Last Updated: June 9, 2026

Glaxosmithkline Company Profile


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Summary for Glaxosmithkline
International Patents:805
US Patents:37
Tradenames:107
Ingredients:93
NDAs:152
Drug Master File Entries: 8
Patent Litigation for Glaxosmithkline: See patent lawsuits for Glaxosmithkline
PTAB Cases with Glaxosmithkline as petitioner: See PTAB cases with Glaxosmithkline as petitioner

Drugs and US Patents for Glaxosmithkline

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-001 Jun 1, 1995 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline SYNCURINE decamethonium bromide INJECTABLE;INJECTION 006931-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline IMITREX STATDOSE sumatriptan succinate INJECTABLE;SUBCUTANEOUS 020080-003 Dec 23, 1996 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline FASTIN phentermine hydrochloride CAPSULE;ORAL 017352-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline ACTIFED pseudoephedrine hydrochloride; triprolidine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018996-001 Jun 17, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline COMPAZINE prochlorperazine edisylate CONCENTRATE;ORAL 011276-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline TOTACILLIN-N ampicillin sodium INJECTABLE;INJECTION 062727-002 Dec 19, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Expired US Patents for Glaxosmithkline

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-003 Oct 4, 1996 RE33994 ⤷  Start Trial
Glaxosmithkline RELENZA zanamivir POWDER;INHALATION 021036-001 Jul 26, 1999 4,811,731 ⤷  Start Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-003 Oct 4, 1996 5,427,798 ⤷  Start Trial
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-003 May 17, 2018 7,629,335 ⤷  Start Trial
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-001 Dec 30, 1985 4,507,323 ⤷  Start Trial
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-002 Dec 30, 1985 3,819,706 ⤷  Start Trial
Glaxosmithkline TRITEC ranitidine bismuth citrate TABLET;ORAL 020559-001 Aug 8, 1996 5,256,684 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Orally Disintegrating Tablets 25 mg, 50 mg, 100 mg, and 200 mg ➤ Subscribe 2009-12-21
➤ Subscribe Injection 6 mg/0.5 mL, 0.5 mL (prefilled syringes) ➤ Subscribe 2006-05-09
➤ Subscribe Tablets 3 mg, 4 mg and 5 mg ➤ Subscribe 2005-02-04
➤ Subscribe Tablets 250 mg/100 mg ➤ Subscribe 2009-04-03
➤ 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 Injection 6 mg/0.5 mL, 0.5 mL vials ➤ Subscribe 2004-10-25
➤ Subscribe Tablets 0.25 mg, 0.5 mg, 1 mg and 2 mg ➤ Subscribe 2004-12-22
➤ Subscribe Tablets 100 mg ➤ Subscribe 2007-10-31
➤ Subscribe Tablets 62.5 mg/25 mg ➤ Subscribe 2010-09-14
➤ 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 Tablets 150 mg ➤ Subscribe 2007-10-30

Supplementary Protection Certificates for Glaxosmithkline Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2924034 300981 Netherlands ⤷  Start Trial PRODUCT NAME: DORAVIRINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN COMBINATIE MET TENOFOVIR OF EEN ESTER DAARVAN, IN HET BIJZONDER EEN DISOPROXIL ESTER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER EEN FUMARAAT ZOUT; REGISTRATION NO/DATE: EU/1/18/1333/001-002 20181126
3494972 301277 Netherlands ⤷  Start Trial PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, WAARONDER DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703
1740177 CA 2014 00052 Denmark ⤷  Start Trial PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140428
0299602 SPC/GB96/040 United Kingdom ⤷  Start Trial PRODUCT NAME: ROPINIROLE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR THE HYDROCHLORIDE SALT; REGISTERED: UK 10592/0085 19960702
0565634 06C0030 France ⤷  Start Trial PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
2924034 1990024-0 Sweden ⤷  Start Trial PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126
2109608 CR 2018 00017 Denmark ⤷  Start Trial PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REG. NO/DATE: EU/1/17/1235 20171120
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Similar Applicant Names
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Here is a list of applicants with similar names.

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

Last updated: February 19, 2026

What is GlaxoSmithKline's (GSK) current global market position?

GSK ranks among the top global pharmaceutical companies, with revenues reaching GBP 35.8 billion ($45.7 billion) in 2022. The company's operations span vaccines, pharmaceuticals, and consumer healthcare. GSK holds approximately 4.5% of the global pharmaceutical market share, positioning it in the top five worldwide.

Market Share Breakdown (2022):

Segment Revenue (GBP Million) Market Share Key Products
Vaccines 10,020 6% Shingrix, Bexsero, Dengvaxia
Pharmaceuticals 18,900 4.5% Trelegy, Benlysta, Tivicay
Consumer Healthcare 6,880 N/A Panadol, Sensodyne, Aquafresh

GSK's strategic focus on vaccines and specialty medicines positions it in high-growth niches within the pharma sector.

What are GSK’s core strengths?

  • Vaccine Portfolio: GSK is a leader with a 14% global share in vaccines, especially in adult vaccines such as Shingrix and pediatric vaccines including Bexsero. Its dominance in vaccines is underpinned by a robust pipeline and strategic licensing agreements with global health agencies.

  • Research and Development (R&D): The company invests roughly GBP 3.3 billion annually into R&D, with a notable focus on infectious diseases, oncology, and immunology. Its pipeline includes 30+ candidates in late-stage development, targeting unmet medical needs.

  • Strategic Patents and Launch Readiness: GSK maintains a strong patent portfolio, with key patents expiring from 2024 onwards, providing a window for new product launches and pipeline expansion.

  • Strategic Partnerships: Collaborations with companies like Vir Biotechnology for COVID-19 therapeutics and with GlaxoSmithKline’s Consumer Healthcare division enhances revenue diversification.

  • Global Footprint: GSK operates in over 150 countries, with strengthened presence in emerging markets like China and India, contributing to revenue growth.

How does GSK compare to key competitors?

Competitor Market Share (2022) Focus Areas R&D Spend (2022) Notable Products
Pfizer 8% Pharmaceuticals, vaccines $13.6 billion Comirnaty, Prevnar
Sanofi 5.5% Vaccines, specialty medicines €4.3 billion Dupixent, Vaccines
Merck & Co. 4.0% Oncology, vaccines $10 billion Keytruda, Gardasil
Johnson & Johnson 4.2% Drugs, vaccines, consumer health $6 billion Stelara, Tylenol

GSK’s vaccine dominance distinguishes it from peers largely focused on oncology and specialty drugs. Its strategic shift to vaccines, especially amid COVID-19, has reinforced its market position.

What are GSK's strategic initiatives?

  • Refocusing on Vaccines and Specialty Medicines: In 2019, GSK announced divestment of its consumer healthcare business, completed in 2022, to concentrate resources on innovative pharmaceuticals and vaccines.

  • Pipeline Expansion: It aims to launch 16 new medicines and vaccines by 2026. Priorities include respiratory diseases, HIV, and oncology.

  • Partnerships and Licensing: GSK entered licensing deals with CureVac and Innovent for mRNA and immuno-oncology platforms, diversifying its R&D sources.

  • Emerging Market Penetration: GSK increased investment in China’s healthcare infrastructure and vaccine market, leveraging local manufacturing capabilities and partnerships with government health agencies.

  • Digital Transformation: The company invests in digital tools for clinical trials, supply chain management, and pharmacovigilance to improve efficiency.

What risks and challenges face GSK?

  • Patent Expirations: Key vaccine patents, such as Shingrix, face expiry starting 2024, risking revenue decline without new product launches.

  • Market Competition: Pfizer’s strong vaccine pipeline and Merck’s oncology portfolio threaten GSK’s market share.

  • Regulatory Environment: Increased regulation, especially in emerging markets, poses hurdles to timely approval and market access.

  • Pricing Pressures: Governments and payers negotiate tariff reductions, affecting profitability on key products.

  • Pipeline Risks: The success of R&D depends on clinical trial results, with high attrition rates increasing investment risk.

What are GSK’s future growth prospects?

  • Vaccine Expansion: Growing demand in flu, COVID-19, and emerging infectious diseases sustains a bullish outlook. GSK’s focus on adjuvants and novel vaccine delivery could create competitive barriers.

  • Oncology and Immunology: Investments in therapies like Zejula and Benlysta aim for a longer product lifecycle and market expansion.

  • Emerging Markets: Increased healthcare infrastructure in China, India, and Southeast Asia offers volume growth opportunities.

  • Innovation through Collaboration: The company’s partnerships with biotech firms provide access to cutting-edge technologies like mRNA and personalized medicine.

What are the implications for investors and R&D stakeholders?

  • Investors should monitor patent expiry timelines and pipeline milestones for key products.

  • R&D resource allocation remains critical, with emphasis on specialties aligned with GSK’s strategic focus.

  • The divestment of consumer healthcare shifts the company’s valuation metrics and risk profile, favoring biotech and vaccine assets.

Key Takeaways

GSK’s market position rests on its vaccine leadership and targeted pharmaceutical portfolio. Its strategic shift towards vaccine and specialty medicine R&D indicates a focus on high-margin, high-growth areas. While patent expiries and competitive pressures pose risks, ongoing pipeline expansion and emerging market penetration support future growth. Effective management of regulatory and pricing challenges will determine its competitive edge over the next five years.

FAQs

  1. What are GSK’s main revenue drivers?
    Vaccines and specialty medicines, particularly in infectious diseases and immunology.

  2. How does GSK plan to counter patent expirations?
    By accelerating new product launches, expanding existing franchise sales, and forming strategic partnerships.

  3. What impact did the consumer healthcare divestiture have?
    It refocused resources on pharmaceuticals and vaccines, eliminating a segment with lower growth prospects.

  4. How significant is GSK’s pipeline?
    Over 30 candidates in late-stage development across vaccines, oncology, and infectious diseases.

  5. What geographic regions drive GSK’s growth?
    Emerging markets such as China and India account for increased sales, complemented by established markets in Europe and North America.

References

[1] GlaxoSmithKline Annual Report 2022. (2022). https://gsk.com/investors/annual-report-2022/
[2] Statista. (2023). Global pharmaceutical market share by company. https://statista.com/
[3] QuintilesIMS. (2023). Worldwide pharmaceutical R&D spending. https://iqvia.com/
[4] EvaluatePharma. (2023). 10-year pharma pipeline analysis. https://evaluate.com/
[5] Reuters. (2023). GlaxoSmithKline predicts growth post-divestment. https://reuters.com/

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