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Last Updated: December 22, 2024

COMBIVENT Drug Patent Profile


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

Combivent is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are six patents protecting this drug.

The generic ingredient in COMBIVENT 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.

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Recent Clinical Trials for COMBIVENT

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SponsorPhase
Ontario Lung AssociationPhase 4
Wouter H. van GeffenPhase 4
University Medical Center GroningenPhase 4

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US Patents and Regulatory Information for COMBIVENT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim COMBIVENT albuterol sulfate; ipratropium bromide AEROSOL, METERED;INHALATION 020291-001 Oct 24, 1996 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Boehringer Ingelheim COMBIVENT RESPIMAT albuterol sulfate; ipratropium bromide SPRAY, METERED;INHALATION 021747-001 Oct 7, 2011 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

COMBIVENT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for COMBIVENT

Overview of COMBIVENT

COMBIVENT, developed by Boehringer Ingelheim, is a crucial medication in the treatment of chronic obstructive pulmonary disease (COPD). It is available in two main forms: COMBIVENT MDI (metered dose inhaler) and COMBIVENT RESPIMAT (a propellant-free inhaler).

Market Position and Competitors

Market Share and Competitors

In the global asthma and COPD therapeutics market, Boehringer Ingelheim is a significant player, particularly with its COPD treatments. COMBIVENT RESPIMAT, along with other products like Spiriva, positions Boehringer Ingelheim as a major competitor in the COPD market[1].

Key Competitors

The market for COPD therapeutics is crowded, with other major players including GSK, AstraZeneca, Novartis, and Merck. Products like GSK’s Incruse Ellipta and Boehringer’s Stiolto Respimat are expected to gain market share during the forecast period, adding to the competitive landscape[1].

Product Evolution and Innovation

Transition from COMBIVENT MDI to COMBIVENT RESPIMAT

The introduction of COMBIVENT RESPIMAT was a significant innovation, driven by the need to phase out chlorofluorocarbons (CFCs) as propellants due to the Montreal Protocol. COMBIVENT RESPIMAT uses a spring mechanism to release the medication, eliminating the need for CFCs or hydrofluoroalkane (HFA) propellants[4].

Clinical Comparability and Patient Benefits

Clinical trials have shown that COMBIVENT RESPIMAT is clinically comparable to COMBIVENT MDI in terms of lung function improvement, measured by FEV1 (the maximal amount of air that can be forcefully exhaled in one second)[4].

Financial Trajectory

Market Size and Growth

The global market for asthma and COPD therapeutics, which includes COMBIVENT, is expected to reach $44.1 billion by 2031, growing at a CAGR of 7.3% over the forecast period. This growth is driven by the increasing prevalence of respiratory diseases and the availability of low-cost prescription drugs[1].

Sales Performance

COMBIVENT RESPIMAT has been a key product for Boehringer Ingelheim, but its financial performance is influenced by various factors. The transition from COMBIVENT MDI to COMBIVENT RESPIMAT was managed to ensure minimal disruption to patients and healthcare providers. However, the overall sales of COMBIVENT could be impacted by the introduction of new market entrants and the patent expiry of other major COPD drugs[1].

Pricing and Cost Considerations

The cost of prescription drugs, including COMBIVENT, has been a significant concern. The rapidly rising cost of prescription drugs places an economic burden on consumers, employers, and public programs. However, Boehringer Ingelheim offers savings programs, such as the COMBIVENT RESPIMAT Savings Card, which can reduce the cost for patients to as little as $35 for a 30-day prescription fill[5].

Regulatory and Safety Considerations

FDA Approval and Safety Profile

COMBIVENT RESPIMAT received FDA approval in 2011, marking a significant regulatory milestone. The product has a well-documented safety profile, with common adverse reactions including bronchitis, upper respiratory tract infection, and headache. However, it also carries warnings for potential cardiovascular effects, increased intraocular pressure, and interactions with other medications[4].

Patient Education and Training

Boehringer Ingelheim has invested in training tools and educational resources to ensure that both healthcare professionals and patients are properly trained on the use of COMBIVENT RESPIMAT. This is crucial for the safe and effective use of the medication[3].

Market Trends and Future Outlook

Increasing Prevalence of COPD

The increasing prevalence of COPD worldwide is a key driver for the growth of the COPD therapeutics market. This trend is expected to continue, driven by factors such as aging populations and increased exposure to risk factors like smoking and air pollution[1].

Advances in Treatment Options

Recent advances in injectable biologics and smart medical devices are opening up new approaches to treating severe asthma and COPD. These innovations are likely to heighten competition but also offer better treatment options for patients[1].

Patent Expiry and New Entrants

The patent expiry of major COPD drugs, such as those from GSK and Boehringer Ingelheim, will introduce new generic and branded competitors into the market. This could impact the sales of COMBIVENT RESPIMAT, although Boehringer Ingelheim’s strong market position and ongoing research in respiratory diseases are expected to mitigate these effects[1].

Key Takeaways

  • Market Growth: The global asthma and COPD therapeutics market, including COMBIVENT, is expected to grow significantly, reaching $44.1 billion by 2031.
  • Innovation: The transition to COMBIVENT RESPIMAT reflects Boehringer Ingelheim’s commitment to innovation and compliance with environmental regulations.
  • Financial Performance: The sales of COMBIVENT RESPIMAT are influenced by market competition, patent expiries, and pricing strategies.
  • Regulatory Compliance: COMBIVENT RESPIMAT has a strong regulatory approval history and a well-documented safety profile.
  • Patient Support: Boehringer Ingelheim offers savings programs and educational resources to support patients using COMBIVENT RESPIMAT.

FAQs

What is COMBIVENT RESPIMAT used for?

COMBIVENT RESPIMAT is used for the treatment of patients with chronic obstructive pulmonary disease (COPD) who require a second bronchodilator to manage bronchospasm.

How does COMBIVENT RESPIMAT differ from COMBIVENT MDI?

COMBIVENT RESPIMAT is a propellant-free inhaler that uses a spring mechanism to release the medication, unlike COMBIVENT MDI which uses chlorofluorocarbons (CFCs) as propellants.

What are the common adverse reactions associated with COMBIVENT RESPIMAT?

Common adverse reactions include bronchitis, upper respiratory tract infection, headache, dyspnea, cough, pain, respiratory disorder, sinusitis, pharyngitis, nausea, and nasopharyngitis.

How does the cost of COMBIVENT RESPIMAT compare to other COPD treatments?

The cost of COMBIVENT RESPIMAT can be managed through savings programs offered by Boehringer Ingelheim, such as the COMBIVENT RESPIMAT Savings Card, which can reduce the cost for patients.

What is the expected market growth for COPD therapeutics?

The global market for asthma and COPD therapeutics is expected to reach $44.1 billion by 2031, growing at a CAGR of 7.3% over the forecast period.

Sources

  1. Global Asthma and COPD Therapeutics Market: iHealthcareAnalyst, "Global Asthma and COPD Therapeutics Market $44.1 Billion by 2031," March 19, 2024.
  2. Review of Prescription Drug Costs and Summary of Potential Strategies: Health Care Authority, "Review of Prescription Drug Costs and Summary of Potential Strategies," November 15, 2016.
  3. Boehringer Ingelheim Launches COMBIVENT RESPIMAT: PR Newswire, "Boehringer Ingelheim Launches COMBIVENT RESPIMAT," September 18, 2012.
  4. FDA Approves COMBIVENT RESPIMAT: PR Newswire, "FDA Approves COMBIVENT RESPIMAT," October 10, 2011.
  5. Savings Card Registration for COMBIVENT RESPIMAT: Boehringer Ingelheim, "Savings Card Registration | COMBIVENT RESPIMAT."

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