Viewing data from:

STRIVERDI RESPIMAT

NDA

OLODATEROL HYDROCHLORIDE | N203108 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expiring < 1yr (1)Today

2027

Today

7727984

Jan. 19, 2027

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

34 trials from ClinicalTrials.gov, 34 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I NCT00793624	Phase 3	Completed	Boehringer Ingelheim	906	2009-02
Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease II NCT00796653	Phase 3	Completed	Boehringer Ingelheim	937	2009-01
Comparing the Efficacy of Tiotropium + Olodaterol Fixed Dose Combination (FDC) Over Tiotropium in Improvement of Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese COPD Patients NCT02629965	Phase 3	Completed	Boehringer Ingelheim	184	2016-02-12 → 2017-04-17
Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.NCT02296138	Phase 3	Completed	Boehringer Ingelheim	7,903	2015-01-13 → 2017-03-29
A Study to Determine the Effect of Tiotropium + Olodaterol Fixed Dose Combination on Exercise Endurance Time During Constant Work Rate Cycle Ergometry Test in COPD NCT01525615	Phase 3	Completed	Boehringer Ingelheim	404	2012-02 → 2013-09
Tiotropium+Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)NCT01431274	Phase 3	Completed	Boehringer Ingelheim	2,624	2011-09 → 2013-09
Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients NCT01969721	Phase 3	Completed	Boehringer Ingelheim	229	2013-10 → 2015-02
Tiotropium +Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD)NCT01431287	Phase 3	Completed	Boehringer Ingelheim	2,539	2011-09 → 2013-11
INvestigating COPD Outcomes, Genomics and Neutrophilic Inflammation With Tiotropium and Olodaterol NCT03152149	Phase 4	Completed	University of Dundee	80	2017-06-01 → 2019-11-26

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

$66.08

per gm

Lowest NADAC/Unit

$66.08

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00597019261STRIVERDI RESPIMAT INHAL SPRAY	$66.08	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$183.33

Highest Price

$185.73

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00597-0192-61STRIVERDI RESPIMAT 2.5MCG 60 METERED INHALATI	$185.73	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0192-61STRIVERDI RESPIMAT 2.5MCG 60 METERED INHALATI	$183.33	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 Striverdi Respimat (2024)

Total Spending

$4.9M

Total Claims

12,563

Beneficiaries

3,519

Avg Cost/Unit

$63.86

Spending Trend

$2.7M(2019)→$3.2M(2020)→$4.7M(2021)→$5.0M(2022)→$5.1M(2023)→$4.9M(2024)

YoY Change:-2.1%

5yr CAGR:+2.5%

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

API Supply Chain3 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

INKE SAOLODATEROL HYDROCHLORIDE

DMF 385582023

BREATHGREEN PHARMACEUTICAL CO LTDOLODATEROL HYDROCHLORIDE

DMF 389162023

BREATHGREEN PHARMACEUTICAL CO LTDOLODATEROL HYDROCHLORIDE (PROCESS 2)

DMF 424312025

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 -23	View Letter (PDF)
Jun 4, 2019	SUPPL -8	View Letter (PDF)
Apr 5, 2018	SUPPL -6	View Letter (PDF)
Jun 10, 2016	SUPPL -3	View Letter (PDF)
Aug 1, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.0025MG BASE/INH

RLD

1 patent0 exclusivities▴

SPRAY, METERED;INHALATION | Approved: Jul 31, 2014

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7727984	Jan 19, 2027	—	Yes	—	—	—