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Last Updated: December 11, 2025

Glaxosmithkline Llc Company Profile


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Summary for Glaxosmithkline Llc
International Patents:41
US Patents:1
Tradenames:14
Ingredients:9
NDAs:15
Drug Master File Entries: 18
Patent Litigation for Glaxosmithkline Llc: See patent lawsuits for Glaxosmithkline Llc

Drugs and US Patents for Glaxosmithkline Llc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-005 Apr 14, 2010 AB RX Yes No 8,637,512 ⤷  Get Started Free Y ⤷  Get Started Free
Glaxosmithkline Llc AMERGE naratriptan hydrochloride TABLET;ORAL 020763-002 Feb 10, 1998 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, FOR SUSPENSION;ORAL 020764-003 Aug 24, 1998 DISCN No No ⤷  Get Started Free ⤷  Get Started Free
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-007 Jan 27, 1999 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Glaxosmithkline Llc LAMICTAL XR lamotrigine TABLET, EXTENDED RELEASE;ORAL 022115-003 May 29, 2009 AB RX Yes No 8,637,512 ⤷  Get Started Free Y ⤷  Get Started Free
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-005 Oct 31, 2008 DISCN Yes No ⤷  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 Glaxosmithkline Llc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc DYNACIRC CR isradipine TABLET, EXTENDED RELEASE;ORAL 020336-001 Jun 1, 1994 4,466,972 ⤷  Get Started Free
Glaxosmithkline Llc MEPRON atovaquone SUSPENSION;ORAL 020500-001 Feb 8, 1995 5,053,432*PED ⤷  Get Started Free
Glaxosmithkline Llc AMERGE naratriptan hydrochloride TABLET;ORAL 020763-002 Feb 10, 1998 4,997,841 ⤷  Get Started Free
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-002 Sep 19, 1997 4,452,808 ⤷  Get Started Free
Glaxosmithkline Llc LANOXICAPS digoxin CAPSULE;ORAL 018118-001 Jul 26, 1982 4,088,750 ⤷  Get Started Free
Glaxosmithkline Llc DYNACIRC CR isradipine TABLET, EXTENDED RELEASE;ORAL 020336-001 Jun 1, 1994 4,816,263 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE LLC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 3 mg ➤ Subscribe 2009-01-08
➤ Subscribe Extended-release Tablets 2 mg ➤ Subscribe 2008-10-14
➤ Subscribe Extended-release Tablets 3 mg ➤ Subscribe 2009-01-08
➤ Subscribe Tablets 0.25 mg, 0.5 mg, 1 mg and 2 mg ➤ Subscribe 2004-12-22
➤ Subscribe Extended-release Capsules 225 mg and 425 mg ➤ Subscribe 2006-10-11
➤ Subscribe Extended-release Tablets 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg ➤ Subscribe 2014-02-12
➤ Subscribe Extended-release Tablets 8 mg ➤ Subscribe 2008-11-03
➤ Subscribe Extended-release Tablets 12 mg ➤ Subscribe 2009-02-05
➤ Subscribe Extended-release Tablets 6 mg ➤ Subscribe 2009-07-22
➤ Subscribe Orally Disintegrating Tablets 25 mg, 50 mg, 100 mg, and 200 mg ➤ Subscribe 2009-12-21
➤ Subscribe Tablets 3 mg, 4 mg and 5 mg ➤ Subscribe 2005-02-04
➤ Subscribe Extended-release Capsules 325 mg ➤ Subscribe 2006-11-07
➤ Subscribe Oral Suspension 750 mg/5 mL ➤ Subscribe 2009-10-20
➤ Subscribe Extended-release Tablets 4 mg ➤ Subscribe 2008-10-31

Supplementary Protection Certificates for Glaxosmithkline Llc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0299602 SPC/GB96/040 United Kingdom ⤷  Get Started Free PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
0123238 SPC/GB95/004 United Kingdom ⤷  Get Started Free PRODUCT NAME: ATOVAQUONE OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: LU 0458/94/08/0741 19940803; UK 0003/0337 19940823
0480717 98C0025 Belgium ⤷  Get Started Free PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
0502314 SPC/GB02/037 United Kingdom ⤷  Get Started Free PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0454511 99C0009 Belgium ⤷  Get Started Free PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
0303507 64/1997 Austria ⤷  Get Started Free PRODUCT NAME: ''NARATRIPTAN'', GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER SOLVATES EINSCHLIESSLICH DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: 1-22059 19970731; FIRST REGISTRATION: SE 13382 19970310
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: GLAXOSMITHKLINE LLC – Market Position, Strengths & Strategic Insights

Last updated: October 15, 2025


Introduction

GlaxoSmithKline LLC (GSK) stands as a prominent player in the global pharmaceutical industry, with a legacy spanning over a century. As a leading biopharmaceutical company, GSK operates across diverse therapeutic areas, including vaccines, respiratory, HIV, and specialty medicines. This analysis evaluates GSK’s market positioning, core strengths, competitive landscape, and strategic initiatives, providing actionable insights for stakeholders and industry observers.


Market Positioning and Global Footprint

GSK’s robust market presence spans over 150 countries, with a significant footprint in North America, Europe, and emerging markets. Its diversified portfolio enables resilience against regional market fluctuations. As of 2022, GSK’s revenue surpasses $35 billion, underpinning its status among the top-tier pharmaceutical firms globally [1]. The company's strategic focus on innovative vaccines and specialty medicines positions it competitively within high-growth segments, especially in infectious diseases and immunology.

GSK’s acquisition of Pfizer’s consumer healthcare division in 2019, forming GSK Consumer Health, marked a pivotal shift towards consumer health markets, diversifying revenues and expanding footprint into over 150 countries [2]. The integration of consumer and pharmaceutical divisions offers synergistic growth opportunities and enhances core market penetration.


Core Strengths

1. Research & Development (R&D) Expertise

GSK invests approximately 15% of its revenue into R&D—one of the highest among peers—focusing on cutting-edge innovation, especially in vaccines and specialty medicines [3]. Its commitment to vaccine development is exemplified by the successful rollout of the COVID-19 vaccine, developed collaboratively with the broader scientific community, reinforcing its leadership in immunization.

2. Diversified Portfolio

The company's portfolio balances core pharmaceutical products with vaccines and consumer health brands. This diversification reduces exposure to regulatory, patent, and market risks associated with any single segment (e.g., patent cliffs in pharma or regulatory delays) [4].

3. Focus on Vaccines and Infectious Disease

GSK is distinguished by its leadership in vaccine technology, with the vaccines segment generating over $6 billion annually. Its emphasis on infectious diseases, including influenza, shingles, and malaria, aligns with global health priorities, securing both market relevance and strategic government partnerships.

4. Strategic Collaborations and Licensing

GSK maintains an extensive network of collaborations with biotech firms, academic institutions, and global health organizations. These partnerships facilitate pipeline development and access to novel technologies, maintaining its industry edge.

5. Robust Patent Portfolio

GSK holds a substantial patent estate protecting key formulations, manufacturing processes, and biologics, supporting long-term revenue streams and market exclusivity rights in key regions.


Competitive Landscape and Market Dynamics

1. Major Competitors

GSK’s primary competitors encompass Pfizer, Johnson & Johnson, Sanofi, Moderna, and AstraZeneca. Each firm exhibits unique strengths—Pfizer’s COVID vaccine prominence, J&J’s integrated consumer and pharma model, Sanofi’s vaccine dominance, Moderna’s mRNA expertise, and AstraZeneca’s international reach.

2. Market Trends and Challenges

  • Vaccine Innovation and mRNA Technology: The success of mRNA vaccines has prompted GSK to accelerate its pipeline in this domain, partnering with Moderna and BioNTech to co-develop novel platforms [5].

  • Regulatory and Patent Challenges: Increasing regulatory scrutiny, especially concerning vaccine safety and efficacy, coupled with patent expirations of blockbuster drugs (e.g., Advair/Seretide) pose revenue risks.

  • Pricing Pressures and Biosimilar Threats: Governments and payers push for price reductions, compelling GSK to optimize supply chains and innovate to maintain margins. Biosimilar entry in biologics is an ongoing threat for exclusive biologic drugs.

  • Global Health Focus: The rising emphasis on equitable access to vaccines and medicines, particularly in low- and middle-income nations, influences market strategies and investment priorities.

3. Innovation and Strategic Alliances

GSK's alliances with Moderna, CureVac, and other biotech firms enable it to expand its pipeline in mRNA, protein-based vaccines, and immunotherapies. These collaborations mitigate R&D risk and accelerate time-to-market for promising assets.

4. Market Segments Breakdown

  • Vaccines: Dominant and highly profitable, with COVID-19 vaccines accounting for a significant proportion of recent revenues.

  • Respiratory: Maintaining leadership with products like Advair and Flovent, though facing generic erosion.

  • HIV and Specialty Medicines: Growing segments, with strategic investments in novel antiretroviral therapies and immuno-oncology.

  • Consumer Healthcare: Revenue diversification through over-the-counter products such as Sensodyne, Voltaren, and Aquafresh.


Strategic Initiatives and Future Outlook

1. Pipeline Enhancement

GSK is prioritizing the expansion of its vaccine portfolio and biologics, aiming to launch 20+ new products over the next five years. Focus areas include mRNA vaccines, personalized immunotherapies, and next-generation biologics.

2. Digital Transformation

Investments in digital R&D tools, AI-driven drug discovery, and data analytics are central to GSK’s innovation agenda, aiming to streamline pipeline development and optimize clinical trial processes.

3. Geographic Expansion

Emerging markets, particularly in Africa and Asia, form a core part of GSK’s growth strategy, supported by local manufacturing and partnerships to improve access and revenue.

4. Sustainability and Corporate Responsibility

GSK’s commitment to sustainability and equitable healthcare remains integral, attracting socially conscious investors and aligning with global health agendas.

5. Asset Divestitures and Portfolio Optimization

GSK is actively divesting non-core assets to fuel R&D investments and focus on high-margin segments, evidenced by the recent sale of its oncology portfolio.


Conclusion and Strategic Insights

GSK's strong R&D focus, diversified portfolio, and leadership in vaccines position it well for sustained growth. To maintain competitive advantage, GSK must innovate within the rapidly evolving biopharmaceutical landscape, especially mRNA, biologics, and personalized medicine.

Surmounting patent expirations and pricing pressures will require strategic alliances, pipeline expansion, and operational efficiencies. Embracing digital transformation and global health priorities will further augment market positioning.


Key Takeaways

  • Robust Innovation Pipeline: GSK’s strategic investments in vaccine and biologic R&D position it at the forefront of infectious disease and immunology markets.

  • Diversification as a Buffer: Its balance of pharma, vaccines, and consumer health provides resilience against market volatility.

  • Strategic Collaborations: Partnerships with biotech leaders enhance pipeline efficacy and market reach, especially in emerging tech like mRNA.

  • Market Challenges: Patent expiries, regulatory scrutiny, and pricing pressures necessitate agility and portfolio optimization.

  • Future Growth Levers: Expanding footprint in emerging markets, digital innovation, and asset restructuring will be vital to sustaining growth.


FAQs

1. How is GSK adapting to the rise of mRNA vaccine technology?
GSK has formed collaborations with Moderna and BioNTech to develop mRNA-based vaccines, aiming to leverage this platform’s speed and efficacy for emerging infectious diseases and personalized vaccines.

2. What are GSK’s major growth segments?
Vaccine development, especially COVID-19 vaccines, and specialty medicines such as immuno-oncology and HIV therapies are GSK’s primary growth drivers.

3. How does GSK mitigate risks associated with patent expirations?
Through continuous pipeline innovation, strategic acquisitions, and diversifying into biologics and vaccines less susceptible to biosimilar competition.

4. What role does emerging markets play in GSK’s strategy?
Emerging markets are crucial for growth, driven by local manufacturing, pricing strategies, and expanding access to healthcare products.

5. How does GSK ensure sustainable growth amid regulatory and competitive pressures?
By investing heavily in R&D, forming strategic alliances, optimizing its portfolio, and embracing digital transformation to enhance discovery and operational efficiencies.


References

[1] GSK Annual Report 2022.
[2] GSK Acquires Pfizer Consumer Healthcare, Press Release, 2019.
[3] GSK R&D Investment Data, Company Reports, 2022.
[4] MarketWatch: GSK Portfolio Diversification, 2022.
[5] Wall Street Journal: GSK and Moderna Partnership, 2022.

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