ANORO ELLIPTA Drug Patent Profile

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

Anoro 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 ANORO ELLIPTA is umeclidinium bromide; vilanterol trifenatate. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the umeclidinium bromide; vilanterol trifenatate profile page.

DrugPatentWatch^® Generic Entry Outlook for Anoro Ellipta

Anoro 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 ANORO ELLIPTA

International Patents:	344
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	47
Patent Applications:	409
Drug Prices:	Drug price information for ANORO ELLIPTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ANORO ELLIPTA
What excipients (inactive ingredients) are in ANORO ELLIPTA?	ANORO ELLIPTA excipients list
DailyMed Link:	ANORO ELLIPTA at DailyMed

See drug prices for ANORO ELLIPTA

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

Constraining patent/regulatory exclusivity:

9,750,726

NDA:

203975

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 ANORO 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 ANORO ELLIPTA clinical trials

Pharmacology for ANORO ELLIPTA

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

US Patents and Regulatory Information for ANORO ELLIPTA

ANORO ELLIPTA is protected by twelve US patents.

This potential generic entry date is based on patent 9,750,726.

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	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	8,309,572
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	8,746,242*PED				Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	9,750,726		Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	9,333,310*PED				Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	7,439,393*PED				Y
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	8,183,257
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013		RX	Yes	Yes	11,090,294

Expired US Patents for ANORO ELLIPTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	8,309,572
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	7,498,440
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	5,873,360
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	7,776,895
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	RE44874
Glaxosmithkline	ANORO ELLIPTA	umeclidinium bromide; vilanterol trifenatate	POWDER;INHALATION	203975-001	Dec 18, 2013	7,361,787

International Patents for ANORO ELLIPTA

When does loss-of-exclusivity occur for ANORO 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 ANORO ELLIPTA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2014204459	COMBINATIONS OF A MUSCARINIC RECEPTOR ANTAGONIST AND A BETA-2 ADRENORECEPTOR AGONIST
Poland	1960021
World Intellectual Property Organization (WIPO)	2005104745
Spain	2524370
Norway	20080474
Japan	2005533583
Norway	20043521

Supplementary Protection Certificates for ANORO ELLIPTA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1740177	C300694	Netherlands		PRODUCT NAME: UMECLIDINIUMBROMIDE; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
1740177	PA2014038	Lithuania		PRODUCT NAME: UMECLIDINIUM BROMIDIUM; REGISTRATION NO/DATE: EU/1/14/922 20140428
1425001	SPC/GB14/034	United Kingdom		PRODUCT NAME: VILANTEROL OR SALTS OR SOLVATES THEREOF (I.E., 4-((1R)-2-((6-(2-((2,6-DICHLOROBENZYL)OXY)ETHOXY)HEXYL)AMINO)-1-HYDROXYETHYL)-2-(HYDROXYMETHYL)PHENOL OR SALTS OR SOLVATES THEREOF); REGISTERED: UK EU/1/13/886/001 20131114; UK EU/1/13/886/002 20131114; UK EU/1/13/886/003 20131114; UK EU/1/13/886/004 20131114; UK EU/1/13/886/005 20131114; UK EU/1/13/886/006 20131114
1425001	1490033-6	Sweden		PRODUCT NAME: VILANTEROL, OCH SALTER OCH SOLVATER DAERAV; REG. NO/DATE: EU/1/13/886 20131113
2506844	132018000000341	Italy		PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
1425001	122014000051	Germany		PRODUCT NAME: VILANTEROL ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/13/886/001-006 20131113
2506844	CA 2018 00023	Denmark		PRODUCT NAME: FARMACEUTISK KOMBINATIONSPRODUKT OMFATTENDE ET FARMACEUTISK ACCEPTABELT SALT AF UMECLIDINIUM (F.EKS. UMECLIDINIUMBROMID), VILANTEROL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF (F.EKS. VILANTEROLTRIFENATAT) OG FLUTICASONFUROAT; REG. NO/DATE: EU/1/17/1236 20171117

Market Dynamics and Financial Trajectory for ANORO ELLIPTA

Introduction

ANORO ELLIPTA, a medication developed by GlaxoSmithKline (GSK) and partnered with Innoviva, is a crucial treatment for chronic obstructive pulmonary disease (COPD). This article delves into the market dynamics and financial trajectory of ANORO ELLIPTA, highlighting key performance metrics, market influences, and future outlook.

Product Overview

ANORO ELLIPTA is a once-daily dual bronchodilator that combines umeclidinium, a long-acting muscarinic antagonist (LAMA), and vilanterol, a long-acting beta2-adrenergic agonist (LABA). It is designed to improve lung function and reduce symptoms in patients with COPD[4].

Market Performance

Global Net Sales

In the fourth quarter of 2022, ANORO ELLIPTA recorded global net sales of $159.8 million, with $82.6 million from the U.S. market and $77.2 million from non-U.S. markets. This reflects a mixed performance, with U.S. sales remaining relatively stable while non-U.S. sales were impacted by foreign exchange rate changes and other market factors[1].

For the third quarter of 2023, global net sales of ANORO ELLIPTA were $175.8 million, with $89.2 million from the U.S. market and $86.6 million from non-U.S. markets. This indicates a slight recovery and growth in both U.S. and non-U.S. markets[5].

Comparative Analysis

Compared to the third quarter of 2021, ANORO ELLIPTA's global net sales decreased by 15% in the third quarter of 2022, primarily due to pricing pressures and foreign currency changes. However, the third quarter of 2023 saw a modest increase, suggesting some stabilization in the market[4][5].

Market Influences

Pricing Pressures

Pricing pressures have been a significant factor affecting the sales of ANORO ELLIPTA. The pharmaceutical industry is highly competitive, and pricing strategies can significantly impact revenue. In the third quarter of 2022, pricing pressures contributed to a 15% decline in global net sales compared to the same period in 2021[4].

Foreign Exchange Rates

Foreign exchange rate fluctuations have also impacted the sales of ANORO ELLIPTA. Changes in exchange rates can affect the revenue generated from non-U.S. markets, as seen in the fourth quarter of 2022 and third quarter of 2023[1][5].

Competitive Landscape

The COPD treatment market is competitive, with several other medications available. The performance of ANORO ELLIPTA is influenced by the presence of other dual and triple therapy inhalers, such as RELVAR/BREO ELLIPTA and TRELEGY ELLIPTA, also developed by GSK[3].

Financial Trajectory

Royalty Revenue

Innoviva, the partner company, receives royalty revenue from the sales of ANORO ELLIPTA. For the third quarter of 2023, Innoviva reported $53.6 million in royalty revenue from ANORO ELLIPTA, which is part of their overall royalty revenue stream[5].

Net Income and Cash Flow

The financial performance of Innoviva is closely tied to the sales of ANORO ELLIPTA. In the third quarter of 2023, Innoviva reported a net income of $82.0 million, which was lower than the third quarter of 2022 due to non-repeated gains from the sale of a subsidiary. The company's cash and cash equivalents totaled $180.0 million as of September 30, 2023[2].

Recent Highlights and Company Progress

Acquisitions and Strategic Moves

Innoviva has been actively expanding its portfolio through strategic acquisitions, such as the acquisition of Entasis and La Jolla, which has given the company a strong footprint in the hospital and infectious disease space. These moves are expected to contribute to future growth and value creation[4].

Share Repurchase Program

Innoviva has also initiated a share repurchase program, reflecting their confidence in the company's prospects and the embedded value within their business. This program is supported by the strength of their balance sheet and cash flows[4].

Future Outlook

Market Growth Potential

Despite current challenges, the COPD treatment market is expected to grow due to increasing prevalence and the need for effective treatments. ANORO ELLIPTA, with its dual bronchodilator mechanism, is well-positioned to capture a significant share of this growing market.

Pipeline Development

GSK and Innoviva continue to focus on pipeline development, including new products and therapies that can complement their existing portfolio. This strategic approach is expected to drive long-term growth and sustainability[3].

Key Takeaways

• Global Sales Performance: ANORO ELLIPTA's global net sales have been influenced by pricing pressures and foreign exchange rate changes, but the third quarter of 2023 showed a slight recovery.
• Market Influences: Pricing and foreign exchange rates are critical factors affecting sales, along with the competitive landscape of COPD treatments.
• Financial Trajectory: Innoviva's royalty revenue and net income are closely tied to ANORO ELLIPTA's sales performance.
• Strategic Moves: Innoviva's acquisitions and share repurchase program indicate a strong strategic focus on growth and value creation.
• Future Outlook: The COPD treatment market's growth potential and ongoing pipeline development are positive indicators for ANORO ELLIPTA's future performance.

FAQs

1. What is ANORO ELLIPTA used for? ANORO ELLIPTA is used for the treatment of chronic obstructive pulmonary disease (COPD).

2. Who are the key partners involved in the development and marketing of ANORO ELLIPTA? ANORO ELLIPTA is developed by GlaxoSmithKline (GSK) and partnered with Innoviva.

3. What were the global net sales of ANORO ELLIPTA in the fourth quarter of 2022? The global net sales of ANORO ELLIPTA in the fourth quarter of 2022 were $159.8 million.

4. How have foreign exchange rates impacted the sales of ANORO ELLIPTA? Foreign exchange rate changes have affected the revenue generated from non-U.S. markets, contributing to fluctuations in global net sales.

5. What strategic moves has Innoviva made to enhance its growth potential? Innoviva has made strategic acquisitions, such as Entasis and La Jolla, and initiated a share repurchase program to enhance its growth potential and create shareholder value.

Sources

1. Innoviva Reports Fourth Quarter 2022 Financial Results and Highlights Recent Company Progress. Innoviva Investor Relations.
2. Innoviva Reports Third Quarter 2023 Financial Results and Highlights Recent Company Progress. Business Wire.
3. Annual Report 2018. GSK.
4. Innoviva Reports Third Quarter 2022 Financial Results and Highlights Recent Company Progress. Business Wire.
5. Innoviva Reports Third Quarter 2023 Financial Results and Highlights Recent Company Progress. Innoviva Investor Relations.