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
Patent Applications:	4,964
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	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
World Intellectual Property Organization (WIPO)	2012087443
Russian Federation	2013128607	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИДЫ, ДЛЯ ТОПИКАЛЬНОГО ПРИМЕНЕНИЯ
South Korea	101967121
Cyprus	1114646

Supplementary Protection Certificates for BRYHALI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	PA2013025,C1304992	Lithuania		PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506

Market Dynamics and Financial Trajectory for BRYHALI

Introduction to BRYHALI

BRYHALI is a brand-name prescription medication approved by the FDA to treat plaque psoriasis in adults. It contains the active ingredient halobetasol propionate, a potent corticosteroid, and is available as a lotion applied topically to affected areas[4].

Market Position and Competition

BRYHALI operates in the dermatology market, specifically targeting the treatment of plaque psoriasis. This market is highly competitive, with various topical and systemic treatments available. However, BRYHALI's unique formulation and efficacy profile position it as a significant player.

• Competitive Landscape: BRYHALI competes with other branded and generic topical corticosteroids, as well as newer biologic agents. Its effectiveness and safety profile, particularly the low incidence of HPA axis suppression, make it a preferred choice for some patients[1][4].

Efficacy and Safety

The efficacy of BRYHALI has been demonstrated in several clinical trials. Here are some key points:

• Clinical Trials: In Phase 2 and Phase 3 trials, BRYHALI showed statistically significant treatment success compared to vehicle controls. For example, in Trials 1 and 2, 37% and 38% of subjects, respectively, achieved treatment success defined as at least a 2-grade improvement from baseline in IGA score and an IGA score equating to “clear” or “almost clear”[1].

• Safety Profile: While BRYHALI is generally well-tolerated, it can cause HPA axis suppression in some patients. However, this side effect was observed in a relatively low percentage of subjects (15.8% in one study), and all subjects had normal HPA axis suppression tests at follow-up visits[1][4].

Market Demand and Patient Needs

The demand for effective psoriasis treatments is high due to the chronic nature of the disease and the significant impact on patients' quality of life.

• Patient Demand: The psoriasis market is driven by patient demand for treatments that offer high efficacy with minimal side effects. BRYHALI's strong patient demand is reflected in its clinical trial outcomes and post-marketing data[1][3].

Financial Performance and Revenue

BRYHALI's financial performance is part of the broader dermatology portfolio of its parent company.

• Revenue Contribution: BRYHALI contributes to the revenue of companies like Roivant Sciences and Bausch Health, which have diversified portfolios in dermatology. For instance, Roivant Sciences highlighted the growth potential of its dermatology products, including BRYHALI, in their financial updates[3][5].

• Market Size and Growth Potential: The psoriasis market is substantial, with a global size that presents significant growth opportunities. BRYHALI, being a branded product, benefits from this market size and the increasing demand for effective treatments. The atopic dermatitis market, which is roughly four times the size of the psoriasis market, also presents a potential future opportunity if BRYHALI is approved for this indication[3].

Strategic Initiatives and Market Expansion

Companies behind BRYHALI are implementing various strategies to enhance its market presence.

• Marketing and Sales Efforts: Companies like Bausch Health are increasing their investment in direct-to-consumer advertising, new sales force capabilities, and leveraging artificial intelligence and machine learning to enhance customer engagement and drive sales[2].

• Geographical Expansion: There is a focus on expanding the reach of BRYHALI and other dermatology products into key markets, including Europe and Asia. The lifting of COVID-19 restrictions in China and other regions is expected to boost the recovery in treatment procedures, further driving revenue[2].

Regulatory and Pipeline Developments

The regulatory environment and pipeline developments are crucial for BRYHALI's long-term success.

• Regulatory Approvals: BRYHALI has already received FDA approval for plaque psoriasis. Future approvals for other indications, such as atopic dermatitis, could significantly expand its market potential[3][5].

• Pipeline and Future Products: The companies associated with BRYHALI have robust pipelines with several products in various stages of development. These include new treatments for other dermatological conditions, which could complement BRYHALI and further strengthen the company's market position[3][5].

Financial Outlook and Growth Drivers

The financial outlook for BRYHALI is positive, driven by several growth factors.

• Revenue Growth: The revenue from BRYHALI is expected to grow as the product gains more market traction and as the company expands its reach into new markets and indications[2][3].

• Cost Management and Efficiency: Companies like Bausch Health are focusing on improving their balance sheets and reducing debt, which will help in investing more in the commercialization and development of products like BRYHALI[2].

Key Takeaways

• Effective Treatment: BRYHALI is an effective treatment for plaque psoriasis with a strong safety profile.
• Market Demand: High demand for psoriasis treatments drives the market.
• Financial Performance: BRYHALI contributes significantly to the revenue of its parent companies.
• Strategic Initiatives: Companies are investing in marketing, sales, and geographical expansion.
• Regulatory and Pipeline Developments: Future approvals and pipeline products will enhance market potential.

Frequently Asked Questions (FAQs)

Q: What is BRYHALI used for? A: BRYHALI is used to treat plaque psoriasis in adults.

Q: What is the active ingredient in BRYHALI? A: The active ingredient in BRYHALI is halobetasol propionate.

Q: Can BRYHALI cause any serious side effects? A: Yes, BRYHALI can cause HPA axis suppression in some patients, although this is relatively rare.

Q: Is BRYHALI available in generic form? A: No, BRYHALI is currently available only as a brand-name medication.

Q: What are the future market expansion plans for BRYHALI? A: Companies are planning to expand BRYHALI's reach into new markets and potentially new indications such as atopic dermatitis.

Cited Sources

1. PrBRYHALITM – Product Monograph. Health Canada, 2021.
2. 2022 ANNUAL REPORT - Bausch Health Companies Inc.. Bausch Health, 2023.
3. February 13, 2023 Financial Results and Business Update for the Quarter Ended December 31, 2022. Roivant Sciences, 2023.
4. Bryhali: Uses, dosage, side effects, alternatives, and more. Medical News Today, 2020.
5. Roivant Corporate Overview - Investor Relations. Roivant Sciences.