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FDA Orange Book · active-ingredient family

Budesonide; formoterol fumarate; glycopyrrolate

Budesonide; 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:BREZTRI AEROSPHERE · NDA 212122

1

Brand (NDA)

0

Generics (ANDA)

9

Listed patents

1

Exclusivity periods

Brand (NDA) products · aerosol, metered

ProductApplicantApplicationTEApproved
BREZTRI AEROSPHERERLD×2ASTRAZENECA ABNDA 212122—Jul 23, 2020

Marketing exclusivity (1)

  • NSNew strength exclusivity (3 years)

    Apr 27, 2029

    in 2 yr 11 mo

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8703806May 28, 2030in 4 yr
U-2889
8808713May 28, 2030in 4 yr
ProductU-2889
8324266May 28, 2030in 4 yr
U-2889
9415009May 28, 2030in 4 yr
U-2889
10716753May 28, 2030in 4 yr
ProductU-2889
9463161May 28, 2030in 4 yr
ProductU-2889
8815258Mar 17, 2031in 4 yr 10 mo
U-2889
11833292Oct 05, 2038in 12 yr 6 mo
Product
11331442Oct 05, 2038in 12 yr 6 mo
Product

Budesonide; formoterol fumarate; glycopyrrolate — frequently asked questions

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

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