spiriva respimat Drug Patent Profile

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

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
Nephron Pharmaceuticals Corporation	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.

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	021936-001	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
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	021936-002	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
Hungary	0102893
Germany	10239443	Blockiervorrichtung für ein Sperrspannwerk mit federbetätigtem Abtrieb (Mechanism comprising a bent leaf spring, is useful for blocking further operation of a device after a specified number of relative rotations of parts of this device)
Eurasian Patent Organization	002787	БАЛЛОНЧИК ДЛЯ ЖИДКОСТИ (CARTRIDGE FOR A LIQUID)
Eurasian Patent Organization	000418	ЗАПОРНЫЙ МЕХАНИЗМ ДЛЯ УСТРОЙСТВА С ПРУЖИННЫМ ПРИВОДОМ (LOCKING MECHANISM FOR A SPRING-ACTUATED DEVICE)
Germany	69629708
Canada	2066248	ESTERS D'ACIDES THIOPHENECARBOXYLIQUES ET D'AMINOALCOOLS; COMPOSES QUATERNAIRES OBTENUS PAR CETTE VOIE; PRODUCTION ET UTILISATION DE CES SUBSTANCES (ESTERS OF THIENYL CARBOXYLIC ACIDS AND AMINO ALCOHOLS, THEIR QUATERNIZATION PRODUCTS, AND MANUFACTURE AND USE OF SAID COMPOUNDS)

Supplementary Protection Certificates for spiriva respimat

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	C300084	Netherlands		PRODUCT NAME: ZOUTEN VAN TRIOTROPIUM, IN HET BIJZONDER TIOTROPIUM BROMIDE; REGISTRATION NO/DATE: RVG 26191 20011009
0418716	05C0039	France		PRODUCT NAME: TIOTROPIUM MONOHYDRATE DE BROMURE; NAT. REGISTRATION NO/DATE: NL 31393 20050708; FIRST REGISTRATION: 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	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