Viewing data from:

SPIRIVA

NDA

TIOTROPIUM BROMIDE | N021395 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expired (1)TodayPED (+6 mo)

2026

Today

8022082

Jul. 19, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. et al v. LUPIN ATLANTIS HOLDINGS SA et al 3:2018cv16708 4 patentsANDA 211287tiotropium bromide	D.N.J.	2018-11-30	Terminated 2019-03-15	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Boehringer Ingelheim Pharmaceuticals, Inc. (Ropes & Gray, LLP) - Citizen Peti... FDA-2012-P-1072 · 6 docket documents Boehringer Ingelheim Pharmaceuticals, Inc. filed this citizen petition on October 13, 2012, requesting that the FDA adopt specific requirements for review and approval of proposed generic and follow-on versions of SPIRIVA HandiHaler (tiotropium bromide) under Sections 505(j) and 505(b)(2) of the Fed	505(q)	2012-11-15	Partially Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

278 trials from ClinicalTrials.gov, 249 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety of 3 Doses of Tiotropium Compared to Placebo in Adolescents (12 to 17 Yrs) With Moderate Asthma NCT01122680	Phase 2	Completed	Boehringer Ingelheim	105	2010-05
Bioavailability of Tiotropium + Olodaterol Fixed-dose Combination (5 μg/ 5 μg) in Chinese COPD Patients NCT02969317	Phase 1	Completed	Boehringer Ingelheim	12	2017-02-24 → 2017-06-15
Pharmacokinetics and Safety Comparison of Tiotropium Inhalation Powder Administered as the Bromide Salt From Hard Polyethylene Capsule Via the HandiHaler® 2 and Spiriva® HandiHaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)NCT02242266	Phase 2	Completed	Boehringer Ingelheim	121	2005-07-28
A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)NCT01372410	Phase 2	Completed	GlaxoSmithKline	163	2011-07-01 → 2011-10-27
Evaluating the Control of COPD Symptoms in Patients Treated With Tiotropium Bromide 18mcg Once Daily Alone, ADOAIR 50/250mcg Twice Daily Alone or ADOAIR 50/250mcg Plus Tiotropium Bromide 18mcg NCT01762800	Phase 4	Completed	GlaxoSmithKline	407	2013-02 → 2015-09
Study to Evaluate Efficacy and Safety of Inhaled BEA 2180 BR in COPD Patients NCT02242279	Phase 2	Completed	Boehringer Ingelheim	37	2004-06
Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With Reference NCT03302065	Phase 1	Completed	Solventum US LLC	38	2016-05 → 2017-01
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in COPD NCT00239447	Phase 3	Completed	Boehringer Ingelheim	131	2002-11-26 → 2004-04-29
Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg NCT00350207	Phase 2	Completed	Boehringer Ingelheim	388	2006-07
A Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent Inhalation Aerosol in COPD Patients.NCT00359788	Phase 4	Completed	Boehringer Ingelheim	349	2006-07

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$11.69

per ea

Lowest NADAC/Unit

$10.62

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00597007575SPIRIVA HANDIHALER 18 MCG CAP	$11.69	EA	Brand	—	2026-06-17
00597007547SPIRIVA HANDIHALER 18 MCG CAP	$10.62	EA	Brand	—	2026-06-17
00597007541SPIRIVA HANDIHALER 18 MCG CAP	$10.62	EA	Brand	$11.68	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$37.27

Highest Price

$998.46

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00597-0075-47SPIRIVA 18MCG CAP/HANDIHALER (NEW)	$998.46	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0075-47SPIRIVA 18MCG CAP/HANDIHALER (NEW)	$816.05	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0075-75SPIRIVA 18MCG CAP/HANDIHALER (NEW)	$37.27	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0075-75SPIRIVA 18MCG CAP/HANDIHALER (NEW)	$37.27	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0075-41SPIRIVA 18MCG CAP/HANDIHALER (NEW)	$332.82	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0075-41SPIRIVA 18MCG CAP/HANDIHALER (NEW)	$277.37	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain10 active DMFs3 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

INDUSTRIALE CHIMICA SRLTIOTROPIUM BROMIDE

DMF 271202013

TAPI NL BVTIOTROPIUM BROMIDE

DMF 275242013

WAVELENGTH ENTERPRISES LTDTIOTROPIUM BROMIDE MONOHYDRATE

DMF 281612013

CERBIOS PHARMA SATIOTROPIUM BROMIDE

DMF 288202015

LUPIN LTDTIOTROPIUM BROMIDE MONOHYDRATE

DMF 297262016

INKE SATIOTROPIUM BROMIDE MONOHYDRATE (MICRONIZED AND NON-MICRONIZED)

DMF 344102020

VAMSI LABS LTDTIOTROPIUM BROMIDE MONOHYDRATE

DMF 348082020

CERBIOS PHARMA SATIOTROPIUM BROMIDE MONOHYDRATE

DMF 362812021

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTIOTROPIUM BROMIDE MONOHYDRATE

DMF 409932025

BREATHGREEN PHARMACEUTICAL CO LTDTIOTROPIUM BROMIDE MONOHYDRATE

DMF 410342024

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveTIOTROPIUM BROMIDE MONOHYDRATE

DMF 181352005

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveTIOTROPIUM BROMIDE MONOHYDRATE

DMF 219392008

NEULAND LABORATORIES LTDInactiveTIOTROPIUM BROMIDE

DMF 224862009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Jan 2, 2025	SUPPL -78	View Letter (PDF)
Feb 2, 2018	SUPPL -48	View Letter (PDF)
Jun 24, 2016	SUPPL -44	View Letter (PDF)
Dec 14, 2015	SUPPL -40	View Letter (PDF)
Aug 1, 2011	SUPPL -33	View Letter (PDF)
Dec 24, 2009	SUPPL -29	View Letter (PDF)
Mar 19, 2009	SUPPL -14	View Letter (PDF)
Nov 18, 2008	SUPPL -27	View Letter (PDF)
Jun 25, 2008	SUPPL -22	View Letter (PDF)
Dec 28, 2006	SUPPL -8	View Letter (PDF)
Dec 28, 2006	SUPPL -15	View Letter (PDF)
Sep 25, 2006	SUPPL -7	View Letter (PDF)
Aug 25, 2004	SUPPL -1	View Letter (PDF)
Mar 16, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.018MG BASE/INH

RLDAB

1 patent0 exclusivities▴

POWDER;INHALATION | Approved: Jan 30, 2004

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8022082	Jan 19, 2026PED: Jul 19, 2026	PED	—	Yes		—