SPIRIVA RESPIMAT Drug Patent Profile

Which patents cover Spiriva Respimat, and what generic alternatives are available?

Spiriva Respimat is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighteen patent family members in thirty-six countries.

The generic ingredient in SPIRIVA RESPIMAT 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 Spiriva Respimat

A generic version of SPIRIVA RESPIMAT was approved as tiotropium bromide by LUPIN on June 20^th, 2023.

Summary for SPIRIVA RESPIMAT

International Patents:	118
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	27
Patent Applications:	3,419
Drug Prices:	Drug price information for SPIRIVA RESPIMAT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPIRIVA RESPIMAT
What excipients (inactive ingredients) are in SPIRIVA RESPIMAT?	SPIRIVA RESPIMAT excipients list
DailyMed Link:	SPIRIVA RESPIMAT at DailyMed

See drug prices for SPIRIVA RESPIMAT

Recent Clinical Trials for SPIRIVA RESPIMAT

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

Sponsor	Phase
University of Saskatchewan	Phase 4
Nemours Children's Clinic	Phase 2
Rho, Inc.	Phase 2

See all SPIRIVA RESPIMAT clinical trials

Pharmacology for SPIRIVA RESPIMAT

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Paragraph IV (Patent) Challenges for SPIRIVA RESPIMAT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPIRIVA RESPIMAT	Inhalation Aerosol	tiotropium bromide	2.5 mcg per actuation	021936	1	2023-03-07

US Patents and Regulatory Information for SPIRIVA RESPIMAT

SPIRIVA RESPIMAT is protected by six 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	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015		RX	Yes	Yes					Y
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014		RX	Yes	Yes					Y
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015		RX	Yes	Yes					Y
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014		RX	Yes	Yes					Y

Expired US Patents for SPIRIVA RESPIMAT

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
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015

International Patents for SPIRIVA RESPIMAT

See the table below for patents covering SPIRIVA RESPIMAT around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2003255479	BLOCKING DEVICE FOR A SPRUNG LOCK WITH A SPRING OPERATION
Austria	357956
Greece	3031558
Denmark	0869825

Supplementary Protection Certificates for SPIRIVA RESPIMAT

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

SPIRIVA RESPIMAT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SPIRIVA RESPIMAT

Introduction

SPIRIVA RESPIMAT, developed by Boehringer Ingelheim, is a significant player in the respiratory therapeutics market, particularly for the treatment of Chronic Obstructive Pulmonary Disease (COPD) and, more recently, severe persistent asthma. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The global respiratory inhalers market, which includes SPIRIVA RESPIMAT, is projected to grow substantially. By 2028, the market is expected to reach $43.44 billion, growing at a CAGR of 5.7% from 2022 to 2028[4].

Product Overview

SPIRIVA RESPIMAT contains the long-acting muscarinic antagonist (LAMA) tiotropium bromide. It is approved for the long-term, once-daily maintenance treatment of COPD and, in some regions, for severe persistent asthma as an add-on treatment to high-dose inhaled corticosteroids (ICS) and long-acting beta agonists (LABA)[3][5].

Clinical Efficacy

The drug has demonstrated statistically significant improvements in lung function and a reduction in severe exacerbations in clinical trials. For patients with severe persistent asthma, SPIRIVA RESPIMAT showed a sustained bronchodilation effect over 24 hours and delayed the time to the first severe exacerbation compared to placebo[3].

Market Position

SPIRIVA RESPIMAT is a major player in the COPD therapeutics market. Despite a decline in sales in recent years, it remains a significant product for Boehringer Ingelheim. In 2021, SPIRIVA generated €1.5 billion in net sales, although this represented an 11.9% decline adjusted for currency effects[2].

Competitive Landscape

The respiratory therapeutics market is highly competitive, with several new entrants and existing products vying for market share. GSK’s Incruse Ellipta and Boehringer’s Stiolto Respimat are among the new entrants expected to gain market share during the forecast period. However, SPIRIVA RESPIMAT’s established presence and clinical efficacy continue to make it a formidable competitor[1].

Regional Performance

SPIRIVA RESPIMAT performs well across various regions. In the U.S., it is one of the key products for Boehringer Ingelheim, contributing to the company’s strong growth in the Human Pharma segment. In Japan, the drug also shows solid performance, driven by the Human Pharma portfolio[2].

Financial Performance

Boehringer Ingelheim’s financial performance is closely tied to the success of its key products, including SPIRIVA RESPIMAT. Despite the decline in SPIRIVA sales, the company reported a successful year in 2021 with net sales of €20.6 billion, a 7.5% growth over the previous year. The Human Pharma segment, which includes SPIRIVA RESPIMAT, saw an 8.4% growth in net sales[2].

Challenges and Opportunities

One of the challenges facing SPIRIVA RESPIMAT is the decline in sales due to patent expiry and increased competition from new market entrants. However, the drug’s approval for additional indications, such as severe persistent asthma, presents new opportunities for growth. The growing demand for portable inhalers, which offer convenience and ease of use, also bodes well for SPIRIVA RESPIMAT[4].

Safety and Side Effects

While SPIRIVA RESPIMAT has a favorable risk-benefit profile, it is associated with certain side effects, including upper respiratory tract infections, dry mouth, sinus infections, and urinary retention. These factors need to be managed to maintain patient compliance and market share[5].

Regulatory Approvals

SPIRIVA RESPIMAT has received regulatory approvals in several regions, including the U.S. and Canada. In Canada, it was approved as the first LAMA for the treatment of severe persistent asthma, highlighting its clinical significance[3][5].

Future Outlook

The future outlook for SPIRIVA RESPIMAT is mixed. While it faces challenges from new competitors and patent expiries, its established brand and expanding indications offer potential for continued market presence. Boehringer Ingelheim’s continuous investments in R&D and its global supply network are expected to support the drug’s performance in the coming years[2].

Key Takeaways

• Market Growth: The global respiratory inhalers market is expected to grow at a CAGR of 5.7% to reach $43.44 billion by 2028.
• Clinical Efficacy: SPIRIVA RESPIMAT has shown significant improvements in lung function and reduction in severe exacerbations.
• Market Position: Despite a decline in sales, SPIRIVA RESPIMAT remains a major player in the COPD therapeutics market.
• Competitive Landscape: The market is highly competitive, with new entrants and existing products competing for market share.
• Financial Performance: Boehringer Ingelheim’s financial performance is strong, with the Human Pharma segment showing significant growth.
• Challenges and Opportunities: Patent expiry and competition are challenges, but new indications and growing demand for portable inhalers offer opportunities.

FAQs

Q: What is the expected market size of the global respiratory inhalers market by 2028? A: The global respiratory inhalers market is expected to reach $43.44 billion by 2028[4].

Q: What is the primary active ingredient in SPIRIVA RESPIMAT? A: The primary active ingredient in SPIRIVA RESPIMAT is tiotropium bromide, a long-acting muscarinic antagonist (LAMA)[3].

Q: For which conditions is SPIRIVA RESPIMAT approved? A: SPIRIVA RESPIMAT is approved for the long-term, once-daily maintenance treatment of COPD and, in some regions, for severe persistent asthma as an add-on treatment[3][5].

Q: What are the common side effects associated with SPIRIVA RESPIMAT? A: Common side effects include upper respiratory tract infections, dry mouth, sinus infections, and urinary retention[5].

Q: How has the sales performance of SPIRIVA RESPIMAT been in recent years? A: SPIRIVA RESPIMAT has seen a decline in sales, with a 11.9% decline in 2021 adjusted for currency effects[2].

Sources

1. Global Asthma and COPD Therapeutics Market $44.1 Billion by 2031 - iHealthcareAnalyst
2. Annual Results Press Conference 2022 - Boehringer Ingelheim
3. Regulatory Decision Summary for Spiriva Respimat - Health Canada
4. Respiratory Inhalers Market to Grow at 5.7% CAGR to Reach $43.44 ... - The Insight Partners
5. SPIRIVA® RESPIMAT® (tiotropium bromide) Inhalation Spray Now ... - PR Newswire