ARMONAIR RESPICLICK Drug Patent Profile

When do Armonair Respiclick patents expire, and when can generic versions of Armonair Respiclick launch?

Armonair Respiclick is a drug marketed by Teva Pharm and is included in one NDA. There are thirteen patents protecting this drug.

This drug has three hundred and three patent family members in thirty-two countries.

The generic ingredient in ARMONAIR RESPICLICK is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Armonair Respiclick

A generic version of ARMONAIR RESPICLICK was approved as fluticasone propionate by FOUGERA PHARMS on May 14^th, 2004.

Summary for ARMONAIR RESPICLICK

International Patents:	303
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Patent Applications:	5,455
Drug Prices:	Drug price information for ARMONAIR RESPICLICK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARMONAIR RESPICLICK
DailyMed Link:	ARMONAIR RESPICLICK at DailyMed

See drug prices for ARMONAIR RESPICLICK

Pharmacology for ARMONAIR RESPICLICK

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for ARMONAIR RESPICLICK

ARMONAIR RESPICLICK is protected by thirteen US patents and three FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017		DISCN	Yes	No	11,969,544*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017		DISCN	Yes	No	9,216,260*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017		DISCN	Yes	No	10,022,510*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017		DISCN	Yes	No	9,463,288*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017		DISCN	Yes	No	9,731,087*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017		DISCN	Yes	No	10,765,820*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-001	Jan 27, 2017		DISCN	Yes	No	10,561,808*PED				Y

Expired US Patents for ARMONAIR RESPICLICK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017	6,871,646
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017	6,748,947
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-001	Jan 27, 2017	6,446,627
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017	6,748,947
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017	6,718,972
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017	6,446,627
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017	6,701,917

International Patents for ARMONAIR RESPICLICK

See the table below for patents covering ARMONAIR RESPICLICK around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2007289716	MEDICAMENT INHALER
Eurasian Patent Organization	201991706	ИНГАЛЯТОРЫ И АДАПТЕРЫ ВОЗДУШНОГО ПОТОКА ДЛЯ ИНГАЛЯТОРОВ
Denmark	1667627
Spain	2544278
Spain	2529229
European Patent Office	2514462
Taiwan	I224511

Supplementary Protection Certificates for ARMONAIR RESPICLICK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1305329	SPC/GB08/026	United Kingdom		PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
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
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
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
2506844	LUC00077	Luxembourg		PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117

ARMONAIR RESPICLICK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ARMONAIR RESPICLICK

Introduction

ARMONAIR RESPICLICK, a multidose, inhalation-driven, dry powder inhaler containing fluticasone propionate, is a significant player in the respiratory inhalers market. This article delves into the market dynamics and financial trajectory of ARMONAIR RESPICLICK, highlighting key factors influencing its growth and performance.

Market Context: Respiratory Inhalers

The global respiratory inhalers market is projected to grow at a CAGR of 5.7% from 2022 to 2028, reaching $43.44 billion by 2028. This growth is driven by several factors, including the increasing prevalence of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD), technological advancements, and rising healthcare expenditure[1].

Product Overview: ARMONAIR RESPICLICK

ARMONAIR RESPICLICK is indicated for the maintenance treatment of asthma and is available in three strengths: 55 mcg, 113 mcg, and 232 mcg of fluticasone propionate per actuation. It is designed for oral inhalation and features a dose counter to help patients track their medication usage[4].

Market Drivers

Increasing Prevalence of Respiratory Diseases

The rising incidence of asthma and COPD is a significant driver for the demand of respiratory inhalers like ARMONAIR RESPICLICK. According to the World Health Organization, an estimated 334 million people worldwide suffer from asthma, contributing to the growing need for effective inhaler treatments[1].

Technological Advancements

The integration of advanced technologies, such as smart inhalers and connected platforms, is enhancing the appeal of respiratory inhalers. For instance, the FDA clearance for Propeller Health's connected platform to be used with AstraZeneca’s Symbicort highlights the trend towards digitized treatment management, which could benefit products like ARMONAIR RESPICLICK[1].

Growing Demand for Portable Inhalers

The convenience and portability of inhalers like ARMONAIR RESPICLICK are increasingly appealing to patients. The demand for portable and user-friendly inhalers is expected to continue, driven by advancements in compact and portable inhaler technologies[1].

Financial Performance of Key Players

Companies like Teva Pharmaceutical Industries Ltd., which could be associated with the distribution or development of similar respiratory products, provide insights into the financial dynamics of the market.

Teva Pharmaceutical Industries Ltd.

In the third quarter of 2020, Teva reported revenues of $3,978 million, a decrease of 3% compared to the previous year. However, the gross profit margin increased to 46.6%, primarily due to operational cost efficiencies and network optimization. This indicates that while overall revenues may fluctuate, companies in the respiratory inhalers market can maintain profitability through efficient operations and product mix adjustments[2].

Competitive Landscape

The respiratory inhalers market is highly competitive, with several major players including AstraZeneca Plc, Beximco Pharmaceuticals Ltd., Boehringer Ingelheim International GmbH, Cipla Ltd., GSK Plc, and others. ARMONAIR RESPICLICK competes in this landscape by offering a reliable and effective treatment option for asthma management[1].

Regulatory and Approval Environment

ARMONAIR RESPICLICK has received necessary regulatory approvals, including its initial U.S. approval in 1994 and subsequent updates. The FDA's approval process and post-marketing surveillance ensure that the product meets stringent safety and efficacy standards, which is crucial for maintaining market trust and compliance[4].

Product Development and Innovations

The continuous development and approval of new inhaler technologies are critical for market growth. For example, the FDA approval of the CapMedic smart inhaler cap in January 2020 demonstrates the industry's focus on innovative solutions that enhance patient compliance and treatment outcomes. Such innovations can drive the adoption of products like ARMONAIR RESPICLICK by offering additional features and benefits[1].

Challenges and Risks

Adverse Effects and Contraindications

ARMONAIR RESPICLICK, like other corticosteroid inhalers, comes with potential risks such as adrenal suppression, decreases in bone mineral density, and the need for careful monitoring of patients, especially those transitioning from systemic corticosteroids. These factors must be managed carefully to ensure patient safety and maintain market confidence[4].

Market Competition

The competitive nature of the respiratory inhalers market means that ARMONAIR RESPICLICK must differentiate itself through its efficacy, safety profile, and user-friendly design to attract and retain patients.

Financial Trajectory

Given the overall growth trends in the respiratory inhalers market and the specific strengths of ARMONAIR RESPICLICK, the financial trajectory for this product is likely positive.

• Revenue Growth: As the demand for respiratory inhalers increases, driven by the factors mentioned above, ARMONAIR RESPICLICK is expected to contribute significantly to the revenue growth of its manufacturers and distributors.
• Market Share: With its established presence and ongoing innovations, ARMONAIR RESPICLICK is poised to maintain or increase its market share within the respiratory inhalers segment.
• Profitability: The product's profitability will be influenced by factors such as production costs, pricing strategies, and the overall efficiency of the company's operations.

Key Takeaways

• The global respiratory inhalers market is growing, driven by increasing prevalence of respiratory diseases, technological advancements, and rising healthcare expenditure.
• ARMONAIR RESPICLICK benefits from these market drivers due to its effectiveness and user-friendly design.
• The product faces competition from other major players in the market but can differentiate itself through its features and regulatory approvals.
• Managing potential risks and adverse effects is crucial for maintaining market confidence.
• The financial trajectory for ARMONAIR RESPICLICK is expected to be positive, aligned with the overall growth trends in the respiratory inhalers market.

FAQs

What is ARMONAIR RESPICLICK used for?

ARMONAIR RESPICLICK is used for the maintenance treatment of asthma. It is available in three strengths: 55 mcg, 113 mcg, and 232 mcg of fluticasone propionate per actuation[4].

What are the key drivers of the respiratory inhalers market?

The key drivers include the increasing prevalence of respiratory diseases, technological advancements, rising geriatric population, and increasing healthcare expenditure[1].

How does ARMONAIR RESPICLICK compare to other inhalers in terms of technology?

ARMONAIR RESPICLICK features a dose counter and is designed for ease of use, aligning with the trend towards more user-friendly and technologically advanced inhalers[4].

What are the potential risks associated with ARMONAIR RESPICLICK?

Potential risks include adrenal suppression, decreases in bone mineral density, and the need for careful monitoring of patients, especially those transitioning from systemic corticosteroids[4].

How is the competitive landscape for respiratory inhalers?

The market is highly competitive with several major players, but ARMONAIR RESPICLICK can differentiate itself through its efficacy, safety profile, and user-friendly design[1].

Sources

1. The Insight Partners, "Respiratory Inhalers Market Size Report, Share, Trends, Growth and Revenue Forecast to 2028 - COVID-19 Impact and Global Analysis By Product Type, and Disease Indication"[1].
2. Teva Pharmaceutical Industries Ltd., "Teva Reports Third Quarter 2020 Financial Results"[2].
3. FDA, "ARMONAIR RESPICLICK - fluticasone propionate inhalation powder"[3].
4. Drugs.com, "ArmonAir Respiclick: Package Insert / Prescribing Info"[4].
5. FDA, "208798Orig1s000 - ARMONAIR RESPICLICK (fluticasone propionate) inhalation powder"[5].