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Last Updated: March 16, 2025

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE Drug Patent Profile


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Which patents cover Albuterol Sulfate And Ipratropium Bromide, and when can generic versions of Albuterol Sulfate And Ipratropium Bromide launch?

Albuterol Sulfate And Ipratropium Bromide is a drug marketed by Aiping Pharm Inc, Apotex Inc, Cipla, Luoxin Aurovitas, Nephron, Ritedose Corp, Sun Pharm, Teva Pharms, and Watson Labs Teva. and is included in nine NDAs.

The generic ingredient in ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Albuterol Sulfate And Ipratropium Bromide

A generic version of ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE was approved as albuterol sulfate; ipratropium bromide by CIPLA on December 31st, 2007.

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Summary for ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
Drug patent expirations by year for ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
Recent Clinical Trials for ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

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

SponsorPhase
James J. Peters Veterans Affairs Medical CenterPhase 2
University of Texas Southwestern Medical CenterPhase 4
DeyPhase 3

See all ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE clinical trials

Pharmacology for ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

US Patents and Regulatory Information for ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Teva Pharms ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 076724-001 Dec 31, 2007 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Aiping Pharm Inc ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 076867-001 Dec 21, 2006 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Apotex Inc ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 077117-001 Dec 31, 2007 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Cipla ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 077559-001 Dec 31, 2007 AN RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Ritedose Corp ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 202496-001 Oct 1, 2012 AN RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Luoxin Aurovitas ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 206532-001 Jul 8, 2020 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sun Pharm ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE albuterol sulfate; ipratropium bromide SOLUTION;INHALATION 207875-001 Aug 7, 2017 AN RX No No ⤷  Try for Free ⤷  Try for Free ⤷  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
Showing 1 to 7 of 7 entries

Market Dynamics and Financial Trajectory for Albuterol Sulfate and Ipratropium Bromide

Introduction

Albuterol sulfate and ipratropium bromide, when combined, form a potent therapeutic agent for treating respiratory diseases such as asthma, bronchial spasm, and chronic obstructive pulmonary disease (COPD). This article delves into the market dynamics, financial trajectory, and key factors influencing the growth and usage of this combination therapy.

Mechanism of Action

The combination of albuterol sulfate and ipratropium bromide works through two distinct mechanisms. Albuterol sulfate, a β2-sympathomimetic, relaxes the smooth muscles in the airways, leading to bronchodilation and improved airflow. Ipratropium bromide, an anticholinergic/parasympatholytic agent, inhibits muscarinic acetylcholine receptors (mAChRs), reducing mucus production and bronchoconstriction. This dual action enhances the therapeutic efficacy compared to using either drug alone[1][4].

Market Size and Growth Projections

The market for albuterol sulfate, including its combination with ipratropium bromide, is experiencing significant growth. The global albuterol sulfate market was valued at USD 5.22 billion in 2023 and is projected to reach USD 9.14 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 8.32% during this period[5].

Key Drivers of Market Growth

Several factors are driving the growth of this market:

Increasing Prevalence of Respiratory Diseases

The rising incidence of respiratory disorders such as asthma, COPD, and bronchitis, largely due to air pollution, urbanization, and lifestyle changes, is a major driver. This increased prevalence translates into higher demand for effective treatments like albuterol sulfate and ipratropium bromide[5].

Advancements in Inhalation Therapy

Innovations in inhaler technology, including metered-dose and dry powder inhalers, as well as nebulization solutions, are expanding treatment options and improving patient compliance. Regulatory approvals for generic formulations also contribute to market growth[5].

Growing Awareness and Diagnosis

Improved awareness and diagnostic techniques have led to earlier detection and better management of respiratory conditions. This increased diagnosis rate further boosts the demand for albuterol sulfate and ipratropium bromide[5].

Financial Impact and Cost Savings

Formulary Substitutions

Studies have shown that formulary substitutions, such as switching from metered-dose inhalers (MDIs) to nebulization solutions, can result in significant cost savings. For instance, substituting ipratropium-albuterol nebulization solution for MDIs resulted in substantial savings, despite additional costs for equipment and personnel[2].

Cost Variability

The cost of albuterol sulfate and ipratropium bromide can vary significantly based on factors such as insurance coverage, treatment plan, and the pharmacy used. Generic forms tend to be less expensive than brand-name versions, and strategies like obtaining a 90-day supply can help reduce long-term costs[5].

Market Opportunities

Combination Therapies

Combination therapies that include albuterol along with other respiratory medications, such as ipratropium bromide, offer significant opportunities for market growth. These therapies provide enhanced efficacy and convenience, simplifying treatment regimens for patients[5].

Innovations in Delivery Systems

Ongoing research into new formulations and delivery systems, such as vibrating mesh nebulizers, is expected to further advance the market. Patient education programs and healthcare reforms promoting respiratory health awareness also support market expansion[5].

Clinical Efficacy and Patient Outcomes

Clinical trials have demonstrated the superior efficacy of the combination therapy. A 12-week study involving 863 COPD patients showed that Ipratropium Bromide and Albuterol Sulfate Inhalation Solution resulted in significantly better changes in FEV1 (forced expiratory volume in one second) compared to either drug used alone. The combination also showed a rapid onset and extended duration of action[4].

Economic Profile

A population-based, retrospective claims analysis highlighted the economic benefits of using the nebulized ipratropium and albuterol combination. The study found that patients using this combination had lower total per-member-per-month expenditures and emergency department costs compared to those using generic ipratropium and albuterol as separate agents[2].

Regulatory Framework

The market is influenced by regulatory approvals and healthcare policies. Changes in these areas can impact the availability and affordability of albuterol sulfate and ipratropium bromide medications. For example, the approval of generic formulations can significantly affect market dynamics[5].

Patient Compliance

Ensuring patient compliance with treatment regimens is crucial. Innovations in inhaler technology and patient education programs can help improve compliance rates. The combination therapy's convenience and efficacy also contribute to better patient adherence[5].

Regional Market Dominance

North America dominates the albuterol sulfate market, accounting for a significant portion of the global market share due to its robust healthcare infrastructure and high prevalence of respiratory disorders[5].

Key Takeaways

  • The market for albuterol sulfate and ipratropium bromide is expected to grow significantly, driven by increasing respiratory disease prevalence, advancements in inhalation therapy, and government initiatives.
  • Combination therapies offer enhanced efficacy and convenience, driving market growth.
  • Formulary substitutions and the use of generic formulations can lead to substantial cost savings.
  • Patient compliance and regulatory frameworks are critical factors influencing market dynamics.
  • Innovations in delivery systems and patient education programs support market expansion.

FAQs

Q: What is the projected growth rate of the albuterol sulfate market? A: The market is expected to grow at a CAGR of 8.32% from 2023 to 2030, according to some reports, and at a CAGR of 7.1% from 2024 to 2031, according to others[5].

Q: Which region dominates the albuterol sulfate inhalation aerosol market? A: North America dominates the market, accounting for 40% of the global market share due to its robust healthcare infrastructure and high prevalence of respiratory disorders[5].

Q: How can formulary substitutions impact costs? A: Formulary substitutions, such as switching from MDIs to nebulization solutions, can result in significant cost savings, despite additional costs for equipment and personnel[2].

Q: What factors influence the cost of albuterol sulfate and ipratropium bromide? A: The cost can vary based on insurance coverage, treatment plan, pharmacy used, and whether the medication is in brand-name or generic form[5].

Q: What are some opportunities for market growth in the albuterol sulfate sector? A: Opportunities include combination therapies, innovations in delivery systems, and patient education programs, all of which enhance efficacy, convenience, and patient compliance[5].

Sources

  1. Ipratropium bromide/Albuterol sulfate's R&D Progress - Synapse Patsnap
  2. Exploratory economic evaluation of patients with COPD on a nebulized ipratropium and albuterol combination - PubMed
  3. Albuterol Sulfate Inhalation Solution Market Size, Opportunities - Verified Market Research
  4. Ipratropium and Albuterol: Package Insert / Prescribing Info - Drugs.com
  5. Albuterol sulfate - Generic Drug Details - Drug Patent Watch

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