Assyro AI

Orange Book product · Brand (NDA)

BREZTRI AEROSPHERE

BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

Brand (NDA)NDA 212122RX ASTRAZENECA AB

At a glance

Jul 23, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

9

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 23, 2020

    6 yr ago

  2. Today

  3. Patent 10716753 expires

    Listed drug product patent expiration.

    May 28, 2030

    in 4 yr

  4. Patent 8324266 expires

    Listed method-of-use patent (U-2889) expiration.

    May 28, 2030

    in 4 yr

  5. Patent 8703806 expires

    Listed method-of-use patent (U-2889) expiration.

    May 28, 2030

    in 4 yr

  6. Patent 8808713 expires

    Listed drug product patent expiration.

    May 28, 2030

    in 4 yr

  7. Patent 9415009 expires

    Listed method-of-use patent (U-2889) expiration.

    May 28, 2030

    in 4 yr

  8. Patent 9463161 expires

    Listed drug product patent expiration.

    May 28, 2030

    in 4 yr

  9. Patent 8815258 expires

    Listed method-of-use patent (U-2889) expiration.

    Mar 17, 2031

    in 4 yr 10 mo

  10. Patent 11331442 expires

    Listed drug product patent expiration.

    Oct 05, 2038

    in 12 yr 6 mo

  11. 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;0.009MG/INH

Dosage form

AEROSOL, METERED

Route

INHALATION

TE code

Not listed

Application

NDA 212122

Product number

001

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.

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-2889
8324266May 28, 2030in 4 yr
U-2889
8703806May 28, 2030in 4 yr
U-2889
8808713May 28, 2030in 4 yr
ProductU-2889
9415009May 28, 2030in 4 yr
U-2889
9463161May 28, 2030in 4 yr
ProductU-2889
8815258Mar 17, 2031in 4 yr 10 mo
U-2889
11331442Oct 05, 2038in 12 yr 6 mo
Product
11833292Oct 05, 2038in 12 yr 6 mo
Product
Agent CTA Background

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