Leo Pharma As Company Profile

What is the competitive landscape for LEO PHARMA AS

LEO PHARMA AS has ten approved drugs.

There are twelve US patents protecting LEO PHARMA AS drugs.

There are one hundred and sixty-five patent family members on LEO PHARMA AS drugs in twenty-six countries and eight supplementary protection certificates in seven countries.

Summary for Leo Pharma As

International Patents:	165
US Patents:	12
Tradenames:	7
Ingredients:	6
NDAs:	10
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	DOVONEX	calcipotriene	OINTMENT;TOPICAL	020273-001	Dec 29, 1993	AB	RX	Yes	No
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015		RX	Yes	Yes	10,660,908		Y
Leo Pharma As	FINACEA	azelaic acid	GEL;TOPICAL	021470-001	Dec 24, 2002	AB	RX	Yes	Yes
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	9,265,725		Y
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015		RX	Yes	Yes	7,700,076		Y
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-002	Dec 8, 2000	AB	RX	Yes	Yes

Expired US Patents for Leo Pharma As

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Leo Pharma As	DOVONEX	calcipotriene	CREAM;TOPICAL	020554-001	Jul 22, 1996	4,866,048
Leo Pharma As	ENSTILAR	betamethasone dipropionate; calcipotriene	AEROSOL, FOAM;TOPICAL	207589-001	Oct 16, 2015	6,753,013
Leo Pharma As	FINACEA	azelaic acid	AEROSOL, FOAM;TOPICAL	207071-001	Jul 29, 2015	10,322,085
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-002	Dec 8, 2000	5,665,727
Leo Pharma As	PROTOPIC	tacrolimus	OINTMENT;TOPICAL	050777-001	Dec 8, 2000	5,385,907
Leo Pharma As	TACLONEX	betamethasone dipropionate; calcipotriene	SUSPENSION;TOPICAL	022185-001	May 9, 2008	RE39706

Paragraph IV (Patent) Challenges for LEO PHARMA AS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Gel	0.05%		2010-12-01
	Ointment	0.03%		2010-11-22
	Gel	15%		2012-07-27
	Topical Solution	0.01%		2006-05-19
	Ointment	0.1%		2010-09-09
	Ointment	0.005%/0.064%		2010-03-31
	Topical Foam	15%		2017-09-14

International Patents for Leo Pharma As Drugs

Country	Patent Number	Estimated Expiration
Canada	2536482
European Patent Office	2257276
Israel	186923
Japan	2008540508
Mexico	2012013591
South Korea	20050083826

Supplementary Protection Certificates for Leo Pharma As Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	132021000000095	Italy		PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
2435024	2021C/518	Belgium		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
2435024	2190014-7	Sweden		PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
2435024	LUC00208	Luxembourg		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
0613371	SPC/GB02/033	United Kingdom		PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
2435024	SPC/GB21/029	United Kingdom		PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Leo Labs
• Leo Pharm
• Leo Pharma As

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

In the dynamic world of pharmaceuticals, understanding the competitive landscape is crucial for success. LEO Pharma AS, a Danish pharmaceutical company with a rich history spanning over a century, has emerged as a significant player in the dermatology and thrombosis sectors. This analysis delves into LEO Pharma's market position, strengths, and strategic insights, providing a comprehensive view of its competitive stance in the pharmaceutical industry.

LEO Pharma's Market Position

LEO Pharma has established itself as a global leader in medical dermatology, serving over 95 million patients annually[3]. The company's focus on innovative treatments for skin conditions has positioned it as a specialist in this therapeutic area.

Revenue Growth and Financial Performance

LEO Pharma has demonstrated strong financial performance in recent years:

• In the first nine months of 2024, the company achieved revenue growth of 11% in constant exchange rates (CER)[1].
• The dermatology portfolio saw an impressive revenue growth of 13%[1].
• For the first half of 2024, LEO Pharma reported revenue growth of 11% (CER) to DKK 6,375 million[5].

These figures indicate a robust market position and sustained growth trajectory for LEO Pharma.

Global Presence

LEO Pharma has a significant global footprint:

• The company has a presence in Europe, the Middle East, Africa, Asia, the Americas, and Oceania[4].
• North America has emerged as a key growth driver, with revenue increasing by 43% in the first half of 2024[5].
• The company is actively expanding its presence in China, as evidenced by the filing of a New Drug Application (NDA) for Enstilar® for adults with plaque psoriasis[1].

LEO Pharma's Strengths

Innovation in Dermatology

LEO Pharma's core strength lies in its focus on dermatological innovations:

• The company has a strong pipeline and aims to launch a new innovative treatment every 2-3 years[2].
• LEO Pharma's commitment to R&D is evident in its accelerated efforts to rapidly diversify its portfolio of innovative medicines[2].

Strategic Partnerships

LEO Pharma has been actively pursuing strategic partnerships to enhance its capabilities:

• The company partnered with ICON for clinical trial execution in dermatology[4].
• A collaboration with Vipergen was established for DNA Encoded Library (DEL)-based drug discovery for dermatology indications[4].

Strong Product Portfolio

LEO Pharma boasts a robust product portfolio in dermatology and thrombosis:

• Key products include Adtralza®/Adbry® for atopic dermatitis, which saw an 84% (CER) increase in revenue in the first half of 2024[5].
• The core dermatology portfolio, including products like Enstilar® and Protopic®, delivered growth of 5% (CER) across markets[5].

Strategic Insights

Focus on Medical Dermatology

LEO Pharma's strategy revolves around solidifying its position as a global leader in medical dermatology:

• The company aims to advance the standard of care for people with skin conditions, their families, and society[3].
• LEO Pharma is continuously building its pipeline through both internal research and strategic partnerships[3].

Transformation and Growth

LEO Pharma is undergoing a significant transformation to ensure future growth:

• The company is preparing for a potential initial public offering (IPO)[3].
• LEO Pharma has implemented cost-cutting measures, reducing operating costs by 14% in 2023 while increasing revenues by 7%[6].

Expansion into New Markets

LEO Pharma is actively expanding its global footprint:

• The company is cementing its worldwide presence, with a focus on becoming a truly global company[1].
• Expansion efforts include launching products in new markets and filing for regulatory approvals in key regions like the U.S. and China[1].

Competitive Analysis

SWOT Analysis

A brief SWOT analysis of LEO Pharma reveals:

• Strengths: Strong dermatology portfolio, global presence, focus on innovation
• Weaknesses: Dependence on a few key products, potential vulnerability to patent expirations
• Opportunities: Expanding into new markets, potential for strategic acquisitions
• Threats: Intense competition in the dermatology sector, regulatory challenges

Competitive Landscape

LEO Pharma faces competition from other pharmaceutical companies focusing on dermatology:

• Major competitors include established players like Novartis, AbbVie, and Pfizer.
• The company's focus on niche areas within dermatology, such as chronic hand eczema, provides a competitive edge.

Future Outlook

LEO Pharma's future looks promising, with several factors contributing to its potential growth:

• The company's strong pipeline, including promising candidates like delgocitinib for chronic hand eczema, positions it well for future success[6].
• LEO Pharma's focus on rare skin diseases, such as congenital ichthyosis, opens up new market opportunities[6].
• The company's transformation efforts and cost-cutting measures are expected to improve profitability in the coming years.

"We are very satisfied with the sales growth in the first nine months of 2024, reflecting that more people than ever are benefiting from our treatments. At the same time, we have taken significant steps toward commercializing Anzupgo® (delgocitinib), securing European approval and launching it in its first European markets."[1] - Christophe Bourdon, CEO of LEO Pharma

Key Takeaways

• LEO Pharma has established itself as a global leader in medical dermatology, with strong revenue growth and a focus on innovation.
• The company's strategic transformation efforts, including cost-cutting measures and potential IPO preparations, position it for future growth.
• LEO Pharma's expansion into new markets and focus on niche dermatological conditions provide competitive advantages.
• The strong product pipeline and strategic partnerships are key drivers of the company's future success.
• LEO Pharma's ability to navigate challenges such as intense competition and regulatory hurdles will be crucial for maintaining its market position.

FAQs

1. What is LEO Pharma's primary focus in the pharmaceutical industry? LEO Pharma primarily focuses on medical dermatology, developing innovative treatments for various skin conditions.

2. How has LEO Pharma's financial performance been in recent years? LEO Pharma has shown strong financial performance, with double-digit revenue growth in constant exchange rates and improved profitability.

3. What are some of LEO Pharma's key products? Some of LEO Pharma's key products include Adtralza®/Adbry® for atopic dermatitis, Enstilar® for psoriasis, and Protopic® for eczema.

4. How is LEO Pharma positioning itself for future growth? LEO Pharma is undergoing a transformation, focusing on innovation, expanding into new markets, and preparing for a potential IPO to drive future growth.

5. What sets LEO Pharma apart from its competitors in the pharmaceutical industry? LEO Pharma's specialization in dermatology, focus on niche areas like chronic hand eczema, and strong global presence set it apart from competitors.

Sources cited: [1] https://www.leo-pharma.com/media-center/news/2024-leo-pharma-continues-to-deliver-double-digit-revenue [2] https://www.leo-pharma.us/media-center/news/leo-pharma-unveils-ambitious-2030-strategy-positioning-itself-for-long-term-growth [3] https://www.leo-pharma.com/your-career/working-with-us [4] https://mckinseywell.com/products/leo-pharma-as-strategic-swot-analysis-review [5] https://www.leo-pharma.com/media-center/news/2024-six-month-interim-report [6] https://www.fiercepharma.com/pharma/after-transformation-under-new-ceo-bourdon-leo-pharma-shows-signs-turnaround