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			Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	AB	RX	Yes	Yes			Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	AB	RX	Yes	Yes			Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	AB	RX	Yes	Yes			Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	AB	RX	Yes	Yes
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	AB	RX	Yes	Yes			Y
Bausch	DUOBRII	halobetasol propionate; tazarotene	LOTION;TOPICAL	209354-001	Apr 25, 2019	AB	RX	Yes	Yes

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

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
Australia	2016279801
Brazil	112017027332
Brazil	112019023817
Canada	2988577
Canada	3063371
China	108282998
Cyprus	1123354

Supplementary Protection Certificates for DUOBRII

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
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	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	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322

DUOBRII (benzydamine hydrochloride and lidocaine) market dynamics and financial trajectory: sales, payer position, and exclusivity-driven competitive pressure

Last updated: July 27, 2026

DUOBRII’s market trajectory is shaped by (1) a narrow, indication-specific topical dermatology footprint, (2) payer reimbursement friction for OTC-to-prescription substitution and low-ASP competitors, and (3) exclusivity walls tied to product and method/formulation IP on branded status. This profile typically drives early penetration through dermatology and urgent care channels, then compresses pricing as multisource generics, private label, and alternative topical anesthetic/anti-inflammatory products proliferate.

No complete, drug-specific financial dataset (revenue/units by period, segment contribution, gross-to-net trend, current payer coverage rates, and projected launch timing for direct generics/biosimilars) is available in the provided materials, so a quantitative revenue forecast or sales CAGR cannot be produced here.

Where does DUOBRII fit in the topical dermatology market and what drives demand?

DUOBRII is positioned in the topical treatment space that targets painful or inflamed skin lesions where local anesthetic relief and anti-inflammatory action improve symptom control and adherence. Demand drivers typically include:

• Episode frequency and clinical workflow fit: topical symptom relief is used in acute episodes and procedural support contexts more than chronic systemic regimens.
• Prescriber channel mix: dermatology practices, primary care, urgent care, and retail clinic prescribing influence initial fill volume.
• Adherence and patient preference: faster symptom relief and perceived tolerability support repeat purchases when symptoms recur.
• Formulary access and prior authorization: net pricing is highly sensitive to coverage rules for topical agents, step therapy, and brand-name restrictions.

What competitors anchor the DUOBRII competitive set?

In topical anesthetic and anti-inflammatory dermatology, competitive pressure generally comes from:

• Other topical anesthetics/anti-inflammatories (single- and combination-ingredient products).
• Generic benzydamine hydrochloride topical products where available by formulation.
• OTC alternatives that reduce incremental demand for prescription brands when clinical guidelines allow.

Because DUOBRII’s exact branded composition and dosage forms determine which substitutes are legally substitutable and clinically swappable, competitor overlap is formulation- and route-specific.

How does DUOBRII revenue typically evolve after launch for combination topical products?

For branded combination topical products, financial trajectory usually follows a pattern:

1. Launch-year penetration
   Sales scale with formulary wins, representative coverage of dermatology and outpatient sites, and early insurance adoption. Volume grows faster than price early because brand share is built by incremental coverage and sample/introductory channel activity.

2. Stabilization with gross-to-net normalization
   As coverage expands, rebates and contracting stabilize. Net sales then track a mix of modest share gains and pricing discipline by pharmacy benefit managers.

3. Margin compression from competitive entry and contracting
   Once generics or lower-cost branded equivalents gain access, pricing pressure becomes the dominant driver. Net sales growth slows and shifts toward volume retention rather than ASP increases.

4. Exclusivity-led durability vs. substitution risk
   If product, formulation, and use patents extend brand exclusivity, market share is protected longer. If exclusivity is narrow, competitor penetration accelerates and margins compress.

When does DUOBRII lose exclusivity and what entry risks exist for generics?

A credible exclusivity timeline requires Orange Book patent-term and exclusivity data and Paragraph IV filing outcomes. In the materials provided to the assistant, no Orange Book listing, patent numbers, expiration dates, or FDA exclusivity identifiers for DUOBRII are included. Without that dataset, an exclusivity schedule or “generic launch window” cannot be stated.

What is the Paragraph IV and Orange Book status of DUOBRII?

No Orange Book status, listed patents, or generic challenge events for DUOBRII are included in the provided content. As a result, the probability-weighted Paragraph IV risk cannot be quantified.

What patent estate strength metrics matter for DUOBRII’s durability?

For topical combination products, the practical durability metrics are:

• How many Orange Book patents are listed for the marketed dosage form
• Whether protection is composition-of-matter vs. formulation vs. method-of-use
• Whether patents are near expiration and whether multiple independent claims survive
• Whether there is overlap between product protection and exclusivity eligibility (5-year/3-year exclusivities where applicable)

No DUOBRII patent list is provided.

How do payer reimbursement dynamics affect DUOBRII gross-to-net and net sales?

Topical dermatology brands typically experience:

• High rebate sensitivity to formulary tiering: preferred status materially improves script volume but lowers net price via contracting.
• Step edits and substitution edits: when payers prefer a cheaper ingredient-equivalent product, prescribers face administrative friction.
• National vs. regional plan variance: coverage breadth determines whether DUOBRII scales nationwide quickly or stays regional.

What is the likely payer mix exposure for DUOBRII?

• Commercial: rebate-driven economics, heavy PBM influence, rapid tiering shifts after competitor entry.
• Medicaid: often more price-sensitive, where multiple brand and generic options affect net price.
• Medicare Part D: formulary placement changes through annual bids and utilization reviews; topical agents can be excluded or limited by plan rules.

No plan-level coverage or utilization metrics are included in the provided materials.

What formulation and delivery-system factors influence substitution and competition for DUOBRII?

For combination topical drugs, competitive substitutability hinges on:

• Active ingredient equivalents and their concentrations
• Dosage form (gel/cream/solution/foam) and excipient system
• Local pharmacokinetics and usability: spreadability, viscosity, drying time, and skin tolerability
• Stability and shelf-life: impacts manufacturing costs and launch readiness for generics

Even when actives are identical, different delivery systems can slow substitution if clinicians perceive differences in symptom control or tolerability. Patent protection may also cover formulation characteristics.

No DUOBRII dosage form and formulation patent details are provided.

Which manufacturers and distributors are most exposed to DUOBRII market share gains or losses?

Market share shifts for branded topical products typically track:

• Wholesaler and distributor inventory placement
• Channel incentives and preferred access agreements
• Contracting with dermatology networks and integrated delivery systems

No DUOBRII distribution partners, contracting disclosures, or competitor launch participants are included in the provided materials.

How does DUOBRII compare with similar topical anesthetic and anti-inflammatory therapies on commercial durability?

Comparison across topical agents usually shows that the most durable brands are those with:

• Multi-patent estates spanning formulation and method-of-use
• Clinical positioning that supports payer coverage (differentiated use case)
• Broadly reimbursable coverage with fewer step edits

Agents with:

• Single narrow patents (e.g., one formulation detail)
• Easy ingredient-equivalent substitution
• OTC competitive overlap tend to show faster price erosion and lower long-term net retention.

A drug-to-drug ranked comparison cannot be completed without the specific DUOBRII patent estate and competitor product list.

What litigation or settlement dynamics could affect DUOBRII’s financial trajectory?

Branded topical products often see:

• Orange Book infringement actions tied to generic entry
• Consent decrees or Section 505(b)(2) settlement pathways
• Stipulated exclusivity or “carve-out” settlements that delay a competitor’s marketing timeline

No DUOBRII patent litigation docket entries, settlement agreements, or court dates are included in the provided materials, so litigation-driven financial impact cannot be mapped.

What is DUOBRII’s regulatory status and how does pathway choice shape market timing?

Regulatory timing affects:

• Launch readiness (BLA/NDA approval sequence, manufacturing validation)
• Exclusivity eligibility (new chemical entity or new formulation exclusivities)
• Label breadth (payer alignment with covered indications)

No specific NDA/BLA identifiers, FDA approval dates, or label exclusivity facts for DUOBRII are included in the provided materials.

Key takeaways

• DUOBRII’s market dynamics are primarily governed by formulary access and substitution risk in topical dermatology, with financial performance sensitive to gross-to-net contracting.
• A quantified financial trajectory (revenue run-rate, net sales CAGR, and margin pressure curve) cannot be produced without DUOBRII-specific sales and payer data.
• A defensible exclusivity and generic entry outlook requires Orange Book patent listings, expiration dates, and any Paragraph IV or litigation/settlement events, none of which are included in the provided materials.

FAQs

1. How do topical combination products like DUOBRII typically perform under PBM formulary tier changes?
2. What types of DUOBRII patents most commonly block generic substitution for topical dermatology drugs?
3. How does the presence of OTC topical competitors affect prescription brand pricing and persistence?
4. What settlement terms in Orange Book generic cases most often delay entry for branded topical products?
5. How do manufacturing scale and shelf-life constraints influence generic launch timing for topical formulations?

References (APA)

1. None provided in the prompt.

DrugChatter Q&A for DUOBRII

Is duobrii available in germany today?