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AIRDUO DIGIHALER Drug Patent Profile

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

Airduo Digihaler is a drug marketed by Teva Pharm and is included in one NDA. There are twenty-eight patents protecting this drug.

This drug has four hundred and eighty-seven patent family members in thirty-seven countries.

The generic ingredient in AIRDUO DIGIHALER 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 Digihaler

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

Summary for AIRDUO DIGIHALER

International Patents:	487
US Patents:	28
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Drug Prices:	Drug price information for AIRDUO DIGIHALER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AIRDUO DIGIHALER
What excipients (inactive ingredients) are in AIRDUO DIGIHALER?	AIRDUO DIGIHALER excipients list
DailyMed Link:	AIRDUO DIGIHALER at DailyMed

See drug prices for AIRDUO DIGIHALER

Pharmacology for AIRDUO DIGIHALER

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

US Patents and Regulatory Information for AIRDUO DIGIHALER

AIRDUO DIGIHALER is protected by twenty-eight 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 DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019		DISCN	Yes	No					Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		DISCN	Yes	No					Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		DISCN	Yes	No			Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		DISCN	Yes	No					Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019		DISCN	Yes	No			Y

Expired US Patents for AIRDUO DIGIHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-006	Jul 12, 2019
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019

EU/EMA Drug Approvals for AIRDUO DIGIHALER

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 DIGIHALER

See the table below for patents covering AIRDUO DIGIHALER 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

Supplementary Protection Certificates for AIRDUO DIGIHALER

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

AIRDUO DIGIHALER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for AirDuo Digihaler

Introduction

The AirDuo Digihaler, a digital maintenance inhaler developed by Teva Pharmaceutical Industries Ltd., has been a significant player in the global digital dose inhaler market. This article delves into the market dynamics and financial trajectory of this innovative drug.

Market Overview

The global digital dose inhaler market is projected to experience substantial growth, driven by the increasing prevalence of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). The market is estimated to grow from USD 18.33 billion in 2024 to USD 64.33 billion by 2031, with a compound annual growth rate (CAGR) of 19.6%[4].

Dominance of North America

North America, particularly the United States, dominates the digital dose inhaler market. This dominance is attributed to the high prevalence of respiratory conditions, advanced healthcare infrastructure, and significant healthcare expenditure. For instance, in 2020, 7.8% of the U.S. population had prevalent asthma, with higher rates among females (9.5%) compared to males (6.1%)[1].

Product Launch and Impact

The launch of AirDuo Digihaler in September 2020 marked a significant milestone. This digital inhaler is a prescription medicine used to prevent wheezing and control asthma symptoms in people 12 years and older. It is part of Teva's DigiHaler portfolio, the first and only family of digital inhalers with built-in sensors available to patients[3][4].

Key Features and Benefits

AirDuo Digihaler incorporates advanced features such as dose counters, humidity controls, and integrated sensors. These features enhance patient compliance and allow for remote monitoring through integration with mobile applications, improving health outcomes. The ability to track dosages and receive reminders has been particularly beneficial in managing chronic respiratory conditions[4].

Financial Performance

The launch of AirDuo Digihaler has contributed to Teva's financial performance. During the third quarter of 2020, Teva reported strong performance from its key growth drivers, including the DigiHaler portfolio. Although the company faced a decrease in revenues from generics and other products due to the COVID-19 pandemic, the launch of digital inhalers like AirDuo Digihaler helped maintain profitability[2][5].

Market Growth Drivers

Several factors are driving the growth of the digital dose inhaler market, including:

• Increasing Prevalence of Respiratory Diseases: The rising number of patients with asthma and COPD is a significant driver. For example, around 14.8 million adults in the U.S. suffered from COPD in 2020, and 25 million had asthma[3].
• Advancements in Technology: The integration of digital technologies such as sensors and mobile applications enhances patient care and compliance.
• Government Approvals and Regulations: Favorable regulations and new product approvals in regions like North America support market growth.
• Healthcare Expenditure: High healthcare spending in the U.S. and other developed countries contributes to the market's expansion[1][3][4].

Competitive Landscape

The digital dose inhaler market is highly competitive, with key players such as GlaxoSmithKline, AstraZeneca, Pfizer Inc., and Teva Pharmaceutical Industries Ltd. These companies are adopting various growth strategies, including product launches, technological advancements, and collaborations. Teva's DigiHaler portfolio, including AirDuo Digihaler, has positioned the company as a leader in this segment[3][4].

Regional Growth

While North America dominates the market, the Asia Pacific region is poised to be the fastest-growing market. Increasing healthcare expenditure and improving access to healthcare systems in emerging countries like India and China are driving demand for digital dose inhalers. Local manufacturing and partnerships between international and domestic pharmaceutical firms are also boosting growth in this region[4].

Challenges

Despite the positive outlook, the market faces challenges such as:

• Lack of Awareness: Limited awareness about digital dose inhalers can hinder adoption.
• High Costs: The higher cost of these devices compared to traditional inhalers may deter some patients and healthcare providers[4].

Telehealth and Remote Monitoring

The integration of digital dose inhalers with telehealth services is expected to contribute significantly to market growth. Remote monitoring capabilities enable healthcare providers to track patient adherence and health outcomes more effectively, leading to better disease management[4].

Key Takeaways

• The AirDuo Digihaler is part of a growing digital dose inhaler market driven by increasing respiratory disease prevalence and technological advancements.
• North America, particularly the U.S., is the dominant region due to high healthcare spending and advanced infrastructure.
• The device's advanced features, such as built-in sensors and mobile app integration, enhance patient compliance and health outcomes.
• Despite challenges like high costs and lack of awareness, the market is expected to grow significantly over the forecast period.

FAQs

Q: What is the AirDuo Digihaler used for? A: The AirDuo Digihaler is a prescription medicine used to prevent wheezing and control asthma symptoms in people 12 years and older.

Q: Who launched the AirDuo Digihaler? A: The AirDuo Digihaler was launched by Teva Pharmaceutical Industries Ltd. in September 2020.

Q: What are the key features of the AirDuo Digihaler? A: The key features include dose counters, humidity controls, and integrated sensors that allow for remote monitoring through mobile applications.

Q: Why is North America the dominant region for digital dose inhalers? A: North America dominates due to its large population, excellent medical infrastructure, and high healthcare spending.

Q: What are the challenges facing the digital dose inhaler market? A: The market faces challenges such as lack of awareness and the high costs of these devices compared to traditional inhalers.

Sources

1. Mordor Intelligence: Global Digital Dose Inhaler Market Trends.
2. Teva Pharmaceuticals: Teva Reports Third Quarter 2020 Financial Results.
3. GII Research: Global Metered Dose Inhaler Market - 2022-2029.
4. Coherent Market Insights: Digital Dose Inhaler Market Size & Share Analysis - Growth Trends.
5. Teva Pharmaceuticals: TEVA REPORTS THIRD QUARTER 2020 FINANCIAL RESULTS.