You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 15, 2025

ARMONAIR DIGIHALER Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Armonair Digihaler patents expire, 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-five patents protecting this drug.

This drug has four hundred and forty-nine 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 14th, 2004.

  Try for Free

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for ARMONAIR DIGIHALER?
  • What are the global sales for ARMONAIR DIGIHALER?
  • What is Average Wholesale Price for ARMONAIR DIGIHALER?
Drug patent expirations by year for ARMONAIR DIGIHALER
Drug Prices for ARMONAIR DIGIHALER

See drug prices for ARMONAIR DIGIHALER

Pharmacology for ARMONAIR DIGIHALER

US Patents and Regulatory Information for ARMONAIR DIGIHALER

ARMONAIR DIGIHALER is protected by twenty-six 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 ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-006 Feb 20, 2020 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-004 Feb 20, 2020 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-004 Feb 20, 2020 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-006 Feb 20, 2020 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Teva Pharm ARMONAIR DIGIHALER fluticasone propionate POWDER;INHALATION 208798-004 Feb 20, 2020 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ARMONAIR DIGIHALER

International Patents for ARMONAIR DIGIHALER

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

Country Patent Number Title Estimated Expiration
Peru 20020163 SISTEMA PRESURIZADO DE RECEPTACULO PARA INHALADOR DE MEDICAMENTO ⤷  Try for Free
South Korea 20190087475 전자 장치를 구비한 약물 전달 기구 ⤷  Try for Free
Denmark 1294421 ⤷  Try for Free
Israel 223116 מוני מינון למשאפים, משאפים ועמודים למשאפים (Dose counters for inhalers, inhalers and shafts thereof) ⤷  Try for Free
Japan 4897570 ⤷  Try for Free
Australia 2020200884 ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARMONAIR DIGIHALER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2506844 SPC/GB18/020 United Kingdom ⤷  Try for Free 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
2506844 18C1022 France ⤷  Try for Free 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
2506844 132018000000341 Italy ⤷  Try for Free 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
1519731 92269 Luxembourg ⤷  Try for Free PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1305329 08C0014 France ⤷  Try for Free PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
2506844 1890025-8 Sweden ⤷  Try for Free PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.