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Last Updated: December 30, 2025

Haleon Us Holdings Company Profile


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Summary for Haleon Us Holdings
International Patents:196
US Patents:8
Tradenames:28
Ingredients:18
NDAs:31

Drugs and US Patents for Haleon Us Holdings

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Haleon Us Holdings JUNIOR STRENGTH ADVIL ibuprofen TABLET, CHEWABLE;ORAL 020944-002 Dec 18, 1998 OTC No No ⤷  Get Started Free ⤷  Get Started Free
Haleon Us Holdings ADVIL DUAL ACTION WITH ACETAMINOPHEN acetaminophen; ibuprofen TABLET;ORAL 211733-001 Feb 28, 2020 OTC Yes Yes 11,918,693 ⤷  Get Started Free Y ⤷  Get Started Free
Haleon Us Holdings ADVIL ALLERGY SINUS chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 021441-001 Dec 19, 2002 OTC Yes Yes 7,863,287 ⤷  Get Started Free Y ⤷  Get Started Free
Haleon Us Holdings CHILDREN'S ADVIL ibuprofen TABLET, CHEWABLE;ORAL 020944-001 Dec 18, 1998 OTC No No ⤷  Get Started Free ⤷  Get Started Free
Haleon Us Holdings FLONASE fluticasone propionate SPRAY, METERED;NASAL 020121-001 Oct 19, 1994 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free
Haleon Us Holdings ADVIL MIGRAINE LIQUI-GELS ibuprofen CAPSULE;ORAL 020402-002 Mar 16, 2000 OTC Yes Yes ⤷  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 Haleon Us Holdings

Paragraph IV (Patent) Challenges for HALEON US HOLDINGS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Capsules 200 mg/30 mg ➤ Subscribe 2004-12-27
➤ Subscribe Capsules 60 mg ➤ Subscribe 2010-09-08
➤ Subscribe Gum 4 mg ➤ Subscribe 2013-01-22
➤ Subscribe Capsules 200 mg/38 mg ➤ Subscribe 2016-02-16
➤ Subscribe Gum 2 mg ➤ Subscribe 2013-01-22

Supplementary Protection Certificates for Haleon Us Holdings Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 SPC/GB18/020 United Kingdom ⤷  Get Started Free PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
1305329 08C0014 France ⤷  Get Started Free PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1519731 92269 Luxembourg ⤷  Get Started Free PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
2506844 132018000000341 Italy ⤷  Get Started Free PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
0428642 57/2007 Austria ⤷  Get Started Free PRODUCT NAME: DOCOSANOL; NAT. REGISTRATION NO/DATE: 1-27014 20070518; FIRST REGISTRATION: SE 18517 20031114
1305329 SPC/GB08/026 United Kingdom ⤷  Get Started Free PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Haleon US Holdings – Market Position, Strengths & Strategic Insights

Last updated: July 28, 2025

Introduction

Haleon US Holdings stands as a prominent player within the highly competitive pharmaceutical landscape, focusing primarily on consumer health solutions. Formed from the spin-off of GSK’s consumer healthcare business in mid-2022, Haleon has quickly established a strategic footprint in the United States—a critical market due to its size, innovation potential, and consumer diversity. This analysis examines Haleon’s market positioning, core strengths, competitive advantages, and strategic pathways amidst evolving industry dynamics and intensifying competition.


Market Position and Business Overview

Haleon operates at the intersection of consumer health and pharmaceutical innovation, involved in over-the-counter (OTC) medicines, nutritional products, oral health, and respiratory care. The company’s strategic separation from GSK was designed to sharpen its focus on consumer-centric offerings, boosting agility and investor appeal.

In the US, Haleon holds a significant share within OTC categories—particularly in cough, cold, allergy, analgesics, and oral health segments. Its product portfolio includes well-established brands such as Centrum, Sensodyne, Voltaren, and Tums, which contribute to its consistent revenue streams and brand recognition. The US market remains competitive, characterized by nimble and entrenched rivals such as Johnson & Johnson, Pfizer, Procter & Gamble, and emerging niche players that leverage digital health trends.

Despite a late entry into some niche markets, Haleon’s strategic emphasis on consumer health differentiation, backed by broad distribution networks and marketing strength, positions it for stable growth, even amid sector volatility driven by supply chain disruptions, regulatory shifts, and evolving consumer preferences.


Strengths of Haleon US Holdings

1. Robust Index of Established Brands

Haleon’s portfolio comprises flagship OTC and health brands with entrenched consumer loyalty. Sensodyne, for example, remains the leading toothpaste brand in the US, while Voltaren dominates topical NSAIDs. This brand equity safeguards market share and facilitates marketing efficiencies.

2. Strategic Focus on Consumer Health

By emphasizing preventative care and wellness-oriented products, Haleon aligns with current consumer health trends. This focus allows the firm to capitalize on the vertical integration of core categories such as oral care, pain management, and nutritional supplements, bolstering revenue stability and growth potential.

3. Extensive Distribution Networks and Retail Presence

Haleon benefits from established distribution channels—mass retailers, pharmacy chains, online platforms—ensuring broad product accessibility. Its deep partnerships with retailers and health practices enable rapid market penetration and consumer engagement.

4. Innovation and Product Development Capacity

While traditionally reliant on brands with heritage, Haleon is expanding its innovation pipeline through strategic acquisitions and R&D investments. Capitalizing on advancements in formulations, delivery mechanisms, and personalization enhances its competitive edge.

5. Financial Backing and Strategic Resources Post-Spin-Off

As a standalone entity, Haleon enjoys increased agility and resource allocation flexibility. Its initial capitalization and backing from GSK provide a stable financial foundation for strategic investments, acquisitions, and marketing endeavors.


Competitive Landscape and Strategic Insights

Market Dynamics and Challenges

The US consumer health sector features aggressive innovation, entry of digital health solutions, and shifting regulatory pathways. Key challenges include regulatory limitations on certain OTC categories, the need for continual product reformulation, and evolving consumer preferences towards natural and organic products.

Furthermore, incumbent giants like Johnson & Johnson leverage their comprehensive product lines and global scale to maintain dominance, while new entrants and startups push digital health integration and personalized nutrition.

Competitive Positioning and Opportunities

Haleon’s proximity to consumer needs through targeted product offerings, differentiated branding, and a commitment to wellness positions it favorably. Capitalizing on growth in self-care, digital engagement, and targeted health solutions can provide competitive leverage.

For instance, expanding into mental wellness products, integrating digital health monitoring, or developing personalized health plans aligned with consumer preferences can unlock additional revenue streams in a saturated market.

Strategic Recommendations

  • Enhance Digital and E-Commerce Channels: Investing in direct-to-consumer platforms, digital marketing, and telehealth partnerships can boost brand engagement and sales channels.

  • Accelerate Innovation and Niche Market Expansion: Developing products that cater to personalized health needs, such as allergen-specific formulations or digital health integration systems, aligns with consumer trends.

  • Expand Acquisition and Partnership Strategies: Targeting innovative startups, especially in the natural and organic categories or digital health space, can augment Haleon’s portfolio and market reach.

  • Leverage Data Analytics for Consumer Insights: Deploying advanced analytics can inform product development, segment targeting, and personalized marketing strategies, fostering higher consumer loyalty.

  • Focus on Sustainability and Transparency: As consumer preferences shift towards natural and eco-friendly products, emphasizing transparency, sustainable sourcing, and eco-innovation can provide differentiation.


Conclusion

Haleon US Holdings maintains a robust market position driven by an extensive, trusted portfolio, strategic focus on consumer health, and a resilient distribution framework. Nevertheless, in a competitive and rapidly evolving landscape, ongoing innovation, digital transformation, and strategic acquisitions are vital. By leveraging core strengths and aligning with contemporary health and wellness trends, Haleon can secure sustained growth and deepened consumer engagement within the US.


Key Takeaways

  • Haleon’s entrenched brand portfolio and focus on consumer health enable stable market positioning.
  • Strategic investments in digital channels and personalized health solutions are critical for growth.
  • Competition remains intense, with major players leveraging innovation, distribution, and brand loyalty.
  • Expanding into emerging health segments and fostering partnerships can unlock new revenue streams.
  • Emphasizing sustainability and transparency aligns Haleon with evolving consumer values.

FAQs

Q1: How does Haleon differentiate itself from major competitors like Johnson & Johnson in the US?
Haleon differentiates through its laser focus on consumer health brands with high consumer loyalty, strategic emphasis on innovation in natural and wellness categories, and agile marketing in digital and retail channels, leveraging heritage brands like Sensodyne and Voltaren that dominate key segments.

Q2: What are the primary growth opportunities for Haleon in the US market?
Main opportunities include expanding into personalized health and wellness products, harnessing digital health platforms, targeting emerging niches such as natural remedies, and leveraging e-commerce and direct-to-consumer channels.

Q3: How does Haleon address regulatory and market access challenges?
Haleon invests in R&D to meet regulatory standards, maintains compliance protocols, and actively monitors legislative changes. Strategic partnerships also facilitate navigation of complex OTC and health product regulations.

Q4: What role will innovation play in Haleon’s future growth strategy?
Innovation is central, focusing on formulation advancements, personalized health solutions, digital integration, and sustainable packaging. These efforts will sustain competitive advantage and meet evolving consumer demands.

Q5: How can Haleon leverage digital health trends effectively?
By investing in digital platforms, incorporating telehealth collaborations, utilizing data analytics for consumer insights, and expanding online marketing efforts, Haleon can enhance consumer engagement and product penetration.


Sources:

[1] Haleon Corporate Website, 2023.
[2] GSK Annual Report, 2022.
[3] IBISWorld Industry Reports, OTC & Consumer Healthcare, 2023.
[4] Mintel Consumer Healthcare Trends, 2023.

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