Orange Book product · Brand (NDA)
BREZTRI AEROSPHERE
BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
At a glance
Jul 23, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 23, 2020
6 yr ago
Today
Patent 10716753 expires
Listed drug product patent expiration.
May 28, 2030
in 4 yr
Patent 8324266 expires
Listed method-of-use patent (U-2889) expiration.
May 28, 2030
in 4 yr
Patent 8703806 expires
Listed method-of-use patent (U-2889) expiration.
May 28, 2030
in 4 yr
Patent 8808713 expires
Listed drug product patent expiration.
May 28, 2030
in 4 yr
Patent 9415009 expires
Listed method-of-use patent (U-2889) expiration.
May 28, 2030
in 4 yr
Patent 9463161 expires
Listed drug product patent expiration.
May 28, 2030
in 4 yr
Patent 8815258 expires
Listed method-of-use patent (U-2889) expiration.
Mar 17, 2031
in 4 yr 10 mo
Patent 11331442 expires
Listed drug product patent expiration.
Oct 05, 2038
in 12 yr 6 mo
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 familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10716753 | May 28, 2030 | in 4 yr | ProductU-2889 |
| 8324266 | May 28, 2030 | in 4 yr | U-2889 |
| 8703806 | May 28, 2030 | in 4 yr | U-2889 |
| 8808713 | May 28, 2030 | in 4 yr | ProductU-2889 |
| 9415009 | May 28, 2030 | in 4 yr | U-2889 |
| 9463161 | May 28, 2030 | in 4 yr | ProductU-2889 |
| 8815258 | Mar 17, 2031 | in 4 yr 10 mo | U-2889 |
| 11331442 | Oct 05, 2038 | in 12 yr 6 mo | Product |
| 11833292 | Oct 05, 2038 | in 12 yr 6 mo | Product |

