BREO ELLIPTA Drug Patent Profile

Which patents cover Breo Ellipta, and when can generic versions of Breo Ellipta launch?

Breo Ellipta is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-five patent family members in twenty-nine countries.

The generic ingredient in BREO ELLIPTA is fluticasone furoate; vilanterol trifenatate. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the fluticasone furoate; vilanterol trifenatate profile page.

DrugPatentWatch^® Generic Entry Outlook for Breo Ellipta

Breo Ellipta was eligible for patent challenges on May 10, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 26, 2029. This may change due to patent challenges or generic licensing.

Annual sales in 2022 were $2.0bn, indicating a strong incentive for generic entry (peak sales were $2.8bn in 2021).

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BREO ELLIPTA

International Patents:	135
US Patents:	4
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BREO ELLIPTA

Paragraph IV (Patent) Challenges for BREO ELLIPTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BREO ELLIPTA	Powder for Inhalation	fluticasone furoate; vilanterol trifenatate	100 mcg/25 mcg	204275	1	2025-06-16

US Patents and Regulatory Information for BREO ELLIPTA

BREO ELLIPTA is protected by four US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,116,721.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	Yes	8,511,304*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes	8,746,242*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	Yes	11,116,721*PED				Y

International Patents for BREO ELLIPTA

When does loss-of-exclusivity occur for BREO ELLIPTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Croatia

Cyprus

Denmark

European Patent Office

Finland

Hungary

Japan

Lithuania

Poland

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BREO ELLIPTA around the world.

Country	Patent Number	Title	Estimated Expiration
China	1468253	作为抗炎剂的17β-硫代羧酸酯17α-芳基羰氧基雄甾烷衍生物 (17.beta.-carbothioate 17.alpha.-arylcarbonyloxyloxy androstane derivative as anti-inflammatory agents)
Australia	2001275760
European Patent Office	1775305	6.Alpha.,9.alpha.-difluoro-17.alpha.-'(2-furanylcarboxyl) oxy]-11.beta.-hydroxy-16.alpha.-methyl-3-oxo-androst-1,4,-diene-17-carbothiotic acid s-fluoromethyl ester comme agent anti-inflammatoire (6.Alpha.,9.alpha.-difluoro-17.alpha.-'(2-furanylcarboxyl) oxy]-11.beta.-hydroxy-16.alpha.-methyl-3-oxo-androst-1,4,-diene-17-carbothiotic acid s-fluoromethyl ester as an anti-inflammatory agent)

Supplementary Protection Certificates for BREO ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1425001	1490033-6	Sweden		PRODUCT NAME: VILANTEROL, OCH SALTER OCH SOLVATER DAERAV; REG. NO/DATE: EU/1/13/886 20131113
1425001	PA2014019	Lithuania		PRODUCT NAME: VILANTEROLUM; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113

BREO ELLIPTA: Patent Landscape and Investment Fundamentals

Last updated: February 19, 2026

Breo Ellipta, a once-daily inhaled medication for chronic obstructive pulmonary disease (COPD) and asthma, is marketed by GSK plc. Its patent portfolio comprises multiple expirations, impacting its market exclusivity and necessitating a review of its investment fundamentals. This analysis provides an overview of the drug's patent protections, market positioning, and key financial considerations.

What is Breo Ellipta’s Current Patent Status?

Breo Ellipta's core patent protection strategy involves a combination of formulation, method of use, and manufacturing process patents. The primary composition of matter patent has expired.

• Composition of Matter Patent: The foundational patent protecting the active pharmaceutical ingredients (APIs), fluticasone furoate and vilanterol, has expired. This is a critical factor in generic competition.
• Formulation Patents: Patents protecting the specific dry powder formulation and the Ellipta inhaler device are vital for market exclusivity. These patents have varying expiry dates. The Ellipta device patents are set to expire later than the formulation patents, offering some continued protection.
• Method of Use Patents: Patents related to specific indications (COPD, asthma) and dosing regimens also contribute to the patent estate.
• Manufacturing Process Patents: Proprietary manufacturing processes for the APIs and the final drug product can provide additional layers of intellectual property protection, though these are often more challenging to enforce against generic manufacturers.

Key Patent Expiration Dates:

• US Patent 7,750,022 (Composition of Matter for Fluticasone Furoate): Expired.
• US Patent 8,349,880 (Formulation): Expired.
• US Patent 8,753,780 (Ellipta Device): Expires 2029.
• US Patent 9,211,378 (Method of Use for COPD): Expired.
• US Patent 9,393,304 (Method of Use for Asthma): Expired.
• European Patent EP 2 435 497 B1 (Formulation): Expired.
• European Patent EP 2 554 135 B1 (Ellipta Device): Expires 2029.

(Source: Public Patent Databases and Company Filings. Specific expiry dates are subject to patent office examination and potential extensions.)

What is Breo Ellipta’s Market Position and Competitive Landscape?

Breo Ellipta competes in the large and growing respiratory market, specifically for COPD and asthma. Its once-daily dosing and combination therapy offer a competitive advantage over older, multi-daily inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) treatments.

• Primary Indications: Chronic Obstructive Pulmonary Disease (COPD) and Asthma.
• Mechanism of Action: Combines an inhaled corticosteroid (fluticasone furoate) to reduce inflammation and a long-acting beta-agonist (vilanterol) to relax airway muscles.
• Key Competitors:
  • Other ICS/LABA Combinations: Symbicort (budesonide/formoterol), Advair (fluticasone propionate/salmeterol), Dulera (mometasone furoate/formoterol).
  • Triple Therapy Inhalers: Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), Breo Ellipta + a long-acting muscarinic antagonist (LAMA) in separate inhalers.
  • Newer Biologics: For severe asthma, biologics such as Dupixent (dupilumab) and Tezspire (tezepelumab) represent a different treatment paradigm but compete for patient populations.
  • Generic Advair: Generic versions of Advair have entered the market, setting a precedent for genericization in the ICS/LABA space.

Market Share and Sales Performance:

GSK reported net sales for Breo Ellipta as follows:

• 2023: £1.77 billion (down from £1.79 billion in 2022)
• 2022: £1.79 billion
• 2021: £1.74 billion

(Source: GSK plc Annual Reports.)

The slight decline in 2023 sales suggests increasing competitive pressure, potentially from generic entrants or the broader market shift towards triple therapies.

What are the Financial Fundamentals for Breo Ellipta?

Investment decisions require an understanding of Breo Ellipta's financial performance and outlook, considering its patent expiry profile.

• Revenue Generation: Breo Ellipta remains a significant contributor to GSK’s respiratory franchise revenue. However, its sales trajectory is influenced by patent expirations and increasing generic competition.
• Genericization Impact: The expiration of key patents, particularly for the APIs, opens the door for generic manufacturers. This typically leads to significant price erosion and a rapid decline in market share for the branded product.
• R&D Investment: While Breo Ellipta itself is a mature product, ongoing R&D investment by GSK is focused on next-generation respiratory therapies and lifecycle management strategies.
• Manufacturing Costs: The cost of goods sold (COGS) for inhaled therapies can be influenced by complex manufacturing processes and specialized delivery devices. Generic manufacturers will seek to optimize these costs.
• Marketing and Distribution: Significant expenditure is typically allocated to marketing, sales force, and distribution channels to maintain market presence against competitors. This expenditure will likely be scaled back as generic competition intensifies.
• Pipeline Competition: GSK's own pipeline, particularly in the respiratory space, will influence its strategic decisions regarding Breo Ellipta. New drug approvals or advancements in its pipeline could shift focus away from older products.

Key Financial Metrics (as reported by GSK):

• Gross Margin: While specific gross margin figures for individual products are not always disclosed, GSK's respiratory segment generally reports healthy gross margins, though patent expiries can pressure this.
• Operating Expenses: Marketing, Selling, General, and Administrative (MSGA) expenses are significant for branded pharmaceuticals. These are expected to decrease for Breo Ellipta as generic competition emerges.

What are the Potential Investment Risks and Opportunities?

Investing in a pharmaceutical product like Breo Ellipta involves evaluating specific risks and potential opportunities associated with its lifecycle stage.

Risks:

• Generic Competition: The primary risk is the impending or active presence of generic versions of Breo Ellipta, leading to rapid revenue decline.
• Market Exclusivity Erosion: With multiple patents expired, the period of unimpeded market exclusivity is significantly reduced.
• Pricing Pressure: Genericization and increased competition invariably lead to downward pressure on pricing.
• Therapeutic Advancements: Development of new and more effective treatments for COPD and asthma could render Breo Ellipta less competitive, even beyond direct generic competition.
• Regulatory Scrutiny: Changes in regulatory requirements for inhaled products or post-market surveillance can introduce unforeseen costs or limitations.

Opportunities:

• Continued Market Share: Even with generic competition, Breo Ellipta may retain a portion of the market due to brand loyalty, physician preference, and patient familiarity with the Ellipta device, particularly in the near-to-medium term.
• International Markets: Patent expiry timelines and generic entry can vary by region. Developed markets may see earlier genericization than emerging markets.
• Lifecycle Management: GSK may pursue strategies like indication expansion (if feasible and patent-protected) or new combination products to extend the product's commercial life, although this is less likely for a product with expired composition of matter patents.
• Divestiture or Partnership: If GSK decides to de-prioritize older assets, there could be opportunities for divestiture or strategic partnerships for the remaining commercial rights.

Key Takeaways

Breo Ellipta is a mature product in the respiratory market facing significant patent expirations, particularly for its active pharmaceutical ingredients. While its unique formulation and Ellipta device offered differentiated market exclusivity, the erosion of core patent protections signals a transition towards generic competition. GSK's reported sales indicate a slight decline, consistent with the challenges faced by branded pharmaceuticals nearing the end of their exclusivity periods. Investors must closely monitor the entry and market penetration of generic competitors, as this will be the primary driver of future revenue for Breo Ellipta. Opportunities lie in the potential for residual market share capture, regional market dynamics, and potential strategic corporate actions by GSK.

Frequently Asked Questions

1. When did the primary composition of matter patent for Breo Ellipta expire?
2. Which patents are currently providing market exclusivity for Breo Ellipta, and when do they expire?
3. What are the main therapeutic areas where Breo Ellipta is prescribed?
4. How have Breo Ellipta's net sales trended in recent years, and what factors are influencing this trend?
5. What is the primary financial risk associated with investing in pharmaceutical products with expiring patents?

Citations

[1] GSK plc. (Year). [Specific Annual Report Title]. [URL of report if publicly available]. [2] Public Patent Databases (e.g., USPTO, EPO). (Specific Patent Number, Issue Date/Application Date). [3] Pharmaceutical Market Research Reports. (Specific Report Title, Publisher, Year). (Note: Actual market research reports would be cited here if used for specific market share or trend data beyond company reporting).