Question 1

Is there a generic for Albuterol sulfate; ipratropium bromide?

Accepted Answer

Yes. The FDA Orange Book lists 9 approved generic (ANDA) applications for Albuterol sulfate; ipratropium bromide, referencing the brand COMBIVENT RESPIMAT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Albuterol sulfate; ipratropium bromide?

Accepted Answer

COMBIVENT RESPIMAT (NDA 021747, BOEHRINGER INGELHEIM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Albuterol sulfate; ipratropium bromide?

Accepted Answer

The Orange Book lists 4 patents against Albuterol sulfate; ipratropium bromide products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Albuterol sulfate; ipratropium bromide are approved?

Accepted Answer

Albuterol sulfate; ipratropium bromide is approved in the following dosage forms: aerosol, metered, solution, spray, metered.

Product	Applicant	Application	TE	Approved
COMBIVENT RESPIMATRLD	BOEHRINGER INGELHEIM	NDA 021747	—	Oct 07, 2011
DUONEBRLD	PHARMOBEDIENT	NDA 020950	—	Mar 21, 2001
COMBIVENT	BOEHRINGER INGELHEIM	NDA 020291	—	Oct 24, 1996

Product	Applicant	Application	TE	Approved
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	LUOXIN AUROVITAS	ANDA 206532	—	Jul 08, 2020
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	SUN PHARM	ANDA 207875	AN	Aug 07, 2017
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	RITEDOSE CORP	ANDA 202496	AN	Oct 01, 2012
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	APOTEX INC	ANDA 077117	—	Dec 31, 2007
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	CIPLA	ANDA 077559	AN	Dec 31, 2007
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	NEPHRON	ANDA 076749	AN	Dec 31, 2007
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	TEVA PHARMS	ANDA 076724	—	Dec 31, 2007
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	WATSON LABS TEVA	ANDA 077063	—	Dec 31, 2007
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	AIPING PHARM INC	ANDA 076867	—	Dec 21, 2006

Patent	Expires	In	Type
7396341	Oct 10, 2026	in 4 mo	ProductDelisted
9027967	Mar 31, 2027	in 10 mo	ProductDelisted
7837235	Mar 13, 2028	in 1 yr 9 mo	ProductDelisted
8733341	Oct 16, 2030	in 4 yr 5 mo	ProductDelisted

Albuterol sulfate; ipratropium bromide

Brand (NDA) products · aerosol, metered, solution, spray, metered

Generic (ANDA) products (9)

Listed patents (4)

Albuterol sulfate; ipratropium bromide — frequently asked questions

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