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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Striverdi Respimat (2023)

Total Spending

$5.1M

Total Claims

12,820

Beneficiaries

3,476

Avg Cost/Unit

$65.22

Spending Trend

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

YoY Change:+3.9%

5yr CAGR:+4.5%

Source: CMS Medicare Part D Spending by Drug (2023). 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	—	—	—