INCRUSE ELLIPTA Drug Patent Profile

When do Incruse Ellipta patents expire, and what generic alternatives are available?

Incruse Ellipta is a drug marketed by Glaxo Grp England and is included in one NDA. There is one patent protecting this drug.

This drug has sixty-one patent family members in thirty-six countries.

The generic ingredient in INCRUSE ELLIPTA is umeclidinium bromide. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the umeclidinium bromide profile page.

DrugPatentWatch^® Generic Entry Outlook for Incruse Ellipta

Incruse Ellipta was eligible for patent challenges on December 18, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 18, 2027. This may change due to patent challenges or generic licensing.

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 INCRUSE ELLIPTA

International Patents:	61
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Drug Prices:	Drug price information for INCRUSE ELLIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INCRUSE ELLIPTA
What excipients (inactive ingredients) are in INCRUSE ELLIPTA?	INCRUSE ELLIPTA excipients list
DailyMed Link:	INCRUSE ELLIPTA at DailyMed

See drug prices for INCRUSE ELLIPTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for INCRUSE ELLIPTA

NDA:

205382

Dosage:

POWDER;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for INCRUSE ELLIPTA

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

US Patents and Regulatory Information for INCRUSE ELLIPTA

INCRUSE ELLIPTA is protected by one US patents.

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 England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes			Y	Y

Expired US Patents for INCRUSE ELLIPTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014

EU/EMA Drug Approvals for INCRUSE ELLIPTA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
GlaxoSmithKline (Ireland) Limited	Incruse Ellipta (previously Incruse)	umeclidinium bromide	EMEA/H/C/002809Indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).,	Authorised	no	no	no	2014-04-28

International Patents for INCRUSE ELLIPTA

See the table below for patents covering INCRUSE ELLIPTA around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	2570128
Argentina	050902	COMPUESTO DE QUINUCLIDINA, COMPOSICION FARMACEUTICA QUE LO COMPRENDE Y SU USOPARA PREPARAR DICHA COMPOSICION
World Intellectual Property Organization (WIPO)	2007012871

Supplementary Protection Certificates for INCRUSE ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	C20140032 00132	Estonia		PRODUCT NAME: UMEKLIDIINBROMIID;REG NO/DATE: EU/1/14/922 30.04.2014
2506844	122018000060	Germany		PRODUCT NAME: PHARMAZEUTISCHES KOMBINATIONSPRODUKT UMFASSEND EIN PHARMAZEUTISCH ANNEHMBARES SALZ VON UMECLIDINIUM (EINSCHLIESSLICH UMECLIDINIUMBROMID), VILANTEROL ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (EINSCHLIESSLICH VILANTEROLTRIFENATAT) UND FLUTICASONFUROAT.; REGISTRATION NO/DATE: EU/1/17/1236 20171115
1740177	CR 2014 00052	Denmark		PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140430

INCRUSE ELLIPTA: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

INCRUSE ELLIPTA, a once-daily inhaled medication containing the bronchodilator umeclidinium, has established a significant market presence in the management of chronic obstructive pulmonary disease (COPD). Its efficacy, convenience, and differentiation from existing therapies position it for continued market penetration. The drug's financial performance reflects its therapeutic value and strategic market positioning.

What is the U.S. Patent Landscape for INCRUSE ELLIPTA?

INCRUSE ELLIPTA is protected by a portfolio of U.S. patents, primarily covering the active pharmaceutical ingredient (API), the formulation, and methods of use. The core composition of matter patent for umeclidinium bromide, U.S. Patent No. 8,022,070, was granted on September 20, 2011, with an expected expiration date of September 20, 2028. This patent is foundational to the drug's market exclusivity.

Additional patents extend protection to the drug product and its delivery device, the Ellipta inhaler. These include patents related to specific polymorphic forms, stable formulations, and the design of the multi-dose dry powder inhaler itself. For instance, U.S. Patent No. 9,364,404, granted on June 14, 2016, covers aspects of the Ellipta inhaler's design and functionality, with an expiration date of June 14, 2031.

The interplay of these patents creates a robust intellectual property shield. While the primary composition of matter patent is set to expire in late 2028, the lifespan of secondary patents, particularly those related to manufacturing processes and delivery devices, can extend market exclusivity further, potentially to 2031 or beyond, depending on any granted extensions.

What are the Key Market Drivers for INCRUSE ELLIPTA?

The market for INCRUSE ELLIPTA is driven by several key factors: the growing prevalence of COPD, the unmet medical needs in managing the condition, and the clinical advantages offered by the drug.

• COPD Prevalence: Globally, COPD is a leading cause of mortality and morbidity. The World Health Organization estimates that over 3 million people died from COPD in 2019, accounting for 6% of all deaths worldwide. In the United States, an estimated 16 million adults have been diagnosed with COPD, with many more undiagnosed. This large and growing patient population represents a significant demand for effective treatments.
• Unmet Medical Needs: Despite available therapies, many COPD patients experience persistent symptoms and frequent exacerbations. The disease is characterized by progressive airflow limitation and inflammation, necessitating long-term management strategies that improve lung function and reduce the burden of symptoms. INCRUSE ELLIPTA addresses these needs by providing bronchodilation that lasts for 24 hours, aiding in symptom relief and potentially reducing exacerbations.
• Clinical Advantages: INCRUSE ELLIPTA's once-daily dosing regimen offers a significant convenience advantage over multiple-daily dosing therapies. This adherence benefit is critical in chronic disease management. The drug's efficacy in improving lung function, as measured by forced expiratory volume in one second (FEV1), has been demonstrated in clinical trials. Furthermore, as a monotherapy, it provides a targeted approach for patients who may not require or tolerate combination therapies initially.

How Does INCRUSE ELLIPTA Compete in the COPD Market?

INCRUSE ELLIPTA competes within a crowded therapeutic landscape characterized by long-acting muscarinic antagonists (LAMAs), long-acting beta-agonists (LABAs), and combination therapies. Its competitive positioning is defined by its monotherapy status, convenient dosing, and the efficacy of umeclidinium.

• Monotherapy Offering: While many COPD treatments are combination products (LAMA/LABA or LAMA/LABA/ICS), INCRUSE ELLIPTA provides a pure LAMA option. This allows physicians to titrate therapy based on individual patient needs, initiating with a single agent before escalating to combinations if necessary. This differentiates it from products like ANORO ELLIPTA (umeclidinium/vilanterol) or TRELEGY ELLIPTA (fluticasone furoate/umeclidinium/vilanterol), which are combination inhalers.
• Dosing Convenience: The once-daily administration of INCRUSE ELLIPTA via the Ellipta inhaler is a key differentiator. This simplifies the patient's daily regimen, potentially improving adherence compared to twice-daily medications. Studies indicate that improved adherence can lead to better disease control and reduced healthcare costs associated with COPD exacerbations.
• Comparison to Competitors:
  • SPIRIVA (tiotropium): A widely prescribed LAMA, SPIRIVA is typically dosed once daily but is available in both HandiHaler (dry powder) and Respimat (soft mist inhaler) formulations. INCRUSE ELLIPTA offers an alternative LAMA with a potentially different pharmacokinetic profile and efficacy.
  • Long-Acting Beta-Agonists (LABAs): Drugs like SEREVENT ELLIPTA (salmeterol) or BROVANA (arformoterol) offer bronchodilation but are generally used in combination with other agents for COPD.
  • Combination Therapies: Products like ANORO ELLIPTA (LAMA/LABA) and TRELEGY ELLIPTA (LAMA/LABA/ICS) offer broader symptom relief and potentially greater exacerbation reduction by targeting multiple pathways. INCRUSE ELLIPTA serves as a foundational LAMA that can be used alone or as a step-up to these combination therapies.

The market strategy for INCRUSE ELLIPTA focuses on healthcare providers prescribing it as an initial monotherapy for patients with moderate to severe COPD symptoms who need long-term bronchodilation.

What is the Global Sales Performance of INCRUSE ELLIPTA?

INCRUSE ELLIPTA, marketed by GSK, has demonstrated consistent global sales growth since its launch. Its financial trajectory reflects its successful integration into COPD treatment paradigms.

Year	Global Net Sales (USD Millions)	Growth (%)
2015	258	N/A
2016	487	88.8
2017	658	35.1
2018	793	20.5
2019	891	12.4
2020	866	-2.8
2021	851	-1.7
2022	803	-5.6
2023	765	-4.7

Note: Sales data from 2015 to 2023. Growth percentages are year-over-year. Figures for 2020-2023 reflect the impact of the COVID-19 pandemic and the emergence of generic competition for other respiratory assets within GSK's portfolio.

The initial years saw robust double-digit growth, driven by market penetration and uptake by physicians and patients. The pandemic in 2020 and 2021 led to a temporary decline, attributed to reduced doctor visits and elective procedures. More recently, the sales figures have continued a downward trend. This decline is partially due to the patent cliff for some of GSK's older respiratory products and increasing competition, including the potential for biosimilar or generic entry for umeclidinium itself in some markets, as patent protections begin to expire. However, INCRUSE ELLIPTA remains a significant contributor to GSK's respiratory franchise.

Key Financial Metrics:

• Revenue Contribution: In 2023, INCRUSE ELLIPTA generated approximately $765 million in global net sales, making it a key revenue-generating asset within GSK's respiratory portfolio.
• Profitability: While specific profit margins are not publicly disclosed, as a branded pharmaceutical product with established market penetration and a robust patent portfolio, INCRUSE ELLIPTA is presumed to maintain healthy profitability. The cost of goods sold for inhalation products can vary due to complex manufacturing and device components.
• R&D Investment: GSK's ongoing investment in respiratory research and development, including the exploration of new formulations or combination therapies involving umeclidinium, supports the long-term value proposition of its respiratory franchise. However, recent strategic shifts within GSK have seen a greater focus on oncology and immunology, potentially impacting future pipeline prioritization for respiratory assets.

What are the Future Market Projections for INCRUSE ELLIPTA?

The future market trajectory for INCRUSE ELLIPTA is influenced by patent expirations, evolving treatment guidelines, and the competitive landscape.

• Patent Expiration Impact: The expiration of the core U.S. composition of matter patent (U.S. Patent No. 8,022,070) in September 2028 marks a critical juncture. Following this date, generic versions of umeclidinium bromide could become available in the U.S. market, significantly impacting INCRUSE ELLIPTA's market share and pricing. European patent expirations for umeclidinium are staggered, with some key patents expiring as early as late 2024.
• Competition: The COPD market continues to evolve with new drug approvals and the expansion of combination therapies. The increasing use of triple therapy (LAMA/LABA/ICS) for patients with frequent exacerbations may shift prescribing patterns away from monotherapy options like INCRUSE ELLIPTA for certain patient segments.
• Market Dynamics: While the patent expiration presents a challenge, INCRUSE ELLIPTA's established brand recognition, demonstrated efficacy, and convenient dosing will likely support its continued use by a segment of the COPD patient population. The availability of generic alternatives may also lead to a bifurcated market, with branded INCRUSE ELLIPTA continuing to serve patients who value brand trust and consistent product quality, while generics capture a share of the cost-sensitive market.
• Geographic Considerations: Market dynamics will vary by region. Developed markets with strong generic price controls and earlier patent expiries will likely see a faster decline in branded sales post-exclusivity. Emerging markets, where generic penetration may be slower, could offer a longer tail for branded INCRUSE ELLIPTA sales.

GSK's strategic focus on simplifying its respiratory portfolio and investing in next-generation respiratory assets may influence its long-term commercial support for INCRUSE ELLIPTA as patent protection wanes. The company may prioritize its newer combination inhalers or pipeline candidates.

Key Takeaways

INCRUSE ELLIPTA has achieved substantial market success in the COPD segment, driven by its efficacy as a LAMA monotherapy and its convenient once-daily dosing. Its U.S. patent protection for the API is set to expire in September 2028, which will likely usher in generic competition and impact future sales. The drug's global sales have peaked and are currently in a declining phase, influenced by the broader market dynamics of respiratory therapeutics, including the shift towards combination therapies and the anticipation of patent expiries. GSK's strategic decisions regarding its respiratory franchise will play a significant role in the drug's long-term commercial trajectory.

Frequently Asked Questions

1. When does the primary U.S. patent for INCRUSE ELLIPTA expire? The primary U.S. composition of matter patent for umeclidinium bromide, U.S. Patent No. 8,022,070, expires on September 20, 2028.

2. What is the indication for INCRUSE ELLIPTA? INCRUSE ELLIPTA is indicated for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

3. What are the main competitors to INCRUSE ELLIPTA in the COPD market? Key competitors include other LAMAs such as SPIRIVA (tiotropium), as well as various LABA monotherapies and, significantly, combination inhalers (LAMA/LABA and LAMA/LABA/ICS) like ANORO ELLIPTA and TRELEGY ELLIPTA, also marketed by GSK.

4. What is the typical dosing regimen for INCRUSE ELLIPTA? INCRUSE ELLIPTA is administered once daily via the Ellipta inhaler.

5. How have recent global events impacted INCRUSE ELLIPTA sales? The COVID-19 pandemic led to a temporary decline in sales due to reduced healthcare interactions. More recently, sales are impacted by patent cliff considerations for other respiratory drugs and increasing competition.

Citations

[1] U.S. Patent and Trademark Office. (2011). U.S. Patent No. 8,022,070. [2] U.S. Patent and Trademark Office. (2016). U.S. Patent No. 9,364,404. [3] World Health Organization. (2021). Chronic obstructive pulmonary disease (COPD). [4] Centers for Disease Control and Prevention. (2022). Chronic Obstructive Pulmonary Disease (COPD) - Data and Statistics. [5] GSK plc. (2016-2023). Annual Reports and Financial Statements.