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 sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred patent family members in fifty-two countries.

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

DrugPatentWatch^® Generic Entry Outlook for Spiriva

Spiriva was eligible for patent challenges on January 30, 2008.

Annual sales in 2019 were $3.0bn, indicating a strong incentive for generic entry (peak sales were $4.4bn in 2013).

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SPIRIVA

International Patents:	300
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	106
Patent Applications:	4,081
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

Anatomical Therapeutic Chemical (ATC) Classes for SPIRIVA

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 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 nine US patents.

Patents protecting SPIRIVA

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		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	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004		RX	Yes	Yes					Y
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004		RX	Yes	Yes					Y
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015		RX	Yes	Yes

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
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004

International Patents for SPIRIVA

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

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	27303
Spain	2227268
Portugal	95312	PROCESSO PARA A PREPARACAO DE NOVOS TIENILCARBOXILATOS DE AMINOALCOOIS E DOS SEUS PRODUTOS DE QUATERNIZACAO, E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM
Denmark	1487832
Taiwan	I312688

Supplementary Protection Certificates for SPIRIVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	05C0039	France		PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009