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AIRDUO RESPICLICK Drug Patent Profile

Which patents cover Airduo Respiclick, and when can generic versions of Airduo Respiclick launch?

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

This drug has three hundred and fifty-one patent family members in thirty-seven countries.

The generic ingredient in AIRDUO RESPICLICK is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Airduo Respiclick

A generic version of AIRDUO RESPICLICK was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17^th, 2020.

Summary for AIRDUO RESPICLICK

International Patents:	351
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	8
Patent Applications:	63
Drug Prices:	Drug price information for AIRDUO RESPICLICK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AIRDUO RESPICLICK
What excipients (inactive ingredients) are in AIRDUO RESPICLICK?	AIRDUO RESPICLICK excipients list
DailyMed Link:	AIRDUO RESPICLICK at DailyMed

See drug prices for AIRDUO RESPICLICK

Pharmacology for AIRDUO RESPICLICK

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

US Patents and Regulatory Information for AIRDUO RESPICLICK

AIRDUO RESPICLICK is protected by sixteen US patents and two 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	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017		RX	Yes	Yes					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	No					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017		RX	Yes	Yes					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	No					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	No					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	No					Y

Expired US Patents for AIRDUO RESPICLICK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017

EU/EMA Drug Approvals for AIRDUO RESPICLICK

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Airexar Spiromax	salmeterol xinafoate, fluticasone propionate	EMEA/H/C/004267 Airexar Spiromax is indicated for use in adults aged 18 years and older only.AsthmaAirexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.Chronic Obstructive Pulmonary Disease (COPD)Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1	Withdrawn	no	no	no	2016-08-18

International Patents for AIRDUO RESPICLICK

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	4169557	INHALATEURS ET ADAPTATEURS D'ÉCOULEMENT D'AIR POUR CEUX-CI (INHALERS AND AIRFLOW ADAPTORS THEREFOR)
European Patent Office	2987523	COMPTEURS DE DOSES POUR INHALATEURS (DOSE COUNTERS FOR INHALERS)
Israel	223116
China	110177592	吸入器和用于吸入器的气流适配器 (INHALERS AND AIRFLOW ADAPTORS THEREFOR)
Portugal	3568181
Hungary	E055042

Supplementary Protection Certificates for AIRDUO RESPICLICK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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
2506844	18C1022	France		PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117
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
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

AIRDUO RESPICLICK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AirDuo RespiClick

Introduction

AirDuo RespiClick, a fixed-dose combination asthma therapy containing fluticasone propionate and salmeterol, was launched by Teva Pharmaceutical Industries Ltd. in April 2017. This product, along with its authorized generic, marked a significant milestone in the respiratory market by offering a more affordable alternative to existing treatments.

Market Need and Launch Strategy

The launch of AirDuo RespiClick and its authorized generic was driven by the need for more affordable asthma treatment options in the U.S. market. Teva's strategy involved launching both the branded and generic versions simultaneously to address this need and to compete effectively in the highly competitive asthma combination controller market[1][3].

Product Features and Benefits

AirDuo RespiClick is distinguished by its use of the RespiClick device, which is breath-activated and does not require hand-breath coordination, making it easier to use, especially for younger and older patients. The device also features a dose counter and is designed to deliver lower doses of salmeterol and fluticasone, potentially minimizing side effects[1][3].

Pricing Strategy

Teva priced AirDuo RespiClick on par with other branded LABA/ICS combination products, approximately $300 for all doses, while the authorized generic was launched at a substantial discount, around $95 per package for all doses. This pricing strategy aimed to capitalize on the demand for affordable treatments while also generating revenue from the branded product[3].

Market Reception and Adoption

Initially, the market reception was mixed, with low awareness among pulmonologists and limited formulary coverage. However, over time, the generic version gained traction, particularly among patients who faced high out-of-pocket costs for branded LABA/ICS combination products. By one year post-launch, many pulmonologists reported using the generic product, especially for new patients starting LABA/ICS combination treatment[3].

Competitive Landscape

The respiratory market, particularly for LABA/ICS combination products, is highly competitive. The launch of AirDuo RespiClick and its generic coincided with other manufacturers' efforts to maintain their market share. For example, GSK introduced Breo, a once-daily LABA/ICS FDC agent, to compete with potential generics of Advair[3].

Financial Performance

Teva's financial performance related to AirDuo RespiClick has been influenced by several factors, including the competitive landscape and the pricing strategy. While the exact financial figures for AirDuo RespiClick are not isolated in Teva's reports, the company's overall respiratory segment has shown mixed results. In the third quarter of 2020, Teva reported a flat profit from its North America segment, partly due to lower revenues offset by a change in product mix[2].

Revenue and Market Share

As of February 2018, AirDuo RespiClick and its generic accounted for only about 1% of all LABA/ICS FDC prescriptions filled, while the branded market was dominated by other products like Advair. However, the launch of the generic helped open generic tiers in managed care organization (MCO) formularies, making the treatment more accessible and potentially increasing sales[3].

Expansion of the RespiClick Family

To further boost sales, Teva expanded the RespiClick family by launching other products, such as ArmonAir RespiClick, a branded-generic fluticasone product. This strategy aimed to offer a seamless transition between different drug classes and enhance the overall sales potential of the RespiClick portfolio[3].

Global Market Trends

The global inhalation and nasal spray generic drugs market, particularly for asthma, is driven by factors such as environmental pollutants, airborne allergens, and respiratory infections. The combination inhaler segment, which includes products like AirDuo RespiClick, dominates the market due to reduced side effects, lower costs, better compliance, and improved efficacy[4].

Geographical Performance

North America and Europe are the leading regions in the global market for inhalation and nasal spray generic drugs, driven by increasing incidence of asthma and COPD, as well as government-sponsored public awareness programs. The Asia Pacific region is expected to grow at the fastest rate due to a large target population and government support for healthcare[4].

Digital Innovation

Teva has also innovated in the digital space by launching digital inhalers such as AirDuo Digihaler and ArmonAir Digihaler. These products, part of the DigiHaler portfolio, are the first and only family of digital inhalers with built-in sensors available to patients. This innovation is expected to enhance patient compliance and outcomes[2].

Key Takeaways

• Affordability: AirDuo RespiClick and its generic offer a more affordable alternative to existing LABA/ICS combination products.
• Innovative Device: The RespiClick device is user-friendly and minimizes side effects.
• Competitive Strategy: Simultaneous launch of branded and generic versions to capture market share.
• Market Reception: Gradual adoption by pulmonologists and patients, especially those with high out-of-pocket costs.
• Global Trends: Growing demand driven by environmental factors and government initiatives.
• Digital Innovation: Integration of digital technology to enhance patient compliance and outcomes.

FAQs

What is AirDuo RespiClick?

AirDuo RespiClick is a fixed-dose combination asthma therapy containing fluticasone propionate and salmeterol, launched by Teva Pharmaceutical Industries Ltd.

What is unique about the RespiClick device?

The RespiClick device is breath-activated, does not require hand-breath coordination, and features a dose counter, making it easier to use and potentially minimizing side effects.

How was AirDuo RespiClick priced compared to its generic?

AirDuo RespiClick was priced on par with other branded LABA/ICS combination products (around $300), while the authorized generic was launched at a substantial discount (around $95).

How has the market received AirDuo RespiClick and its generic?

Initially, there was low awareness and limited formulary coverage, but over time, the generic gained traction, especially among patients with high out-of-pocket costs.

What is the competitive landscape for LABA/ICS combination products?

The market is highly competitive, with other manufacturers introducing new products to maintain their market share, such as GSK's Breo.

How has Teva innovated in the digital space with AirDuo RespiClick?

Teva has launched digital inhalers like AirDuo Digihaler with built-in sensors to enhance patient compliance and outcomes.

Sources

1. Teva Pharmaceutical Industries Ltd. - "Teva Launches AirDuo™ RespiClick® and its Authorized Generic."
2. Teva Pharmaceutical Industries Ltd. - "Teva Reports Third Quarter 2020 Financial Results."
3. Pharmaceutical Online - "Teva's Unorthodox Strategy For The Respiratory Market — Will It Work."
4. iHealthcareAnalyst - "Global Inhalation and Nasal Spray Drugs Market $65.3 Billion by 2031."