Viewing data from:

STIOLTO RESPIMAT

NDA

OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | N206756 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents (4 delisted) by expiration date

Expiring < 1yr (3)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

7727984

Jan. 19, 2027

7396341

Apr. 10, 2027Delisted

7837235

Sep. 13, 2028Delisted

8733341

Oct. 16, 2030Delisted

9027967

Mar. 31, 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 2:2024cv09135 4 patentsANDA 218956tiotropium bromide and olodaterol hydrochloride	D.N.J.	2024-09-12	Active	—

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
Ultra-long Acting Bronchodilator Therapy in Smoking Asthmatics NCT02682862	Phase 4	Completed	University of Dundee	17	2016-07-11 → 2019-05-22

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

$115.81

per gm

Lowest NADAC/Unit

$115.81

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00597015561STIOLTO RESPIMAT INHALER (60)	$115.81	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

$40.14

Highest Price

$312.89

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00597-0155-61STIOLTO RESPIMAT 2.5MCG/2.5MCG INHL	$312.89	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0155-61STIOLTO RESPIMAT 2.5MCG/2.5MCG INHL	$312.89	Big4	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0155-70STIOLTO RESPIMAT	$45.01	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0155-70STIOLTO RESPIMAT	$40.14	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 Stiolto Respimat (2024)

Total Spending

$448.6M

Total Claims

695,441

Beneficiaries

167,334

Avg Cost/Unit

$113.32

Spending Trend

$221.4M(2019)→$265.0M(2020)→$345.6M(2021)→$387.1M(2022)→$432.3M(2023)→$448.6M(2024)

YoY Change:-4.2%

5yr CAGR:+2.2%

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jan 2, 2025	SUPPL -36	View Letter (PDF)
Jun 4, 2019	SUPPL -11	View Letter (PDF)
Oct 15, 2018	SUPPL -9	View Letter (PDF)
Jun 10, 2016	SUPPL -6	View Letter (PDF)
Mar 22, 2016	SUPPL -2	View Letter (PDF)
Jun 18, 2015	SUPPL -1	View Letter (PDF)
May 21, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH

RLD

5 patents0 exclusivities▴

SPRAY, METERED;INHALATION | Approved: May 21, 2015

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7396341	Oct 10, 2026PED: Apr 10, 2027	PED	—	Yes	—	Delisted
7727984	Jan 19, 2027	—	Yes	—	—	—
7837235	Mar 13, 2028PED: Sep 13, 2028	PED	—	Yes	—	Delisted
8733341	Oct 16, 2030	—	—	Yes	—	Delisted
9027967	Mar 31, 2027	—	—	Yes	—	Delisted