Viewing data from:

SPIRIVA RESPIMAT

NDA

TIOTROPIUM BROMIDE | N021936 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC

2 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents (4 delisted) by expiration date

Expiring < 1yr (2)Active (2)TodayPED (+6 mo)Delisted

4 patents delisted from Orange Book — may indicate settlement, invalidation, or voluntary withdrawal

2027

2028

2029

2030

2031

Today

7396341

Apr. 10, 2027Delisted

7837235

Sep. 13, 2028Delisted

8733341

Apr. 16, 2031Delisted

9027967

Sep. 30, 2027Delisted

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 (1 active) from PACER

Case	Court	Filed	Status	Judge
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. et al v. ANOBRI PHARMACEUTICALS US, LLC 2:2023cv03530 6 patentsANDA 216581tiotropium bromide inhalation spray	D.N.J.	2023-06-29	Active	—

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 | 1 NDC

Highest NADAC/Unit

$126.16

per gm

Lowest NADAC/Unit

$126.16

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00597010061SPIRIVA RESPIMAT 2.5 MCG INH	$126.16	GM	Brand	—	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$27.92

Highest Price

$411.68

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00597-0100-51SPIRIVA RESPIMAT	$35.18	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0100-51SPIRIVA RESPIMAT	$27.92	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0100-61SPIRIVA RESPIMAT 2.5MCG 60 METERED INHALATION	$411.68	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0100-61SPIRIVA RESPIMAT 2.5MCG 60 METERED INHALATION	$392.80	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027

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

Medicare Part D Spending

CMS annual spending data for Spiriva Respimat (2024)

Total Spending

$877.2M

Total Claims

1,276,042

Beneficiaries

327,575

Avg Cost/Unit

$119.52

Spending Trend

$671.2M(2019)→$804.6M(2020)→$856.8M(2021)→$891.5M(2022)→$923.6M(2023)→$877.2M(2024)

YoY Change:-3.1%

5yr CAGR:+2.8%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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

5 letters from Drugs@FDA

Date	Submission	Document
Dec 30, 2024	SUPPL -36	View Letter (PDF)
Feb 21, 2019	SUPPL -12	View Letter (PDF)
Jun 10, 2016	SUPPL -5	View Letter (PDF)
Jan 20, 2016	SUPPL -3	View Letter (PDF)
Sep 26, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 0.0025MG BASE/INH

RLD

4 patents0 exclusivities▴

SPRAY, METERED;INHALATION | Approved: Sep 24, 2014

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7396341	Oct 10, 2026PED: Apr 10, 2027	PED	—	Yes	—	Delisted
7837235	Mar 13, 2028PED: Sep 13, 2028	PED	—	Yes	—	Delisted
8733341	Oct 16, 2030PED: Apr 16, 2031	PED	—	Yes	—	Delisted
9027967	Mar 31, 2027PED: Sep 30, 2027	PED	—	Yes	—	Delisted

#002 — EQ 0.00125MG BASE/INH

RLD

0 patents0 exclusivities▾

SPRAY, METERED;INHALATION | Approved: Sep 15, 2015