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Last Updated: December 22, 2024

TIOTROPIUM BROMIDE Drug Patent Profile


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Which patents cover Tiotropium Bromide, and what generic alternatives are available?

Tiotropium Bromide is a drug marketed by Lupin and is included in one NDA.

The generic ingredient in TIOTROPIUM BROMIDE is tiotropium bromide. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the tiotropium bromide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tiotropium Bromide

A generic version of TIOTROPIUM BROMIDE was approved as tiotropium bromide by LUPIN on June 20th, 2023.

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Drug patent expirations by year for TIOTROPIUM BROMIDE
Recent Clinical Trials for TIOTROPIUM BROMIDE

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SponsorPhase
Guangzhou Institute of Respiratory DiseaseN/A
Boehringer IngelheimN/A
University of SaskatchewanPhase 4

See all TIOTROPIUM BROMIDE clinical trials

Pharmacology for TIOTROPIUM BROMIDE
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
Medical Subject Heading (MeSH) Categories for TIOTROPIUM BROMIDE
Paragraph IV (Patent) Challenges for TIOTROPIUM BROMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SPIRIVA RESPIMAT Inhalation Aerosol tiotropium bromide 2.5 mcg per actuation 021936 1 2023-03-07
SPIRIVA Inhalation Powder Capsules tiotropium bromide 18 mcg 021395 1 2018-05-11

US Patents and Regulatory Information for TIOTROPIUM BROMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin TIOTROPIUM BROMIDE tiotropium bromide POWDER;INHALATION 211287-001 Jun 20, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

TIOTROPIUM BROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tiotropium Bromide

Introduction

Tiotropium bromide, marketed under the brand name SPIRIVA, is a prominent anticholinergic medication used primarily for the treatment of chronic obstructive pulmonary disease (COPD) and, in some cases, asthma. This article delves into the market dynamics and financial trajectory of tiotropium bromide, highlighting key factors, trends, and projections.

Market Size and Revenue

The global market for tiotropium bromide has been substantial and is expected to continue growing. As of 2023, the global market size for tiotropium bromide was estimated to be approximately USD 4.5 billion. Projections indicate that this market is set to expand, reaching around USD 7.8 billion by 2032[4].

Sales Performance

Despite the expiration of some patents, SPIRIVA, the branded version of tiotropium bromide, still generates significant revenue. In the previous year, it generated $1.7 billion in sales, with $1.3 billion of that coming from the U.S. market alone[2].

Patent Landscape

The patent landscape for tiotropium bromide is complex, with multiple patents protecting the drug. There are sixty patent family members in thirty-two countries, and nine patents specifically protecting SPIRIVA. However, the approval of generic versions, such as the one by LUPIN in June 2023, is expected to impact the market dynamics[2].

Generic Competition

The entry of generic versions of tiotropium bromide is a critical factor affecting the market. The approval of generic tiotropium bromide by LUPIN in June 2023 marks a significant shift, as it introduces competition to the branded market. This competition is likely to reduce the market share and revenue of the branded version, SPIRIVA[2].

Regional Analysis

The global tiotropium bromide market is segmented by region, with different regions exhibiting varying growth rates. The U.S. market has been a major contributor to the revenue, but other regions, particularly in Asia-Pacific, are expected to show significant growth due to increasing healthcare expenditure and a rising prevalence of COPD and asthma[1][4].

Segment Analysis

The market is segmented by type, including inhalation powder and inhalation spray forms. The inhalation powder form, particularly SPIRIVA HandiHaler, has historically been the dominant segment. However, the inhalation spray form, such as SPIRIVA Respimat, is gaining traction due to its ease of use and patient preference[1][5].

Market Trends

Several trends are influencing the tiotropium bromide market:

Increasing Prevalence of COPD and Asthma

The rising prevalence of COPD and asthma globally is driving the demand for tiotropium bromide. This trend is particularly pronounced in regions with aging populations and increasing air pollution[1][4].

Technological Advancements

Advancements in inhalation technology, such as the development of soft mist inhalers like SPIRIVA Respimat, are enhancing patient compliance and efficacy. These innovations are expected to continue shaping the market[5].

Cost Savings Initiatives

Boehringer Ingelheim's recent initiative to cap inhaler prices at $35 for commercially insured or uninsured individuals in the U.S. is aimed at making the medication more accessible. This move could impact the financial trajectory by potentially increasing market share among price-sensitive patients[5].

Drivers and Opportunities

Pharmacoeconomic Benefits

Adding tiotropium bromide to treatment regimens for severe COPD patients can lead to significant cost savings for healthcare systems. This pharmacoeconomic benefit is a strong driver for the adoption of the drug[3].

Expanding Indications

The potential expansion of tiotropium bromide's indications to include other respiratory conditions could open up new market opportunities. Research into its efficacy in asthma and other diseases is ongoing[5].

Restraints and Challenges

Patent Expirations

The expiration of key patents has allowed generic versions to enter the market, which is expected to reduce the revenue of branded versions like SPIRIVA. This competition will be a significant restraint on the financial growth of the branded market[2].

Regulatory Environment

Changes in regulatory policies and pricing pressures can impact the market. For instance, federal laws preventing price cap programs for government-insured patients limit the reach of cost-saving initiatives[5].

Competitive Landscape

The competitive landscape of the tiotropium bromide market includes major pharmaceutical companies like Boehringer Ingelheim, as well as generic manufacturers such as LUPIN. The entry of new players and the expansion of existing ones are expected to intensify competition[2][4].

Financial Projections

The financial trajectory of tiotropium bromide is expected to be influenced by both the growing demand for COPD and asthma treatments and the increasing competition from generic versions. Despite the challenges, the market is projected to grow, driven by the expanding patient base and technological advancements in inhalation devices[1][4].

Key Takeaways

  • The global tiotropium bromide market is projected to grow from USD 4.5 billion in 2023 to USD 7.8 billion by 2032.
  • The U.S. market remains a significant contributor to the revenue, but other regions are expected to show substantial growth.
  • Generic competition, particularly from LUPIN's approved generic version, will impact the market dynamics.
  • Technological advancements and pharmacoeconomic benefits are key drivers for the market.
  • Patent expirations and regulatory challenges are significant restraints.

FAQs

What is the primary use of tiotropium bromide?

Tiotropium bromide is primarily used for the treatment of chronic obstructive pulmonary disease (COPD) and, in some cases, asthma.

How has the approval of generic tiotropium bromide impacted the market?

The approval of generic tiotropium bromide has introduced competition to the branded market, potentially reducing the market share and revenue of SPIRIVA.

What are the key drivers for the tiotropium bromide market?

Key drivers include the increasing prevalence of COPD and asthma, technological advancements in inhalation devices, and pharmacoeconomic benefits.

Which region is expected to dominate the global tiotropium bromide market?

The U.S. market has been dominant, but other regions, particularly in Asia-Pacific, are expected to show significant growth.

What is the impact of Boehringer Ingelheim's price cap initiative on the market?

The price cap initiative is aimed at making the medication more accessible, potentially increasing market share among price-sensitive patients.

Sources

  1. Cognitivemarketresearch.com: Tiotropium Bromide Market Report 2024 (Global Edition)
  2. Drugpatentwatch.com: SPIRIVA Drug Patent Profile
  3. Pubmed.ncbi.nlm.nih.gov: Evaluating the pharmacoeconomic effect of adding tiotropium bromide for severe COPD patients
  4. Dataintelo.com: Tiotropium bromide Market Research Report 2032
  5. Aafa.org: Tiotropium Bromide – SPIRIVA Respimat

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