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Last Updated: December 18, 2025

Leo Pharma As Company Profile


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Summary for Leo Pharma As
International Patents:212
US Patents:13
Tradenames:8
Ingredients:7
NDAs:11
Drug Master File Entries: 7

Drugs and US Patents for Leo Pharma As

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 INNOHEP tinzaparin sodium INJECTABLE;INJECTION 020484-001 Jul 14, 2000 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 RX Yes Yes 9,211,259 ⤷  Get Started Free ⤷  Get Started Free
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 RX Yes Yes 9,566,286 ⤷  Get Started Free Y ⤷  Get Started Free
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 RX Yes Yes 10,617,698 ⤷  Get Started Free Y ⤷  Get Started Free
Leo Pharma As DOVONEX calcipotriene CREAM;TOPICAL 020554-001 Jul 22, 1996 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started 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 Leo Pharma As

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185-001 May 9, 2008 6,787,529 ⤷  Get Started Free
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185-001 May 9, 2008 6,753,013 ⤷  Get Started Free
Leo Pharma As TACLONEX betamethasone dipropionate; calcipotriene SUSPENSION;TOPICAL 022185-001 May 9, 2008 RE39706 ⤷  Get Started Free
Leo Pharma As FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 6,730,288 ⤷  Get Started Free
Leo Pharma As FINACEA azelaic acid GEL;TOPICAL 021470-001 Dec 24, 2002 4,713,394 ⤷  Get Started Free
Leo Pharma As PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000 5,665,727 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for LEO PHARMA AS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Gel 15% ➤ Subscribe 2012-07-27
➤ Subscribe Topical Solution 0.01% ➤ Subscribe 2006-05-19
➤ Subscribe Ointment 0.1% ➤ Subscribe 2010-09-09
➤ Subscribe Ointment 0.005%/0.064% ➤ Subscribe 2010-03-31
➤ Subscribe Topical Foam 15% ➤ Subscribe 2017-09-14
➤ Subscribe Gel 0.05% ➤ Subscribe 2010-12-01
➤ Subscribe Ointment 0.03% ➤ Subscribe 2010-11-22

Supplementary Protection Certificates for Leo Pharma As Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2460806 CR 2025 00010 Denmark ⤷  Get Started Free PRODUCT NAME: DELGOCITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ELLER ET SOLVAT DERAF; REG. NO/DATE: EU/1/24/1851 20240923
2460806 CA 2025 00010 Denmark ⤷  Get Started Free PRODUCT NAME: DELGOCITINIB I ALLE FORMER BESKYTTET AF BASISPATENTET; REG. NO/DATE: EU/1/24/1851 20240923
2435024 301102 Netherlands ⤷  Get Started Free PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024 2021C/518 Belgium ⤷  Get Started Free PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
2460806 122025000013 Germany ⤷  Get Started Free PRODUCT NAME: DELGOCITINIB IN ALLEN DURCH DAS GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1851 20240919
2460806 2025C/512 Belgium ⤷  Get Started Free PRODUCT NAME: DELGOCITINIB IN ALLE VORMEN DIE DOOR HET BASISOCTROOI WORDEN BESCHERMD; AUTHORISATION NUMBER AND DATE: EU/1/24/1851 20240923
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
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Pharmaceutical Competitive Landscape Analysis: Leo Pharma A/S — Market Position, Strengths & Strategic Insights

Last updated: July 27, 2025

Introduction

Leo Pharma A/S, founded in 1908 and headquartered in Denmark, stands as a prominent player in the dermatology and critical care segments. Specializing in dermatology, infectious diseases, and rare skin conditions, the company leverages decades of expertise to innovate treatments for complex skin disorders. Analyzing Leo Pharma's competitive positioning involves assessing its market share, core strengths, strategic initiatives, and future growth avenues within the dynamically evolving pharmaceutical landscape.

Market Position: Segment Focus and Global Footprint

Core Therapeutic Areas

Leo Pharma primarily operates within dermatology, targeting conditions such as psoriasis, atopic dermatitis, and infectious skin diseases like impetigo and bacterial infections. Its portfolio also encompasses niche treatments for rare skin conditions, including genodermatoses.

Geographic Presence

Leo Pharma maintains a robust global presence, with significant markets in North America, Europe, and Asia-Pacific. Its strategic acquisitions and partnerships have facilitated penetration into emerging markets, bolstering revenue streams and market share.

Market Share and Revenue Streams

In the dermatology segment, Leo Pharma has carved a credible share, particularly in niche indications. Its revenue is predominantly driven by proprietary biologics and innovative topical formulations. As per 2021 financial disclosures, the company reported revenues exceeding €1 billion, with a CAGR of approximately 6% over five years, underscoring steady growth driven by new product launches and expanding market reach.

Competitive Standing

While giants like Johnson & Johnson, Novartis, and AbbVie lead globally in dermatology, Leo Pharma maintains a strong niche position, especially in psoriasis and atopic dermatitis, owing to its targeted R&D focus and specialized product offerings.

Strengths of Leo Pharma

1. Focused R&D and Innovation

Leo Pharma invests substantially in dermatology-specific R&D, leading to innovative biologics such as tralokinumab and deucravacitinib, which target key cytokines involved in psoriasis and atopic dermatitis. Its emphasis on precision medicine enhances its competitive edge, allowing for tailored therapies with higher efficacy.

2. Robust Portfolio and Proprietary Products

The company's pipeline comprises multiple late-stage candidates, including biologics and small molecules targeting unmet needs in dermatology. Its flagship products, such as Kyntheum (an IL-17 inhibitor) and Finacea (azelaic acid), enjoy strong market positions, supported by clinical efficacy and favorable safety profiles.

3. Strategic Collaborations and Licensing Agreements

Leo Pharma has established strategic partnerships with biotech firms and academic institutions to foster innovation and expand its portfolio. Collaborations with firms like AbbVie and Eli Lilly have facilitated access to novel biologics and enhanced market penetration.

4. Regulatory Expertise and Strong Intellectual Property

The company maintains a formidable IP portfolio, protecting its innovations globally. Its expertise in navigating complex regulatory environments, notably in the US and EU, helps accelerate product approval and commercialization.

5. Focused Market Strategy

Unlike diversified conglomerates, Leo Pharma adopts a specialized approach, focusing exclusively on dermatology and certain infectious diseases. This focus enables more efficient R&D, tailored marketing, and deeper engagement with dermatology specialists.

Strategic Insights: Opportunities and Challenges

Opportunities

  • Expansion into Emerging Markets: With rising prevalence of dermatological conditions in Asia, Latin America, and Africa, Leo Pharma can intensify growth through local partnerships and tailored marketing strategies.
  • Next-Generation Biologics and Biosimilars: Developing biosimilars and novel biologics targeting resistant or refractory conditions can expand its pipeline and address unmet needs.
  • Digital Health Integration: Leveraging teledermatology, AI-driven diagnostics, and patient monitoring can enhance treatment adherence and outcomes, reinforcing its market leadership.

Challenges

  • Intense Competition: Giants like Novartis and Johnson & Johnson invest heavily in dermatology, intensifying pricing pressures and innovation race.
  • Regulatory and Patent Risks: Patent expirations and regulatory hurdles pose risks to product lifecycle management.
  • Pricing and Reimbursement Pressures: Growing scrutiny over healthcare costs may impact profitability, especially in payor-driven markets.

Strategic Recommendations

  • Prioritize R&D in personalized medicine to differentiate offerings.
  • Expand geographic footprint through acquisitions or partnerships, especially in high-growth markets.
  • Invest in digital health tools to enhance patient engagement and treatment outcomes.
  • Maintain vigilance over intellectual property rights and patent strategies.

Competitive Landscape Comparison

Key Competitors

  • Johnson & Johnson: Market leader with a diversified portfolio including Stelara (ustekinumab) for psoriasis and other biologics.
  • Novartis: Major player with Cosentyx (secukinumab) and its expanding pipeline in dermatology.
  • AbbVie: Strong presence with Humira (adalimumab) and Skyrizi (risankizumab).

Differentiators

Leo Pharma’s differentiation lies in its exclusive focus on dermatology, fostering specialized expertise and tailored solutions. In comparison, larger competitors pursue broader indications, which can dilute focus but provide diversified revenue streams.

Future Outlook

The dermatology market is projected to grow at a CAGR of approximately 8% until 2028, driven by rising prevalence, aging populations, and innovation in biologics. Leo Pharma's continued investment in targeted therapies, strategic expansion, and digital integration positions it favorably to capitalize on this growth. Its niche positioning and specialized pipeline offer resilience amid an increasingly competitive landscape.

Key Takeaways

  • Leo Pharma solidifies its position as a specialized leader in dermatology with a focus on innovative biologics and targeted therapies.
  • Its strategic partnerships, proprietary IP, and market focus sustain competitive advantages amid industry rivalry.
  • Expansion into emerging markets and investment in digital health present significant growth opportunities.
  • Navigating regulatory challenges and competitive pressures require ongoing strategic agility.
  • A continued emphasis on R&D and personalized medicine will be critical to maintaining leadership and driving future growth.

FAQs

Q1. How does Leo Pharma differentiate itself from major competitors in dermatology?
Leo Pharma’s exclusive focus on dermatology and infectious skin diseases allows it to develop highly specialized, targeted therapies. Its emphasis on innovation, regulatory expertise, and tailored marketing strategies distinguish it from broader competitors like Johnson & Johnson and Novartis.

Q2. What are the key growth drivers for Leo Pharma in the upcoming years?
Primary growth drivers include expanding into emerging markets, investing in next-generation biologics, leveraging digital health tools, and capitalizing on unmet needs in rare dermatological conditions.

Q3. How vulnerable is Leo Pharma to patent expirations and generic competition?
While patent expirations pose risks, Leo Pharma mitigates this through strategic IP management, developing new biologics within its pipeline, and focusing on specialty formulations less susceptible to generic entry.

Q4. What strategic partnerships does Leo Pharma pursue to bolster its innovation pipeline?
The company partners with biotech firms, academic institutions, and larger pharma companies to access novel molecules, co-develop therapies, and expand its market reach.

Q5. What role does digital health play in Leo Pharma's strategic outlook?
Digital health tools such as teledermatology, patient monitoring applications, and AI diagnostics are integral to Leo Pharma’s strategy to improve patient adherence, optimize treatment outcomes, and differentiate its offerings.

Conclusion

Leo Pharma A/S’s strategic focus on dermatology, combined with its robust pipeline, innovation-driven approach, and global expansion efforts, positions it as a formidable player in the pharmaceutical industry. Balancing ongoing R&D investments with strategic market penetration and digital transformation will be pivotal in sustaining its competitive edge within a complex and rapidly evolving landscape.

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