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Last Updated: February 11, 2025

TACLONEX Drug Patent Profile


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Which patents cover Taclonex, and when can generic versions of Taclonex launch?

Taclonex is a drug marketed by Leo Pharma As and is included in two NDAs.

The generic ingredient in TACLONEX is betamethasone dipropionate; calcipotriene. There are sixty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; calcipotriene profile page.

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

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Recent Clinical Trials for TACLONEX

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

SponsorPhase
Taro Pharmaceuticals USAPhase 1
Glenmark Pharmaceuticals Ltd. IndiaPhase 3
Tolmar Inc.Phase 1

See all TACLONEX clinical trials

Paragraph IV (Patent) Challenges for TACLONEX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TACLONEX Ointment betamethasone dipropionate; calcipotriene 0.005%/0.064% 021852 1 2010-03-31

US Patents and Regulatory Information for TACLONEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 021852-001 Jan 9, 2006 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185-001 May 9, 2008 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TACLONEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 021852-001 Jan 9, 2006 RE39706 ⤷  Try for Free
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 021852-001 Jan 9, 2006 4,866,048 ⤷  Try for Free
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185-001 May 9, 2008 6,787,529 ⤷  Try for Free
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene OINTMENT;TOPICAL 021852-001 Jan 9, 2006 5,763,426 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TACLONEX

See the table below for patents covering TACLONEX around the world.

Country Patent Number Title Estimated Expiration
Spain 2000823 METODO PARA LA PRODUCCION DE COMPUESTOS ANALOGOS A LA VITAMINA D (NOVEL VITAMIN D ANALOGUES.) ⤷  Try for Free
Japan 5886999 ⤷  Try for Free
Denmark 2455083 ⤷  Try for Free
European Patent Office 2915534 Composition pharmaceutique pour le traitement dermique du psoriasis comprenant une vitamine D et une corticostéroïde (Pharmaceutical composition for dermal use to treat psoriasis comprising a vitamin D and a corticosteroid) ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for Taclonex

Introduction

Taclonex, a topical suspension combining calcipotriene and betamethasone dipropionate, is a significant player in the treatment of plaque psoriasis. This article delves into the market dynamics and financial trajectory of Taclonex, highlighting its position, growth prospects, and key factors influencing its market performance.

Market Position of Taclonex

Taclonex is a first-line treatment for both scalp and body plaque psoriasis in adults and, more recently, in pediatric patients aged 12 to 17 years. This dual-action topical therapy is distinguished by its once-daily application and effectiveness in treating psoriasis lesions on the scalp and body[4].

Competitive Landscape

The psoriasis treatment market is highly competitive, with various drugs vying for market share. Taclonex competes with other topical treatments, biologics, and systemic therapies. Key competitors include other topical combinations, biologics like secukinumab and ixekizumab, and systemic agents such as apremilast and methotrexate[1].

Revenue Forecasts and Market Share

Historical data indicates that Taclonex has been a stable contributor to the revenue of its manufacturer, LEO Pharma. In the period from 2012 to 2023, Taclonex, along with other products like Daivobet/Dovobet, was forecasted to maintain a significant market share in the psoriasis treatment market. The revenue forecasts for Taclonex during this period showed steady growth, although the exact figures varied based on geographical and market conditions[1].

Geographical Performance

Taclonex has performed well in various geographical markets. In the EU5 (Germany, France, UK, Italy, and Spain) and the US, Taclonex has been a key product in LEO Pharma's dermatology portfolio. The acquisition of the global dermatology portfolio from Astellas in 2016 further boosted LEO Pharma's revenue, including that from Taclonex, particularly in regions like Europe and Japan[2].

Financial Performance of LEO Pharma

LEO Pharma's financial performance provides insight into the trajectory of Taclonex. In 2017, LEO Pharma's revenue exceeded DKK 10 billion for the first time, with a significant increase driven by the full-year effect of sales from the acquired Astellas portfolio. The operating profit more than doubled compared to 2016, reaching DKK 852 million, largely due to cost control and efficiency projects[2].

Key Products and Revenue Contribution

Taclonex is one of the key products in LEO Pharma's psoriasis franchise, which grew by 6% in local currencies in 2017. This growth was primarily driven by markets in China and Japan. While specific revenue figures for Taclonex are not isolated, it is clear that the product contributes substantially to the overall revenue of LEO Pharma's psoriasis segment[2].

Regulatory Approvals and Expansions

Recent regulatory approvals have expanded the use of Taclonex. For instance, in 2014, Taclonex received an indication for the treatment of plaque psoriasis of the scalp in pediatric patients aged 12 to 17 years, marking a significant expansion of its target market[4].

Market Trends and Growth Drivers

The psoriasis treatment market is driven by several trends, including the increasing prevalence of psoriasis, advancements in therapeutic options, and the economic and quality of life impacts associated with the disease. The introduction of new treatments and the growing awareness of psoriasis management strategies are key growth drivers for products like Taclonex[1][3].

Challenges and Opportunities

Despite its strong market position, Taclonex faces challenges such as competition from newer biologic agents and potential side effects associated with long-term use of topical steroids. However, opportunities arise from the growing demand for effective and safe treatments, especially in developing nations with favorable reimbursement policies[1][3].

Future Outlook

The future outlook for Taclonex remains positive, driven by its established efficacy and the expanding market for psoriasis treatments. As LEO Pharma continues to optimize its operations and invest in research and development, Taclonex is likely to maintain its position as a leading topical treatment for plaque psoriasis.

"LEO Pharma’s operating profit improvements were mainly driven by cost control and the full-year effect of sales from the global dermatology portfolio from Astellas, which LEO Pharma acquired in April 2016."[2]

Key Takeaways

  • Market Position: Taclonex is a first-line treatment for plaque psoriasis, effective for both scalp and body lesions.
  • Revenue Contribution: It is a significant contributor to LEO Pharma's revenue, particularly within the psoriasis franchise.
  • Geographical Performance: Strong performance in EU5 and the US, with growth driven by markets in China and Japan.
  • Regulatory Approvals: Recent approvals have expanded its use to pediatric patients.
  • Market Trends: Driven by increasing prevalence, therapeutic advancements, and economic impacts of psoriasis.
  • Challenges and Opportunities: Faces competition from biologics but benefits from growing demand and favorable reimbursement policies.

FAQs

What is Taclonex used for?

Taclonex is used for the treatment of plaque psoriasis on the scalp and body in adults and pediatric patients aged 12 to 17 years.

Who manufactures Taclonex?

Taclonex is manufactured by LEO Pharma.

What are the key ingredients in Taclonex?

The key ingredients in Taclonex are calcipotriene and betamethasone dipropionate.

How has Taclonex performed financially?

Taclonex has contributed significantly to LEO Pharma's revenue, with the company's overall revenue exceeding DKK 10 billion in 2017.

What are the future prospects for Taclonex?

The future outlook for Taclonex is positive, driven by its established efficacy and the expanding market for psoriasis treatments.

Sources

  1. Psoriasis Treatment: World Drug Market 2013-2023 - PR Newswire
  2. LEO Pharma A/S - Annual Reports - Annual Reports
  3. Atopic Dermatitis Drugs Market to Surge, Hitting US$ 24.5 Billion - Market.US
  4. LEO Pharma Announced New Taclonex® (Calcipotriene and Betamethasone Dipropionate) Topical Suspension - BioSpace

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