SPIRIVA Drug Patent Profile

Which patents cover Spiriva, and when can generic versions of Spiriva launch?

Spiriva is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has sixty patent family members in thirty-two countries.

The generic ingredient in SPIRIVA 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

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

Summary for SPIRIVA

International Patents:	60
US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	107
Patent Applications:	4,054
Drug Prices:	Drug price information for SPIRIVA
Drug Sales Revenues:	Drug sales revenues for SPIRIVA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPIRIVA
What excipients (inactive ingredients) are in SPIRIVA?	SPIRIVA excipients list
DailyMed Link:	SPIRIVA at DailyMed

See drug prices for SPIRIVA

See drug sales revenues for SPIRIVA

Recent Clinical Trials for SPIRIVA

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

Sponsor	Phase
Theravance Biopharma	Phase 4
Mylan Inc.	Phase 4
Nemours Children's Clinic	Phase 2

See all SPIRIVA clinical trials

Pharmacology for SPIRIVA

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Paragraph IV (Patent) Challenges for SPIRIVA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SPIRIVA	Inhalation Powder Capsules	tiotropium bromide	18 mcg	021395	1	2018-05-11

US Patents and Regulatory Information for SPIRIVA

SPIRIVA is protected by three 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	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	7,896,264*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 RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014		RX	Yes	Yes	7,837,235*PED				Y

Expired US Patents for SPIRIVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	7,642,268*PED
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	5,478,578
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	7,309,707*PED
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	RE38912*PED

International Patents for SPIRIVA

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

Country	Patent Number	Title	Estimated Expiration
Germany	4140689	Inhalationspulver und Verfahren zu ihrer Herstellung
Ecuador	SP034540	MONOHIDRATO CRISTALINO, PROCEDIMIENTO PARA SU PREPARACION Y SU UTILIZACION PARA LA PREPARACION DE UN MEDICAMENTO
Eurasian Patent Organization	004689	СПОСОБ ПОЛУЧЕНИЯ ПОРОШКОВЫХ КОМПОЗИЦИЙ (METHOD FOR PRODUCING POWDERY FORMULATIONS)
Croatia	P20030277	POSTUPAK ZA PROIZVODNJU PRAŠKASTIH FORMULACIJA (METHOD FOR PRODUCING POWDERY FORMULATIONS)

Supplementary Protection Certificates for SPIRIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0418716	05C0039	France		PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009
0418716	C300084	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	300084	Netherlands		PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009

SPIRIVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: SPIRIVA

Introduction

SPIRIVA, a blockbuster drug developed by Boehringer Ingelheim, has been a cornerstone in the treatment of Chronic Obstructive Pulmonary Disease (COPD) and other respiratory conditions. Here, we delve into the market dynamics and financial trajectory of SPIRIVA, exploring its historical performance, current market status, and future outlook.

Historical Performance

SPIRIVA was first approved by the FDA in 2004 as a COPD maintenance therapy and later in 2009 for COPD exacerbations. Another formulation, SPIRIVA Respimat, was approved in 2014 for COPD and in 2015 for asthma[4].

Peak Sales and Market Dominance

At its peak, SPIRIVA generated significant revenue, exceeding $5 billion in sales worldwide in 2015. This success was largely due to its exclusivity in the market and strong marketing efforts by Boehringer Ingelheim[4].

Current Market Status

Sales Decline

In recent years, SPIRIVA has faced a decline in sales. For instance, in 2022, SPIRIVA recorded sales of 1.5 billion EUR, which represents an 11.9% decrease adjusted for currency effects compared to the previous year[1]. This decline is attributed to increasing competition and the onset of generic competition in Europe starting in 2021[4].

Generic Competition

A significant milestone in the market dynamics of SPIRIVA is the approval of its generic version. Lupin Ltd became the first company to receive FDA approval for a generic version of SPIRIVA HandiHaler in the U.S. in June 2023[4]. This approval marks the beginning of a new era of competition for Boehringer Ingelheim.

Market Size and Potential

The generic market for SPIRIVA is estimated to be substantial, with the U.S. market size alone projected at $700 million. Lupin is expected to capture a significant share of this market, potentially earning around $150 million with a 30% market share and a 30% discount[2].

Financial Impact

Revenue Contribution

SPIRIVA has been a major contributor to Boehringer Ingelheim's revenue. Despite the decline, it still generated $1.7 billion in sales in the previous year, with $1.3 billion of that coming from the U.S. market[4].

Profit Margins

The generic version of SPIRIVA is expected to be a high-margin product for Lupin, given its limited competition in the U.S. market. This could significantly aid Lupin's financial performance and contribute to its profitability[2].

Regional Performance

United States

The U.S. remains the largest market for SPIRIVA, accounting for a significant portion of its sales. Despite facing generic competition, the U.S. market continues to be crucial for Boehringer Ingelheim and now for Lupin as well[1][4].

Europe

The introduction of generic competition in Europe in 2021 has led to a decline in SPIRIVA's sales in this region. This trend is expected to continue as more generics enter the market[4].

Emerging Markets

In emerging markets, such as China, SPIRIVA continues to see growth, although at a slower pace. The expansion of Boehringer Ingelheim's activities in these regions, including investments in production and R&D, is expected to support future growth[1].

Regulatory and Manufacturing Challenges

FDA Approvals and Inspections

Lupin's generic version of SPIRIVA faced regulatory delays due to inspection issues at its manufacturing facility in India. The FDA cited several violations, which delayed the launch of the generic product[4].

Patent Exclusivity

Boehringer Ingelheim holds patents on SPIRIVA until 2027, according to the FDA's Orange Book database. However, the approval of Lupin's generic version indicates that these patents may not preclude the launch of generic products[4].

Future Outlook

Competitive Landscape

The approval of generic versions of SPIRIVA will significantly alter the competitive landscape. Companies like Lupin are poised to benefit from limited competition in the short term, while Boehringer Ingelheim will need to adapt its strategy to maintain market share[2][4].

Pricing Strategies

To mitigate the impact of generic competition, Boehringer Ingelheim has implemented pricing strategies, such as capping patient out-of-pocket costs for its inhalers. Starting June 1, 2024, eligible patients will pay no more than $35 a month for all Boehringer Ingelheim inhalers, including SPIRIVA[5].

Innovation and R&D

Boehringer Ingelheim continues to invest heavily in R&D, with a focus on developing new treatments and improving existing ones. This investment is crucial for maintaining a competitive edge in the market[1].

Key Takeaways

• Historical Success: SPIRIVA was a blockbuster drug with peak sales exceeding $5 billion in 2015.
• Sales Decline: Recent years have seen a decline in sales due to competition and generic entries.
• Generic Competition: Lupin's approval for a generic version marks a significant shift in the market dynamics.
• Financial Impact: SPIRIVA remains a major revenue contributor, but generic competition will impact profitability.
• Regional Performance: The U.S. is the largest market, while Europe faces declining sales due to generics.
• Regulatory Challenges: Manufacturing and regulatory issues have delayed generic launches.
• Future Outlook: The competitive landscape will change with generics, and pricing strategies will be crucial.

FAQs

What is SPIRIVA used for?

SPIRIVA is used for the long-term, once-daily maintenance treatment of patients with COPD, including chronic bronchitis and/or emphysema, and for treating bouts of wheezing, coughing, and shortness of breath[4].

Who approved the generic version of SPIRIVA?

The FDA approved Lupin Ltd's generic version of SPIRIVA HandiHaler in June 2023[4].

What is the estimated market size for the generic version of SPIRIVA in the U.S.?

The estimated market size for the generic version of SPIRIVA in the U.S. is $700 million[2].

How will Boehringer Ingelheim mitigate the impact of generic competition?

Boehringer Ingelheim is implementing pricing strategies, such as capping patient out-of-pocket costs, and continues to invest in R&D to develop new treatments[5][1].

What are the patent exclusivity details for SPIRIVA?

Boehringer Ingelheim holds patents on SPIRIVA until 2027, but the approval of generic versions indicates these patents may not preclude generic launches[4].

Sources

1. Boehringer Ingelheim - Annual Results Press Conference 2022
2. CNBC TV18 - Lupin investors await details on inhaler drug Spiriva generic
3. Pulmatrix - Zacks Initiates on Pulmatrix (NASDAQ:PULM)
4. Fierce Pharma - Lupin scores FDA nod for first generic version of BI's Spiriva
5. Boehringer Ingelheim - Boehringer Ingelheim caps patient out-of-pocket costs for its inhaler portfolio