PROAIR DIGIHALER Drug Patent Profile

When do Proair Digihaler patents expire, and when can generic versions of Proair Digihaler launch?

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

This drug has three hundred and forty-three patent family members in twenty-nine countries.

The generic ingredient in PROAIR DIGIHALER is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Proair Digihaler

A generic version of PROAIR DIGIHALER was approved as albuterol sulfate by SUN PHARM INDUSTRIES on December 5^th, 1989.

Summary for PROAIR DIGIHALER

International Patents:	343
US Patents:	21
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	1
Patent Applications:	5,671
Drug Prices:	Drug price information for PROAIR DIGIHALER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROAIR DIGIHALER
What excipients (inactive ingredients) are in PROAIR DIGIHALER?	PROAIR DIGIHALER excipients list
DailyMed Link:	PROAIR DIGIHALER at DailyMed

See drug prices for PROAIR DIGIHALER

Recent Clinical Trials for PROAIR DIGIHALER

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wake Forest University Health Sciences	Early Phase 1
Teva Branded Pharmaceutical Products R&D, Inc.	Early Phase 1
University of North Carolina, Chapel Hill	Early Phase 1

See all PROAIR DIGIHALER clinical trials

Pharmacology for PROAIR DIGIHALER

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

US Patents and Regulatory Information for PROAIR DIGIHALER

PROAIR DIGIHALER is protected by twenty-one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		DISCN	Yes	No	11,351,317		Y
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		DISCN	Yes	No	9,463,288		Y
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		DISCN	Yes	No	10,569,034		Y
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		DISCN	Yes	No	11,000,653		Y
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		DISCN	Yes	No	11,464,923		Y

Expired US Patents for PROAIR DIGIHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018	7,540,282
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018	6,701,917
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018	8,006,690
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018	6,871,646
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018	6,748,947

International Patents for PROAIR DIGIHALER

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1330280
Japan	7054724
Slovenia	2514467
Taiwan	201617102	Compliance monitoring module for a breath-actuated inhaler
Argentina	102057	MÓDULO DE MONITOREO DE LA DOCILIDAD PARA UN INHALADOR ACCIONADO POR EL ALIENTO

PROAIR DIGIHALER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ProAir Digihaler

Introduction

The ProAir Digihaler, developed by Teva Pharmaceuticals, represents a significant advancement in the management of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). This smart inhaler has integrated digital health technologies, enhancing patient care and doctor-patient communication. Here, we delve into the market dynamics and financial trajectory of the ProAir Digihaler.

Market Context and Growth

The global respiratory inhalers market, which includes smart inhalers like the ProAir Digihaler, is experiencing substantial growth. The market is projected to grow from USD 31.14 billion in 2022 to USD 43.44 billion by 2028, at a CAGR of 5.7%[4].

Smart Inhalers Market

The smart inhalers segment, in particular, is expected to see rapid growth, driven by the increasing adoption of telehealth and remote patient monitoring, especially accelerated by the COVID-19 pandemic. The smart inhalers market is estimated to reach USD 3.42 billion by 2029, growing at a CAGR of 15.07% from 2024 to 2029[3].

Product Launch and Approval

Teva's ProAir Digihaler was first approved by the FDA in late 2018 and was launched in the U.S. market in July 2020. This launch was part of Teva's broader strategy to introduce a portfolio of smart inhalers, including the AirDuo Digihaler and ArmonAir Digihaler, which were also approved in 2019 and early 2020, respectively[1].

Key Features and Benefits

The ProAir Digihaler is a powdered albuterol dispenser that connects wirelessly to a companion app. It tracks event data, including timestamps of use and inhalation characteristics such as inspiratory flow rate. This data can be viewed by patients and transmitted to their doctors, facilitating better condition management and treatment improvement[1].

Patient Adherence and Doctor-Patient Communication

One of the significant challenges in managing respiratory conditions is ensuring patient adherence to inhaler regimens. The ProAir Digihaler addresses this by providing medication reminders and tips to improve inhaler technique. This enhances patient adherence and allows for more productive doctor-patient discussions about managing the illness[1].

Financial Impact

Revenue and Pricing

The ProAir Digihaler is available by prescription with a U.S. list price of $146.67. While specific revenue figures for the ProAir Digihaler are not provided, the launch of this and other smart inhalers is part of Teva's broader strategy to drive revenue through innovative products.

Teva's Financial Performance

In the third quarter of 2020, Teva reported a GAAP operating loss of $4,342 million, largely due to goodwill and intangible asset impairments. However, non-GAAP operating income was $1,025 million, a decrease of 3% compared to the third quarter of 2019. This indicates that while Teva faced significant financial challenges, its operational performance remained relatively stable[2].

In 2022, Teva's financial results showed a mixed picture. The company reported revenues of $3.6 billion, with a GAAP gross profit of $1,669 million, a decrease of 7% compared to the third quarter of 2021. Non-GAAP gross profit was $1,906 million, also down by 9%. Despite these challenges, Teva's adjusted EBITDA remained strong at $1,089 million, though it was a decrease of 7% from the previous year[5].

Market Drivers and Challenges

Technological Advancements

The integration of digital health solutions into respiratory care is a major driver for the adoption of smart inhalers. Technological advancements such as dose counters, inhaler analytics, and mobile app integration are enhancing the effectiveness of these devices[3].

Competitive Landscape

The respiratory inhalers market is competitive, with several players including AstraZeneca and GSK. Teva's smart inhaler portfolio, including the ProAir Digihaler, is positioned to compete effectively by offering unique data-driven capabilities that enhance patient care and doctor-patient communication[1].

Regulatory and Generic Competition

Teva's ProAir Digihaler faces competition from generic versions of its base ProAir inhaler. However, the unique features of the ProAir Digihaler, such as its digital connectivity, are expected to mitigate some of this competition[1].

Impact of COVID-19

The COVID-19 pandemic has accelerated the adoption of telehealth and remote patient monitoring, which has been beneficial for the ProAir Digihaler. The pandemic highlighted the importance of respiratory health and the need for remote monitoring solutions, driving increased awareness and adoption of smart inhaler technologies[3].

Key Takeaways

• Market Growth: The smart inhalers market is expected to grow significantly, driven by technological advancements and the need for remote patient monitoring.
• Product Features: The ProAir Digihaler offers unique features such as data tracking and transmission, enhancing patient adherence and doctor-patient communication.
• Financial Performance: Teva's financial results indicate a mixed picture, but the company's innovative products like the ProAir Digihaler are crucial for driving revenue.
• Market Drivers: Technological advancements and the COVID-19 pandemic are key drivers for the adoption of smart inhalers.
• Competitive Landscape: The market is competitive, but Teva's smart inhaler portfolio is well-positioned to compete effectively.

FAQs

What is the ProAir Digihaler?

The ProAir Digihaler is a smart inhaler developed by Teva Pharmaceuticals for the management of respiratory conditions like asthma and COPD. It connects wirelessly to a companion app to track event data and provide patient feedback.

How does the ProAir Digihaler enhance patient care?

The ProAir Digihaler enhances patient care by tracking inhaler usage, providing medication reminders, and offering tips to improve inhaler technique. It also allows patients to transmit data to their doctors, facilitating better condition management.

What is the market outlook for smart inhalers?

The smart inhalers market is expected to grow from USD 1.69 billion in 2024 to USD 3.42 billion by 2029, at a CAGR of 15.07%.

How has the COVID-19 pandemic impacted the adoption of smart inhalers?

The COVID-19 pandemic has accelerated the adoption of telehealth and remote patient monitoring, highlighting the importance of respiratory health and driving increased awareness and adoption of smart inhaler technologies.

What are the key financial highlights for Teva related to the ProAir Digihaler?

While specific revenue figures for the ProAir Digihaler are not provided, Teva's overall financial performance indicates a mixed picture, with non-GAAP operating income and adjusted EBITDA remaining significant despite some declines.

Sources

1. Fierce Pharma: Teva's ProAir Digihaler breezes into U.S. market[1].
2. Teva Pharmaceuticals: Teva Reports Third Quarter 2020 Financial Results[2].
3. Mordor Intelligence: Smart Inhalers Market Size & Share Analysis[3].
4. The Insight Partners: Respiratory Inhalers Market Size Report, Share, Trends, Growth and Revenue Forecast to 2028[4].
5. Teva Pharmaceuticals: Teva Reports Third Quarter 2022 Financial Results[5].