Question 1

Is there a generic for Olodaterol hydrochloride; tiotropium bromide?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Olodaterol hydrochloride; tiotropium bromide. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Olodaterol hydrochloride; tiotropium bromide?

Accepted Answer

STIOLTO RESPIMAT (NDA 206756, 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 Olodaterol hydrochloride; tiotropium bromide?

Accepted Answer

The Orange Book lists 7 patents against Olodaterol hydrochloride; tiotropium 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 Olodaterol hydrochloride; tiotropium bromide are approved?

Accepted Answer

Olodaterol hydrochloride; tiotropium bromide is approved in the following dosage form: spray, metered.

Patent	Expires	In	Type
7396341	Oct 10, 2026	in 4 mo	ProductDelisted
7727984	Jan 19, 2027	in 7 mo	Substance
9027967	Mar 31, 2027	in 10 mo	ProductDelisted
7396341*PED	Apr 10, 2027	in 10 mo
7837235	Mar 13, 2028	in 1 yr 9 mo	ProductDelisted
7837235*PED	Sep 13, 2028	in 2 yr 3 mo
8733341	Oct 16, 2030	in 4 yr 5 mo	ProductDelisted

Olodaterol hydrochloride; tiotropium bromide

Brand (NDA) products · spray, metered

Listed patents (7)

Olodaterol hydrochloride; tiotropium bromide — frequently asked questions

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