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Last Updated: April 19, 2025

Biofrontera Company Profile


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Summary for Biofrontera
International Patents:26
US Patents:2
Tradenames:2
Ingredients:2
NDAs:2
PTAB Cases with Biofrontera as petitioner: See PTAB cases with Biofrontera as petitioner

Drugs and US Patents for Biofrontera

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biofrontera AKTIPAK benzoyl peroxide; erythromycin GEL;TOPICAL 050769-001 Nov 27, 2000 DISCN Yes No ⤷  Try for Free ⤷  Try for Free
Biofrontera AMELUZ aminolevulinic acid hydrochloride GEL;TOPICAL 208081-001 May 10, 2016 RX Yes Yes 11,235,169 ⤷  Try for Free ⤷  Try for Free
Biofrontera AMELUZ aminolevulinic acid hydrochloride GEL;TOPICAL 208081-001 May 10, 2016 RX Yes Yes ⤷  Try for Free ⤷  Try for Free
Biofrontera AMELUZ aminolevulinic acid hydrochloride GEL;TOPICAL 208081-001 May 10, 2016 RX Yes Yes 11,540,981 ⤷  Try for Free Y ⤷  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

Supplementary Protection Certificates for Biofrontera Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0186118 SPC/GB05/029 United Kingdom ⤷  Try for Free PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218
1458369 CA 2008 00029 Denmark ⤷  Try for Free PRODUCT NAME: ADAPALEN, BENZOYLPEROXID
0137963 97C0042 Belgium ⤷  Try for Free PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
0526708 C300097 Netherlands ⤷  Try for Free PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228
1458369 122008000041 Germany ⤷  Try for Free PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218
1667986 92172 Luxembourg ⤷  Try for Free PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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Pharmaceutical Competitive Landscape Analysis: Biofrontera – Market Position, Strengths & Strategic Insights

In the ever-evolving world of pharmaceuticals, companies must constantly innovate and adapt to stay ahead of the competition. One such player making waves in the dermatology sector is Biofrontera Inc. Let's dive into a comprehensive analysis of Biofrontera's market position, strengths, and strategic insights to understand how this US-based biopharmaceutical company is carving out its niche in the competitive landscape.

Biofrontera: A Rising Star in Dermatological Treatments

Biofrontera Inc. is a US-based biopharmaceutical company that has been making significant strides in the dermatology market. With a laser focus on photodynamic therapy (PDT) and topical antibiotics, Biofrontera has positioned itself as a specialist in treating various skin conditions[1].

The Flagship Products: Ameluz® and Xepi®

At the heart of Biofrontera's success are two key products:

  1. Ameluz®: An FDA-approved drug for the treatment of actinic keratoses (AK), one of the most common precancerous skin conditions.

  2. Xepi®: An FDA-approved topical antibiotic for treating impetigo.

These products form the backbone of Biofrontera's portfolio, demonstrating the company's commitment to addressing critical dermatological needs[1].

A Commitment to Innovation and Patient Care

Biofrontera's mission goes beyond just selling products. The company is deeply committed to advancing treatment options and patient care, working closely with dermatologists to ensure their products meet the highest standards of efficacy and safety[1].

"We have brought together a committed and experienced leadership team with an established track record in commercialization of specialty dermatology products and late stage clinical development in an entrepreneurial environment." - Biofrontera Inc.[1]

Market Position: Carving Out a Niche in Dermatology

Biofrontera has strategically positioned itself in the dermatology market, focusing on areas where it can make the most significant impact.

Specialization in Photodynamic Therapy

One of Biofrontera's key strengths lies in its expertise in photodynamic therapy. The company has been researching and improving PDT treatment possibilities for skin diseases for over a decade, establishing itself as a leader in this field[9].

Strong Presence in Key Markets

Biofrontera has established a robust presence in both the US and European markets, particularly in Germany. In 2022, the company generated around €32 million in revenue from the German market alone[2].

Rapid Growth in the US Market

The company has experienced substantial growth in the US market, with sales increasing by 67% in 2023 compared to 2022[2]. This rapid expansion underscores Biofrontera's successful penetration of the lucrative US dermatology market.

Strengths: What Sets Biofrontera Apart

Biofrontera's success in the competitive pharmaceutical landscape can be attributed to several key strengths:

1. Robust Product Portfolio

Biofrontera boasts a comprehensive range of dermatology products, primarily focused on treating skin conditions such as actinic keratosis and basal cell carcinoma. In 2022, the Ameluz product line alone contributed approximately $18 million to the company's revenue[2].

2. Strong Relationships with Healthcare Providers

The company has built enduring relationships with healthcare providers, particularly dermatologists. A 2023 survey revealed that 78% of dermatologists regularly prescribe Biofrontera's products, indicating a high level of trust and preference for the company's offerings[2].

3. Commitment to Research and Development

Biofrontera invests heavily in R&D, allocating approximately 20% of its total revenue to these initiatives. This commitment has enabled the development of novel treatments and formulation enhancements, positioning the company as a leader in dermatological innovations[2].

4. Regulatory Approvals

All of Biofrontera's key products, including Ameluz and BF-200 ALA, have received approval from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). As of 2023, the company has a total of five products approved by these regulatory bodies, enhancing its market credibility and patient trust[2].

Strategic Insights: Navigating the Competitive Landscape

To maintain its competitive edge, Biofrontera has adopted several strategic approaches:

1. Focus on Photodynamic Therapy

Biofrontera has positioned itself as an expert in photodynamic therapy, a growing field in dermatology. By focusing on this niche, the company has differentiated itself from competitors and established a strong market position[9].

2. Expansion into New Markets

The company is actively exploring opportunities to expand into emerging markets. With the global dermatology market expected to reach $37.6 billion by 2026, Biofrontera is well-positioned to capitalize on this growth[2].

3. Continuous Innovation

Biofrontera's commitment to R&D ensures a pipeline of innovative products. The company has invested over $5 million in R&D aimed at enhancing its product portfolio, demonstrating its focus on staying ahead of the curve[2].

4. Strategic Partnerships

Biofrontera has formed strategic partnerships with leading pharmaceutical and biotech companies, including Bayer and Galderma. These collaborations provide access to broader distribution networks and commercialization expertise, enabling Biofrontera to accelerate the adoption of its PDT technologies worldwide[4].

Challenges and Opportunities in the Competitive Landscape

While Biofrontera has many strengths, it also faces challenges in the competitive pharmaceutical landscape:

1. Intense Competition

The global dermatology market is highly competitive, with both established pharmaceutical giants and emerging companies vying for market share. Competitors such as Amgen, AbbVie, and Galderma have robust product portfolios that challenge Biofrontera's market position[2].

2. Potential for Generic Drug Competition

The risk of generic drug competition is a persistent threat to Biofrontera's revenue. With generic drugs accounting for about 90% of total prescriptions in the US, there's potential for significant revenue reductions if generic alternatives to Biofrontera's products enter the market[2].

3. Limited Diversification

As of 2023, over 97% of Biofrontera's total revenue was generated from products within dermatology, showcasing a lack of diversification. This heavy reliance on a single therapeutic area could pose risks if the dermatology market faces challenges[2].

4. Opportunities for Growth

Despite these challenges, Biofrontera has significant opportunities for growth:

  • Expansion into new international markets, particularly in the Asia-Pacific region where healthcare spending is increasing[2].
  • Development of new products and treatment options, leveraging its strong R&D capabilities[2].
  • Potential for increased market share as awareness and adoption of photodynamic therapy grow[9].

Financial Performance and Future Outlook

Biofrontera's financial performance reflects its growing market position:

1. Revenue Growth

The company has experienced strong revenue growth, doubling its revenue year-over-year for the past three years[5].

2. Market Valuation

As of 2024, Biofrontera's financial metrics include:

  • Annual Revenue: $48.3 million
  • Research Patents: 12 active pharmaceutical patents
  • Market Penetration: 7.2% dermatological treatment market share[3]

3. Future Projections

Biofrontera has ambitious goals for the future. The company aims to achieve revenue between EUR 200 million and EUR 400 million by 2025[7].

Biofrontera's Competitive Edge: Innovation and Customer Focus

What truly sets Biofrontera apart in the competitive landscape is its dual focus on innovation and customer service:

1. Innovative Technology

Biofrontera's nanoemulsion technology, used in the development of formulations for various active ingredients, has the potential to increase clinical efficacy by improving stability and penetrating skin deeper[9].

2. Customer-Centric Approach

The company aims to be a trusting, consultative partner, providing superior full-service customer support to healthcare providers and patients[9].

Key Takeaways

  • Biofrontera has established itself as a specialist in dermatological treatments, with a focus on photodynamic therapy and topical antibiotics.
  • The company's flagship products, Ameluz® and Xepi®, have gained significant market traction and regulatory approvals.
  • Biofrontera's strengths include a robust product portfolio, strong relationships with healthcare providers, commitment to R&D, and regulatory approvals in key markets.
  • The company faces challenges from intense competition and potential generic drug threats but has significant opportunities for growth in new markets and through product development.
  • Biofrontera's financial performance shows strong revenue growth, with ambitious projections for the future.
  • The company's competitive edge lies in its innovative technology and customer-centric approach.

In the dynamic and competitive pharmaceutical landscape, Biofrontera has carved out a unique position through its focus on dermatological treatments and photodynamic therapy. While challenges remain, the company's strategic approach, commitment to innovation, and strong market presence position it well for future growth and success in the global dermatology market.

FAQs

  1. Q: What is Biofrontera's main focus in the pharmaceutical industry? A: Biofrontera specializes in dermatological treatments, with a particular focus on photodynamic therapy (PDT) and topical antibiotics.

  2. Q: What are Biofrontera's key products? A: Biofrontera's flagship products are Ameluz®, used for treating actinic keratoses, and Xepi®, a topical antibiotic for treating impetigo.

  3. Q: How has Biofrontera's revenue growth been in recent years? A: Biofrontera has experienced strong revenue growth, doubling its revenue year-over-year for the past three years.

  4. Q: What are some of the challenges Biofrontera faces in the competitive landscape? A: Key challenges include intense competition from established pharmaceutical companies, potential for generic drug competition, and limited diversification beyond dermatology products.

  5. Q: What are Biofrontera's future growth projections? A: Biofrontera aims to achieve revenue between EUR 200 million and EUR 400 million by 2025.

Sources cited: [1] https://investors.biofrontera-us.com/corporate-information/ [2] https://dcf.fm/products/bfri-swot-analysis [3] https://dcfmodeling.com/blogs/vision/bfri-mission-vision [4] https://www.kappasignal.com/2024/01/biofrontera-brighter-days-ahead-bfriw.html [5] https://www.biofrontera.com/fileadmin/files/PDFs/Presentations/20190906_WS_Biofrontera%20AG_corporate%20slide%20deck.pdf [7] https://www.biofrontera.com/fileadmin/user_upload/PDFs/Presentations/20200915_CompanyPresentation_Biofrontera_AG_LakeStreetBIG4.pdf [9] https://www.biofrontera-us.com

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