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Last Updated: May 21, 2025

Gilead Company Profile


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Summary for Gilead

Drugs and US Patents for Gilead

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes 8,865,730 ⤷  Try for Free Y Y ⤷  Try for Free
Gilead Sciences Inc SOVALDI sofosbuvir PELLETS;ORAL 212480-002 Aug 28, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes 8,981,103*PED ⤷  Try for Free Y ⤷  Try for Free
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir PELLETS;ORAL 214187-001 Jun 10, 2021 RX Yes No 8,575,135*PED ⤷  Try for Free Y ⤷  Try for Free
Gilead Sciences Inc VEKLURY remdesivir POWDER;INTRAVENOUS 214787-001 Oct 22, 2020 RX Yes Yes 11,492,353*PED ⤷  Try for Free Y ⤷  Try for Free
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes 9,296,769*PED ⤷  Try for Free Y ⤷  Try for Free
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-002 Aug 28, 2019 RX Yes No 9,284,342*PED ⤷  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 Gilead

Paragraph IV (Patent) Challenges for GILEAD drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Tablets 200 mg/300 mg ➤ Subscribe 2008-09-26
➤ Subscribe Tablets 600 mg/200 mg/300 mg ➤ Subscribe 2008-12-29
➤ Subscribe Tablets 150 mg, 200 mg, and 250 mg ➤ Subscribe 2012-05-17
➤ Subscribe Tablets 150 mg, 150 mg, 200 mg, 300 mg ➤ Subscribe 2018-10-04
➤ Subscribe Capsules 200 mg ➤ Subscribe 2012-07-16
➤ Subscribe Tablets 5 mg and 10 mg ➤ Subscribe 2015-02-09
➤ Subscribe Tablets 100 mg/150 mg, 133 mg/200 mg, and 167 mg/250 mg ➤ Subscribe 2017-05-19
➤ Subscribe Tablets 300 mg ➤ Subscribe 2010-01-26
➤ Subscribe Tablets 200 mg/25 mg/300 mg ➤ Subscribe 2015-05-20
➤ Subscribe Tablets 150 mg ➤ Subscribe 2015-12-09
➤ Subscribe Tablets 10 mg ➤ Subscribe 2010-06-08

Supplementary Protection Certificates for Gilead Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3808743 C20220027 00378 Estonia ⤷  Try for Free PRODUCT NAME: EMTRITSITABIIN/ RILPIVIRIIN;REG NO/DATE: EU/1/11/737 28.11.2011
1663240 PA2016045 Lithuania ⤷  Try for Free PRODUCT NAME: RILPIVIRINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1663240 15C0073 France ⤷  Try for Free PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE DE TENOFOVIR EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1419152 C 2012 015 Romania ⤷  Try for Free PRODUCT NAME: RILPIVIRINA SI TOATE FORMELE ECHIVALENTE TERAPEUTIC ALEACESTEIA CUM AR FI SARURILE DE ADITIE ALE RILPIVIRINEI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREA RILPIVIRINEI CU ACIDULCLORHIDRIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/736/001; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/736/001; DATE OF FIRST AUTHORISATION IN EEA: 20111128
1353647 11C0030 France ⤷  Try for Free PRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/543/001 DU 20090921; REGISTRATION NO/DATE AT EEC: EU/1/09/543/001 DU 20090921
3347352 55/2022 Austria ⤷  Try for Free PRODUCT NAME: LENACAPAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, INSBESONDERE LENACAPAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/22/1671 (MITTEILUNG) 20220819
1663240 PA2016044 Lithuania ⤷  Try for Free PRODUCT NAME: RILPIVIRINAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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Pharmaceutical Competitive Landscape Analysis: Gilead's Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, Gilead Sciences has established itself as a formidable player, known for its innovative therapies and strategic approach to market challenges. This comprehensive analysis delves into Gilead's current market position, its strengths, and the strategic insights that shape its competitive landscape.

Gilead's Market Position: A Leader in HIV and Beyond

Gilead Sciences has carved out a dominant position in the pharmaceutical industry, particularly in the realm of HIV treatments. The company's market presence extends beyond this core area, encompassing hepatitis, oncology, and other therapeutic domains.

HIV Treatment Dominance

Gilead's stronghold in the HIV treatment market is undeniable. The company's HIV drug portfolio generated an impressive $23.6 billion in revenue in 2023, accounting for a significant portion of its total sales[7]. This success is largely attributed to blockbuster drugs like Biktarvy and Descovy.

As of 2024, Gilead Sciences holds approximately 70% market share in HIV treatment medications[7].

Expanding Oncology Presence

While HIV remains Gilead's primary focus, the company has been making significant strides in the oncology sector. In 2023, Gilead's oncology sales increased by 37% year-over-year, indicating a growing presence in this competitive market[6].

Hepatitis and Inflammatory Diseases

Gilead continues to maintain a strong position in hepatitis treatments, which accounted for 22% of its revenue in 2023[7]. Additionally, the company has been expanding its portfolio in inflammatory diseases, which contributed 12% to its revenue stream.

Gilead's Key Strengths: Innovation, Financial Robustness, and Strategic Acquisitions

Gilead's competitive edge in the pharmaceutical landscape is built on several key strengths that set it apart from its rivals.

Robust Research and Development Capabilities

At the heart of Gilead's success lies its commitment to innovation. In 2023, the company invested a substantial $5.1 billion in R&D, representing 15.3% of its total revenue[7]. This significant investment fuels a pipeline of potential breakthrough therapies and maintains Gilead's position at the forefront of pharmaceutical innovation.

Strong Financial Performance

Gilead's financial health provides a solid foundation for its competitive strategies. In 2023, the company reported:

  • Total Revenue: $33.2 billion
  • Net Income: $7.6 billion
  • Gross Profit Margin: 81.4%[7]

These robust financial metrics underscore Gilead's ability to fund research, pursue strategic acquisitions, and weather market fluctuations.

Strategic Acquisitions and Partnerships

Gilead has demonstrated a keen eye for strategic acquisitions that complement its existing portfolio and expand its market reach. Notable acquisitions include:

  • Immunomedics (2020): $21 billion
  • MYR Pharmaceuticals (2021): $4.9 billion[7]

These acquisitions have bolstered Gilead's oncology pipeline and expanded its therapeutic reach.

Competitive Landscape: Challenges and Opportunities

While Gilead maintains a strong market position, it operates in a highly competitive industry with numerous challenges and opportunities.

Intense Competition in Key Markets

Gilead faces stiff competition in its core markets, particularly HIV and oncology. Competitors are continuously developing new treatments and entering markets where Gilead has established dominance[4].

Patent Expirations and Generic Competition

Like many pharmaceutical companies, Gilead must navigate the challenges posed by patent expirations and the subsequent entry of generic competitors. This necessitates a continuous focus on innovation and pipeline development to maintain market share.

Regulatory Environment

The pharmaceutical industry is heavily regulated, and changes in healthcare policies or drug pricing regulations can significantly impact Gilead's operations and profitability.

Strategic Insights: Gilead's Path Forward

To maintain its competitive edge, Gilead is pursuing several strategic initiatives that leverage its strengths and address market challenges.

Focus on Long-Acting HIV Treatments

Gilead is investing heavily in the development of long-acting HIV treatments, such as lenacapavir. The company is gearing up for a potential mid-2025 launch of lenacapavir as a pre-exposure prophylactic for HIV, which could revolutionize HIV prevention[5].

Expanding Oncology Portfolio

Gilead is actively expanding its presence in the oncology market. The company's CAR T therapies, Trodelvy and Yescarta, have shown promising growth, contributing to a 12% year-over-year increase in oncology sales for the full year 2024[1].

Continued Investment in R&D

Gilead's commitment to innovation remains unwavering. The company's robust R&D pipeline, with 12 active clinical trials and 8 potential breakthrough therapies in development[7], positions it well for future growth and market expansion.

Strategic Partnerships and Collaborations

Gilead continues to forge strategic partnerships with academic institutions, research organizations, and other biopharmaceutical companies. These collaborations enhance its research capabilities and provide access to complementary technologies and expertise[3].

Financial Outlook and Market Expectations

Gilead's financial performance and market expectations provide insights into its competitive positioning and future prospects.

2024 Financial Performance

Gilead reported strong financial results for 2024:

  • Total revenue increased 6% to $28.8 billion
  • Product sales excluding Veklury increased 8% to $26.8 billion
  • Biktarvy sales increased 13% to $13.4 billion
  • Oncology sales increased 12% to $3.3 billion[1]

2025 Guidance

For 2025, Gilead projects:

  • Product sales between $28.2 billion and $28.6 billion
  • Non-GAAP diluted EPS between $7.70 and $8.10[1]

These projections reflect Gilead's confidence in its competitive position and growth prospects.

Gilead's Global Footprint and Market Access

Gilead's global presence plays a crucial role in its competitive strategy, allowing the company to access diverse markets and collaborate with healthcare professionals worldwide.

International Operations

With operations in multiple countries, Gilead can leverage regional expertise and adapt to local healthcare needs. This global footprint enables the company to mitigate risks associated with market-specific challenges and capitalize on growth opportunities across different regions.

Market Access Strategies

Gilead employs various strategies to ensure broad access to its medications:

  • Tiered pricing models for different markets
  • Patient assistance programs
  • Collaborations with governments and NGOs to improve healthcare access in developing countries

These initiatives not only support Gilead's market penetration but also contribute to its corporate social responsibility efforts.

Innovation Pipeline: Gilead's Future Growth Drivers

Gilead's robust pipeline of innovative therapies is crucial to its long-term competitiveness and growth prospects.

HIV Pipeline

In addition to lenacapavir, Gilead is developing several other long-acting HIV treatments and prevention methods. These innovations aim to address unmet needs in HIV care and maintain Gilead's leadership in this therapeutic area.

Oncology Pipeline

Gilead's oncology pipeline includes promising candidates in various stages of development. The company is particularly focused on expanding the indications for Trodelvy and advancing its cell therapy programs.

Liver Disease and Inflammation

While these areas have shown slightly slower growth compared to HIV and oncology, Gilead continues to invest in developing new treatments for liver diseases and inflammatory conditions, recognizing their potential for future growth.

Competitive Advantages: Gilead's Unique Selling Propositions

Several factors contribute to Gilead's competitive edge in the pharmaceutical market:

Scientific Expertise

Gilead's team of over 250 active research scientists[7] brings a wealth of expertise to its R&D efforts, enabling the company to tackle complex scientific challenges and develop innovative therapies.

Manufacturing Capabilities

The company's advanced manufacturing facilities and processes ensure high-quality production of its medications, supporting its reputation for reliability and efficacy.

Patient-Centric Approach

Gilead's focus on patient needs drives its research priorities and access programs, fostering goodwill and loyalty among patients and healthcare providers.

Market Challenges and Gilead's Response

While Gilead maintains a strong market position, it faces several challenges that require strategic responses:

Pricing Pressures

Increasing scrutiny of drug prices poses a challenge for Gilead. The company is addressing this through:

  • Value-based pricing models
  • Transparency initiatives
  • Engagement with policymakers on healthcare reform

Emerging Competitors

New entrants and emerging biotechnology companies present competitive threats. Gilead responds by:

  • Accelerating its own innovation efforts
  • Pursuing strategic partnerships and acquisitions
  • Leveraging its established market presence and brand reputation

Evolving Treatment Paradigms

Shifts in treatment approaches, such as the move towards personalized medicine, require Gilead to adapt. The company is investing in:

  • Precision medicine initiatives
  • Biomarker research
  • Digital health technologies

Sustainability and Corporate Responsibility: A Competitive Differentiator

Gilead's commitment to sustainability and corporate responsibility enhances its competitive position by strengthening its reputation and attracting socially conscious investors and partners.

Environmental Stewardship

Gilead has set ambitious environmental goals, including:

  • Reducing greenhouse gas emissions
  • Improving water efficiency
  • Minimizing waste in its operations

Social Impact Initiatives

The company's social impact programs focus on:

  • Improving access to healthcare in underserved communities
  • Supporting STEM education initiatives
  • Promoting diversity and inclusion in the workplace

Ethical Business Practices

Gilead's commitment to ethical business practices includes:

  • Transparent clinical trial reporting
  • Responsible marketing practices
  • Strong governance structures

These initiatives not only contribute to Gilead's positive corporate image but also help mitigate risks associated with regulatory scrutiny and public perception.

Key Takeaways

  • Gilead Sciences maintains a dominant position in the HIV treatment market, with approximately 70% market share.
  • The company's financial strength, with $33.2 billion in revenue and an 81.4% gross profit margin in 2023, provides a solid foundation for growth and innovation.
  • Gilead's robust R&D investment, totaling $5.1 billion in 2023, fuels a promising pipeline of potential breakthrough therapies.
  • Strategic acquisitions and partnerships have expanded Gilead's therapeutic reach, particularly in oncology.
  • The company faces challenges from intense competition, patent expirations, and pricing pressures but is responding with focused strategies in long-acting HIV treatments, oncology expansion, and continued innovation.
  • Gilead's global footprint and market access strategies support its competitive position across diverse markets.
  • The company's commitment to sustainability and corporate responsibility enhances its reputation and attracts socially conscious stakeholders.

As Gilead Sciences navigates the complex pharmaceutical landscape, its strong market position, innovative pipeline, and strategic initiatives position it well for continued success and growth in the face of evolving industry challenges.

FAQs

  1. Q: How does Gilead's market share in HIV treatments compare to its competitors? A: Gilead holds approximately 70% market share in HIV treatment medications, significantly outpacing its competitors in this therapeutic area.

  2. Q: What are Gilead's key growth drivers for the future? A: Gilead's future growth is expected to be driven by its HIV franchise, expanding oncology portfolio, potential breakthrough therapies in its pipeline, and strategic acquisitions.

  3. Q: How is Gilead addressing the challenge of patent expirations? A: Gilead is focusing on continuous innovation, developing new formulations and combinations of existing drugs, and expanding into new therapeutic areas to offset potential revenue losses from patent expirations.

  4. Q: What sets Gilead apart from other pharmaceutical companies in terms of R&D? A: Gilead's significant R&D investment (15.3% of total revenue in 2023), focus on unmet medical needs, and track record of developing breakthrough therapies distinguish it in the pharmaceutical landscape.

  5. Q: How is Gilead preparing for the potential launch of lenacapavir for HIV PrEP? A: Gilead is gearing up for a potential mid-2025 launch of lenacapavir, with preparations including market education, access strategies, and manufacturing readiness to meet anticipated high demand.

Sources cited: [1] https://www.gilead.com/news/news-details/2025/gilead-sciences-announces-fourth-quarter-and-full-year-2024-financial-results [3] https://canvasbusinessmodel.com/blogs/growth-strategy/gilead-sciences-growth-strategy [4] https://www.hivelr.com/2024/08/gilead-sciences-gild-porters-five-forces-industry-and-competition-analysis/ [5] https://www.biospace.com/business/anticipating-approval-gilead-gears-up-for-mid-year-launch-for-lenacapavir-prep [6] https://www.gilead.com/news/news-details/2024/gilead-sciences-announces-fourth-quarter-and-full-year-2023-financial-results [7] https://dcfmodeling.com/products/gild-swot-analysis

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.