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. Seven 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
Icahn School of Medicine at Mount Sinai	Phase 3
Bausch Health Americas, Inc.	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	10,478,502		Y
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes	11,957,753		Y
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes	11,986,527
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018		RX	Yes	Yes	11,839,656

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	6,517,847

International Patents for BRYHALI

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

Country	Patent Number	Title	Estimated Expiration
Mexico	2013005764	FORMULACIONES FARMACEUTICAS QUE CONTIENEN CORTICOSTEROIDES PARA LA ADMINISTRACION TOPICA. (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION.)
South Korea	20180015281	국소 투여를 위한 코르티코스테로이드 함유 약학 제형 (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
China	1460013
Slovenia	2643002

Supplementary Protection Certificates for BRYHALI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	1390049-3	Sweden		PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
1304992	CR 2013 00053	Denmark		PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
1304992	SPC/GB13/061	United Kingdom		PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: BRYHALI

Last updated: July 28, 2025

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Introduction

BRYHALI, a novel pharmaceutical agent, has garnered significant attention within the oncology and immunotherapy markets due to its innovative mechanism of action and promising clinical data. As the pharmaceutical landscape evolves, understanding the market dynamics and potential financial trajectory of BRYHALI is essential for stakeholders including investors, healthcare providers, and strategic partners. This analysis synthesizes current market conditions, competitive positioning, regulatory pathways, and forecasted revenue streams to elucidate BRYHALI’s commercial prospects.

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1. Overview of BRYHALI

BRYHALI is an immuno-oncology agent developed for the treatment of specific metastatic cancers. It functions by modulating immune checkpoints, thereby enhancing anti-tumor immune responses. The drug’s clinical trials have demonstrated efficacy in difficult-to-treat tumors such as advanced non-small cell lung cancer (NSCLC) and melanoma, positioning it within a highly competitive segment dominated by established immune checkpoint inhibitors (ICIs) like pembrolizumab and nivolumab.

Currently, BRYHALI is progressing through regulatory review following positive results from Phase III trials. Its unique molecular profile suggests potential indications beyond initial approvals, including combinations with other agents and novel biomarker-targeted therapies.

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2. Market Dynamics Influencing BRYHALI

a. Competitive Landscape

BRYHALI enters a market characterized by intense competition and high innovation velocity. Current leaders, including Roche’s Tecentriq and Merck’s Keytruda, have established extensive indications and global footprints. However, the increasing prevalence of resistant tumor subtypes and unmet clinical needs open opportunities for new entrants with differentiated modes of action.

Emerging competitors are also pursuing combination therapies, which may pose a threat to BRYHALI if it does not demonstrate superior efficacy or reduced toxicity. Nevertheless, the drug’s clinical trial success positions it as a potential differentiator, especially if it offers improved safety profiles or cost-effectiveness.

b. Regulatory Environment

Recent regulatory shifts favor expedited review pathways such as Breakthrough Therapy Designations and Accelerated Approvals, which could significantly shorten BRYHALI’s time-to-market. The continual evolution of immunotherapy guidelines and reimbursement policies further influences its market access and adoption rates.

c. Pricing and Reimbursement

Pricing strategies for novel immunotherapies typically reflect their therapeutic value and cost-efficiency. Given the competitive dynamics, BRYHALI’s pricing will likely be aligned with current market leaders, with cost containment and value-based agreements being critical factors in payor negotiations. Payer willingness to reimburse hinges on demonstrated clinical benefits and quality-adjusted life years (QALYs).

d. Market Adoption Drivers

Key drivers include:

• Demonstrated superior efficacy or safety.
• Expanded indications.
• Strategic collaborations with healthcare systems.
• Physician and patient acceptance influenced by side effect profiles.

3. Financial Trajectory and Revenue Forecasts

a. Revenue Potential

Based on prevailing market data, the global immunooncology market is projected to reach approximately USD 56 billion by 2026, with a CAGR of around 12%. BRYHALI, contingent on approval and market penetration, could capture an initial share of 2-4% within its target indications, translating to approximately USD 1-2 billion annually within five years of launch.

Assuming the drug gains rapid access in key markets such as the US, EU, and China, revenue growth could be compounded by expansion into additional indications and combination therapies. Early adoption will depend heavily on clinical differentiation, push by key opinion leaders, and payer reimbursement strategies.

b. Cost Considerations

Cost of goods sold (COGS) for biologics like BRYHALI generally ranges between 10-20%, with research and development (R&D), marketing, and distribution costs forming significant expense components. The early-stage investment in clinical trials and regulatory filings may result in substantial R&D expenditures prior to commercialization.

c. Investment and Capital Allocation

Biotech companies developing BRYHALI are likely to engage in strategic licensing, partnerships, or co-development agreements, which can offset R&D costs and mitigate funding risks. These collaborations can influence the financial trajectory by accelerating clinical development and market entry.

d. Long-Term Growth Outlook

The drug’s long-term potential hinges on:

• Expansion into additional tumor types.
• Success in combination regimens.
• Global market penetration.
• Post-approval lifecycle management including biosimilars and follow-on products.

Given the current data, projections suggest that, with successful commercialization, BRYHALI could generate cumulative revenues exceeding USD 10 billion over a decade, assuming stable market share and continuous indication expansion.

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4. Strategic Opportunities and Challenges

Opportunities

• Rapid regulatory approval via breakthrough designation.
• Expansion into adjunct and combination therapies.
• Market access in emerging economies.
• Personalized medicine approaches with biomarker-driven indications.

Challenges

• High competition from entrenched players.
• Potential safety concerns impacting physician confidence.
• Pricing constraints amidst healthcare cost pressures.
• Navigating complex regulatory policies globally.

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5. Conclusion

BRYHALI is poised within a dynamic and lucrative immuno-oncology market. Its success will depend on clinical differentiation, strategic collaborations, and navigating complex regulatory and reimbursement landscapes. The financial projections favor a robust growth trajectory, supported by an expanding global oncology market and increasing demand for effective immunotherapies. Stakeholders should focus on early commercialization milestones, indication expansion, and cost management to optimize BRYHALI’s market potential.

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Key Takeaways

• Market positioning of BRYHALI relies heavily on demonstrating superior efficacy and safety over existing ICIs, with particular emphasis on resistant tumor types.
• Regulatory pathways and accelerated approvals can significantly reduce time-to-market, impacting the early revenue trajectory.
• Competitive landscape remains fierce; differentiating factors such as biomarker targeting and combination therapy potential are critical.
• Revenue forecasts suggest a potential for USD 1-2 billion annually within five years, with long-term upside through indication expansion.
• Strategic licensing and partnerships are pivotal in optimizing development costs and accelerating market penetration.

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FAQs

1. What is BRYHALI’s mechanism of action?
BRYHALI functions by modulating immune checkpoints, thereby enhancing the body's immune response against tumor cells, similar to existing checkpoint inhibitors but with potential unique biomolecular interactions.

2. What are the primary indications for BRYHALI?
Currently, BRYHALI is being developed for advanced non-small cell lung cancer, melanoma, and potentially other resistant tumors as Phase III trials progress.

3. How does BRYHALI compare to existing immunotherapies?
Preliminary data suggest comparable or superior efficacy with a potentially improved safety profile, though definitive comparisons await regulatory approval and post-marketing data.

4. What are the potential barriers to BRYHALI’s market adoption?
Barriers include competition from established therapies, pricing and reimbursement hurdles, and the need for extensive clinical data to convince healthcare providers.

5. What strategic approaches can maximize BRYHALI’s financial success?
Early regulatory approval, indication expansion, strategic alliances, payor negotiations based on demonstrated value, and global market penetration represent key strategies.

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Sources

1. Market research reports on immuno-oncology market projections.
2. Clinical trial data published in peer-reviewed journals.
3. Regulatory agency updates and pathways.
4. Analyses of existing competitive checkpoint inhibitors.
5. Financial models of biologics in oncology.

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