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 seven patents protecting this drug.

This drug has one hundred and sixty-seven patent family members in forty-four countries.

The generic ingredient in SPIRIVA RESPIMAT 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 Respimat

Indicators of Generic Entry

Summary for SPIRIVA RESPIMAT

International Patents:	167
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	27
Patent Applications:	3,500
Drug Prices:	Drug price information 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
Nephron Pharmaceuticals Corporation	Phase 2

See all SPIRIVA RESPIMAT clinical trials

Pharmacology for SPIRIVA RESPIMAT

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for SPIRIVA RESPIMAT

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

US Patents and Regulatory Information for SPIRIVA RESPIMAT

SPIRIVA RESPIMAT is protected by seven US patents.

Patents protecting SPIRIVA RESPIMAT

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	021936-002	Sep 15, 2015		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
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	021936-001	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

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	021936-001	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
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
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
Germany	10017443
Bulgaria	102540
Australia	4829993
Canada	2232151	DISPOSITIF, SOUS FORME MINIATURE, DESTINE A PRODUIRE UNE PRESSION ELEVEE DANS UN FLUIDE A ATOMISER (DEVICE OF MINIATURISED CONSTRUCTION FOR PRODUCING HIGH PRESSURE IN A FLUID TO BE ATOMISED)
European Patent Office	0860210	Buse pour utilisation dans un dispositif de pulvérisation (A nozzle assembly for use in a spray generating device)
European Patent Office	1493492	Buse à microstructure pour haute pression avec fonction de filtrage (Microstructured high-pressure nozzle with integrated filter function)
New Zealand	320179	DEVICE OF MINIATURISED CONSTRUCTION FOR PRODUCING HIGH PRESSURE IN A FLUID TO BE ATOMISED

Supplementary Protection Certificates for SPIRIVA RESPIMAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
0418716	300084	Netherlands		PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009