TIOTROPIUM BROMIDE - Generic Drug Details

What are the generic sources for tiotropium bromide and what is the scope of freedom to operate?

Tiotropium bromide is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim and Lupin, and is included in three NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tiotropium bromide has one hundred and seventy-eight patent family members in thirty-seven countries.

There are seven drug master file entries for tiotropium bromide. Three suppliers are listed for this compound.

Summary for TIOTROPIUM BROMIDE

International Patents:	178
US Patents:	9
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	115
Patent Applications:	5,784
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIOTROPIUM BROMIDE
What excipients (inactive ingredients) are in TIOTROPIUM BROMIDE?	TIOTROPIUM BROMIDE excipients list
DailyMed Link:	TIOTROPIUM BROMIDE at DailyMed

Recent Clinical Trials for TIOTROPIUM BROMIDE

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

Sponsor	Phase
Guangzhou Institute of Respiratory Disease	N/A
Boehringer Ingelheim	N/A
University of Saskatchewan	Phase 4

See all TIOTROPIUM BROMIDE clinical trials

Pharmacology for TIOTROPIUM BROMIDE

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for TIOTROPIUM BROMIDE

Bronchodilator Agents

Cholinergic Antagonists

Parasympatholytics

Anatomical Therapeutic Chemical (ATC) Classes for TIOTROPIUM BROMIDE

A07DA	Antipropulsives
A07D	ANTIPROPULSIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014		RX	Yes	Yes	9,027,967*PED				Y
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014		RX	Yes	Yes	7,396,341*PED				Y
Lupin	TIOTROPIUM BROMIDE	tiotropium bromide	POWDER;INHALATION	211287-001	Jun 20, 2023	AB	RX	No	No
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014		RX	Yes	Yes	7,837,235*PED				Y
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015		RX	Yes	Yes	7,396,341*PED				Y
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	AB	RX	Yes	Yes	9,010,323		Y
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015		RX	Yes	Yes	8,733,341*PED				Y

Expired US Patents for TIOTROPIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015	6,846,413*PED
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015	7,246,615
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014	6,726,124*PED
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015	7,988,001*PED
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014	6,846,413*PED
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	7,070,800*PED
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	RE39820*PED

International Patents for TIOTROPIUM BROMIDE

Country	Patent Number	Title	Estimated Expiration
Canada	2651190	PULVERISATEUR ET PROCEDE DE PULVERISATION D'UN FLUIDE (ATOMIZER AND METHOD OF ATOMIZING FLUID)
Hong Kong	1093175	MICROSTRUCTURED HIGH PRESSURE NOZZLE WITH AN IN-BUILT FILTER FUNCTION, SPRAYER WITH THE NOZZLE AND MANUFACTURING METHOD OF THE NOZZLE
Cyprus	1111564
Montenegro	00797	SREDSTVO ZA DRŽANJE FLUIDNE KOMPONENTE (DEVICE FOR HOLDING A FLUIDIC COMPONENT)
Japan	4382097
Peru	20050026	BOQUILLA MICROESTRUCTURADA DE ALTA PRESION CON FUNCION DE FILTRO INCORPORADA
Brazil	0309117	Kit de inalação compreendendo pó inalável de tiotropium

Supplementary Protection Certificates for TIOTROPIUM BROMIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0418716	0290010-8	Sweden		PRODUCT NAME: TIOTROPIUM, 3BETA-(DI(2-TIENYL)HYDROXIACETOXI)-6BETA,7BETA-EPO XI-8METYL-1ALFAH,5ALFAH-TROPANIUM, ELLER ETT SALT DAERAV; NAT. REGISRTATION NO/DATE: 18094 20020503; FIRST REGISTRATION: NL RVG 26 191 20011009
0418716	300084	Netherlands		PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716	SPC/GB02/036	United Kingdom		PRODUCT NAME: SCOPINE DI-(2-THIENYL)GLYCOLATE IN THE FORM OF THE QUATERNARY SALTS - ESPECIALLY SALTS OF TIOTROPIUM - PREFERRED TIOTROPIUMBROMIDE AND TIOTROPIUMBROMIDE MONOHYDRATE; REGISTERED: NL RVG26191 20011009; UK PL14598/0062 20020514
0418716	C300084	Netherlands		PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716	05C0039	France		PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009

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