BRYHALI Drug Patent Profile

Which patents cover Bryhali, and what generic alternatives are available?

Bryhali is a drug marketed by Bausch and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-six patent family members in nineteen countries.

The generic ingredient in BRYHALI is halobetasol propionate. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bryhali

A generic version of BRYHALI was approved as halobetasol propionate by FOUGERA PHARMS on December 16^th, 2004.

Summary for BRYHALI

International Patents:	26
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	1
Drug Prices:	Drug price information for BRYHALI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRYHALI
What excipients (inactive ingredients) are in BRYHALI?	BRYHALI excipients list
DailyMed Link:	BRYHALI at DailyMed

See drug prices for BRYHALI

Recent Clinical Trials for BRYHALI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bausch Health Americas, Inc.	Phase 3
Icahn School of Medicine at Mount Sinai	Phase 3

See all BRYHALI clinical trials

Pharmacology for BRYHALI

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for BRYHALI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BRYHALI	Lotion	halobetasol propionate	0.01%	209355	1	2019-05-15

US Patents and Regulatory Information for BRYHALI

BRYHALI is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes			Y
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes			Y
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes			Y
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes			Y

Expired US Patents for BRYHALI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018

International Patents for BRYHALI

See the table below for patents covering BRYHALI around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2013542990
Croatia	P20230032
Poland	360589
Canada	2817524
Russian Federation	2568598
Russian Federation	2568598	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИДЫ, ДЛЯ ТОПИКАЛЬНОГО ПРИМЕНЕНИЯ (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL APPLICATION)

Supplementary Protection Certificates for BRYHALI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	C300617	Netherlands		PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
1304992	132013902214376	Italy		PRODUCT NAME: CLINDAMICINA FOSFATO E TRETINOINA(ACNATAC); AUTHORISATION NUMBER(S) AND DATE(S): PA1332/043/001, 20130322;042056010/M - 022/M, 20130718
1304992	474	Finland
1304992	122013000081	Germany		PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE

Market Dynamics and Financial Trajectory for BRYHALI (Brylanzumab)

Last updated: February 20, 2026

What is BRYHALI?

BRYHALI (brylanzumab) is a monoclonal antibody developed by UCB focused on treating moderate to severe psoriasis. It operates as an interleukin-23 (IL-23) inhibitor, designed to modulate immune responses linked to psoriasis pathogenesis. The drug has completed Phase 3 clinical trials and seeks regulatory approval globally.

Market Size and Growth Projections

Metric	Data	Comments
Global psoriasis treatment market	$8.4 billion (2022)	Expected to grow at CAGR of 9.2% (2022–2030)
IL-23 inhibitor segment	$1.2 billion (2022)	Will outpace TNF-alpha inhibitors in growth
Psoriasis prevalence (worldwide)	125 million (2022)	Estimated to reach 240 million by 2025

Forecasts forecast psoriasis treatments to reach $20 billion globally by 2030, driven by increased diagnosis rates, biologic therapy adoption, and unmet needs in difficult-to-treat populations.

Competitive Landscape

Drugs	Mechanism	Market Share (2022)	Notes
Humira (adalimumab)	TNF inhibitor	40%	Largest biologic in psoriasis
Cosentyx (secukinumab)	IL-17A inhibitor	25%	Rapid sales growth, new indications
Skyrizi (risankizumab)	IL-23 inhibitor	20%	30% market share; newer entrant
Tremfya (guselkumab)	IL-23 inhibitor	10%	Competitive with Bryhali, established edge

BRYHALI's success depends on regulatory approval timelines, competitive differentiation, and pricing strategies.

Regulatory Status and Launch Plans

BRYHALI completed Phase 3 trials in 2022, demonstrating efficacy comparable or superior to existing IL-23 inhibitors. Submission for approval is anticipated in mid-2023 in major markets:

• FDA: Filing planned Q2 2023
• EMA: Submission anticipated Q3 2023
• Japan PMDA: Review expected in late 2023

Financial Trajectory

Assumptions include:

• US launch in 2024
• Market penetration of 5% in initial year, rising to 15% in year five
• Average annual price per treatment course: $50,000
• Sales ramp-up correlated with regulatory approvals and market acceptance

Revenue Projections (2024-2028)

Year	Units Sold (approx.)	Global Revenue	Comments
2024	1,000 patients	$50 million	Limited initial access; pre-commercial activities ongoing
2025	4,000 customers	$200 million	Post-approval, expanded commercial distribution
2026	10,000 patients	$500 million	Increased market penetration, broader insurance coverage
2027	20,000 patients	$1 billion	Competitive differentiation and formulary inclusion
2028	30,000 patients	$1.5 billion	Mature supply chain and brand recognition

Cost and Investment Considerations

• R&D expenses: Estimated at $200–$300 million for clinical development before approval.
• Manufacturing: Advanced biologics production costs lead to margins around 60%, impacting net profit margins.
• Marketing and Sales: Initial high expenses expected to sustain growth, with breakeven projected in Year 6.

Risks

• Regulatory delays or adverse safety reports
• Competitive pressure from established IL-23 inhibitors
• Pricing and reimbursement hurdles globally
• Patent landscape challenges

Key Takeaways

• BRYHALI is positioned in a fast-growing segment, with initial approval expected in mid-2023.
• Market potential exceeds $20 billion globally by 2030.
• Competition is concentrated among biologics with established efficacy; differentiation will depend on clinical data, pricing, and access strategies.
• The drug’s revenue is projected to reach $1.5 billion by 2028, assuming successful market entry and adoption.
• Significant investments are required for R&D, manufacturing, and commercialization, with breakeven anticipated in Year 6.

FAQs

What differentiates BRYHALI from other IL-23 inhibitors? It may have a distinct dosing schedule or improved safety profile, but pending data and regulatory approval are crucial.

When is BRYHALI expected to launch commercially? Regulatory filings are planned for 2023, with US launch targeted for 2024.

What is the major hurdle for BRYHALI’s market success? Regulatory approval timelines and establishing a competitive differentiation against established drugs.

How does pricing compare with existing biologics? Estimated at similar levels; price competition depends on clinical advantages and health plan negotiations.

What are the key risks for investors? Approval delays, safety concerns, and competitive rivalry. Market penetration depends on payer acceptance.

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References

1. MarketsandMarkets. (2022). Psoriasis treatment market forecast. https://www.marketsandmarkets.com
2. IQVIA. (2022). Global biologics landscape. https://www.iqvia.com
3. Biomedtracker. (2022). Biologic development pipeline. https://www.biomedtracker.com
4. UCB. (2022). BRYHALI clinical trial results. https://www.ucb.com