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Last Updated: July 29, 2025

Genentech Inc Company Profile


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Summary for Genentech Inc
International Patents:1035
US Patents:63
Tradenames:6
Ingredients:6
NDAs:10
Drug Master File Entries: 7

Drugs and US Patents for Genentech Inc

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 AB RX Yes Yes 7,767,700 ⤷  Try for Free ⤷  Try for Free
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 AB RX Yes Yes 8,318,780 ⤷  Try for Free ⤷  Try for Free
Genentech Inc ESBRIET pirfenidone CAPSULE;ORAL 022535-001 Oct 15, 2014 AB RX Yes Yes 8,013,002 ⤷  Try for Free ⤷  Try for Free
Genentech Inc ITOVEBI inavolisib TABLET;ORAL 219249-001 Oct 10, 2024 RX Yes No 11,028,100 ⤷  Try for Free Y Y ⤷  Try for Free
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-003 Mar 18, 2021 RX Yes Yes 10,633,397 ⤷  Try for Free ⤷  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
Showing 1 to 6 of 6 entries

Expired US Patents for Genentech Inc

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-003 Jan 11, 2017 9,561,217 ⤷  Try for Free
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 9,561,217 ⤷  Try for Free
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-002 Jan 11, 2017 9,561,217 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 entries
Paragraph IV (Patent) Challenges for GENENTECH INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 267 mg, 534 mg and 801 mg ➤ Subscribe 2018-10-15

International Patents for Genentech Inc Drugs

CountryPatent NumberEstimated Expiration
Canada 2937365 ⤷  Try for Free
Japan 2013214066 ⤷  Try for Free
Mexico 2022015606 ⤷  Try for Free
Mexico 2012004528 ⤷  Try for Free
South Korea 20180021775 ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2015173181 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration
Showing 1 to 6 of 6 entries

Supplementary Protection Certificates for Genentech Inc Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
2620436 122021000017 Germany ⤷  Try for Free PRODUCT NAME: BALOXAVIR MARBOXIL SOWIE SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1500 20210107
3143025 2190034-5 Sweden ⤷  Try for Free PRODUCT NAME: RISDIPLAM OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1531 20210329
1934174 C20160012 00193 Estonia ⤷  Try for Free PRODUCT NAME: KOBIMETINIIB;REG NO/DATE: EU/1/15/1048 24.11.2015
1934174 CA 2016 00021 Denmark ⤷  Try for Free PRODUCT NAME: COBIMETINIB, EVENTUELT I EN HVILKEN SOM HELST FORM BESKYTTET AF GRUNDPATENTET, DER INDBEFATTER FARMACEUTISK ACCEPTABLE SALTE OG SOLVATER, SAERLIGT COBIMETINIB HEMIFUMARAT; REG. NO/DATE: EU/1/15/1048 20151124
1934174 PA2016016,C1934174 Lithuania ⤷  Try for Free PRODUCT NAME: KOBIMETINIBAS, PASIRINKTINAI KAIP JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS IR SOLVATAI, YPAC KOBIMETINIBO HEMIFUMARATAS; REGISTRATION NO/DATE: EU/1/15/1048 20151120
3143025 PA2021010,C3143025 Lithuania ⤷  Try for Free PRODUCT NAME: RISDIPLAMAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1531 20210326
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 6 of 6 entries
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

Last updated: July 28, 2025

Introduction

Genentech Inc., a pioneer in the biotechnology industry, has established a formidable presence in the global pharmaceutical landscape. As a wholly owned subsidiary of Roche, Genentech specializes in the development, manufacturing, and commercialization of innovative biologic therapies primarily targeting oncology, immunology, and neuroscience. Understanding its competitive positioning, strengths, and strategic initiatives offers vital insights for stakeholders navigating an increasingly crowded and innovation-driven market.

Market Position of Genentech Inc.

Market Leadership in Oncology and Immunology

Genentech has maintained its industry leadership through a robust portfolio comprising pioneering biologics and biosimilars. Its flagship products—such as Avastin (bevacizumab), Rituxan (rituximab), and Herceptin (trastuzumab)—are among the top-selling oncology therapeutics globally. The company's focus on personalized medicine and targeted therapies has positioned it at the forefront of precision oncology.

Global Reach and Commercial Footprint

With a dense network of regional offices and manufacturing facilities, Genentech extends its influence across North America, Europe, and emerging markets. Its strategic partnership with Roche enables accelerated market access and broad distribution, bolstering its competitive advantage despite patent cliffs faced by flagship products.

Pipeline Robustness and Innovation Focus

Genentech’s pipeline includes numerous promising candidates in late-stage development, especially within oncology (e.g., EGFR inhibitors), immunology, and rare disease areas. This pipeline fortifies its long-term growth trajectory, especially as some blockbuster drugs face biosimilar competition.

Core Strengths of Genentech Inc.

1. Scientific Excellence and Innovation

Genentech’s legacy of innovation is rooted in its early role as a biotech trailblazer. Its emphasis on R&D yields an extensive portfolio of biologics, with annual R&D investments exceeding industry averages. The company leverages cutting-edge technologies such as antibody engineering, cell therapy, and immunomodulation to develop breakthrough therapies.

2. Specialized Product Portfolio

The company's focus on high-value, complex biologics creates formidable barriers to entry for competitors. Its dominant products, notably Avastin and Rituxan, benefit from extensive clinical validation, strong physician relationships, and established payer coverage.

3. Strategic Collaborations and Licensing Deals

Genentech maintains strategic partnerships with global biopharma firms, academic institutions, and technology companies. Collaborations, such as with MorphoSys for bispecific antibodies, expand its pipeline and technological capabilities, fostering sustained innovation.

4. Robust Manufacturing and Supply Chain

Advanced manufacturing facilities with flexible production lines enable rapid scale-up and ensure quality compliance. This operational excellence supports the timely delivery of therapies, especially during high-demand periods, such as during the COVID-19 pandemic.

5. Regulatory Expertise and Market Access

Decades of experience navigating complex regulatory environments in multiple jurisdictions give Genentech a competitive edge. It benefits from Roche’s global regulatory network, enabling expedited approvals and efficient market rollouts.

Strategic Insights

1. Navigating Patent Expirations Through Biosimilars

Patent cliffs threaten flagship products like Herceptin and Avastin. Genentech's proactive investments in biosimilar development and lifecycle management strategies aim to mitigate revenue erosion and maintain market share.

2. Diversification into Emerging Therapeutic Areas

By expanding into neuroscience (e.g., Alzheimer’s disease) and rare diseases, Genentech seeks to reduce dependence on oncology and immunology. These high-unmet-need segments offer lucrative opportunities amid fierce oncology competition.

3. Digital Transformation and Data-Driven Innovation

Genentech invests heavily in digital health initiatives, AI-driven drug discovery, and real-world evidence generation. These efforts streamline R&D processes, enhance clinical trial efficiency, and facilitate personalized treatment approaches.

4. Focus on Precision Medicine and Biomarker Development

Strategic emphasis on companion diagnostics and biomarkers enables tailored therapies with higher efficacy and safety profiles. This precision medicine approach solidifies its competitive edge in targeted therapy segments.

5. Commitment to Sustainability and Patient-Centric Care

Genentech underscores sustainability metrics and patient engagement initiatives, bolstering brand loyalty and societal reputation. Its patient support programs facilitate access and adherence, critical for long-term therapeutic success.

Competitive Challenges and Risks

  • Biosimilar Competition: As patents expire, biosimilar entrants threaten revenue streams. Genentech must innovate continuously to sustain its market dominance.
  • Pricing Pressures: Increasing payer scrutiny and cost-containment policies risk impacting pricing and reimbursement strategies.
  • Regulatory and Intellectual Property Risks: Evolving regulations and patent disputes can delay product launches or erode exclusivity.
  • Emergence of New Therapeutic Modalities: Competition from cell and gene therapies, with potentially transformative effects, necessitates adaptive strategic planning.

Conclusion

Genentech’s dominance in biotechnology is anchored in its scientific innovation, specialized product portfolio, and strategic collaborations. While patent expirations and regulatory challenges pose risks, their proactive pipeline management, diversification strategies, and embrace of digital technologies position them well for sustained growth. Stakeholders should monitor its pipeline developments, biosimilar strategies, and evolving market dynamics to make informed investment and partnership decisions.


Key Takeaways

  • Market Leadership: Genentech remains a pioneer in oncology and immunology, with a strong global presence.
  • Innovation as Core Competence: Heavy R&D investments drive pipeline strength and technological leadership.
  • Pipeline and Diversification: Expansion into neuroscience and rare diseases mitigates dependence on flagship products.
  • Biosimilar Strategy: Active development and licensing of biosimilars defend against patent expiration impacts.
  • Digital and Personalized Medicine: Adoption of digital health tools and biomarker-driven treatments align with future healthcare trends.

FAQs

1. How does Genentech differentiate itself from competitors?
Genentech emphasizes cutting-edge biologic innovation, a deep product pipeline, and strategic collaborations, allowing it to deliver highly targeted therapies that are difficult to replicate.

2. What are the primary risks facing Genentech’s future growth?
Patent expirations of key products, biosimilar competition, regulatory changes, and rapid technological evolution in therapies pose significant challenges.

3. How is Genentech leveraging digital health technologies?
Genentech invests in AI, real-world data analytics, and digital patient engagement platforms to streamline R&D, improve clinical outcomes, and enhance patient access.

4. What strategic moves can Genentech make to ensure pipeline success?
Prioritizing disruptive innovation, expanding collaborations, and investing in frontier areas like cell and gene therapy will be critical to pipeline vitality.

5. How do biosimilars impact Genentech’s market competitiveness?
Biosimilars can erode sales of blockbuster biologics post-patent expiry; thus, Genentech’s biosimilar development efforts serve as both a risk mitigation and market expansion strategy.


References

  1. [1] Genentech Official Website. "Innovation at Genentech."
  2. [2] Roche Investor Reports. "Annual Review of R&D Investment."
  3. [3] MarketWatch. "Biotech Industry Outlook 2023."
  4. [4] Biospace. "Biosimilar Competition and Strategies."
  5. [5] Deloitte Insights. "Digital Transformation in Pharma."

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