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Last Updated: June 14, 2025

Biogen Inc Company Profile


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Summary for Biogen Inc
International Patents:236
US Patents:17
Tradenames:3
Ingredients:3
NDAs:3
PTAB Cases with Biogen Inc as patent owner: See PTAB cases with Biogen Inc as patent owner

Drugs and US Patents for Biogen Inc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biogen Inc ZURZUVAE zuranolone CAPSULE;ORAL 217369-003 Oct 31, 2023 RX Yes Yes 10,342,810 ⤷  Try for Free ⤷  Try for Free
Biogen Inc ZURZUVAE zuranolone CAPSULE;ORAL 217369-002 Oct 31, 2023 RX Yes No 11,884,696 ⤷  Try for Free ⤷  Try for Free
Biogen Inc ZURZUVAE zuranolone CAPSULE;ORAL 217369-001 Oct 31, 2023 RX Yes No ⤷  Try for Free ⤷  Try for Free
Biogen Inc ZURZUVAE zuranolone CAPSULE;ORAL 217369-001 Oct 31, 2023 RX Yes No 11,236,121 ⤷  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

Expired US Patents for Biogen Inc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 7,803,840 ⤷  Try for Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 7,619,001 ⤷  Try for Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 8,524,773 ⤷  Try for Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 8,759,393 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for BIOGEN INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Delayed-releaseCapsules 120 mg and 240 mg ➤ Subscribe 2017-03-27

Supplementary Protection Certificates for Biogen Inc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2653873 301215 Netherlands ⤷  Try for Free PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837 20140203
2970101 2022C/507 Belgium ⤷  Try for Free PRODUCT NAME: DIROXIMEL FUMARATE; AUTHORISATION NUMBER AND DATE: EU/1/21/1585 20211116
2970101 PA2022003 Lithuania ⤷  Try for Free PRODUCT NAME: DIROKSIMELIO FUMARATAS ; REGISTRATION NO/DATE: EU/1/21/1585 20211115
2970101 301165 Netherlands ⤷  Try for Free PRODUCT NAME: DIROXIMELFUMARAAT; REGISTRATION NO/DATE: 68066 20210920
>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: Biogen Inc – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, Biogen Inc. stands as a prominent player, known for its innovative approaches to neuroscience and biotechnology. As we delve into Biogen's market position, strengths, and strategic insights, we'll uncover the factors that have shaped its competitive landscape and explore the challenges and opportunities that lie ahead.

Biogen's Market Position in the Pharmaceutical Industry

Biogen Inc., headquartered in Cambridge, Massachusetts, has established itself as a leader in the biotechnology sector, with a particular focus on neurological and neurodegenerative diseases. As of 2025, the company boasts a market capitalization of $21.9 billion, solidifying its position as a large-cap stock in the pharmaceutical industry[1].

Market Share and Competitive Standing

Within the Biotechnology & Pharmaceuticals Industry, Biogen holds a significant market share:

  • As of Q3 2024, Biogen's market share stood at 12.99% for the most recent quarter[5].
  • In the broader Healthcare Sector, Biogen commanded a 1.52% market share in Q3 2024[5].

These figures demonstrate Biogen's strong presence in its niche, particularly in neuroscience, while also highlighting the intense competition within the larger healthcare landscape.

Key Competitors

Biogen faces competition from several major pharmaceutical companies, including:

  1. Johnson and Johnson (13.88% market share)
  2. Pfizer Inc (13.98% market share)
  3. Amgen Inc (35.05% market share within the Biotechnology & Pharmaceuticals Industry)
  4. Roche
  5. Novartis
  6. Sanofi[5][6]

Biogen's Core Strengths and Competitive Advantages

Robust Product Portfolio

Biogen's strength lies in its diverse and innovative product lineup, particularly in the areas of multiple sclerosis (MS), spinal muscular atrophy (SMA), and Alzheimer's disease. Key products include:

  • Tecfidera (MS treatment): Generated $4.1 billion in annual sales (2022)
  • Spinraza (SMA treatment): Generated $1.7 billion in annual sales (2022)[2]

Strong Focus on Neurological Disease Research

Biogen's commitment to neuroscience research is evident in its substantial R&D investments:

  • Total R&D investment in 2022: $2.8 billion
  • Multiple Sclerosis research: $872 million
  • Alzheimer's research: $456 million[2]

This focused approach has allowed Biogen to maintain a competitive edge in developing treatments for complex neurological disorders.

Advanced Biotechnology Capabilities

Biogen's intellectual property portfolio is a significant asset:

  • Total Patents: 1,245
  • Pending Patent Applications: 387
  • Patent Expiration Protection: Through 2035 for key compounds[2]

This robust IP portfolio provides Biogen with a strong foundation for continued innovation and market exclusivity.

Experienced Leadership Team

Biogen's leadership brings extensive experience in neuroscience:

  • Christopher A. Viehbacher (CEO): 25 years in neuroscience
  • Michael D. Ehlers (Chief Scientific Officer): 22 years in neuroscience[2]

This depth of expertise at the helm positions Biogen to navigate the complex landscape of neurological drug development effectively.

Strategic Insights: Biogen's Approach to Growth and Innovation

Pipeline Development and Expansion

Biogen's strategy for growth heavily relies on its robust pipeline:

  • Approximately 30 clinical programs across various disease areas and modalities
  • 10 programs in Phase 3 or filed stage[10]

This diverse pipeline demonstrates Biogen's commitment to expanding its therapeutic reach and securing future revenue streams.

Focus on High-Conviction Assets

Biogen is prioritizing the development of high-conviction assets with multi-billion dollar potential. Key programs include:

  • LEQEMBI for Alzheimer's disease (intravenous maintenance dosing approved by FDA)
  • Dapirolizumab pegol for systemic lupus erythematosus (Phase 3 study initiated)
  • Nusinersen (SPINRAZA) higher dose regimen for SMA (FDA PDUFA of September 22, 2025)[9]

Strategic Collaborations and Acquisitions

Biogen has been actively pursuing strategic partnerships and acquisitions to enhance its product offerings and technological capabilities. Notable examples include:

  • Acquisition of Reata and HI-Bio
  • Collaboration with Eisai for Alzheimer's treatments
  • Partnership with Sage Therapeutics for postpartum depression drug development[3][4]
"Biogen's commitment to scientific innovation, quality, and patient-centered solutions underscores its position as a key player in advancing neuroscience and addressing the evolving needs of patients worldwide."[1]

Challenges and Threats in Biogen's Competitive Landscape

Patent Expirations and Generic Competition

Like many pharmaceutical companies, Biogen faces the challenge of patent expirations:

  • TECFIDERA, a key MS drug, is facing patent challenges and potential generic competition[4].
  • This threat underscores the need for Biogen to continuously innovate and diversify its product portfolio.

Pricing Pressures and Reimbursement Challenges

The pharmaceutical industry is under increasing scrutiny regarding drug pricing:

  • Biogen must navigate complex pricing negotiations with payers.
  • Reimbursement challenges can impact the adoption and profitability of its drugs[6].

Intense Competition in Core Therapeutic Areas

Biogen faces significant competitive pressures, particularly in its core therapeutic areas:

  • In the Alzheimer's market, competitors like Eli Lilly are making strong advances[8].
  • The MS market continues to see new entrants and innovative therapies.

Financial Performance and Outlook

Recent Financial Results

Biogen's financial performance in 2024 demonstrated both challenges and opportunities:

  • Full year 2024 total revenue declined by a mid-single digit percentage at constant currency versus 2023.
  • Non-GAAP diluted EPS for 2025 is expected to be between $15.25 and $16.25[9].

Market Performance

Despite its strong market position, Biogen's stock has faced some challenges:

  • As of January 2025, Biogen's shares were trading 43.9% below their 52-week high of $268.30 (reached on Jan. 3, 2024).
  • Over the past three months, the stock has fallen 24.6%[1].

Biogen's Corporate Responsibility and ESG Initiatives

Biogen has demonstrated a strong commitment to corporate responsibility and environmental, social, and governance (ESG) initiatives:

  • Ranked No. 2 on Fierce Pharma's Top 10 list of ESG leaders in the pharmaceutical industry.
  • Achieved 100% on the Disability Equality Index for the 4th consecutive year[10].

These efforts not only contribute to Biogen's positive corporate image but also align with growing investor and consumer expectations for responsible business practices.

Future Outlook and Strategic Direction

Expansion into New Therapeutic Areas

Biogen is actively exploring opportunities to leverage its expertise in neurology and autoimmune disorders to expand into new therapeutic areas. This diversification strategy aims to reduce dependence on a few key products and tap into new markets[6].

Digital Health Initiatives

Biogen is investing in digital health technologies to enhance its drug development processes and patient care:

  • Development of validated digital biomarkers to accelerate clinical development.
  • Exploration of digital therapeutics to address unmet patient needs[10].

Continued Focus on Neuroscience Leadership

Despite challenges, Biogen remains committed to maintaining its leadership in neuroscience:

  • Ongoing development of treatments for Alzheimer's disease, multiple sclerosis, and other neurological disorders.
  • Exploration of novel therapeutic approaches to identify and address risk factors before symptoms appear[10].

Key Takeaways

  1. Biogen maintains a strong market position in neuroscience, with a 12.99% market share in the Biotechnology & Pharmaceuticals Industry.
  2. The company's core strengths include a robust product portfolio, significant R&D investments, and advanced biotechnology capabilities.
  3. Biogen faces challenges from patent expirations, pricing pressures, and intense competition in core therapeutic areas.
  4. Strategic focus on pipeline development, high-conviction assets, and strategic collaborations drive Biogen's growth strategy.
  5. The company is expanding into new therapeutic areas and investing in digital health initiatives to secure future growth.
  6. Biogen's commitment to corporate responsibility and ESG initiatives enhances its corporate image and aligns with stakeholder expectations.

FAQs

  1. Q: What are Biogen's main therapeutic areas of focus? A: Biogen primarily focuses on neurological and neurodegenerative diseases, including multiple sclerosis, Alzheimer's disease, and spinal muscular atrophy.

  2. Q: How is Biogen addressing the challenge of patent expirations? A: Biogen is investing heavily in R&D, pursuing strategic collaborations, and diversifying its product portfolio to mitigate the impact of patent expirations.

  3. Q: What sets Biogen apart from its competitors in the pharmaceutical industry? A: Biogen's strong focus on neuroscience, substantial R&D investments, and advanced biotechnology capabilities give it a competitive edge in developing treatments for complex neurological disorders.

  4. Q: How is Biogen incorporating digital health into its strategy? A: Biogen is developing digital biomarkers to accelerate clinical development and exploring digital therapeutics to address unmet patient needs in neuroscience.

  5. Q: What are some of Biogen's key ESG initiatives? A: Biogen has been recognized for its ESG leadership, achieving high rankings in industry ESG assessments and maintaining a perfect score on the Disability Equality Index for four consecutive years.

Sources cited: [1] https://www.nasdaq.com/articles/biogen-stock-biib-underperforming-healthcare-sector [2] https://dcfmodeling.com/products/biib-swot-analysis [3] https://healtheconomics.com/jp-morgan-week-biogens-strategic-challenges-and-acquisition-efforts/ [4] https://www.gurufocus.com/news/2695251/decoding-biogen-inc-biib-a-strategic-swot-insight [5] https://csimarket.com/stocks/competitionSEG2.php?code=BIIB [6] https://pitchgrade.com/companies/biogen-idec [8] https://www.investing.com/news/swot-analysis/biogens-swot-analysis-neurology-giant-faces-pipeline-hurdles-stock-outlook-mixed-93CH-3838567 [9] https://investors.biogen.com/static-files/a4eadd7a-6e77-4110-8289-94816df02324 [10] https://www.biogen.com/content/dam/corporate/international/global/en-US/docs/responsibility/reporting-and-principles/reports/Biogen-YearInReview-2021.pdf

Last updated: 2025-02-13

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