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Last Updated: February 17, 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 ODT lamotrigine TABLET, ORALLY DISINTEGRATING;ORAL 022251-004 May 8, 2009 AB RX Yes No ⤷  Try for Free ⤷  Try for Free
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, FOR SUSPENSION;ORAL 020764-002 Aug 24, 1998 AB RX Yes Yes ⤷  Try for Free ⤷  Try for Free
Glaxosmithkline Llc LANOXICAPS digoxin CAPSULE;ORAL 018118-003 Jul 26, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free
Glaxosmithkline Llc LAMICTAL lamotrigine TABLET;ORAL 020241-004 Dec 27, 1994 DISCN Yes No ⤷  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 Glaxosmithkline Llc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-004 Sep 19, 1997 4,452,808 ⤷  Try for Free
Glaxosmithkline Llc LAMICTAL CD lamotrigine TABLET, FOR SUSPENSION;ORAL 020764-002 Aug 24, 1998 5,698,226*PED ⤷  Try for Free
Glaxosmithkline Llc DYNACIRC CR isradipine TABLET, EXTENDED RELEASE;ORAL 020336-002 Jun 1, 1994 4,783,337 ⤷  Try for Free
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-005 Oct 31, 2008 8,303,986 ⤷  Try for 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 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
➤ 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

Supplementary Protection Certificates for Glaxosmithkline Llc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0502314 SPC/GB02/037 United Kingdom ⤷  Try for 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
0303507 64/1997 Austria ⤷  Try for 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
0303507 C970035 Netherlands ⤷  Try for Free PRODUCT NAME: NARATRIPTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAA RDBAAR ZOUT OF SOLVAAT, IN HET BIJZONDER NARATRIPTAN-HYDROCHLOR IDE; NAT. REGISTRATION NO/DATE: RVG 21444 19970801; FIRST REGISTRATION: SE 13382 19970310
0480717 98C0025 Belgium ⤷  Try for Free PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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Pharmaceutical Competitive Landscape Analysis: GLAXOSMITHKLINE LLC – Market Position, Strengths & Strategic Insights

In the ever-evolving pharmaceutical industry, GlaxoSmithKline (GSK) stands as a formidable player, consistently demonstrating its ability to adapt, innovate, and maintain a strong market position. This comprehensive analysis delves into GSK's current standing, exploring its strengths, strategic initiatives, and the challenges it faces in a highly competitive landscape.

GSK's Market Position

GSK has firmly established itself as a global pharmaceutical powerhouse. As of 2024, the company ranks 10th among the world's largest pharmaceutical companies based on prescription drug sales[5]. This positioning reflects GSK's significant market presence and its ability to compete effectively in a crowded industry.

In the UK market, GSK's prominence is even more pronounced. The company holds the second position among UK pharmaceutical and biotechnology companies when ranked by market capitalization in late 2024[5]. This strong domestic standing provides GSK with a solid foundation for its global operations and strategic initiatives.

Financial Performance and Growth

GSK's financial performance in recent years has been robust, showcasing the company's ability to generate substantial revenue and maintain profitability. In 2023, GSK reported total sales of £30.3 billion, representing a 5% increase year-over-year[1]. When excluding COVID-related sales, the growth was even more impressive at 14%[1].

The company's strong financial performance extends beyond top-line growth. In 2023, GSK achieved:

  • 12% growth in adjusted operating profit
  • 16% increase in adjusted earnings per share (EPS)[1]

These figures demonstrate GSK's ability to not only drive sales but also improve operational efficiency and deliver value to shareholders.

Product Portfolio and Key Growth Drivers

GSK's success is underpinned by a diverse and robust product portfolio spanning multiple therapeutic areas. The company's key business segments include:

  1. Vaccines
  2. Specialty Medicines
  3. General Medicines

Vaccines

GSK's vaccine business has been a significant growth driver for the company. In 2023, vaccine sales grew by an impressive 25% (24% excluding COVID-related products)[1]. This growth was primarily driven by two key products:

  • Shingrix: GSK's shingles vaccine generated £3.4 billion in sales, representing a 17% increase[1].
  • Arexvy: The company's newly launched respiratory syncytial virus (RSV) vaccine for older adults contributed £1.2 billion in its first year on the market[1].

The success of Arexvy is particularly noteworthy, as it represents GSK's ability to bring innovative products to market and address unmet medical needs.

Specialty Medicines

While GSK's specialty medicines segment saw an 8% decline in overall sales in 2023, this was primarily due to reduced COVID-related revenue. Excluding these factors, the segment actually grew by 15%[1]. A standout performer in this category was GSK's HIV portfolio, which achieved 13% growth[1].

General Medicines

GSK's general medicines segment demonstrated steady growth, with sales increasing by 5% in 2023[1]. This performance underscores the continued relevance of GSK's established products and the company's ability to maintain market share in competitive therapeutic areas.

Research and Development

GSK's commitment to innovation is evident in its substantial investment in research and development (R&D). In 2023, the company allocated £6.2 billion to R&D efforts[3]. This significant investment underscores GSK's focus on developing new and improved treatments across various therapeutic areas.

The company's R&D pipeline is robust, with at least 12 major launches planned between 2025 and 2031[1]. These upcoming products span multiple areas, including:

  • Infectious diseases
  • HIV
  • Respiratory conditions
  • Oncology

GSK's strong pipeline positions the company for sustained growth and reinforces its ability to address evolving healthcare needs.

Strategic Initiatives and Future Outlook

GSK's leadership has outlined a clear strategy for future growth and market expansion. Key elements of this strategy include:

  1. Focus on Biopharmaceuticals: Following the demerger of its consumer healthcare business (now Haleon) in 2022, GSK has sharpened its focus on innovative vaccines and medicines[6].

  2. Pipeline Progression: The company is prioritizing the development and launch of new products, with a particular emphasis on vaccines and specialty medicines[1].

  3. Operational Efficiency: GSK is committed to improving its operating margin in the coming years, building on its recent cost discipline efforts[6].

  4. Strategic Acquisitions: The company has demonstrated a willingness to bolster its portfolio through strategic acquisitions, such as the purchase of Bellus Health and Aiolos Bio[2].

  5. Long-term Growth Targets: GSK has upgraded its growth outlooks for 2026 and 2031, projecting more than 7% and 11% growth, respectively[6].

"GSK delivered excellent performance in 2023, with clear highlights being the exceptional launch of Arexvy and continued progress in our pipeline. We are now planning for at least 12 major launches from 2025, with new Vaccines and Specialty Medicines for infectious diseases, HIV, respiratory and oncology." - Emma Walmsley, Chief Executive Officer, GSK[1]

Competitive Advantages

Several factors contribute to GSK's strong competitive position in the pharmaceutical industry:

  1. Diverse Product Portfolio: GSK's broad range of products across multiple therapeutic areas helps mitigate risks and capitalize on various market opportunities[4].

  2. Global Presence: With operations in over 150 countries, GSK has established a strong international footprint, allowing it to access diverse markets and leverage growth opportunities worldwide[3].

  3. Brand Reputation: GSK has built a strong brand reputation over the years, known for quality products and commitment to healthcare[4].

  4. Strategic Partnerships: The company actively collaborates with academic institutions, research centers, and other pharmaceutical companies, fostering innovation and accessing new technologies[4].

  5. Focus on Sustainability: GSK's commitment to sustainability and corporate social responsibility resonates with consumers and stakeholders, potentially providing a competitive edge in an increasingly environmentally conscious market[4].

Challenges and Future Considerations

Despite its strong position, GSK faces several challenges that could impact its future performance:

  1. Intense Competition: The pharmaceutical industry is highly competitive, with numerous companies vying for market share in key therapeutic areas[3].

  2. Regulatory Compliance: Navigating complex and evolving regulatory landscapes across multiple markets remains an ongoing challenge[4].

  3. R&D Productivity: Maintaining a high level of R&D productivity and successfully bringing new products to market is crucial for long-term success[4].

  4. Pricing Pressures: Increasing scrutiny on drug pricing and healthcare costs could impact GSK's pricing strategies and profitability[4].

  5. Global Economic Uncertainties: Economic fluctuations and geopolitical tensions can affect market dynamics and impact GSK's operations in various regions.

Key Takeaways

  • GSK maintains a strong market position, ranking 10th among global pharmaceutical companies and 2nd in the UK market by market capitalization.
  • The company delivered robust financial performance in 2023, with total sales of £30.3 billion and significant growth in adjusted operating profit and EPS.
  • GSK's vaccine business, particularly Shingrix and the newly launched Arexvy, has been a key growth driver.
  • The company's R&D pipeline is strong, with at least 12 major launches planned between 2025 and 2031.
  • GSK's strategic focus on biopharmaceuticals, operational efficiency, and long-term growth targets positions it well for future success.
  • Challenges include intense competition, regulatory compliance, and maintaining R&D productivity.

FAQs

  1. What is GSK's current market position in the pharmaceutical industry? GSK ranks 10th among global pharmaceutical companies based on prescription drug sales and holds the 2nd position among UK pharmaceutical and biotechnology companies by market capitalization.

  2. How has GSK's financial performance been in recent years? GSK reported strong financial performance in 2023, with total sales of £30.3 billion, representing a 5% increase year-over-year. The company also achieved 12% growth in adjusted operating profit and a 16% increase in adjusted earnings per share.

  3. What are GSK's key growth drivers? GSK's vaccine business, particularly Shingrix and the newly launched Arexvy, has been a significant growth driver. The company's specialty medicines segment, especially its HIV portfolio, has also shown strong performance.

  4. How is GSK investing in research and development? In 2023, GSK allocated £6.2 billion to R&D efforts. The company has a robust pipeline with at least 12 major launches planned between 2025 and 2031, focusing on areas such as infectious diseases, HIV, respiratory conditions, and oncology.

  5. What are the main challenges facing GSK in the coming years? Key challenges for GSK include intense competition in the pharmaceutical industry, navigating complex regulatory landscapes, maintaining R&D productivity, addressing pricing pressures, and managing global economic uncertainties.

Sources cited: [1] https://www.gsk.com/en-gb/media/press-releases/gsk-delivers-strong-2023-performance-and-upgrades-growth-outlooks/ [2] https://www.proclinical.com/blogs/2024-7/who-are-the-top-10-pharma-companies-in-the-world-2024 [3] https://www.marketing91.com/swot-analysis-gsk/ [4] https://canvasbusinessmodel.com/blogs/target-market/glaxosmithkline-target-market [5] https://www.statista.com/topics/12090/gsk-glaxosmithkline/ [6] https://www.gsk.com/media/11007/annual-report-2023.pdf

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