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Last Updated: December 17, 2025

Biogen Inc Company Profile


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Summary for Biogen Inc
International Patents:248
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 ⤷  Get Started Free ⤷  Get Started Free
Biogen Inc ZURZUVAE zuranolone CAPSULE;ORAL 217369-002 Oct 31, 2023 RX Yes No ⤷  Get Started Free ⤷  Get Started Free
Biogen Inc ZURZUVAE zuranolone CAPSULE;ORAL 217369-002 Oct 31, 2023 RX Yes No 9,512,165 ⤷  Get Started Free Y Y ⤷  Get Started Free
Biogen Inc VUMERITY diroximel fumarate CAPSULE, DELAYED RELEASE;ORAL 211855-001 Oct 29, 2019 AB RX Yes Yes 9,090,558 ⤷  Get Started Free ⤷  Get Started Free
Biogen Inc ZURZUVAE zuranolone CAPSULE;ORAL 217369-003 Oct 31, 2023 RX Yes Yes 10,342,810 ⤷  Get Started Free ⤷  Get Started Free
Biogen Inc ZURZUVAE zuranolone CAPSULE;ORAL 217369-001 Oct 31, 2023 RX Yes No 10,172,871 ⤷  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 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 8,524,773 ⤷  Get Started Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 8,524,773 ⤷  Get Started Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 6,509,376 ⤷  Get Started Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 7,320,999 ⤷  Get Started Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-002 Mar 27, 2013 7,619,001 ⤷  Get Started Free
Biogen Inc TECFIDERA dimethyl fumarate CAPSULE, DELAYED RELEASE;ORAL 204063-001 Mar 27, 2013 8,759,393 ⤷  Get Started 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
3191475 LUC00372 Luxembourg ⤷  Get Started Free PRODUCT NAME: CRYSTALLINE FORMS OF 6-((6, 7-DIMETHOXYQUINAZOLIN-4-YL)OXY) - N,2-DIMETHYLBENZOFURAN-3-CARBOXAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/24/1827 20240625
2653873 2023C/501 Belgium ⤷  Get Started Free PRODUCT NAME: FUMARATE DE DIMETHYLE; AUTHORISATION NUMBER AND DATE: EU/1/13/837 20140203
2137537 PA2014024,C2137537 Lithuania ⤷  Get Started Free PRODUCT NAME: DIMETILFUMARATAS; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2970101 122022000014 Germany ⤷  Get Started Free PRODUCT NAME: DIROXIMELFUMARAT; NAT. REGISTRATION NO/DATE: EU/1/21/1585 20211115; FIRST REGISTRATION: SCHWEIZ 68066 20210920
2137537 122014000069 Germany ⤷  Get Started Free PRODUCT NAME: DIMETHYLFUMARAT; REGISTRATION NO/DATE: EU/1/13/837/001-002 20140130
2653873 301215 Netherlands ⤷  Get Started Free PRODUCT NAME: DIMETHYLFUMARAAT; REGISTRATION NO/DATE: EU/1/13/837 20140203
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Biogen Inc – Market Position, Strengths & Strategic Insights

Last updated: July 30, 2025


Introduction

Biogen Inc., a pioneer in neurodegenerative and rare disease treatments, maintains a significant footprint within the pharmaceutical industry. With a focus on innovative biologics targeting multiple sclerosis (MS), spinal muscular atrophy (SMA), and Alzheimer’s disease, Biogen’s strategic positioning influences market dynamics and competitive responses. This report offers an in-depth analysis of Biogen’s market position, core strengths, and strategic considerations vital for business professionals navigating the evolving biopharmaceutical landscape.


Market Position of Biogen Inc.

Biogen stands among the leading biotech firms globally, particularly in neurological and neurodegenerative indications. As of 2022, the company ranked as a top-tier player in multiple sclerosis therapeutics, with its flagship drug, Tecfidera (dimethyl fumarate), capturing a substantial share of the MS market. Its portfolio extends into spinal muscular atrophy via Spinraza (nusinersen), and recently, into Alzheimer’s disease with aducanumab and lecanemab.

Revenue and Market Share

In 2022, Biogen reported revenues exceeding $10 billion, predominantly driven by MS and SMA products. Its MS franchise accounts for roughly 50% of sales, positioning it as a dominant player. The company’s strategic focus on neuroscience affords it high visibility, although competition from Novartis (e.g., Gilenya), Roche, and emerging biologics constrains growth potential.

Pipeline and Future Outlook

Biogen’s pipeline includes multiple early and late-stage candidates targeting Alzheimer’s, Parkinson’s, and multiple sclerosis. The recent FDA approval of lecanemab, an anti-amyloid antibody for Alzheimer’s, signifies a pivotal foray into disease-modifying therapies, potentially expanding its pipeline's impact on revenue streams.


Strengths of Biogen Inc.

1. Portfolio of Proven Neurotherapeutics

Biogen’s multi-product portfolio, anchored by Tecfidera and Spinraza, provides diversified revenue streams. Spinraza remains the standard of care in SMA, with over 25,000 patients treated globally, reinforcing Biogen’s leadership in rare neurological disorders. Its neurology franchise benefits from established efficacy data, broad payer coverage, and patient acceptance.

2. Strategic Focus on Neuroscience

Biogen’s exclusive focus on neuroscience facilitates specialization and innovation in complex disease areas. This focus allows deep expertise, strong clinical pipeline development, and concentrated R&D efforts, leveraging decades of neurological research.

3. Robust R&D Capabilities

With a significant investment in clinical research, Biogen maintains a pipeline with over 40 assets spanning early to late development stages, including promising disease-modifying therapies for Alzheimer’s and multiple other neurodegenerative conditions. Strategic collaborations with academic institutions and biotech firms enhance scientific innovation.

4. Global Market Penetration

Biogen has established a substantial global presence through its commercial operations, especially in North America and Europe. Its established distribution channels, combined with strategic regional partnerships, facilitate product accessibility across diverse markets.

5. Focused Strategic Acquisitions

Recent acquisitions, such as the completion of the Aseptica biosimilar portfolio, exemplify Biogen’s focus on expanding its technological footprint and diversification. This strategic approach enhances its capacity for future revenue streams beyond core neurotherapeutics.


Strategic Challenges and Opportunities

Challenges

  • Intense Competition: Gilenya (Novartis), Mavenclad (Eisai), and emerging biologics challenge Tecfidera’s market dominance, while Baxter’s and Roche's biosimilars threaten Spinraza’s profitability.
  • Pricing Pressures: Increasing scrutiny on drug prices, especially in the US, risks pressure on profit margins, requiring strategic payer negotiations.
  • Regulatory Risks: Approval delays or regulatory withdrawals—highlighted by previous setbacks in Alzheimer’s candidate approvals—pose ongoing threats.

Opportunities

  • Innovative Alzheimer’s Therapeutics: Lecanemab's accelerated approval signifies a potential paradigm shift in Alzheimer’s disease management, opening new revenue horizons.
  • Expansion in Rare Diseases: Growing prevalence of rare neurodegenerative conditions underscores the opportunity for personalized biologics.
  • Digital and Precision Medicine: Integrating digital health tools can optimize patient management and compliance, adding value and differentiation.

Competitive Landscape Analysis

Biogen operates amidst a competitive environment characterized by innovation, patent expiry risks, and strategic collaborations. Major competitors include:

  • Novartis: Gilenya dominates MS, with offerings in biosimilars that threaten Spinraza.
  • Roche: Rivals in Alzheimer’s via several pipeline candidates and biosimilar versions of existing drugs.
  • Eisai and Biogen’s joint ventures: Focused on Alzheimer’s, intensifying R&D rivalry.
  • Emerging Biotechs: Smaller firms developing gene therapies and novel biologics pose disruptive threats, particularly in rare neurodegenerative diseases.

Strategic Insights for Stakeholders

  • Leveraging Core Competencies: Biogen should deepen its neuroscience expertise while exploring novel modalities such as gene editing.
  • Pipeline Optimization: Prioritizing high-potential assets like lecanemab can multiply revenue impact and reinforce market positioning.
  • Collaborations and Licensing: Expanding partnerships with biotech firms can mitigate R&D risk and accelerate innovation.
  • Market Expansion: Tailoring regional strategies, especially in emerging markets, can diversify revenue streams.
  • Pricing and Reimbursement Strategies: Proactive engagement with payers is essential to sustain affordability and access amid mounting cost pressures.

Conclusion

Biogen Inc. exemplifies a specialized neurobiotech firm with robust product offerings and a promising pipeline, particularly in Alzheimer’s therapy development. Its strengths lie in clinical expertise, diversified portfolio, and strategic focus, but competitive pressures and regulatory hurdles remain significant. To sustain and enhance its market position, Biogen must capitalize on innovation, expand partnerships, and navigate pricing complexities with agility.


Key Takeaways

  • Biogen’s leadership in MS and SMA provides a foundation for growth, but competition and biosimilars threaten long-term margins.
  • Its pioneering work in Alzheimer’s disease, exemplified by lecanemab, positions it at the forefront of neurodegenerative disease innovation.
  • Strategic pipeline prioritization, collaboration, and market expansion are critical for future revenue growth.
  • Pricing strategies and regulatory vigilance will be pivotal in maintaining profitability amid industry pressures.
  • Focusing on personalized medicine and digital health integration can differentiate Biogen in a competitive landscape.

Frequently Asked Questions

1. How does Biogen’s focus on neuroscience influence its competitive edge?
Biogen’s dedicated neuroscience focus allows it to harness specialized R&D expertise, develop targeted therapies, and build deep relationships with specialists and patient communities, enhancing its market competitiveness.

2. What are the major risks facing Biogen’s pipeline, particularly its Alzheimer’s candidates?
Regulatory approval delays or denials, clinical trial failures, or safety concerns could impede pipeline progress. Past setbacks underscore the importance of rigorous trial design and safety profiling.

3. How does Biogen plan to mitigate biosimilar threats to its established products?
Biogen invests in innovation, diversifies its portfolio, and advocates for strong patent protections while exploring combination therapies and personalized treatment approaches.

4. What strategic moves could strengthen Biogen’s position in emerging markets?
Localized clinical trials, partnerships with regional healthcare providers, and affordability programs can enhance access and market penetration.

5. How important are collaborations and acquisitions to Biogen’s future?
They are vital for expanding technological capabilities, accessing novel assets, and diversifying revenue sources amidst intense R&D competition.


References

[1] Biogen Annual Report 2022.
[2] FDA approvals and pipeline data.
[3] Market analysis reports, 2022.
[4] Industry competitive intelligence.

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