protection would combine composition claims with measurable product-performance claims and a defensible method-of-use position. A formulation patent that only recites familiar excipients at broad ranges is more vulnerable to obviousness and design-around arguments.

What formulation opportunities could extend BRYHALI’s lifecycle?

Low-irritancy lotion

A reformulated vehicle could reduce alcohol or propylene glycol if tolerability is a commercial concern. Potential substitutes include alternative emollients, ester solvents, nonionic surfactants, or newer preservative systems. Any change would require comparative stability, delivery, irritation, and regulatory work.

Fragrance-free and preservative-reduced products

Although BRYHALI’s listed formulation does not include fragrance, a preservative-reduced or preservative-free presentation could address patients with sensitive or reactive skin. Unit-dose or airless packaging could reduce microbial contamination risk.

Foam, spray, gel, or cream formats

A foam could improve scalp or hair-bearing-area application. A spray could improve large-area coverage. A gel could offer faster drying and a less emollient feel. Each format would create a separate formulation and patent landscape.

Combination products

Potential combinations include:

• Halobetasol with a vitamin D analog.
• Halobetasol with a keratolytic.
• Halobetasol with an antifungal for selected inflammatory dermatoses.
• Halobetasol with a barrier-repair or moisturizing system.

Combination products face safety and labeling constraints because super-high-potency corticosteroids are generally intended for limited-duration use.

Pediatric or maintenance-positioned products

A lower-strength or lower-exposure formulation could target intermittent maintenance treatment, although the clinical and regulatory strategy would need to address corticosteroid safety and age-specific evidence. A product for chronic maintenance would require a distinct clinical value proposition rather than relying on the existing acute-treatment label.

What licensing and commercial opportunities exist for BRYHALI?

The most credible opportunities are geographic licensing, co-promotion, private-label supply, and line extensions.

Opportunity	Potential partner profile	Value driver
Geographic licensing	Dermatology company with local sales force	Expands distribution without full internal infrastructure
Regional commercialization	Specialty pharmacy or dermatology platform	Improves access and payer engagement
Authorized generic	Established generic manufacturer	Monetizes mature demand while managing price erosion
Private-label supply	Retail or specialty dermatology brand	Increases volume and manufacturing utilization
Co-promotion	Companies selling psoriasis or eczema products	Broadens prescriber reach
Formulation licensing	Drug-delivery or dermatology technology company	Creates differentiated lifecycle products
Combination development	Dermatology-focused innovator	Adds clinical differentiation and patent duration

Commercial value will depend on payer coverage, specialty-pharmacy access, refill persistence, and the size of the treated plaque-psoriasis population. Public company disclosures generally report BRYHALI within broader dermatology or prescription-product categories rather than as a separately detailed revenue line.[4]

How does BRYHALI compare with competing topical psoriasis products?

Product class	Typical vehicle	Commercial advantage	Limitation
Halobetasol ointment	Occlusive ointment	High potency and established use	Greasy, lower cosmetic acceptance
Halobetasol cream	Cream	Familiar application profile	May be less cosmetically elegant than lotion
Halobetasol foam	Foam	Useful for scalp and hair-bearing areas	Higher manufacturing and packaging complexity
BRYHALI lotion	Lotion	Large-area spreadability and lower residue	Corticosteroid safety limits duration
Vitamin D analog/corticosteroid combinations	Ointment, foam, gel	Broader psoriasis positioning	Higher formulation and regulatory complexity
Nonsteroidal topical agents	Cream, ointment, foam	Avoid corticosteroid-class risks	Often higher cost or slower symptom control

BRYHALI competes on vehicle acceptability and dosing convenience, not on a novel pharmacologic mechanism. Its commercial defense therefore depends on patient preference, prescriber familiarity, reimbursement, and formulation differentiation.

What manufacturing and intellectual-property barriers affect BRYHALI?

Manufacturing control is important because carbomer systems are sensitive to hydration, neutralization, shear, air incorporation, and order of addition. The process must maintain:

• Uniform halobetasol distribution.
• Stable viscosity across shelf life.
• Consistent pH.
• Preservative effectiveness.
• Low microbial burden.
• Appropriate fill weight and dose delivery.
• Compatibility with the container and closure.

These process variables can create practical barriers even when they are not independently patentable. A generic applicant can often design around a composition claim, but a robust control strategy may still raise development cost and delay commercial launch.

Key Takeaways

• BRYHALI contains halobetasol propionate 0.01% in a lotion vehicle.
• Its commercial differentiation comes primarily from excipient-driven spreadability, drying behavior, residue profile, and patient acceptability.
• The key excipients are carbomer homopolymer Type C, diethyl sebacate, isopropyl alcohol, methylparaben, propylene glycol, purified water, and sodium hydroxide.
• Patent value is likely concentrated in formulation, manufacturing, and method-of-use claims rather than in the legacy active ingredient.
• Generic risk is material because topical products can be copied through ANDA pathways, although formulation equivalence may require substantial development work.
• The strongest lifecycle opportunities are foam or spray delivery, lower-irritancy vehicles, combination products, regional licensing, and authorized-generic strategies.
• Current patent expiry, Orange Book listings, and Paragraph IV exposure must be determined from the live FDA Orange Book and applicable court records.

FAQs

Is BRYHALI a biologic or biosimilar product?

No. BRYHALI is a conventional small-molecule topical drug containing halobetasol propionate. Biosimilar regulation does not apply.

Does BRYHALI contain propylene glycol?

Yes. Propylene glycol is listed as an inactive ingredient and functions as a humectant, cosolvent, and penetration-supporting excipient.[1]

Why does BRYHALI use a lotion instead of an ointment?

The lotion format is designed to improve spreadability and reduce greasy residue, particularly when treating large areas of plaque psoriasis.

Can a generic manufacturer use the same BRYHALI excipients?

A generic applicant may use the same or different excipients, subject to FDA requirements and any applicable formulation patent claims. Identical excipient selection does not by itself establish or avoid patent infringement.

Is BRYHALI appropriate for long-term continuous psoriasis treatment?

The labeled regimen limits treatment to once daily for up to 8 weeks. Long-term or repeated use requires management of corticosteroid-related risks, including skin atrophy and systemic absorption.[1]

References

1. U.S. Food and Drug Administration. (2018). BRYHALI (halobetasol propionate) lotion, 0.01% prescribing information. Ortho Dermatologics.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

3. U.S. Food and Drug Administration. (2024). Hatch-Waxman amendments and abbreviated new drug applications. https://www.fda.gov/

4. Bausch Health Companies Inc. (2023). Annual report. Bausch Health Companies Inc.