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

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 Spiriva Respimat (2023)

Total Spending

$923.6M

Total Claims

1,313,138

Beneficiaries

333,929

Avg Cost/Unit

$123.39

Spending Trend

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

YoY Change:+3.8%

5yr CAGR:+5.1%

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