TIOTROPIUM BROMIDE - Generic Drug Details

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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:	5,499
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
Boehringer Ingelheim	N/A
Guangzhou Institute of Respiratory Disease	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

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for TIOTROPIUM BROMIDE

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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	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	SPIRIVA	tiotropium bromide	POWDER;INHALATION	021395-001	Jan 30, 2004	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-001	Sep 24, 2014	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936-002	Sep 15, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for TIOTROPIUM BROMIDE

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Country	Patent Number	Title	Estimated Expiration
Japan	2009536051		⤷ Sign Up
Germany	102008014025	Inhalator und Sieb für einen Inhalator	⤷ Sign Up
Japan	5649980		⤷ Sign Up
Australia	2003226775	INHALATION KIT COMPRISUNG INHALABLE POWDER OF TIOTROPIUM	⤷ Sign Up
Ukraine	85865	ПРИСТРІЙ ДЛЯ КРІПЛЕННЯ СТРУМИННОЇ ДЕТАЛІ;устройство для крепления струйной детали (Device for fastening of fluidic component)	⤷ Sign Up
Croatia	P20040933	INHALATION KIT COMPRISUNG INHALABLE POWDER OF TIOTROPIUM	⤷ Sign Up
Brazil	0313816	Dispositivo de bloqueio para um mecanismo tensor de bloqueio com saìda ativada à mola	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TIOTROPIUM BROMIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0418716	05C0039	France	⤷ Sign Up	PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: RVG 26191 20011009
0418716	C300084	Netherlands	⤷ Sign Up	PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716	SPC/GB02/036	United Kingdom	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716	0290010-8	Sweden	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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