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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)NCT02676089	Phase 3	Completed	Chiesi Farmaceutici S.p.A.	1,437	2016-04-06 → 2018-05-28

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

Medicare Part D Spending

CMS annual spending data for Spiriva Handihaler (2023)

Total Spending

$782.9M

Total Claims

946,781

Beneficiaries

236,984

Avg Cost/Unit

$17.73

Spending Trend

$1.3B(2019)→$1.2B(2020)→$1.0B(2021)→$935.5M(2022)→$782.9M(2023)

YoY Change:+3.9%

5yr CAGR:+5.3%

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

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)

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