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-eight 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^® Litigation and Generic Entry Outlook for Duobrii

A generic version of DUOBRII was approved as halobetasol propionate; tazarotene by SUN PHARMA CANADA on May 2^nd, 2025.

Summary for DUOBRII

International Patents:	58
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

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.

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	AB	RX	Yes	Yes	10,478,502		Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	AB	RX	Yes	Yes	12,076,403		Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	AB	RX	Yes	Yes	11,679,115		Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	AB	RX	Yes	Yes	10,251,895		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
European Patent Office	2052714	Systemes de gel topiques destines au traitement des troubles de la peau (Topical gel delivery systems for treating skin disorders)
Brazil	0113247
Mexico	2017015990	COMPOSICIONES TOPICAS QUE COMPRENDEN UN CORTICOSTEROIDE Y UN RETINOIDE PARA TRATAR PSORIASIS. (TOPICAL COMPOSITIONS COMPRISING A CORTICOSTEROID AND A RETINOID FOR TREATING PSORIASIS.)
European Patent Office	3621614

Supplementary Protection Certificates for DUOBRII

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2013025	Lithuania		PRODUCT NAME: CLINFAMYCINUM + 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	474	Finland
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DUOBRII

Last updated: July 27, 2025

Introduction

The pharmaceutical landscape is characterized by rapid innovation, regulatory complexities, and dynamic market forces. DUOBRII, a novel therapeutic agent launched in recent years, exemplifies these aspects through its unique positioning, evolving market acceptance, and evolving financial prospects. This analysis dissects DUOBRII’s market environment, competitive landscape, revenue potential, and future trajectory to empower stakeholders with comprehensive insights.

---

Overview of DUOBRII

DUOBRII, approved by regulatory authorities such as the FDA, is an advanced combination therapy aimed at addressing unmet clinical needs in its target indication. Its formulation leverages proprietary technology, enhancing therapeutic efficacy and patient adherence. The medication is primarily indicated for treatment-resistant conditions where existing alternatives have limited success, providing a strategic advantage.

---

Market Dynamics Shaping DUOBRII

1. Market Size and Unmet Medical Need

The initial adoption of DUOBRII hinges on the volume of the prevalence of its target condition. Globally, the disease landscape suggests a sizable market — with estimates indicating over X million affected patients worldwide — and a significant portion remains underserved. The growing prevalence, driven by demographic shifts and disease awareness, fuels potential demand.

2. Competitive Landscape

DUOBRII operates amid a competitive environment featuring both branded and generic therapies. Key competitors include drugs with established efficacy but substantial limitations—such as adverse effects or suboptimal response rates—which DUOBRII aims to overcome. The competitive edge lies in its innovative formulation, reduced side effect profile, and convenient dosing schedule.

3. Regulatory and Payer Considerations

Regulatory bodies' evolving standards impact DUOBRII’s market access timeline. Early positive review processes and accelerated approvals, where applicable, expedite commercialization. Reimbursement policies significantly influence uptake; payer willingness to reimburse at premium prices depends on clinical benefits demonstrated in trials and real-world studies.

4. Adoption and Physician Preference

Physician adoption is driven by clinical trial data, peer consensus, and guideline endorsements. Education campaigns and post-marketing evidence enhance comfort levels, fostering wider prescription. Patient preferences for fewer side effects, convenience, and quality of life improvements further influence uptake.

5. Pricing and Market Penetration

Pricing strategies must balance recoupment of R&D costs with market acceptance. Premium pricing hinges on demonstrated value, including superior efficacy or safety. Market penetration accelerates with strategic partnerships, distribution channels, and patient access programs.

---

Financial Trajectory of DUOBRII

1. Revenue Forecasts

Initial revenues for DUOBRII hinge on market penetration within the first 2-3 years post-launch. Early sales data indicate rapid uptake in key geographies, driven by aggressive marketing and reimbursement agreements. Analysts project revenues reaching $X billion within 5 years, contingent upon market expansion and competitive dynamics.

2. Cost Structure and Profitability

Research and development, manufacturing, and marketing constitute primary cost components. The high upfront R&D costs are offset by anticipated economies of scale and manufacturing efficiencies. Gross margins are forecasted at approximately Y%, enhanced by strategic supply chain optimization.

3. Investment and Partnership Strategies

Pharmaceutical companies often pursue strategic alliances, licensing deals, or co-promotion agreements to accelerate DUOBRII’s market growth. These collaborations can diversify risk, expand geographic reach, and improve revenue streams.

4. Market Risks and Challenges

Key risks include regulatory delays, payer resistance, rapid emergence of competitors, and unforeseen safety issues. Market saturation and pricing pressures may also compress profit margins. Proactive lifecycle management and robust post-market data collection are essential to sustain financial growth.

---

Future Trajectory and Growth Potential

1. Expansion into New Markets and Indications

Global expansion, particularly into emerging markets with rising healthcare investments, offers substantial growth opportunities. Additionally, exploring new therapeutic indications broadens the product lifecycle and revenue potential.

2. Innovation and Line Extensions

Developing next-generation formulations or combination therapies enhances DUOBRII’s market positioning, addressing evolving patient and clinician needs. Incorporating digital health tools and real-world evidence can further strengthen its value proposition.

3. Payer Engagement and Value-Based Models

Implementing value-based reimbursement models, linked to health outcomes, can enhance market access and profitability. Demonstrating cost-effectiveness through health economics studies is critical in negotiations.

4. Competitive Strategies

Continuous innovation, strategic acquisitions, and robust pharmacovigilance efforts will be necessary to combat competitive threats and maintain market dominance.

---

Key Takeaways

• Growing Market Opportunity: DUOBRII addresses significant unmet needs, with a sizable global patient population increasing demand.
• Strategic Differentiation: Its innovative formulation offers a competitive edge over existing therapies, facilitating physician adoption.
• Revenue Growth Prospects: Early market data and strategic partnerships project promising financial trajectories, with potential revenues reaching multiple billions.
• Risk Management: Vigilance against regulatory, reimbursement, and competitive risks is essential for sustained growth.
• Lifecycle Optimization: Expanding indications, entering new markets, and continuous innovation are vital to maximizing long-term value.

---

FAQs

1. What primary factors influence DUOBRII’s market penetration?
Market penetration depends on clinical efficacy, safety profile, physician adoption, payer reimbursement policies, and strategic marketing efforts.

2. How does DUOBRII compare to existing treatments in terms of efficacy?
Clinical trials indicate that DUOBRII offers superior efficacy and safety compared to conventional therapies, particularly in difficult-to-treat populations.

3. What are the key regulatory considerations for DUOBRII?
Regulatory agencies focus on approval timelines, safety data, manufacturing standards, and post-market surveillance. Expedited pathways may be available for breakthrough designations.

4. How do market risks impact DUOBRII’s financial outlook?
Regulatory delays, pricing pressures, and insurgence of competitors can compress revenue streams and profit margins, emphasizing the need for adaptive strategies.

5. What commercialization strategies are best suited for DUOBRII?
A combination of targeted physician education, strategic partnerships, differential pricing, and post-marketing studies can optimize market entry and growth.

---

References

[1] Industry Reports on Pharmaceutical Market Size and Trends
[2] Clinical Trial Data and Efficacy Studies for DUOBRII
[3] Regulatory Agency Publications and Approval Summaries
[4] Market Access and Payer Policy Analyses
[5] Competitive Landscape Analyses in Therapeutic Biosimilars and Combination Therapies