GLAXOSMITHKLINE Company Profile

What is the competitive landscape for GLAXOSMITHKLINE

GLAXOSMITHKLINE has one hundred and fifty approved drugs.

There are thirty-one US patents protecting GLAXOSMITHKLINE drugs.

There are seven hundred and thirty-eight patent family members on GLAXOSMITHKLINE drugs in sixty-one countries and one hundred and ninety-five supplementary protection certificates in twenty countries.

Summary for GLAXOSMITHKLINE

International Patents:	738
US Patents:	31
Tradenames:	105
Ingredients:	91
NDAs:	150
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	POTIGA	ezogabine	TABLET;ORAL	022345-003	Jun 10, 2011		DISCN	Yes	No
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes	9,750,726		Y
Glaxosmithkline Llc	MEPRON	atovaquone	TABLET;ORAL	020259-001	Nov 25, 1992		DISCN	Yes	No
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-004	Feb 1, 2023		DISCN	Yes	No	11,643,397			Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No	8,859,562
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-004	Apr 10, 1987		DISCN	No	No
Glaxosmithkline	COMPAZINE	prochlorperazine maleate	CAPSULE, EXTENDED RELEASE;ORAL	021019-001	Oct 6, 1999		DISCN	No	No

Expired US Patents for GLAXOSMITHKLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	VENTOLIN	albuterol sulfate	SYRUP;ORAL	019621-001	Jun 10, 1987	3,705,233
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-002	Apr 10, 1987	4,012,444
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-002	Jun 23, 1995	4,957,924*PED
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	6,510,969*PED
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	6,431,168*PED
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-003	Dec 30, 1985	4,393,078
Glaxosmithkline	IMITREX	sumatriptan	SPRAY;NASAL	020626-003	Aug 26, 1997	5,307,953*PED

Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	3 mg		2009-01-08
	Injection	6 mg/0.5 mL, 0.5 mL vials		2004-10-25
	Tablets	0.25 mg, 0.5 mg, 1 mg and 2 mg		2004-12-22
	Tablets	100 mg		2007-10-31
	Tablets	62.5 mg/25 mg		2010-09-14
	Extended-release Capsules	225 mg and 425 mg		2006-10-11
	Extended-release Tablets	25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg		2014-02-12
	Extended-release Tablets	8 mg		2008-11-03
	Extended-release Tablets	12 mg		2009-02-05
	Extended-release Tablets	6 mg		2009-07-22
	Tablets	150 mg		2007-10-30
	Orally Disintegrating Tablets	25 mg, 50 mg, 100 mg, and 200 mg		2009-12-21
	Injection	6 mg/0.5 mL, 0.5 mL (prefilled syringes)		2006-05-09
	Tablets	3 mg, 4 mg and 5 mg		2005-02-04
	Tablets	250 mg/100 mg		2009-04-03
	Extended-release Capsules	325 mg		2006-11-07
	Oral Suspension	750 mg/5 mL		2009-10-20
	Extended-release Tablets	4 mg		2008-10-31
	Extended-release Tablets	3 mg		2009-01-08
	Extended-release Tablets	2 mg		2008-10-14

International Patents for GLAXOSMITHKLINE Drugs

Country	Patent Number	Estimated Expiration
Portugal	1524981
Mexico	2019011496
Denmark	2506844
European Patent Office	2839857
Spain	2392848
South Korea	101742140
Brazil	122020010759

Supplementary Protection Certificates for GLAXOSMITHKLINE Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3490560	LUC50015	Luxembourg		PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN PARTICULAR NIRAPARIB TOSYLATE IN PARTICULAR NIRAPARIB TOSYLATE MONOHYDRATE, OPTIONALLY IN COMBINATION WITH ABIRATERONE IN PARTICULAR ABIRATERONE ACETATE; AUTHORISATION NUMBER AND DATE: EU/1/23/1722 20230420
0303507	97C0102	Belgium		PRODUCT NAME: NARATRIPTAN HYDROCHLORIDUM; REGISTRATION NO/DATE: 725 IS 278 F 3 19970818; FIRST REGISTRATION: SE 13382 19970310
2506844	C20180017 00244	Estonia		PRODUCT NAME: FLUTIKASOONFUROAAT/UMEKLIDIINIUM/VILANTEROOL;REG NO/DATE: EU/1/17/1236 17.11.2017
2240466	2018/020	Ireland		PRODUCT NAME: NIRAPARIB TOSYLATE OR A HYDRATE THEREOF, ESPECIALLY THE TOSYLATE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171116
1633724	S1500012	Hungary		PRODUCT NAME: OLAPARIB
1740177	C01740177/02	Switzerland		PRODUCT NAME: UMECLIDINIUM BROMID + VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 63152 14.07.2014
0123238	SPC/GB95/004	United Kingdom		PRODUCT NAME: ATOVAQUONE OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: LU 0458/94/08/0741 19940803; UK 0003/0337 19940823

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Glaxo Grp England
• Glaxo Grp Ltd
• Glaxosmithkline
• Glaxosmithkline Cons
• Glaxosmithkline Llc

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

Last updated: November 24, 2025

Introduction

GlaxoSmithKline (GSK), a leading global pharmaceutical and healthcare firm, holds a significant position in the industry’s competitive landscape. With a diverse portfolio spanning vaccines, pharmaceutical medicines, and consumer health products, GSK’s strategic maneuvers are crucial to understanding its market dynamics. This analysis evaluates GSK's current market position, core strengths, and strategic initiatives aimed at maintaining its competitive edge amid evolving industry challenges.

Market Position

Global Footprint and Revenue Streams

GSK ranks among the world's top pharmaceutical companies, consistently positioning within the top five by revenue. In 2022, the company's revenue reached approximately £34 billion, reflecting robust operational performance (GSK Annual Report 2022)[1]. Its market presence extends across leading regions—North America, Europe, Asia, and emerging markets—highlighting a balanced geographic footprint.

Pipeline and Innovation

GSK maintains substantial R&D investments (~£3 billion annually)[2], fueling an active pipeline with over 50 candidates spanning vaccines, oncology, respiratory diseases, and immunology. Recent collaboratives, such as the partnership with Vir Biotechnology for COVID-19 therapeutics, demonstrate commitment to innovation, reinforcing its strategic focus on high-value, differentiated assets.

Product Portfolio and Market Segments

• Vaccines: The core revenue driver, with GSK holding approximately 30% market share globally[3], supported by a strong portfolio including Shingrix (herpes zoster), Cervarix (HPV), and the COVID-19 vaccine.
• Pharmaceuticals: Focused on respiratory (e.g., Advair), HIV (e.g., Tivicay), and oncology products, GSK faces fierce competition from players like Pfizer and Merck.
• Consumer Healthcare (CH): Sold to GSK Consumer Healthcare division prior to the 2019 spin-off, GSK strategically divested its consumer segment to focus on pharmaceuticals and vaccines, emphasizing high-margin prescription medicines.

Competitive Position

GSK's strategic focus on vaccines and specialty medicines places it in a premium niche, differentiating it from rivals primarily targeting mass-market generics or broad-spectrum drugs. Its collaborations and pipeline investments bolster its position against competitors such as Pfizer, Roche, and Sanofi.

Strengths

1. Robust Vaccine Portfolio and Leadership

GSK’s global vaccine market share and leading positions, especially with the Shingrix vaccine, underpin its revenue resilience. The company’s vaccine R&D pipeline aims to expand into areas like influenza, RSV, and COVID-19, ensuring long-term growth opportunities.

2. Focused R&D Strategy and Innovative Pipeline

GSK allocates significant resources to R&D, emphasizing disease areas with high unmet medical needs. Its strategic partnerships with biotech firms and academic institutions enhance its pipeline and accelerate delivery of novel therapeutics.

3. Strategic Divestments and Focused Business Model

The $3.3 billion sale of its consumer healthcare division to Pfizer in 2019 allowed GSK to streamline operations and allocate resources more effectively toward pharmaceuticals. This strategic refocusing has improved profitability and operational agility.

4. Strong Global Presence and Market Access

GSK’s established distribution networks across emerging markets, coupled with partnerships in developing nations, enhance market penetration. Its legacy of localized manufacturing and regulatory expertise facilitates entry into high-growth markets.

5. Commitment to Sustainability and Digital Innovation

GSK's sustainability initiatives, including commitments to reduce carbon footprint and improve access to medicines, bolster its corporate reputation. Its investments in digital health solutions for clinical trials and patient engagement provide operational efficiencies and data-driven insights.

Strategic Insights

1. Emphasizing Vaccines and Specialty Medicines to Sustain Growth

GSK’s strategic emphasis on vaccines and specialty medicines positions it favorably amid patent cliff challenges faced by traditional pharma. Recent advancements in mRNA vaccine development and biotherapeutics expansion are critical to this strategy.

2. Leveraging Collaborations and Partnerships

Collaborations like those with Vir Biotechnology exemplify GSK’s strategy to co-develop innovative therapeutics, reducing R&D risks and accelerating time-to-market for novel products.

3. Digital Transformation and Data Analytics

Integrating digital health strategies, such as real-world evidence generation and AI-driven R&D, enables GSK to optimize clinical trials, tailor therapies, and enhance patient outcomes—thus maintaining a technological edge.

4. Focused Market Entry and Expansion in Emerging Economies

GSK’s targeted investments in high-growth regions, supported by local manufacturing and partnerships, aim to capture increased healthcare spending and population health improvements.

5. Navigating Regulatory and Competitive Challenges

GSK’s geographic and portfolio diversification buffers against regulatory hurdles in specific markets. However, the company must stay agile amid increasing scrutiny over vaccine safety, pricing pressures, and patent disputes.

Competitive Landscape and Key Rivalry Dynamics

Major competitors include Pfizer, Merck & Co., Sanofi, and Roche. Pfizer’s recent victory with its COVID-19 vaccine and R&D investments pose significant competition. Merck’s expanding oncology portfolio also threatens GSK’s oncology ambitions. Sanofi remains a formidable rival in vaccines, challenging GSK’s market share.

GSK’s competitive strategy emphasizes product differentiation through innovation, continued pipeline development, and strategic partnerships. its focus on high-margin specialty therapeutics and vaccines positions it favorably relative to rivals heavily reliant on generics.

Conclusion

GlaxoSmithKline’s strategic repositioning toward vaccines and specialty medicines has strengthened its market standing, especially in endemic disease areas and emerging markets. Its substantial R&D investments, collaborative strategies, and operational focus underpin its resilience and growth trajectory. As the pharmaceutical landscape becomes increasingly competitive and regulated, GSK’s agility and innovation capacity will be vital for maintaining its leadership and expanding its global footprint.

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Key Takeaways

• GSK’s leadership in vaccines and focus on specialty medicines serve as key differentiators in a competitive landscape.
• Strategic divestments have allowed GSK to concentrate on high-margin, high-growth sectors, improving profitability.
• Continuous pipeline development, enhanced by collaborations, sustains innovation and addresses unmet medical needs.
• Geographic diversification, especially in emerging markets, underpins sales growth and market share expansion.
• Digital transformation initiatives increase operational efficiencies, accelerate R&D, and improve patient engagement.

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FAQs

1. How does GSK differentiate itself from competitors like Pfizer and Sanofi?
GSK’s primary differentiation lies in its leadership in vaccines and a strategic focus on specialty medicines such as immunology and oncology, supported by a robust pipeline and innovation-driven collaborations.

2. What are GSK’s key growth areas for the next five years?
Vaccine development, particularly for respiratory and emerging infectious diseases, along with innovative therapeutics in oncology and immunology, are central to GSK’s growth strategy.

3. How does GSK’s divestment of consumer health impact its market focus?
By divesting its consumer healthcare division, GSK sharper its focus on pharmaceuticals and vaccines, enabling targeted R&D investments and strategic alignment with high-margin, high-growth sectors.

4. What role do global collaborations and partnerships play in GSK’s strategy?
Collaborations enhance GSK’s R&D capabilities, facilitate faster product development, mitigate risk, and expand its geographic reach into high-growth markets.

5. How is GSK preparing for future industry challenges?
GSK invests heavily in R&D, digital health, and strategic partnerships, while emphasizing sustainability and market agility to navigate regulatory changes, pricing pressures, and competitive threats.

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Sources:
[1] GSK Annual Report 2022.
[2] GSK R&D Investment Data, 2022.
[3] IQVIA Data on Vaccine Market Share, 2022.