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FDA Orange Book · active-ingredient family

Aclidinium bromide; formoterol fumarate

Aclidinium bromide; formoterol fumarate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:DUAKLIR PRESSAIR · NDA 210595

1

Brand (NDA)

0

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · powder, metered

ProductApplicantApplicationTEApproved
DUAKLIR PRESSAIRRLDAZURITYNDA 210595—Mar 29, 2019

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10085974Mar 13, 2029in 2 yr 9 mo
ProductU-2513
11000517Mar 13, 2029in 2 yr 9 mo
ProductU-2513

Aclidinium bromide; formoterol fumarate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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