Orange Book product · Brand (NDA)
AIRSUPRA
ALBUTEROL SULFATE; BUDESONIDE
At a glance
Jan 10, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 10, 2023
3 yr 6 mo ago
Exclusivity ends · NP
New product exclusivity (3 years)
Jan 10, 2026
5 mo ago
Today
Exclusivity ends · M-317
New use / labeling-change exclusivity (3 years)
Sep 15, 2028
in 2 yr 3 mo
Patent 9415009 expires
Listed method-of-use patent (U-3509) expiration.
May 28, 2030
in 4 yr
Pharmaceutical detail
Active ingredient
ALBUTEROL SULFATE; BUDESONIDE
Strength
EQ 0.09MG BASE/INH;0.08MG/INH
Dosage form
AEROSOL, METERED
Route
INHALATION
TE code
Not listed
Application
NDA 214070
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 (2)
- NPNew product exclusivity (3 years)
Jan 10, 2026
5 mo ago
- M-317New use / labeling-change exclusivity (3 years)
Sep 15, 2028
in 2 yr 3 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9415009 | May 28, 2030 | in 4 yr | U-3509 |
