Assyro AI

Orange Book product · Brand (NDA)

BREZTRI AEROSPHERE

BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

Brand (NDA)NDA 212122RX ASTRAZENECA AB

At a glance

Apr 27, 2026

Approved

Brand (NDA)

Application

Not listed

TE code

9

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 27, 2026

    2 mo ago

  2. Today

  3. Exclusivity ends · NS

    New strength exclusivity (3 years)

    Apr 27, 2029

    in 2 yr 11 mo

  4. Patent 10716753 expires

    Listed drug product patent expiration.

    May 28, 2030

    in 4 yr

  5. Patent 8324266 expires

    Listed method-of-use patent (U-4503) expiration.

    May 28, 2030

    in 4 yr

  6. Patent 8703806 expires

    Listed method-of-use patent (U-4503) expiration.

    May 28, 2030

    in 4 yr

  7. Patent 8808713 expires

    Listed drug product patent expiration.

    May 28, 2030

    in 4 yr

  8. Patent 9415009 expires

    Listed method-of-use patent (U-4503) expiration.

    May 28, 2030

    in 4 yr

  9. Patent 9463161 expires

    Listed drug product patent expiration.

    May 28, 2030

    in 4 yr

  10. Patent 8815258 expires

    Listed method-of-use patent (U-4503) expiration.

    Mar 17, 2031

    in 4 yr 10 mo

  11. Patent 11331442 expires

    Listed drug product patent expiration.

    Oct 05, 2038

    in 12 yr 6 mo

  12. Patent 11833292 expires

    Listed drug product patent expiration.

    Oct 05, 2038

    in 12 yr 6 mo

Pharmaceutical detail

Active ingredient

BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

Strength

0.16MG/INH;0.0048MG/INH;0.018MG/INH

Dosage form

AEROSOL, METERED

Route

INHALATION

TE code

Not listed

Application

NDA 212122

Product number

002

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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
10716753May 28, 2030in 4 yr
ProductU-4503
8324266May 28, 2030in 4 yr
U-4503
8703806May 28, 2030in 4 yr
U-4503
8808713May 28, 2030in 4 yr
ProductU-4503
9415009May 28, 2030in 4 yr
U-4503
9463161May 28, 2030in 4 yr
ProductU-4503
8815258Mar 17, 2031in 4 yr 10 mo
U-4503
11331442Oct 05, 2038in 12 yr 6 mo
Product
11833292Oct 05, 2038in 12 yr 6 mo
Product
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.