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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Combivent Respimat (2023)

Total Spending

$456.4M

Total Claims

683,764

Beneficiaries

176,341

Avg Cost/Unit

$125.19

Spending Trend

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

YoY Change:+3.7%

5yr CAGR:+5.2%

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