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breo ellipta Drug Patent Profile

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

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

This drug has two hundred and fourteen patent family members in thirty-two 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 2021 were $2.8bn, indicating a strong incentive for generic entry.

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 breo ellipta

International Patents:	214
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	47
Patent Applications:	38
Drug Prices:	Drug price information for breo ellipta
Drug Sales Revenues:	Drug sales revenues for breo ellipta
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for breo ellipta
What excipients (inactive ingredients) are in breo ellipta?	breo ellipta excipients list
DailyMed Link:	breo ellipta at DailyMed

See drug prices for breo ellipta

See drug sales revenues for breo ellipta

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for breo ellipta

Constraining patent/regulatory exclusivity:

11,116,721*PED

NDA:

204275

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.

Recent Clinical Trials for breo ellipta

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Baylor Research Institute	Phase 4
Chiesi Farmaceutici S.p.A.	Phase 4
Luis Puente Maestu	Phase 4

See all breo ellipta clinical trials

Pharmacology for breo ellipta

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for breo ellipta

breo ellipta is protected by seven 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	No	7,439,393*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013		RX	Yes	Yes
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015		RX	Yes	Yes	8,511,304*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	No	11,116,721*PED				Y
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-003	May 12, 2023		RX	Yes	No	8,746,242*PED				Y

Expired US Patents for breo ellipta

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	7,776,895
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015	5,873,360
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	5,873,360
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-002	Apr 30, 2015	6,537,983
Glaxo Grp Ltd	BREO ELLIPTA	fluticasone furoate; vilanterol trifenatate	POWDER;INHALATION	204275-001	May 10, 2013	7,101,866

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

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
Norway	324747
Cyprus	1111614
Poland	207531
Brazil	0113039	Composto ou um seu sal ou solvato fisiologicamente aceitável, uso do mesmo, composição farmacêutica, formulação farmacêutica em aerossol, método para o tratamento de um indivìduo humano ou animal com uma condição antiinflamatória e/ou alérgica, e, processo para preparar um composto
Poland	2400950

Supplementary Protection Certificates for breo ellipta

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1425001	CA 2014 00021	Denmark		PRODUCT NAME: VILANTEROL ELLER ET SALT ELLER SOLVAT DERAF, HERUNDER VILANTEROL TRIFENATAT; REG. NO/DATE: EU/1/13/886/001-006 20131113
1305329	326	Finland
1519731	13C0067	France		PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
1425001	C01425001/02	Switzerland		PRODUCT NAME: VILANTEROL UND FLUTICASON FUROAT; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014
1305329	CA 2008 00022	Denmark

Breo ellipta Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for BREO ELLIPTA

Introduction to BREO ELLIPTA

BREO ELLIPTA, a combination drug containing fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist, is a pivotal treatment for respiratory disorders such as chronic obstructive pulmonary disease (COPD) and asthma. This drug has gained significant traction globally due to its efficacy in reducing inflammation and relaxing the muscles in the airways, thereby improving breathing.

Market Drivers

Growing Prevalence of Respiratory Disorders

The global BREO ELLIPTA drugs market is driven by the increasing prevalence of COPD and asthma. Factors such as an aging population, urbanization, and rising air pollution levels are expected to significantly increase the incidence of these respiratory diseases over the coming years[1][3][5].

Technological Advancements

Advancements in technology and drug delivery systems have played a crucial role in the growth of the BREO ELLIPTA drugs market. The development of inhalers with improved drug delivery and reduced side effects has expanded the reach of BREO ELLIPTA drugs and helped meet the growing demand for these medications[1][3].

Regional Market Dynamics

• North America: This region is currently the largest market for BREO ELLIPTA drugs, driven by a high prevalence of respiratory disorders, well-established healthcare infrastructure, and strong investment in research and development[1][3].
• Europe: Countries such as Germany, France, and the UK are significant markets, driven by a large population base, increasing prevalence of respiratory disorders, and the availability of BREO ELLIPTA drugs through various distribution channels[1][3].
• Asia Pacific: This region is experiencing significant growth due to a large population base, increasing awareness about respiratory disorders, and government initiatives to address these conditions[1][3].

Financial Performance

Revenue and Sales

In the second quarter of 2023, net sales of RELVAR®/BREO® ELLIPTA® by GSK were $363.0 million, with $149.8 million coming from the U.S. market. This indicates a strong revenue stream from the drug, although there was a decrease in royalties compared to the previous year due to the sale of Innoviva's subsidiary, Theravance Respiratory Company, and its TRELEGY® ELLIPTA® royalty stream[2].

Royalty Income

Innoviva reported significant royalty income from BREO ELLIPTA, with $54.4 million in royalties from global net sales in the second quarter of 2023. However, this was lower than the $59.3 million reported in the second quarter of 2022, primarily due to the divestiture of Theravance Respiratory Company[2].

Net Income and Cash Reserves

For the second quarter of 2023, Innoviva's net income was $1.3 million, or $0.02 per basic share, compared to a net income of $0.9 million, or $0.01 per basic share, in the second quarter of 2022. The company also had cash and cash equivalents totaling $173.0 million as of June 30, 2023[2].

Market Segmentation

The BREO ELLIPTA drugs market can be segmented in several ways:

By Indication Type

• COPD
• Asthma
• Cystic Fibrosis
• Chronic Bronchitis
• Others

By Mode of Administration

• Dry Powder Inhaler
• Respimat Soft Mist Inhaler
• Pressurized Metered Dose Inhaler
• Nebulizers
• Others

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies[3].

Growth Projections

The global BREO ELLIPTA drugs market is expected to grow at a CAGR of 4.50% during the forecast period of 2023-2031. This growth is anticipated to be driven by the increasing prevalence of respiratory disorders and the need for innovative and effective treatments. The market is projected to grow by USD 4.16 billion by 2030, reaching a significant market size[1][3][5].

Challenges and Barriers

Despite the positive growth projections, there are significant barriers to accessing BREO ELLIPTA drugs, particularly in low- and middle-income countries. These barriers include limited healthcare infrastructure and resources, which hinder the widespread adoption of the drug. Efforts are underway to address these challenges and improve global access to BREO ELLIPTA[1][3].

Key Takeaways

• The global BREO ELLIPTA drugs market is driven by the growing prevalence of COPD and asthma.
• Technological advancements in drug delivery systems are a key driver of market growth.
• North America and Europe are the largest markets, with significant growth expected in the Asia Pacific region.
• Financial performance is strong, with substantial revenue and royalty income.
• Market segmentation includes indication type, mode of administration, and distribution channels.
• Growth projections indicate a CAGR of 4.50% during the forecast period.
• Challenges in low- and middle-income countries need to be addressed to improve global access.

FAQs

What is BREO ELLIPTA used for?

BREO ELLIPTA is used to treat respiratory disorders such as chronic obstructive pulmonary disease (COPD) and asthma by reducing inflammation and relaxing the muscles in the airways.

What are the key drivers of the BREO ELLIPTA market?

The key drivers include the growing prevalence of COPD and asthma, technological advancements in drug delivery systems, and increasing awareness about the importance of effective treatment for respiratory disorders.

Which regions dominate the BREO ELLIPTA market?

North America and Europe are currently the largest markets for BREO ELLIPTA, with significant growth expected in the Asia Pacific region.

What are the financial projections for the BREO ELLIPTA market?

The market is expected to grow at a CAGR of 4.50% during the forecast period of 2023-2031, with a projected growth of USD 4.16 billion by 2030.

What challenges does the BREO ELLIPTA market face?

The market faces challenges in terms of accessibility, particularly in low- and middle-income countries, where healthcare infrastructure and resources may be limited.

Cited Sources

1. ResearchAndMarkets.com, "BREO Ellipta Drugs Market - Global Forecast Report 2023-2031"
2. Innoviva, "Innoviva Reports Second Quarter 2023 Financial Results and Highlights Recent Company Progress"
3. BusinessWire, "Global BREO Ellipta Drugs Market to Witness Rapid Growth by 2031 Fueled by Growing Chronic Obstructive Pulmonary Disease (COPD) Drugs Market"
4. BioSpace, "Innoviva Reports Fourth Quarter 2022 Financial Results and Highlights Recent Company Progress"
5. 360iResearch, "BREO Ellipta Drugs Market Size & Share 2025-2030"