ARMONAIR DIGIHALER Drug Patent Profile

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

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

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

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Armonair Digihaler

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

Summary for ARMONAIR DIGIHALER

International Patents:	450
US Patents:	24
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 DIGIHALER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARMONAIR DIGIHALER
What excipients (inactive ingredients) are in ARMONAIR DIGIHALER?	ARMONAIR DIGIHALER excipients list
DailyMed Link:	ARMONAIR DIGIHALER at DailyMed

See drug prices for ARMONAIR DIGIHALER

Pharmacology for ARMONAIR DIGIHALER

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for ARMONAIR DIGIHALER

ARMONAIR DIGIHALER is protected by twenty-five 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	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-005	Feb 20, 2020		DISCN	Yes	No					Y
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-004	Feb 20, 2020		DISCN	Yes	No					Y
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-004	Feb 20, 2020		DISCN	Yes	No
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-006	Feb 20, 2020		DISCN	Yes	No					Y
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-004	Feb 20, 2020		DISCN	Yes	No
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-005	Feb 20, 2020		DISCN	Yes	No

Expired US Patents for ARMONAIR DIGIHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-004	Feb 20, 2020
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-004	Feb 20, 2020
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-006	Feb 20, 2020
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-006	Feb 20, 2020
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-005	Feb 20, 2020
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-006	Feb 20, 2020

International Patents for ARMONAIR DIGIHALER

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

Country	Patent Number	Title	Estimated Expiration
Spain	2988391
European Patent Office	2436414	Compteur de doses pour inhalateurs et inhalateur (Dose counter for inhalers and inhaler)
Eurasian Patent Organization	201300230	СПОСОБ СЕРИЙНОГО ПРОИЗВОДСТВА ИНКРЕМЕНТАЛЬНЫХ СЧЕТЧИКОВ ДОЗ ДЛЯ ИНГАЛЯТОРОВ И СПОСОБ ИЗГОТОВЛЕНИЯ СЕРИИ ИНГАЛЯТОРОВ
Japan	2020501855	組み込まれた電子モジュールを有する吸入デバイス
Denmark	2514462
Denmark	3002022

Supplementary Protection Certificates for ARMONAIR DIGIHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	SPC/GB18/020	United Kingdom		PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
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
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
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
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

Market Dynamics and Financial Trajectory for ArmonAir Digihaler

Introduction to ArmonAir Digihaler

ArmonAir Digihaler, developed by Teva Pharmaceutical Industries Ltd., is a digital maintenance inhaler designed for the long-term treatment of asthma in patients 12 years and older. This innovative device is part of Teva's DigiHaler portfolio, which integrates advanced digital technology to enhance patient compliance and health outcomes.

Market Size and Growth

The global digital dose inhaler market, which includes products like ArmonAir Digihaler, is experiencing significant growth. As of 2024, the market is valued at USD 18.33 billion and is projected to reach USD 64.33 billion by 2031, with a compound annual growth rate (CAGR) of 19.6% from 2024 to 2031[1][4].

Key Drivers of Market Growth

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

Rising Prevalence of Respiratory Diseases

The increasing prevalence of chronic respiratory diseases such as asthma and Chronic Obstructive Pulmonary Disease (COPD) is a major driver. These conditions require effective and monitored treatment, making digital dose inhalers like ArmonAir Digihaler highly relevant[1][4].

Advanced Features and Integration

ArmonAir Digihaler features dose counters, humidity controls, and integrated sensors that enhance patient compliance. The ability to integrate these devices with mobile applications enables remote monitoring, improving health outcomes and patient care[1].

Telehealth and Remote Monitoring

The integration of telehealth and remote monitoring capabilities is another significant driver. These features allow healthcare providers to monitor patients more effectively, especially in the context of the COVID-19 pandemic, which has accelerated the adoption of digital healthcare solutions[1].

Regional Market Dynamics

North America

North America, particularly the U.S., is the dominant region in the digital dose inhaler market, accounting for 38.3% of the market share in 2024. The presence of leading pharmaceutical companies, well-established healthcare infrastructure, and favorable regulations contribute to this dominance. Teva Pharmaceutical Industries Ltd., with its headquarters in the U.S., plays a significant role in this market[1].

Asia Pacific

The Asia Pacific region is poised to be the fastest-growing market for digital dose inhalers. Countries like India and China offer immense growth opportunities due to large patient pools affected by respiratory diseases and increasing healthcare expenditure. Government initiatives to promote generic and low-cost drugs also favor local manufacturing and market growth[1].

Financial Performance and Launch Impact

Teva Pharmaceutical Industries Ltd. Financials

The launch of ArmonAir Digihaler, along with AirDuo Digihaler, was part of Teva's strategic efforts to drive growth. In the third quarter of 2020, despite the challenges posed by the COVID-19 pandemic, Teva reported strong performance from its key growth drivers, including the DigiHaler portfolio. The company saw a GAAP gross profit of $1,852 million, a 1% increase compared to the third quarter of 2019[2][5].

Revenue and Market Share

The launch of these digital inhalers contributed to Teva's revenue stability and growth. Although the overall revenue in the third quarter of 2020 was affected by the pandemic, the company's debt reduction and cost-saving measures helped maintain profitability. The DigiHaler portfolio is expected to continue contributing to Teva's financial growth as the market for digital dose inhalers expands[2][3].

Challenges and Restraints

High Costs and Lack of Awareness

Despite the growth potential, the market faces challenges such as the high costs of digital dose inhalers and a lack of awareness about these devices. These factors could hamper market growth over the forecast period. However, ongoing educational efforts and the integration of these devices into healthcare systems are expected to mitigate these challenges[1].

Competitive Landscape

ArmonAir Digihaler operates in a competitive market with several key players, including AstraZeneca, Novartis AG, Propeller Health, and Glenmark Pharmaceuticals Ltd. The competitive landscape is driven by product innovation, strategic partnerships, and regulatory approvals. Teva's strong presence in the U.S. and its extensive research and development activities position ArmonAir Digihaler as a significant player in the market[1][4].

Future Outlook

The future outlook for ArmonAir Digihaler is promising, given the growing demand for digital healthcare solutions and the increasing prevalence of respiratory diseases. As the global population ages and healthcare systems evolve, the need for advanced, monitored treatment options will continue to drive the market. Here is a highlight from an industry report:

"The global digital dose inhaler market is expected to grow at a CAGR of 19.4% from 2023 to 2030, driven by the upsurge in the prevalence of chronic respiratory diseases and the need for effective monitoring of dosing"[4].

Key Takeaways

• The global digital dose inhaler market is projected to grow significantly, driven by the rising prevalence of respiratory diseases and the adoption of digital healthcare.
• ArmonAir Digihaler, part of Teva's DigiHaler portfolio, offers advanced features that enhance patient compliance and health outcomes.
• North America is the dominant region, but the Asia Pacific is expected to be the fastest-growing market.
• High costs and lack of awareness are potential restraints, but ongoing educational efforts and integration into healthcare systems are expected to address these challenges.
• The competitive landscape is driven by innovation, partnerships, and regulatory approvals.

Frequently Asked Questions (FAQs)

Q: What is the expected growth rate of the global digital dose inhaler market? A: The global digital dose inhaler market is expected to grow at a CAGR of 19.6% from 2024 to 2031[1].

Q: What are the key features of ArmonAir Digihaler? A: ArmonAir Digihaler features dose counters, humidity controls, and integrated sensors, and can be integrated with mobile applications for remote monitoring[1].

Q: Which region is expected to be the fastest-growing market for digital dose inhalers? A: The Asia Pacific region is expected to be the fastest-growing market due to a large patient pool and increasing healthcare expenditure[1].

Q: How has the COVID-19 pandemic impacted the market for digital dose inhalers? A: The pandemic has accelerated the adoption of digital healthcare solutions, including remote monitoring and telehealth, which has positively impacted the market[1].

Q: What are the main challenges facing the growth of the digital dose inhaler market? A: High costs and a lack of awareness about digital dose inhalers are the main challenges, although ongoing educational efforts and integration into healthcare systems are addressing these issues[1].

Sources:

1. Coherent Market Insights: Digital Dose Inhaler Market Size & Share Analysis - Growth Trends
2. Teva Pharmaceutical Industries Ltd.: TEVA REPORTS THIRD QUARTER 2020 FINANCIAL RESULTS
3. Teva Pharmaceutical Industries Ltd.: Q3 2020 Earnings Call Transcript
4. Grand View Research: Digital Dose Inhaler Market Size, Share Analysis Report 2030
5. Teva Pharmaceutical: Teva Reports Third Quarter 2020 Financial Results

Last updated: 2024-12-16