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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 are seven patents protecting this drug.

This drug has one hundred and eight patent family members in thirty-seven 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 two 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:	108
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Patent Applications:	289
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

Constraining patent/regulatory exclusivity:

7,488,827

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 seven US patents.

This potential generic entry date is based on patent 7,488,827.

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	8,183,257
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes	8,201,556		Y
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes	9,333,310		Y
Glaxo Grp England	INCRUSE ELLIPTA	umeclidinium bromide	POWDER;INHALATION	205382-001	Apr 30, 2014		RX	Yes	Yes	8,309,572

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	5,873,360

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/002809 Indicated 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
South Africa	200800693	MEDICAMENT DISPENSER
Hong Kong	1102423	MUSCARINIC ACETYLCHOLINE RECEPTOR ANTAGONISTS
Mexico	2007001956	ABASTECEDOR DE MEDICAMENTOS. (MEDICAMENT DISPENSER.)
South Africa	200509978	Medicament dispenser

Supplementary Protection Certificates for INCRUSE ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	CR 2014 00052	Denmark		PRODUCT NAME: UMECLIDINIUMBROMID; REG. NO/DATE: EU/1/14/922/001-003 20140430
1740177	122014000096	Germany		PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
1740177	92565	Luxembourg		PRODUCT NAME: BROMURE D'UMECLIDINUM; FIRST REGISTRATION DATE: 20140428
2506844	2018C/022	Belgium		PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117

INCRUSE ELLIPTA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Incruse Ellipta

Overview of Incruse Ellipta

Incruse Ellipta, developed by GlaxoSmithKline (GSK), is a long-acting muscarinic antagonist (LAMA) indicated for the long-term, once-daily maintenance bronchodilator treatment of chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis[3].

Market Positioning

Competitive Landscape

In the COPD therapeutics market, Incruse Ellipta competes with other LAMAs such as Boehringer’s Spiriva, AstraZeneca’s Brimica Genuair and Eklira Genuair, and Novartis’s Utibron Neohaler and Seebri Neohaler. Despite this competition, Incruse Ellipta is poised to gain market share due to its efficacy and once-daily dosing regimen[1].

Market Share and Growth

The global market for asthma and COPD therapeutics is expected to reach $44.1 billion by 2031, growing at a CAGR of 7.3%. Within this market, new products like Incruse Ellipta are expected to heighten competition but also drive growth. The drug is anticipated to capture a significant market share, especially as other products like GSK’s Advair face declining sales due to patent expiry and negative publicity[1].

Financial Performance

Revenue and Sales

Incruse Ellipta has been a contributor to GSK's revenue growth in the General Medicines segment. For instance, GSK's General Medicines segment, which includes Incruse Ellipta, saw sales of £10.1 billion in 2022, with a growth rate of 5% at actual exchange rates (AER) and 1% at constant exchange rates (CER)[2].

Cost-Effectiveness

Pharmacoeconomic analyses have shown that Incruse Ellipta is associated with cost savings compared to other LAMAs. A study by the Common Drug Review indicated that the use of Incruse Ellipta could result in significant cost savings over a five-year period, particularly if it captures a larger market share[3].

Patent and Exclusivity

Patent Expiry

Incruse Ellipta's patent is set to expire in 2029, which could impact its market share and revenue. However, until then, it is expected to remain a major player in the COPD market. The patent expiry will also open up opportunities for generic versions, which could further alter the market dynamics[1].

Clinical and Economic Benefits

Efficacy and Safety

Incruse Ellipta has demonstrated efficacy in improving lung function and reducing symptoms in patients with COPD. Its once-daily dosing regimen enhances patient compliance, which is a significant clinical benefit. The drug has also shown a favorable safety profile, which is crucial for long-term treatment[3].

Economic Impact

The cost-effectiveness of Incruse Ellipta is a key factor in its adoption. Studies have shown that it can reduce the annual cost of treatment compared to other LAMAs, making it an attractive option for healthcare systems and payers[3].

Market Trends and Future Outlook

Increasing Demand for COPD Therapeutics

The global COPD therapeutics market is driven by an increasing prevalence of COPD, improved diagnostic techniques, and the introduction of new treatments. Incruse Ellipta is well-positioned to benefit from these trends, especially as it continues to demonstrate its efficacy and cost-effectiveness[1].

Competitive Strategies

GSK is investing in research and development and launching new products to maintain its market position. The company's broad-based performance, including the success of Incruse Ellipta, supports strong growth in operating profit and earnings per share[2].

Regulatory Environment

Approval and Listings

Incruse Ellipta has been approved for use in various countries and is listed on several national formularies. The drug's inclusion in these formularies is based on its clinical and economic benefits, which are continuously evaluated by regulatory bodies[3].

Key Takeaways

• Market Growth: Incruse Ellipta is expected to contribute to the growth of the global COPD therapeutics market, which is projected to reach $44.1 billion by 2031.
• Competitive Advantage: The drug's once-daily dosing regimen and cost-effectiveness give it a competitive edge in the market.
• Financial Performance: Incruse Ellipta has been a revenue contributor to GSK's General Medicines segment, with potential for continued growth.
• Patent and Exclusivity: The drug's patent expiry in 2029 will impact its market share, but it remains a significant player until then.
• Clinical and Economic Benefits: Incruse Ellipta offers improved lung function, reduced symptoms, and cost savings, making it a favorable option for patients and healthcare systems.

FAQs

What is Incruse Ellipta used for?

Incruse Ellipta is used for the long-term, once-daily maintenance bronchodilator treatment of chronic obstructive pulmonary disease (COPD), including emphysema and chronic bronchitis[3].

How does Incruse Ellipta compare to other LAMAs in terms of cost?

Incruse Ellipta is associated with cost savings compared to other LAMAs, making it a cost-effective option for the treatment of COPD[3].

What is the patent status of Incruse Ellipta?

The patent for Incruse Ellipta is set to expire in 2029, which could impact its market share and revenue[1].

How has Incruse Ellipta contributed to GSK's financial performance?

Incruse Ellipta has contributed to the revenue growth in GSK's General Medicines segment, supporting strong growth in operating profit and earnings per share[2].

What are the clinical benefits of Incruse Ellipta?

Incruse Ellipta improves lung function, reduces symptoms, and enhances patient compliance due to its once-daily dosing regimen[3].

Sources

1. Global Asthma and COPD Therapeutics Market: iHealthcareAnalyst, March 19, 2024.
2. Full-year and fourth quarter 2022 results announcement: GSK, February 1, 2023.
3. CDR Pharmaceconomic Review Report for Incruse Ellipta: Common Drug Review, January 1, 2018.
4. Net Present Value Model: Incruse Ellipta: GlobalData, November 24, 2022.
5. Q4 2023 Announcement: GSK, January 31, 2024.