Viewing data from:

COMBIVENT RESPIMAT

NDA

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | N021747 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents (4 delisted) by expiration date

Expiring < 1yr (2)Active (2)TodayDelisted

4 patents delisted from Orange Book — may indicate settlement, invalidation, or voluntary withdrawal

2027

2028

2029

2030

2031

Today

7396341

Oct. 10, 2026Delisted

7837235

Mar. 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 from PACER

Case	Court	Filed	Status	Judge
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. et al v. ANOBRI PHARMACEUTICALS US, LLC et al 2:2023cv03531 6 patentsANDA 216580ipratropium bromide and albuterol inhalation spray	D.N.J.	2023-06-29	Terminated 2023-12-18	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Crossover Study in the Treatment of Patients With COPD NCT00462540	Phase 3	Completed	Dey	100	2007-05 → 2007-10
Acute Bronchodilator Effect of Inhaled Albuterol Sulfate and Ipratropium Bromide in Patients With Stable COPD NCT03480997	Phase 1	Completed	Pneuma Respiratory, Inc	46	2016-12-27 → 2017-04-28

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

$124.21

per gm

Lowest NADAC/Unit

$124.21

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00597002402COMBIVENT RESPIMAT 20-100 MCG	$124.21	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

$367.81

Highest Price

$395.93

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00597-0024-02COMBIVENT RESPIMAT/EQ 0.1/0.2MG INHALER	$395.93	FSS	Boehringer Ingelheim Pharmaceuticals, Inc.	09/14/2027
00597-0024-02COMBIVENT RESPIMAT/EQ 0.1/0.2MG INHALER	$367.81	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 Combivent Respimat (2024)

Total Spending

$387.9M

Total Claims

602,035

Beneficiaries

154,264

Avg Cost/Unit

$121.11

Spending Trend

$508.2M(2019)→$546.3M(2020)→$520.3M(2021)→$484.6M(2022)→$456.4M(2023)→$387.9M(2024)

YoY Change:-3.3%

5yr CAGR:+2.7%

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Sep 29, 2020	SUPPL -20	View Letter (PDF)
Jun 10, 2016	SUPPL -13	View Letter (PDF)
Feb 1, 2016	SUPPL -10	View Letter (PDF)
Oct 22, 2014	SUPPL -5	View Letter (PDF)
Aug 31, 2012	SUPPL -1	View Letter (PDF)
Oct 12, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.1MG BASE/INH;0.02MG/INH

RLD

4 patents0 exclusivities▴

SPRAY, METERED;INHALATION | Approved: Oct 7, 2011

Patents (4)

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