ATROVENT HFA Drug Patent Profile

When do Atrovent Hfa patents expire, and what generic alternatives are available?

Atrovent Hfa is a drug marketed by Boehringer Ingelheim and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in nine countries.

The generic ingredient in ATROVENT HFA is ipratropium bromide. There are eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ipratropium bromide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Atrovent Hfa

A generic version of ATROVENT HFA was approved as ipratropium bromide by RITEDOSE CORP on January 26^th, 2001.

Summary for ATROVENT HFA

International Patents:	10
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	14
Clinical Trials:	47
Patent Applications:	4,306
Drug Prices:	Drug price information for ATROVENT HFA
DailyMed Link:	ATROVENT HFA at DailyMed

See drug prices for ATROVENT HFA

See drug sales revenues for ATROVENT HFA

Recent Clinical Trials for ATROVENT HFA

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

Sponsor	Phase
Hat Yai Medical Education Center	Phase 3
Nationwide Children's Hospital	Phase 4
University of Nevada, Las Vegas	Phase 4

See all ATROVENT HFA clinical trials

Pharmacology for ATROVENT HFA

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Paragraph IV (Patent) Challenges for ATROVENT HFA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATROVENT HFA	Inhalation Aerosol	ipratropium bromide	0.21 mg/Inh	021527	1	2023-12-29

US Patents and Regulatory Information for ATROVENT HFA

ATROVENT HFA is protected by 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
Boehringer Ingelheim	ATROVENT HFA	ipratropium bromide	AEROSOL, METERED;INHALATION	021527-001	Nov 27, 2004		RX	Yes	Yes	8,474,447		Y

Expired US Patents for ATROVENT HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	ATROVENT HFA	ipratropium bromide	AEROSOL, METERED;INHALATION	021527-001	Nov 27, 2004	6,739,333
Boehringer Ingelheim	ATROVENT HFA	ipratropium bromide	AEROSOL, METERED;INHALATION	021527-001	Nov 27, 2004	5,676,930
Boehringer Ingelheim	ATROVENT HFA	ipratropium bromide	AEROSOL, METERED;INHALATION	021527-001	Nov 27, 2004	6,983,743
Boehringer Ingelheim	ATROVENT HFA	ipratropium bromide	AEROSOL, METERED;INHALATION	021527-001	Nov 27, 2004	5,766,573
Boehringer Ingelheim	ATROVENT HFA	ipratropium bromide	AEROSOL, METERED;INHALATION	021527-001	Nov 27, 2004	5,695,743

International Patents for ATROVENT HFA

See the table below for patents covering ATROVENT HFA around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	205866
Australia	772768
European Patent Office	0995434
Germany	69324161
China	1106999

ATROVENT HFA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ATROVENT HFA

Introduction

ATROVENT HFA (ipratropium bromide HFA) is a metered-dose inhaler (MDI) used primarily for the treatment of chronic obstructive pulmonary disease (COPD) and other respiratory conditions. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Characterization of MDIs

The U.S. metered-dose inhaler market, which includes ATROVENT HFA, is characterized by several key factors:

• HFC Propellant Usage: In 2020, approximately 1,284 metric tons of HFC-134a and 207 metric tons of HFC-227ea were used in MDIs sold in the United States. This usage is expected to grow at a rate of about 1% per year through 2030 and 0.8% per year from 2030 through 2040, aligning with population growth projections[1][4].

• Market Size and Growth: The HFC MDI market, including ATROVENT HFA, is projected to retain its size post-2018 with a growth rate of approximately 1% per year through 2025. This growth is driven by the increasing prevalence of COPD and asthma, although the actual prevalence rates of these conditions have remained relatively constant[4].

Product Efficacy and Safety

ATROVENT HFA has been extensively studied for its efficacy and safety:

• Clinical Trials: Studies have shown that ATROVENT HFA is clinically comparable to its CFC-based predecessor. It demonstrates significant improvements in pulmonary function, with mean peak improvements in FEV1 (Forced Expiratory Volume in one second) comparable to the CFC formulation. The drug shows rapid onset of action, with improvements in FEV1 within 15 minutes, peaking in 1-2 hours, and persisting for 2-4 hours[3].

• Adverse Events: Common drug-related adverse events include dry mouth, taste perversion, and other anticholinergic effects such as urinary retention and constipation. However, these events are generally mild and infrequent[3].

Financial Impact

The financial trajectory of ATROVENT HFA is influenced by several factors, including market demand, competition, and cost-saving initiatives:

• Cost Savings through Formulary Substitution: Studies have shown that substituting MDIs with alternative inhalation therapies can result in significant cost savings. For example, a study on ipratropium-albuterol therapy found that switching from MDIs to nebulization solutions resulted in a three-month savings of $99,359 and an extrapolated full-year savings of $397,436. While this study did not specifically focus on ATROVENT HFA, it highlights the potential for cost savings in respiratory medication management[2].

• Market Competition: The respiratory drug market is highly competitive, with various inhaler types and formulations available. ATROVENT HFA competes with other HFA-based MDIs and newer inhaler technologies like Respimat. Patient satisfaction and performance metrics have shown that patients generally accept and prefer the newer inhaler technologies, which could impact the market share of ATROVENT HFA[5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of ATROVENT HFA:

• Transition from CFC to HFA: The transition from chlorofluorocarbon (CFC) to hydrofluoroalkane (HFA) propellants was mandated due to environmental concerns. ATROVENT HFA, being an HFA-based product, aligns with these regulations. However, the potential replacement of current HFC propellants with alternatives like HFC-152a could impact future market dynamics[1][4].

Patient Compliance and Satisfaction

Patient compliance and satisfaction are key factors in the long-term financial success of ATROVENT HFA:

• Compliance Rates: Studies have shown that patient compliance with ATROVENT HFA is generally high, with patients recording dosing in e-diaries showing compliance rates similar to other inhaler types. High compliance rates can lead to better health outcomes and reduced healthcare costs[5].

• Patient Satisfaction: Patients have reported high satisfaction with ATROVENT HFA, with no major issues in using and accepting the drug. This satisfaction can lead to increased patient retention and reduced switching to alternative therapies[5].

Projected Market Growth

The projected market growth for ATROVENT HFA is tied to the overall growth of the HFC MDI market:

• Population Growth: The market is expected to grow in line with population growth, with an estimated annual growth rate of about 1% through 2030 and 0.8% from 2030 through 2040[1][4].

• Prevalence of Respiratory Conditions: The growth in the prevalence of COPD and asthma, although constant in terms of percentage, contributes to the increasing demand for respiratory medications like ATROVENT HFA[4].

Key Takeaways

• Market Stability: The HFC MDI market, including ATROVENT HFA, is expected to retain its size with a moderate growth rate.
• Efficacy and Safety: ATROVENT HFA has been shown to be clinically effective and safe, with comparable efficacy to its CFC-based predecessor.
• Financial Impact: Cost-saving initiatives and formulary substitutions can significantly impact the financial trajectory of ATROVENT HFA.
• Regulatory Compliance: The transition to HFA propellants aligns with environmental regulations, but future transitions to alternative propellants could affect market dynamics.
• Patient Compliance and Satisfaction: High patient compliance and satisfaction rates are crucial for the long-term success of ATROVENT HFA.

FAQs

What is ATROVENT HFA used for?

ATROVENT HFA is used primarily for the treatment of chronic obstructive pulmonary disease (COPD) and other respiratory conditions.

How does ATROVENT HFA compare to its CFC-based predecessor?

ATROVENT HFA has been shown to be clinically comparable to its CFC-based predecessor in terms of efficacy and safety.

What are the common adverse events associated with ATROVENT HFA?

Common adverse events include dry mouth, taste perversion, and other anticholinergic effects such as urinary retention and constipation.

How does the regulatory environment impact ATROVENT HFA?

The transition from CFC to HFA propellants was mandated due to environmental concerns, and future transitions to alternative propellants like HFC-152a could impact market dynamics.

What are the projected growth rates for the HFC MDI market?

The HFC MDI market is expected to grow at a rate of about 1% per year through 2030 and 0.8% per year from 2030 through 2040.

Sources

1. ICF International for the U.S. Environmental Protection Agency (EPA). Market Characterization of the U.S. Metered Dose Inhaler Industry.
2. American Society of Health-System Pharmacists, Inc. Financial effect of converting ipratropium-albuterol therapy from metered-dose inhalers to nebulization solution.
3. FDA. ATROVENT HFA (ipratropium bromide HFA) Inhalation Aerosol.
4. EPA. Market Characterization of the U.S. Metered Dose Inhaler Industry.
5. FDA. Combivent Respimat 20/100 Inhalation Spray.