TRELEGY ELLIPTA Drug Patent Profile

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

Trelegy Ellipta is a drug marketed by Glaxosmithkline and is included in one NDA. There are twelve patents protecting this drug.

This drug has three hundred and forty-four patent family members in fifty-one countries.

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

DrugPatentWatch^® Generic Entry Outlook for Trelegy Ellipta

Trelegy 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 November 29, 2030. 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 TRELEGY ELLIPTA

International Patents:	344
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	4
Drug Prices:	Drug price information for TRELEGY ELLIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRELEGY ELLIPTA
What excipients (inactive ingredients) are in TRELEGY ELLIPTA?	TRELEGY ELLIPTA excipients list
DailyMed Link:	TRELEGY ELLIPTA at DailyMed

See drug prices for TRELEGY ELLIPTA

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

NDA:

209482

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 TRELEGY ELLIPTA

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

Sponsor	Phase
Baylor Research Institute	Phase 4
GlaxoSmithKline	Phase 4

See all TRELEGY ELLIPTA clinical trials

Pharmacology for TRELEGY ELLIPTA

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

US Patents and Regulatory Information for TRELEGY ELLIPTA

TRELEGY ELLIPTA is protected by thirteen 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
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes			Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes					Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes			Y	Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017		RX	Yes	Yes					Y
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020		RX	Yes	Yes					Y

Expired US Patents for TRELEGY ELLIPTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-002	Sep 9, 2020
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017
Glaxosmithkline	TRELEGY ELLIPTA	fluticasone furoate; umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	209482-001	Sep 18, 2017

International Patents for TRELEGY ELLIPTA

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

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Eurasian Patent Organization

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Norway

Peru

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Turkey

Ukraine

United Kingdom

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 TRELEGY ELLIPTA around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	2170359
Australia	2003266390	NOVEL CRYSTALLINE COMPLEXES
South Africa	200401990	Phenethanolamine derivatives for treatment or respiratory diseases.
Australia	2021204302	COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
China	1294141
Japan	2006528500

Supplementary Protection Certificates for TRELEGY ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1425001	C01425001/02	Switzerland		PRODUCT NAME: VILANTEROL UND FLUTICASON FUROAT; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014
1425001	C 2014 016	Romania		PRODUCT NAME: VILANTEROL SAU O SARE SAU SOLVAT AL ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/886/001, EU/1/13/886/002, EU/1/13/886/003, EU/1/13/886/004, EU/1/13/886/005, EU/1/13/886/006; DATE OF NATIONAL AUTHORISATION: 20131113; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/886/001, EU/1/13/886/002, EU/1/13/886/003, EU/1/13/886/004, EU/1/13/886/005, EU/1/13/886/006; DATE OF FIRST AUTHORISATION IN EEA: 20131113
1305329	122008000029	Germany		PRODUCT NAME: FLUTICASONFUROAT UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/07/434/001-003 20080111
1519731	132013902182575	Italy		PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
1740177	208 50012-2014	Slovakia		PRODUCT NAME: UMEKLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001 - EU/1/14/922/003 20140430
1425001	C20140013 00103	Estonia		PRODUCT NAME: VILANTEROOLTRIFENATAAT;REG NO/DATE: K(2013)8089 (LOPLIK) 13.11.2013

Market Dynamics and Financial Trajectory for TRELEGY ELLIPTA

Introduction

TRELEGY ELLIPTA, a triple-combination therapy developed by GlaxoSmithKline (GSK), has been a significant player in the respiratory disease treatment market, particularly for chronic obstructive pulmonary disease (COPD) and asthma. Here, we delve into the market dynamics and financial trajectory of this drug.

Mechanism of Action and Clinical Significance

TRELEGY ELLIPTA combines an inhaled corticosteroid (fluticasone furoate), a long-acting muscarinic antagonist (umeclidinium), and a long-acting beta2-adrenergic agonist (vilanterol) in a single inhaler, administered once daily. This combination has been shown to improve lung function, reduce exacerbations, and enhance the quality of life for patients with moderate to severe COPD and asthma[1].

Market Performance

In 2021, TRELEGY ELLIPTA generated sales of $1.68 billion, representing a 57% increase at constant exchange rates compared to the previous year. This robust growth underscores the drug's effectiveness and its increasing adoption by healthcare providers and patients[1].

Financial Transactions and Partnerships

In July 2022, Royalty Pharma agreed to acquire the royalty interest in TRELEGY ELLIPTA from Theravance and Innoviva for $1.31 billion, with potential milestones of up to $300 million. This transaction highlights the drug's financial potential and its strategic importance in the respiratory therapy market. The deal also includes an estimated net present value (NPV) of approximately $200 million for rights to outer-year royalties[1][3].

Impact on Royalty Pharma

The acquisition of TRELEGY ELLIPTA royalties is expected to significantly contribute to Royalty Pharma's long-term Adjusted Cash Receipts growth. This transaction further diversifies Royalty Pharma’s portfolio with a premier, blockbuster therapy, aligning with their strategy to invest in high-value, market-leading assets[1].

GSK's Financial Performance

GSK's financial performance has been positively impacted by the success of TRELEGY ELLIPTA. In 2022, GSK reported total operating profit of £6,433 million, up from £4,357 million in 2021, partly due to the strong sales growth of TRELEGY ELLIPTA. The adjusted operating profit was £8,151 million, a 26% increase at actual exchange rates compared to the previous year[2].

Market Forecast

The market forecast for TRELEGY ELLIPTA is promising, with the drug expected to continue its strong performance. A market report predicts comprehensive growth in the seven major markets (the United States, EU4, the United Kingdom, and Japan) from 2024 to 2032. The report provides detailed insights into the mechanism of action, dosage, administration, and future market assessments, including forecasted sales data[4].

Competitive Landscape

TRELEGY ELLIPTA operates in a competitive respiratory disease treatment market, but its unique triple-combination therapy sets it apart. The drug has been shown to offer superior benefits in terms of symptom control and exacerbation reduction compared to other treatments. This competitive edge is crucial in maintaining market share and driving future growth[4].

Regulatory and Developmental Activities

TRELEGY ELLIPTA has undergone extensive clinical trials and has received regulatory approvals in various regions. The drug is not authorized for the treatment of asthma in the European Union, but it continues to be a significant player in the global respiratory market. Ongoing research and development activities, including regulatory milestones, are expected to further solidify its market position[4].

Financial Contributions to Partners

The sale of TRELEGY ELLIPTA royalty interests has provided significant financial benefits to Theravance and Innoviva. Theravance Biopharma received approximately $1.1 billion in upfront cash, with potential sales-based milestone payments of up to $250 million. This transaction also includes an investment by Royalty Pharma of up to $40 million to advance the development of ampreloxetine in multiple system atrophy (MSA)[3].

Investor and Market Reaction

The financial community has reacted positively to the transactions and performance of TRELEGY ELLIPTA. The acquisition by Royalty Pharma and the strong sales figures have been seen as indicators of the drug's long-term value and growth potential. This positive sentiment is reflected in the financial reports and market analyses of the companies involved[1][2][3].

Conclusion

TRELEGY ELLIPTA has established itself as a leading therapy in the respiratory disease market, driven by its clinical efficacy and strong market performance. The financial transactions involving the drug's royalties highlight its significant value and growth potential. As the market continues to evolve, TRELEGY ELLIPTA is poised to remain a key player, contributing substantially to the financial trajectories of GSK, Royalty Pharma, Theravance, and Innoviva.

Key Takeaways

• Strong Sales Growth: TRELEGY ELLIPTA generated $1.68 billion in sales in 2021, with a 57% increase at constant exchange rates.
• Financial Transactions: Royalty Pharma acquired the royalty interest for $1.31 billion, with potential milestones of up to $300 million.
• Market Forecast: The drug is expected to continue its strong performance from 2024 to 2032 in major markets.
• Competitive Edge: TRELEGY ELLIPTA's unique triple-combination therapy sets it apart in the respiratory disease treatment market.
• Regulatory and Developmental Activities: Ongoing clinical trials and regulatory approvals continue to support its market position.

FAQs

Q: What is the mechanism of action of TRELEGY ELLIPTA? A: TRELEGY ELLIPTA combines an inhaled corticosteroid (fluticasone furoate), a long-acting muscarinic antagonist (umeclidinium), and a long-acting beta2-adrenergic agonist (vilanterol) in a single inhaler.

Q: How much did TRELEGY ELLIPTA generate in sales in 2021? A: TRELEGY ELLIPTA generated $1.68 billion in sales in 2021, representing a 57% increase at constant exchange rates.

Q: Who acquired the royalty interest in TRELEGY ELLIPTA and for how much? A: Royalty Pharma acquired the royalty interest in TRELEGY ELLIPTA from Theravance and Innoviva for $1.31 billion, with potential milestones of up to $300 million.

Q: What is the forecasted market performance of TRELEGY ELLIPTA from 2024 to 2032? A: The drug is expected to continue its strong performance in the seven major markets, with detailed forecasted sales data provided in market reports.

Q: How does TRELEGY ELLIPTA differentiate itself in the respiratory disease treatment market? A: TRELEGY ELLIPTA's unique triple-combination therapy sets it apart, offering superior benefits in terms of symptom control and exacerbation reduction compared to other treatments.

Sources

1. Royalty Pharma Agrees to Acquire Royalty Interest in Trelegy Ellipta From Theravance and Innoviva for $1.31 Billion and Potential Milestones of $300 Million - Royalty Pharma.
2. Press release - Full-year and fourth quarter 2022 - GSK.
3. Theravance Biopharma to Sell TRELEGY ELLIPTA Royalty Interests to Royalty Pharma for Approximately $1.1 Billion in Upfront Cash with Over $1.5 Billion in Potential Total Value - Theravance Biopharma.
4. TRELEGY ELLIPTA Market Size, Forecast, and Market Insight - 2032 - GII Research.