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Last Updated: December 25, 2024

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DUOBRII Drug Patent Profile


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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

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Summary for DUOBRII
Drug patent expirations by year for DUOBRII
Drug Prices for DUOBRII

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DUOBRII
Generic Entry Date for DUOBRII*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Dermatology Consulting Services, PLLCPhase 4
Icahn School of Medicine at Mount SinaiPhase 3
Bausch Health Americas, Inc.Phase 3

See all DUOBRII clinical trials

Pharmacology for DUOBRII
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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DUOBRII is ⤷  Subscribe.

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 ⤷  Subscribe Y ⤷  Subscribe
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes 12,076,403 ⤷  Subscribe Y ⤷  Subscribe
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes 11,679,115 ⤷  Subscribe Y ⤷  Subscribe
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes 10,251,895 ⤷  Subscribe Y ⤷  Subscribe
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes 10,426,787 ⤷  Subscribe ⤷  Subscribe
Bausch DUOBRII halobetasol propionate; tazarotene LOTION;TOPICAL 209354-001 Apr 25, 2019 RX Yes Yes 11,648,256 ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 11345240
Patent: Pharmaceutical formulations containing corticosteroids for topical administration
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2013012476
Patent: formulações farmacêuticas contendo corticosteróides para administração tópica
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 17524
Patent: FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTEROIDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
Estimated Expiration: ⤷  Subscribe

Patent: 55328
Patent: FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTEROIDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
Estimated Expiration: ⤷  Subscribe

China

Patent: 3228281
Patent: Pharmaceutical formulations containing corticosteroids for topical administration
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0230032
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 43002
Patent: FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTÉROÏDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
Estimated Expiration: ⤷  Subscribe

Patent: 33838
Patent: FORMULATIONS PHARMACEUTIQUES CONTENANT DES CORTICOSTÉROÏDES POUR ADMINISTRATION TOPIQUE (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 61270
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 6398
Patent: פורמולציות רקחייות המכילות קורטיקוסטראוידים למתן על העור (Pharmaceutical formulations containing corticosteroids for topical administration)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 11007
Estimated Expiration: ⤷  Subscribe

Patent: 13542990
Estimated Expiration: ⤷  Subscribe

Lithuania

Patent: 43002
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 6961
Patent: FORMULACIONES FARMACEUTICAS QUE CONTIENEN CORTICOSTEROIDES PARA LA ADMINISTRACION TOPICA. (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION.)
Estimated Expiration: ⤷  Subscribe

Patent: 13005764
Patent: FORMULACIONES FARMACEUTICAS QUE CONTIENEN CORTICOSTEROIDES PARA LA ADMINISTRACION TOPICA. (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION.)
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 0659
Patent: Pharmaceutical formulations containing corticosteroids for topical administration
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 43002
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 43002
Estimated Expiration: ⤷  Subscribe

Russian Federation

Patent: 68598
Patent: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИДЫ, ДЛЯ ТОПИКАЛЬНОГО ПРИМЕНЕНИЯ (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL APPLICATION)
Estimated Expiration: ⤷  Subscribe

Patent: 13128607
Patent: ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ КОРТИКОСТЕРОИДЫ, ДЛЯ ТОПИКАЛЬНОГО ПРИМЕНЕНИЯ
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 43002
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 1967121
Estimated Expiration: ⤷  Subscribe

Patent: 140043044
Patent: PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION
Estimated Expiration: ⤷  Subscribe

Patent: 180015281
Patent: 국소 투여를 위한 코르티코스테로이드 함유 약학 제형 (PHARMACEUTICAL FORMULATIONS CONTAINING CORTICOSTEROIDS FOR TOPICAL ADMINISTRATION)
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 35814
Estimated Expiration: ⤷  Subscribe

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
Cyprus 1114646 ⤷  Subscribe
New Zealand 610659 Pharmaceutical formulations containing corticosteroids for topical administration ⤷  Subscribe
Argentina 030093 SISTEMA PARA LA DISTRIBUCION TOPICA DEL GEL ⤷  Subscribe
Denmark 3310389 ⤷  Subscribe
Germany 60138549 ⤷  Subscribe
European Patent Office 2052714 Systemes de gel topiques destines au traitement des troubles de la peau (Topical gel delivery systems for treating skin disorders) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DUOBRII

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1304992 SPC/GB13/061 United Kingdom ⤷  Subscribe PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992 2013C/060 Belgium ⤷  Subscribe PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992 474 Finland ⤷  Subscribe
1304992 CR 2013 00053 Denmark ⤷  Subscribe PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
1304992 2013/044 Ireland ⤷  Subscribe PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992 1390049-3 Sweden ⤷  Subscribe PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

DUOBRII Market Analysis and Financial Projection Experimental

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]

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.