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Last Updated: May 23, 2025

Genentech Inc Company Profile


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Summary for Genentech Inc
International Patents:1031
US Patents:63
Tradenames:6
Ingredients:6
NDAs:10
Drug Master File Entries: 7

Drugs and US Patents for Genentech Inc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 AB RX Yes No 7,910,610 ⤷  Try for Free ⤷  Try for Free
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 AB RX Yes No 8,383,150 ⤷  Try for Free Y ⤷  Try for Free
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 AB RX Yes No 10,188,637 ⤷  Try for Free Y ⤷  Try for Free
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes 9,255,087 ⤷  Try for Free ⤷  Try for Free
Genentech Inc XOFLUZA baloxavir marboxil TABLET;ORAL 210854-002 Oct 24, 2018 RX Yes No 9,815,835 ⤷  Try for Free Y ⤷  Try for Free
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-002 Jan 11, 2017 DISCN Yes No 8,013,002 ⤷  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

Expired US Patents for Genentech Inc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-001 Jan 11, 2017 9,561,217 ⤷  Try for Free
Genentech Inc ESBRIET pirfenidone TABLET;ORAL 208780-003 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
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

Supplementary Protection Certificates for Genentech Inc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2176231 2020042 Norway ⤷  Try for Free PRODUCT NAME: ENTREKTINIB ELLER ISOMERER TAUTOMERER, ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV; REG. NO/DATE: EU/1/20/1460 20200810
2176231 2090052-8 Sweden ⤷  Try for Free PRODUCT NAME: ENTRECTINIB OR TAUTOMERS, OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/20/1460 20200803
3143025 132021000000149 Italy ⤷  Try for Free PRODUCT NAME: RISDIPLAM O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(EVRYSDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/21/1531, 20210329
1934174 2016C/029 Belgium ⤷  Try for Free PRODUCT NAME: COBIMETINIB IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI, INCLUSIEF FARMACEUTISCH AANVAARDBARE ZOUTEN EN SOLVATEN DAARVAN, IN HET BIJZONDER COBIMETINIB HEMIFUMARAAT; AUTHORISATION NUMBER AND DATE: EU/1/15/1048 20111120
1934174 22/2016 Austria ⤷  Try for Free PRODUCT NAME: COBIMETINIB ALS EIN EINZELNES STEREOISOMER ODER ALS EINE MISCHUNG VON STEREOISOMEREN DAVON, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE UND SOLVATE, INSBESONDERE COBIMETINIB HEMIFUMARAT; REGISTRATION NO/DATE: EU/1/15/1048 (MITTEILUNG) 20151124
2176231 C202030070 Spain ⤷  Try for Free PRODUCT NAME: ENTRECTINIB O SUS ISOMEROS, TAUTOMEROS, O SALES FARMACEUTICAMENTE ACEPTABLES.; NATIONAL AUTHORISATION NUMBER: EU/1/20/1460; DATE OF AUTHORISATION: 20200731; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1460; DATE OF FIRST AUTHORISATION IN EEA: 20200731
>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: Genentech Inc – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, Genentech Inc. stands out as a pioneer and powerhouse. This comprehensive analysis delves into Genentech's market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

Genentech's Legacy and Current Standing

Genentech, founded in 1976, is widely regarded as the world's first biotechnology company[4]. Now a member of the Roche Group, Genentech has been at the forefront of biotechnology for over 45 years[1]. The company's commitment to groundbreaking science and innovative medicine development has solidified its position as a leader in the pharmaceutical industry.

"Considered the founder of the industry, Genentech, now a member of the Roche Group, has been delivering on the promise of biotechnology for more than 45 years."[1]

Core Business Model and Focus Areas

Genentech's business model revolves around research and development, with a particular emphasis on:

  1. Oncology
  2. Immunology
  3. Ophthalmology

The company's dedication to scientific excellence has resulted in the development of blockbuster drugs like Avastin, Herceptin, and Rituxan, which have revolutionized cancer treatment[3].

Genentech's Competitive Advantages

Strong R&D Capabilities

Genentech boasts world-class research and development capabilities, consistently delivering innovative therapies that address unmet medical needs. This commitment to scientific rigor has resulted in a robust pipeline of promising therapies in clinical trials[3].

Brand Reputation and Patient Trust

The company has established a strong brand reputation for its commitment to patient-centricity and scientific excellence. This has translated into high levels of trust and loyalty among patients and healthcare professionals alike[3].

Experienced Leadership

Genentech is led by a team of seasoned executives with deep expertise in the biotechnology industry. This experienced leadership provides strategic direction and ensures the company's continued success in a rapidly evolving market[3].

Financial Strength

As a subsidiary of Roche, Genentech enjoys a strong financial position. This financial backing allows the company to invest heavily in research and development, expand its product portfolio, and navigate market fluctuations with relative ease[3].

Intellectual Property and Market Protection

Robust Patent Portfolio

Genentech holds a vast portfolio of patents and other intellectual property rights, protecting its innovative therapies and ensuring a competitive advantage in the market. This strong intellectual property portfolio provides significant protection against competition and allows Genentech to maximize the value of its products[3].

Global Reach and Market Penetration

Operating on a global scale, Genentech leverages its presence in key regions to reach a wider patient population. This global reach allows the company to expand its market share and capitalize on emerging opportunities in different healthcare systems[3].

Challenges and Potential Weaknesses

High Development Costs

The process of developing innovative therapies is extremely costly, requiring significant investment in research, clinical trials, and regulatory approval processes. These high development costs can potentially limit Genentech's ability to invest in a wider range of therapies and may impact profitability[3].

Intense Competition

The biotechnology industry is highly competitive, with numerous players vying for market share. Genentech faces competition from established pharmaceutical companies, smaller biotech startups, and generic drug manufacturers. This intense competition can put pressure on pricing and profitability, requiring Genentech to constantly innovate and differentiate its products[3].

Regulatory Hurdles

The regulatory landscape for pharmaceutical products is complex and constantly evolving. Genentech faces challenges in navigating regulatory approvals, complying with changing regulations, and managing potential safety concerns. These regulatory hurdles can delay product launches and impact the company's overall growth strategy[3].

Product Concentration Risk

Genentech's revenue is concentrated in a few key products, making the company vulnerable to market fluctuations and potential patent expirations. This dependence on key products exposes Genentech to risks associated with competition, generic drug entry, and changes in market demand[3].

Strategic Initiatives and Future Outlook

Personalized Medicine and AI Integration

Genentech is actively leveraging advancements in artificial intelligence to enhance its research and development capabilities, improve clinical trial efficiency, and develop new therapies. The company is also focusing on personalized medicine, tailoring treatment approaches to individual patients based on their genetic makeup and other factors[2].

Expansion into Emerging Markets

Recognizing the potential in rapidly growing economies, Genentech is expanding its presence in emerging markets such as China and India. This strategic move allows the company to reach a wider patient population and access new growth avenues[3].

Sustainability Initiatives

Sustainability is becoming increasingly important in the pharmaceutical industry. Genentech is enhancing its sustainability efforts by adopting circular economy practices, which not only benefits the environment but also improves the company's public image and potentially opens up new market opportunities[3].

Addressing Biosimilar Competition

To counter the threat posed by biosimilars, Genentech is developing strategies such as focusing on differentiated products, building strong patient relationships, and engaging in price competition when necessary[3].

Collaborative Efforts and Partnerships

Genentech has a history of successful collaborations that have contributed to its market position. Some notable partnerships include:

  1. Collaboration with Roche and GlycArt to develop obinutuzumab (2008)
  2. Partnership with University of California, San Francisco for small molecule drug discovery in neurology (2010)
  3. Collaboration with NewLink Genetics on checkpoint inhibitors (2014)
  4. Partnership with 23andMe for access to genomic and patient-reported data (2015)
  5. Collaboration with Nimbus Therapeutics for in silico drug discovery (2015)
  6. Partnership with Epizyme for clinical trials on potential synergies between their respective drugs (2016)
  7. Collaboration with Carmot Therapeutics for new drug candidate discovery (2016)
  8. Partnership with BioLineRx on checkpoint inhibitors (2016)[4]

These collaborations demonstrate Genentech's commitment to leveraging external expertise and resources to drive innovation and maintain its competitive edge.

Product Pipeline and Recent Approvals

Genentech's product pipeline is a key indicator of its future market potential. Some recent and notable product approvals include:

  1. Actemra (tocilizumab): The first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat rheumatoid arthritis (2010)
  2. Zelboraf (vemurafenib): Treatment for metastatic melanoma caused by BRAF mutation (2011)
  3. Kadcyla (ado-trastuzumab emtansine): The first Genentech antibody-drug conjugate (ADC) to receive FDA approval (2013)
  4. Gazyva (obinutuzumab): The first drug with breakthrough therapy designation to receive FDA approval (2013)
  5. Alecensa (alectinib): Treatment for non-small cell lung cancer (NSCLC) (2015)
  6. Venclexta (venetoclax): Treatment for chronic lymphocytic leukemia (CLL) with specific genetic markers (2016)[4]

These approvals showcase Genentech's continued ability to bring innovative therapies to market, addressing unmet medical needs and potentially securing future revenue streams.

Market Trends and Genentech's Response

Shift Towards Targeted Therapies

The pharmaceutical industry is moving towards a model of many products used by smaller groups of patients, given the increasingly sophisticated understanding of diseases. Genentech is adapting to this trend by retooling its commercialization strategies and leveraging digital technologies like generative AI to ensure that the right medicines are getting to the right patient populations[2].

Digital Marketing and Personalization

In response to the shift towards targeted therapies, Genentech is focusing on tailoring and personalizing its marketing efforts. The company aims to deliver information through the right channels in a timely way for the right patient, moving away from mass marketing approaches[2].

Key Takeaways

  1. Genentech, a pioneer in biotechnology, maintains a strong market position through its focus on innovative research and development.
  2. The company's strengths include robust R&D capabilities, a strong brand reputation, experienced leadership, and financial backing from Roche.
  3. Challenges include high development costs, intense competition, regulatory hurdles, and product concentration risk.
  4. Genentech is actively pursuing strategies in personalized medicine, AI integration, and expansion into emerging markets to maintain its competitive edge.
  5. Collaborations and partnerships play a crucial role in Genentech's innovation strategy.
  6. The company's product pipeline and recent approvals demonstrate its continued ability to bring groundbreaking therapies to market.
  7. Genentech is adapting to market trends by focusing on targeted therapies and personalized marketing approaches.

FAQs

  1. What sets Genentech apart from other pharmaceutical companies? Genentech's pioneering status in biotechnology, coupled with its strong focus on innovative research and development, sets it apart. The company's ability to consistently deliver groundbreaking therapies and its backing from Roche give it a unique position in the market.

  2. How is Genentech addressing the challenge of biosimilars? Genentech is developing strategies to address biosimilar competition, including focusing on differentiated products, building strong patient relationships, and engaging in price competition when necessary.

  3. What role does artificial intelligence play in Genentech's research and development? Genentech is leveraging AI to enhance its research and development capabilities, improve clinical trial efficiency, and develop new therapies. This integration of AI is part of the company's strategy to stay at the forefront of pharmaceutical innovation.

  4. How is Genentech adapting to the trend of personalized medicine? Genentech is focusing on developing targeted therapies and tailoring its marketing approaches to reach specific patient populations. The company is leveraging its expertise in genomics and molecular biology to develop personalized therapies that offer improved efficacy and reduced side effects.

  5. What are some of Genentech's most significant recent product approvals? Some of Genentech's notable recent approvals include Kadcyla (the first Genentech antibody-drug conjugate), Gazyva (the first drug with breakthrough therapy designation to receive FDA approval), and Venclexta (for chronic lymphocytic leukemia with specific genetic markers).

Sources cited: [1] https://www.gene.com/about-us [2] https://www.mckinsey.com/capabilities/growth-marketing-and-sales/our-insights/science-for-good-how-genentechs-mission-yields-innovation-and-growth [3] https://fernfortuniversity.com/essay/swot1/genentech-216 [4] https://en.wikipedia.org/wiki/Genentech

Last updated: 2025-02-12

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.