Orange Book product · Brand (NDA)
SYMBICORT AEROSPHERE
BUDESONIDE; FORMOTEROL FUMARATE
At a glance
Apr 28, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 28, 2023
3 yr 2 mo ago
Today
Exclusivity ends · I-988
New indication exclusivity (3 years)
Apr 27, 2029
in 2 yr 11 mo
Patent 10716753 expires
Listed drug product patent expiration.
May 28, 2030
in 4 yr
Patent 10716753 expires
Listed drug product patent expiration.
May 28, 2030
in 4 yr
Patent 9415009 expires
Listed method-of-use patent (U-3203) expiration.
May 28, 2030
in 4 yr
Patent 9415009 expires
Listed method-of-use patent (U-4513) expiration.
May 28, 2030
in 4 yr
Pharmaceutical detail
Active ingredient
BUDESONIDE; FORMOTEROL FUMARATE
Strength
0.16MG/INH;0.0048MG/INH
Dosage form
AEROSOL, METERED
Route
INHALATION
TE code
Not listed
Application
NDA 216579
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.
Marketing exclusivity (1)
- I-988New indication exclusivity (3 years)
Apr 27, 2029
in 2 yr 11 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10716753 | May 28, 2030 | in 4 yr | ProductU-3203 |
| 10716753 | May 28, 2030 | in 4 yr | ProductU-4513 |
| 9415009 | May 28, 2030 | in 4 yr | U-3203 |
| 9415009 | May 28, 2030 | in 4 yr | U-4513 |
