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:	3,803
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.

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	AB	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

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

International Patents for SPIRIVA

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

Country	Patent Number	Title	Estimated Expiration
Ireland	903342
South Africa	200302500	Crystalline monohydrate, method for producing the same and the use thereof in the production of a medicament.
Argentina	034389	MONOHIDRATO CRISTALINO DE BROMURO DE TIOTROPIO, PROCEDIMIENTO PARA SU PREPARACION, SU UTILIZACIÓN PARA LA PREPARACION DE UN MEDICAMENTO, UN MEDICAMENTO QUE LO CONTIENE, LOS HIDRATOS CRISTALINOS DEL BROMURO DE TIOTROPIO Y UN PROCEDIMIENTO PARA PREPARACION DE ESTOS HIDRATOS CRISTALINOS

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	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