DUOBRII Drug Patent Profile

When do Duobrii patents expire, and what generic alternatives are available?

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

This drug has fifty-four patent family members in twenty-two countries.

The generic ingredient in DUOBRII is halobetasol propionate; tazarotene. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the halobetasol propionate; tazarotene profile page.

DrugPatentWatch^® Generic Entry Outlook for Duobrii

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 2, 2031. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for DUOBRII

International Patents:	54
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	6
Drug Prices:	Drug price information for DUOBRII
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DUOBRII
What excipients (inactive ingredients) are in DUOBRII?	DUOBRII excipients list
DailyMed Link:	DUOBRII at DailyMed

See drug prices for DUOBRII

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DUOBRII

Constraining patent/regulatory exclusivity:

10,478,502

NDA:

209354

Dosage:

LOTION;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DUOBRII

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

Sponsor	Phase
Dermatology Consulting Services, PLLC	Phase 4
Icahn School of Medicine at Mount Sinai	Phase 3
Bausch Health Americas, Inc.	Phase 3

See all DUOBRII clinical trials

Pharmacology for DUOBRII

Drug Class	Corticosteroid Retinoid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for DUOBRII

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DUOBRII	Lotion	halobetasol propionate; tazarotene	0.01%/0.045%	209354	1	2020-06-11

US Patents and Regulatory Information for DUOBRII

DUOBRII is protected by ten US patents.

This potential generic entry date is based on patent 10,478,502.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	10,478,502		Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	12,076,403		Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019		RX	Yes	Yes	11,679,115		Y

Expired US Patents for DUOBRII

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	6,517,847

International Patents for DUOBRII

When does loss-of-exclusivity occur for DUOBRII?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

European Patent Office

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Poland

Portugal

Russian Federation

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DUOBRII around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	3310389
Serbia	60672	TOPIKALNE KOMPOZICIJE KOJE SADRŽE KORTIKOSTEROIDE I RETINOID ZA LEČENJE PSORIJAZE (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID AND A RETINOID FOR TREATING PSORIASIS)
Mexico	346961	FORMULACIONES FARMACEUTICAS QUE CONTIENEN CORTICOSTEROIDES PARA LA ADMINISTRACION TOPICA. (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION.)

Supplementary Protection Certificates for DUOBRII

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	474	Finland
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

Market Dynamics and Financial Trajectory for Duobrii

Introduction to Duobrii

Duobrii, developed by Ortho Dermatologics, a division of Bausch Health Companies, is a groundbreaking topical treatment for plaque psoriasis. It is the first and only topical formulation that combines a potent corticosteroid (ulobetasol) with a retinoid (tazarotene) in a single product. This unique combination leverages the anti-inflammatory properties of ulobetasol and the cellular turnover effects of tazarotene, providing a dual mechanism of action that effectively treats plaque psoriasis[1].

Market Growth Drivers

The plaque psoriasis market, in which Duobrii operates, is experiencing significant growth driven by several key factors:

Novel Biological Treatments

The increasing adoption of novel biological treatments is a major trend in the plaque psoriasis market. Biologics offer more targeted and effective treatment options, which has led to a higher demand for these therapies[1].

Customized Treatment Approaches

The market is also driven by the need for customized treatment approaches. Patients are seeking treatments that are tailored to their specific needs, and Duobrii's unique formulation addresses this demand by offering a combination therapy that is both effective and convenient[1].

Oral Small-Molecule Inhibitors

In addition to biologics, oral small-molecule inhibitors like apremilast are gaining traction due to their convenience and effectiveness. However, topical treatments like Duobrii remain a preferred option for many patients due to their localized action and lower systemic side effects[1].

Market Size and Growth Rate

The plaque psoriasis market is projected to exhibit a robust growth rate, with a Compound Annual Growth Rate (CAGR) of 8.93% during the period from 2024 to 2034. This growth is largely driven by the increasing demand for effective and convenient treatments like Duobrii[1].

Financial Performance of Duobrii

Revenue Growth

Duobrii has shown promising revenue growth since its launch. For instance, Bausch Health Companies anticipates that Duobrii, along with another drug Xifaxan, could account for approximately 25% of the company's operating income within five years. This indicates a strong financial trajectory for the product[5].

Market Share

Duobrii has quickly gained traction in the market, positioning itself as a leading topical treatment for plaque psoriasis. The product's unique formulation and effectiveness have contributed to its market share, making it a significant contributor to Bausch Health's revenue[1].

Competitive Landscape

The global topical drugs market, which includes treatments like Duobrii, is highly competitive. Key players such as Bayer AG, Cipla, Inc., GSK Group of Companies, Johnson & Johnson Private Limited, and Novartis AG are also active in this space. However, Duobrii's unique combination of a corticosteroid and a retinoid sets it apart from other treatments, giving it a competitive edge[4].

Regulatory and Market Approval

Duobrii has received regulatory approval and has been successfully launched in the market. For example, in September 2020, Bausch Health, Canada launched Duobrii lotion, marking a significant milestone in the treatment of psoriasis patients[4].

Patient Demand and Payer Acceptance

The launch of Duobrii has been met with strong patient demand. The product's effectiveness and convenience have led to positive conversations with payers, resulting in improved net yield and revenue growth. For instance, the net yield for Duobrii has increased from 12% to 18% in subsequent quarters, indicating good payer progress and strong patient demand[3].

Future Outlook

The future outlook for Duobrii is promising, given the growing demand for topical treatments in the psoriasis market. Here are some key points to consider:

Expanding Indications

While Duobrii is currently approved for plaque psoriasis, the broader topical drugs market is expanding to include treatments for other skin disorders such as atopic dermatitis and eczema. This expansion could provide additional growth opportunities for Duobrii or similar products[4].

Strategic Collaborations

The industry is witnessing strategic collaborations between key players, which could further drive innovation and growth. Such collaborations could lead to new formulations or indications for existing products like Duobrii[4].

Financial Projections

Bausch Health Companies is expected to continue its recovery and growth, with Duobrii playing a significant role in this trajectory. The company's financial health, including its operating income and revenue projections, is closely tied to the performance of key products like Duobrii[5].

Key Takeaways

• Unique Formulation: Duobrii's combination of a corticosteroid and a retinoid makes it a unique and effective treatment for plaque psoriasis.
• Market Growth: The plaque psoriasis market is growing at a CAGR of 8.93% from 2024 to 2034, driven by novel biological treatments and customized treatment approaches.
• Revenue Growth: Duobrii has shown strong revenue growth and is expected to contribute significantly to Bausch Health's operating income.
• Competitive Edge: Duobrii's unique formulation sets it apart in a competitive market.
• Regulatory Approval: Duobrii has received regulatory approval and has been successfully launched.
• Future Outlook: The product has a promising future with potential expansion into other indications and strategic collaborations.

FAQs

Q: What is Duobrii, and how does it treat plaque psoriasis? A: Duobrii is a topical treatment that combines a potent corticosteroid (ulobetasol) with a retinoid (tazarotene) to treat plaque psoriasis. It leverages the anti-inflammatory properties of ulobetasol and the cellular turnover effects of tazarotene.

Q: What is the projected growth rate of the plaque psoriasis market? A: The plaque psoriasis market is projected to grow at a CAGR of 8.93% from 2024 to 2034.

Q: How does Duobrii compare to other treatments in the market? A: Duobrii's unique combination of a corticosteroid and a retinoid sets it apart from other treatments, giving it a competitive edge in the market.

Q: What is the current financial performance of Duobrii? A: Duobrii has shown strong revenue growth and is expected to contribute significantly to Bausch Health's operating income, potentially accounting for about 25% of the company's operating income within five years.

Q: What are the future growth opportunities for Duobrii? A: Future growth opportunities include expansion into other indications such as atopic dermatitis and eczema, as well as potential strategic collaborations that could drive innovation and growth.

Cited Sources

1. Biospace: "Plaque Psoriasis Market Estimated to Reach a CAGR of 8.93% During 2024-2034"[1]
2. Roivant Investor Relations: "Roivant 2Q 2022 Earnings Call"[2]
3. Roivant Investor Relations: "February 13, 2023 Financial Results and Business Update for the"[3]
4. Business Wire: "Global Topical Drugs Market (2022 to 2030) - Size, Share & Trends Analysis Report"[4]
5. Morningstar: "Bausch's Recovery on Track With B+L Spin on Horizon, Deleveraging Still Priority Number One"[5]