PROAIR RESPICLICK Drug Patent Profile

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

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

This drug has two hundred and seven patent family members in twenty-seven countries.

The generic ingredient in PROAIR RESPICLICK 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 Respiclick

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

Summary for PROAIR RESPICLICK

International Patents:	207
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	81
Patent Applications:	5,404
Drug Prices:	Drug price information for PROAIR RESPICLICK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROAIR RESPICLICK
What excipients (inactive ingredients) are in PROAIR RESPICLICK?	PROAIR RESPICLICK excipients list
DailyMed Link:	PROAIR RESPICLICK at DailyMed

See drug prices for PROAIR RESPICLICK

Pharmacology for PROAIR RESPICLICK

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

US Patents and Regulatory Information for PROAIR RESPICLICK

PROAIR RESPICLICK is protected by nine 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 RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015		RX	Yes	Yes	9,463,288		Y
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015		RX	Yes	Yes	10,765,820		Y
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015		RX	Yes	Yes	9,731,087		Y
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015		RX	Yes	Yes	10,022,510		Y
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015		RX	Yes	Yes	8,651,103		Y
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015		RX	Yes	Yes	9,216,260		Y

Expired US Patents for PROAIR RESPICLICK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015	8,006,690
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015	6,446,627
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015	7,540,282
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015	6,871,646
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015	6,748,947
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015	6,701,917

International Patents for PROAIR RESPICLICK

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

Country	Patent Number	Title	Estimated Expiration
South Korea	100517900
Israel	223116
China	106999681	吸入器的依从性辅助模块 (Compliance-assisting module for an inhaler)
Canada	3145869	DISPOSITIF D'ADMINISTRATION DE MEDICAMENT DOTE D'ELECTRONIQUE ET A GESTION DE PUISSANCE (DRUG DELIVERY DEVICE WITH ELECTRONICS AND POWER MANAGEMENT)
Israel	266814	התקן שאיפה עם מודול אלקטרוניקה משולב (Inhalation device with integrated electronics module)
South Korea	20130103823

PROAIR RESPICLICK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PROAIR RESPICLICK

Introduction

PROAIR RESPICLICK, a prescription medicine used to treat or prevent bronchospasm in patients with reversible obstructive airway disease, is a significant player in the bronchodilators market. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global bronchodilators market, within which PROAIR RESPICLICK operates, was estimated at USD 22.19 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 3.29% by 2030[1].

Segment Performance

The asthma segment, which is a primary indication for PROAIR RESPICLICK, accounted for the largest revenue share of 41.9% in the bronchodilators market in 2022. This segment is expected to expand at the fastest CAGR of 3.31% over the forecast period, driven by the increasing prevalence of asthma globally[1].

Regional Market

The Asia Pacific region is expected to be the fastest-growing market for bronchodilators, including PROAIR RESPICLICK, due to a high prevalence of asthma and the presence of key players such as Glenmark Pharmaceuticals Limited and Cipla Inc., which specialize in low-cost generic bronchodilators[1].

Product Approval and Launches

The approval and launch of advanced products, such as generic versions of established drugs, are driving the market growth. For instance, Mylan’s first generic of Symbicort, an inhalation aerosol, received FDA approval in March 2022, which can impact the competitive landscape for PROAIR RESPICLICK[1].

Financial Performance of Key Players

Teva Pharmaceuticals, the manufacturer of PROAIR RESPICLICK, has reported mixed financial results in recent quarters. In Q3 2023, Teva delivered strong revenue growth of 7% compared to Q3 2022, reaching $3.9 billion. However, the operating income was lower due to higher legal settlements, R&D, and sales & marketing expenses[2].

Revenue Trends

• In the fourth quarter of 2021, revenues from PROAIR (HFA and RespiClick) in Teva's North America segment decreased by 40% to $40 million, largely due to the ongoing impact of the COVID-19 pandemic and changes in customer stocking and purchasing patterns[5].

Operating Income and Expenses

• The operating income for Teva in Q3 2023 was $355 million, down from $419 million in Q3 2022, primarily due to higher R&D and sales & marketing expenses. Non-GAAP operating income, however, was $1,020 million, representing a non-GAAP operating margin of 26.5%[2].

Product Usage and Safety Profile

PROAIR RESPICLICK is used for treating or preventing bronchospasm in people 4 years of age and older. The drug has a well-documented safety profile, with common adverse reactions including upper respiratory infection, nasopharyngitis, sinusitis, and headache. It is crucial for patients to use this medication as directed, as increased usage can be a marker of destabilized asthma requiring re-evaluation of the treatment regimen[3][4].

Dosage and Administration

The recommended dosage for adults and adolescents 12 years of age or older is 2 inhalations 15 to 30 minutes before exercise to prevent exercise-induced bronchospasm. Each actuation provides a metered dose of 2.6 mg of the formulation containing 117 mcg of albuterol sulfate[4].

Competitive Landscape

The bronchodilators market is competitive, with several key players including Teva Pharmaceuticals, Mylan, and others. The launch of generic and advanced inhaler bronchodilators, such as Zydus Cadila's Forglyn pMDI, further intensifies the competition in the market[1].

Impact of COVID-19

The COVID-19 pandemic had a positive impact on the bronchodilators market, including PROAIR RESPICLICK, due to the off-label use of bronchodilators for inpatient treatment. The pandemic also highlighted the susceptibility of patients with lung diseases to viral infections, increasing the demand for bronchodilators[1].

Future Outlook

Given the growing geriatric population and the increasing prevalence of lung diseases, the demand for bronchodilators like PROAIR RESPICLICK is expected to rise. The development of advanced products and the strong research pipeline, particularly for asthma treatment, will continue to drive market growth.

Key Takeaways

• The global bronchodilators market, including PROAIR RESPICLICK, is expected to grow at a CAGR of 3.29% by 2030.
• The asthma segment dominates the market and is expected to expand at the fastest CAGR.
• Teva Pharmaceuticals, the manufacturer of PROAIR RESPICLICK, has reported mixed financial results but maintains a strong presence in the market.
• The product has a well-documented safety profile and is used widely for treating bronchospasm.
• The competitive landscape is intense, with several key players and the launch of generic and advanced inhaler bronchodilators.

FAQs

What is the current market size of the global bronchodilators market?

The global bronchodilators market size was estimated at USD 22.19 billion in 2022[1].

What is the expected growth rate of the bronchodilators market by 2030?

The market is expected to expand at a compound annual growth rate (CAGR) of 3.29% by 2030[1].

Which segment dominates the bronchodilators market?

The asthma segment accounted for the largest revenue share of 41.9% in the market in 2022[1].

How has the COVID-19 pandemic impacted the bronchodilators market?

The pandemic had a positive impact on the market due to the off-label use of bronchodilators for inpatient treatment and increased susceptibility to lung diseases[1].

What are the common adverse reactions associated with PROAIR RESPICLICK?

Common adverse reactions include upper respiratory infection, nasopharyngitis, sinusitis, and headache[3][4].

Cited Sources:

1. Grand View Research. Bronchodilators Market Size & Trends Analysis Report, 2030.
2. Teva Pharmaceuticals. Teva Reports Third Quarter 2023 Financial Results and Increases Revenue Guidance.
3. FDA. PROAIR RESPICLICK (albuterol sulfate) inhalation powder, for oral inhalation use.
4. FDA. PROAIR RESPICLICK (albuterol sulfate) inhalation powder, for oral inhalation use.
5. Teva Pharmaceuticals. TEVA REPORTS FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS.