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Last Updated: December 12, 2025

Leo Pharm Company Profile


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Summary for Leo Pharm
International Patents:212
US Patents:13
Tradenames:9
Ingredients:8
NDAs:13
Drug Master File Entries: 2
Patent Litigation for Leo Pharm: See patent lawsuits for Leo Pharm

Drugs and US Patents for Leo Pharm

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 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 PROTOPIC tacrolimus OINTMENT;TOPICAL 050777-001 Dec 8, 2000 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free
Leo Pharm PINDAC pinacidil CAPSULE, EXTENDED RELEASE;ORAL 019456-002 Dec 28, 1989 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Leo Pharma As ENSTILAR betamethasone dipropionate; calcipotriene AEROSOL, FOAM;TOPICAL 207589-001 Oct 16, 2015 RX Yes Yes 10,716,799 ⤷  Get Started Free Y ⤷  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 Pharm

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 6,753,013 ⤷  Get Started Free
Leo Pharma As DESONATE desonide GEL;TOPICAL 021844-001 Oct 20, 2006 6,387,383 ⤷  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 FINACEA azelaic acid AEROSOL, FOAM;TOPICAL 207071-001 Jul 29, 2015 8,722,021 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for LEO PHARM drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Gel 15% ➤ Subscribe 2012-07-27
➤ Subscribe Gel 0.05% ➤ Subscribe 2010-12-01
➤ Subscribe Ointment 0.03% ➤ Subscribe 2010-11-22
➤ Subscribe Topical Solution 0.01% ➤ Subscribe 2006-05-19
➤ Subscribe Topical Foam 15% ➤ Subscribe 2017-09-14
➤ Subscribe Ointment 0.1% ➤ Subscribe 2010-09-09
➤ Subscribe Ointment 0.005%/0.064% ➤ Subscribe 2010-03-31

Supplementary Protection Certificates for Leo Pharm Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435024 21C1020 France ⤷  Get Started Free PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024 LUC00208 Luxembourg ⤷  Get Started Free PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210
2460806 301321 Netherlands ⤷  Get Started Free PRODUCT NAME: DELGOCITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN; REGISTRATION 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Leo Pharma – Market Position, Strengths & Strategic Insights

Last updated: July 29, 2025

Introduction

Leo Pharma stands as a prominent player within the global dermatology and critical care pharmaceutical markets. Established in 1908 and headquartered in Ballerup, Denmark, Leo Pharma has positioned itself as a leader in innovative therapies targeting dermatological, sexually transmitted, and thrombotic diseases. Understanding Leo Pharma’s market positioning, core strengths, and strategic moves offers critical insights into its resilience and growth potential amid a rapidly evolving pharmaceutical landscape.

Market Position Overview

Global Reach and Market Share

Leo Pharma's footprint extends across key markets including North America, Europe, and emerging economies in Asia and Latin America. The company's global revenues are primarily driven by the management of dermatological conditions like psoriasis, atopic dermatitis, and other inflammatory skin diseases, as well as bleeding disorders.

According to recent fiscal reports, Leo Pharma’s revenues have exhibited steady growth, with the dermatology segment comprising approximately 70% of total income. Its strategic focus on specialized immune-mediated skin conditions has bolstered its market standing against competitors like AbbVie, Novartis, and Johnson & Johnson, especially with proprietary therapies such as Cutivate and Kyntheum (tildrakizumab).

Competitive Positioning

Leo Pharma’s niche specialization in dermatology and bleeding disorders affords it a differentiated position, allowing it to avoid direct confrontations with larger conglomerates dominating broader therapeutic categories. Its commitment to innovation and targeted therapies grants it high brand recognition within specialist medical communities.

Despite its relatively smaller scale compared to industry titans, Leo Pharma’s extensive pipeline and recent strategic acquisitions have reinforced its competitive stance, particularly in segments with high unmet needs.

Strengths of Leo Pharma

1. Focused Portfolio on Dermatology and Hematology

Leo Pharma’s concentration on dermatology and hematology enables it to allocate R&D resources efficiently, fostering specialized expertise. Its robust portfolio includes biologics for psoriasis and atopic dermatitis, such as Kyntheum (tildrakizumab), which competes effectively within the biologic segment by offering alternative mechanisms of action.

2. Innovative R&D Ecosystem

The company's commitment to research is evidenced by ongoing development programs targeting next-generation biologics and small molecules aimed at chronic inflammatory skin diseases and bleeding disorders. Notably, its investment in biosimilars and novel delivery mechanisms positions it at the forefront of innovation.

3. Strategic Partnerships and Alliances

Leo Pharma’s collaborations with biotech firms and academic institutions facilitate the development of cutting-edge therapies. The company’s recent partnership agreements, such as with the German biotech Boehringer Ingelheim, have accelerated pipeline advancement and market entry strategies.

4. Strong Market Presence in Niche Segments

Leo Pharma’s leadership in niche segments like dermatology critical care—particularly in managing difficult-to-treat conditions—provides a competitive moat. Its products are extensively recommended by dermatologists and specialists globally, helping sustain premium pricing models.

5. Focused Geographical Expansion Strategy

While maintaining a strong European base, Leo Pharma has expanded into emerging markets through strategic licensing agreements and local manufacturing capabilities. This diversification reduces reliance on saturated markets and leverages growth opportunities in Asia, Latin America, and the Middle East.

Strategic Insights and Future Outlook

1. Emphasis on Biosimilars and Generic Competition

Leo Pharma has increasingly embraced biosimilars as a strategic growth lever. The entry of biosimilars can erode revenues from branded biologics, but Leo Pharma’s proactive pipeline diversification buffers against this threat. Its current biosimilar programs target blockbuster biologics in dermatology.

2. Digital and Patient-Centric Innovation

Investments in digital health initiatives—such as teledermatology platforms and remote patient monitoring—are set to enhance therapeutic adherence and data collection. These initiatives foster stronger patient engagement and open new avenues for personalized medicine.

3. Mergers & Acquisitions for Portfolio Expansion

Leo Pharma’s acquisition of Virosa in 2021 showcased its focus on expanding in antiviral and skin microbiome markets. Continued M&A activity will likely target companies with complementary portfolios—particularly in biologics, small molecules, and innovative drug delivery systems.

4. Regulatory Landscape and Market Entry

Navigating regulatory frameworks remains a critical factor. Leo Pharma’s experience in gaining EMA and FDA approvals can fast-track its pipeline’s market entry, especially with therapies for rare or orphan diseases where regulatory pathways favor smaller, specialized firms.

5. Challenges & Risks

Key risks include patent expirations, intense competition from emerging biotech firms, and global supply chain disruptions. Strategic investment in pipeline innovation and agility in licensing will be essential to mitigate these vulnerabilities.

Conclusion

Leo Pharma’s entrenched focus on dermatology and hematology, combined with its commitment to innovation and strategic collaborations, positions it as a resilient and growing player in the competitive pharmaceutical landscape. Its targeted approach and expanding pipeline suggest a trajectory toward sustained profitability and market expansion, particularly as personalized and biologic therapies continue to dominate specialty markets.


Key Takeaways

  • Leo Pharma’s market position is reinforced by its specialized focus in dermatology and bleeding disorders, enabling it to carve out substantial niche dominance.
  • The company’s strengths include a robust R&D pipeline, strategic alliances, and emphasis on digital health initiatives, which collectively support long-term growth.
  • Its proactive expansion into biosimilars and emerging markets reflects adaptive strategy amid patent cliffs and competitive pressures.
  • Future growth hinges on pipeline innovation, strategic M&A, and leveraging digital health to enhance patient outcomes.
  • Navigating regulatory regimes and managing global supply chains remain ongoing challenges requiring agile adaptation.

FAQs

1. How does Leo Pharma differentiate itself from larger pharmaceutical companies?
Leo Pharma focuses on highly specialized therapeutic areas like dermatology and hematology, allowing it to develop deep expertise, foster strong clinician relationships, and position itself as an innovation leader within niche markets.

2. What are Leo Pharma’s main growth drivers for the next five years?
Key drivers include pipeline expansion with next-generation biologics, development of biosimilars, entry into emerging markets, and strategic M&A activities to diversify its portfolio.

3. How does Leo Pharma address competition from biosimilar manufacturers?
The company invests proactively in innovative biologics and novel delivery systems, while also developing biosimilars of established biologics to capture market share and maintain competitiveness.

4. What role does digital health play in Leo Pharma’s strategic vision?
Digital health enhances patient engagement, adherence, and data collection, enabling more personalized therapies and strengthening customer loyalty in a highly specialized field.

5. What risks could impact Leo Pharma’s future growth?
Potential risks include patent expirations, increasing competition, regulatory hurdles, and supply chain disruptions. Strategic diversification and continuous innovation are critical mitigants.


References

[1] Leo Pharma Annual Report 2022.
[2] Market Intelligence Reports: Global Dermatology Market 2022.
[3] Industry Analysis: Biosimilars & Specialty Biologics.
[4] Strategic Partnership Announcements, 2021-2023.
[5] Regulatory Agency Publications: EMA & FDA Approvals and Guidelines.

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