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FDA Orange Book · active-ingredient family

Formoterol fumarate; glycopyrrolate

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

Reference-listed drug:BEVESPI AEROSPHERE · NDA 208294

1

Brand (NDA)

0

Generics (ANDA)

7

Listed patents

0

Exclusivity periods

Brand (NDA) products · aerosol, metered

ProductApplicantApplicationTEApproved
BEVESPI AEROSPHERERLDASTRAZENECANDA 208294—Apr 25, 2016

Listed patents (7)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8324266May 28, 2030in 4 yr
U-2889
10716753May 28, 2030in 4 yr
ProductU-2889
9415009May 28, 2030in 4 yr
U-2889
8703806May 28, 2030in 4 yr
U-2889
8808713May 28, 2030in 4 yr
ProductU-2889
9463161May 28, 2030in 4 yr
ProductU-2889
8815258Mar 17, 2031in 4 yr 10 mo
U-2889

Formoterol fumarate; glycopyrrolate — frequently asked questions

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

Agent CTA Background

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