Glaxosmithkline Company Profile

What is the competitive landscape for GLAXOSMITHKLINE

GLAXOSMITHKLINE has one hundred and fifty-one approved drugs.

There are thirty-four US patents protecting GLAXOSMITHKLINE drugs.

There are seven hundred and sixty-one patent family members on GLAXOSMITHKLINE drugs in sixty-two countries and one hundred and seventy-nine supplementary protection certificates in twenty-one countries.

Summary for Glaxosmithkline

International Patents:	761
US Patents:	34
Tradenames:	106
Ingredients:	92
NDAs:	151
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	TOTACILLIN-N	ampicillin sodium	INJECTABLE;INJECTION	060677-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No	8,071,623		Y	Y
Glaxosmithkline	BACTOCILL	oxacillin sodium	INJECTABLE;INJECTION	061334-008	Mar 26, 1982		DISCN	No	No
Glaxosmithkline	TRANDATE HCT	hydrochlorothiazide; labetalol hydrochloride	TABLET;ORAL	019174-003	Apr 10, 1987		DISCN	No	No
Glaxosmithkline	TOTACILLIN-N	ampicillin sodium	INJECTABLE;INJECTION	060677-005	Approved Prior to Jan 1, 1982		DISCN	No	No
Glaxosmithkline	IMITREX STATDOSE	sumatriptan succinate	INJECTABLE;SUBCUTANEOUS	020080-003	Dec 23, 1996	AB	RX	Yes	Yes

Expired US Patents for Glaxosmithkline

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ZYBAN	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020711-003	May 14, 1997	5,763,493
Glaxosmithkline	FLOVENT	fluticasone propionate	POWDER;INHALATION	020549-003	Nov 7, 1997	4,335,121*PED
Glaxosmithkline	WELLBUTRIN	bupropion hydrochloride	TABLET;ORAL	018644-002	Dec 30, 1985	4,425,363
Glaxosmithkline	ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER	ondansetron hydrochloride	INJECTABLE;INJECTION	020403-001	Jan 31, 1995	4,753,789*PED
Glaxosmithkline Llc	REQUIP XL	ropinirole hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022008-004	Jun 13, 2008	7,927,624
Glaxosmithkline	VENTOLIN HFA	albuterol sulfate	AEROSOL, METERED;INHALATION	020983-001	Apr 19, 2001	6,315,173*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
Norway	2018018
Taiwan	I363759
Israel	273282
Australia	2021204302
Norway	338959
Montenegro	02965

Supplementary Protection Certificates for Glaxosmithkline Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1480644	SPC/GB17/004	United Kingdom		PRODUCT NAME: COMBINATION OF CEFTAZIDIME, OR A SALT THEREOF, AND AVIBACTAM, OR A SALT THEREOF; REGISTERED: UK EU/1/16/1109/001 20160628
1633724	C01633724/01	Switzerland		PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016
2240466	2018/020	Ireland		PRODUCT NAME: NIRAPARIB TOSYLATE OR A HYDRATE THEREOF, ESPECIALLY THE TOSYLATE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171116
3494972	301277	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT, WAARONDER DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; REGISTRATION NO/DATE: EU/1/19/1370 20190703
0984957	C300517	Netherlands		PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
0526543	99C0042	Belgium		PRODUCT NAME: ZANAMIVIR; NAT. REGISTRATION NO/DATE: 725 IS 380 F 11 19990906; FIRST REGISTRATION: SE 14997 19990209

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: 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.

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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/