Orange Book product · Brand (NDA)
EOHILIA
BUDESONIDE
At a glance
Feb 09, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 09, 2024
2 yr 5 mo ago
Today
Patent 11197822 expires
Listed drug product patent expiration.
Nov 09, 2026
in 5 mo
Patent 11413296 expires
Listed drug product patent expiration.
Nov 09, 2026
in 5 mo
Patent 8497258 expires
Listed method-of-use patent (U-3820) expiration.
Nov 09, 2026
in 5 mo
Patent 8679545 expires
Listed drug product patent expiration.
Nov 09, 2026
in 5 mo
Patent 8975243 expires
Listed method-of-use patent (U-3820) expiration.
Nov 09, 2026
in 5 mo
Patent 9119863 expires
Listed method-of-use patent (U-3820) expiration.
Nov 09, 2026
in 5 mo
Exclusivity ends · NP
New product exclusivity (3 years)
Feb 09, 2027
in 8 mo
Patent 11357859 expires
Listed method-of-use patent (U-3820) expiration.
Nov 12, 2028
in 2 yr 5 mo
Patent 10293052 expires
Listed drug product patent expiration.
Nov 22, 2028
in 2 yr 6 mo
Patent 9050368 expires
Listed drug product patent expiration.
Aug 01, 2029
in 3 yr 2 mo
Patent 8324192 expires
Listed method-of-use patent (U-3820) expiration.
Aug 03, 2029
in 3 yr 2 mo
Exclusivity ends · ODE-466
Orphan-drug exclusivity (7 years)
Feb 09, 2031
in 4 yr 9 mo
Patent 11260064 expires
Listed drug product patent expiration.
Jan 10, 2039
in 12 yr 9 mo
Patent 11564934 expires
Listed method-of-use patent (U-3820) expiration.
Jan 10, 2039
in 12 yr 9 mo
Pharmaceutical detail
Active ingredient
BUDESONIDE
Strength
2MG/10ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 213976
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.
- 2021TARPEYOBrand (NDA)
NDA 215935 · CALLIDITAS
- 2019ORTIKOSBrand (NDA)
NDA 211929 · SUN PHARM INDS INC
- 2015RHINOCORT ALLERGYBrand (NDA)
NDA 020746 · KENVUE BRANDS
- 2014UCERISBrand (NDA)
NDA 205613 · SALIX
- 2013UCERISBrand (NDA)
NDA 203634 · SALIX
- 2006PULMICORT FLEXHALERBrand (NDA)
NDA 021949 · CHEPLAPHARM
- 2001ENTOCORT ECBrand (NDA)
NDA 021324 · PADAGIS US
- 2000PULMICORT RESPULESBrand (NDA)
NDA 020929 · ASTRAZENECA
- 1997PULMICORTBrand (NDA)
NDA 020441 · ASTRAZENECA
- 1994RHINOCORTBrand (NDA)
NDA 020233 · ASTRAZENECA
- 2023BUDESONIDEGeneric (ANDA)
ANDA 216667 · EUGIA PHARMA
- 2023BUDESONIDEGeneric (ANDA)
ANDA 215328 · PADAGIS ISRAEL
Marketing exclusivity (2)
- NPNew product exclusivity (3 years)
Feb 09, 2027
in 8 mo
- ODE-466Orphan-drug exclusivity (7 years)
Feb 09, 2031
in 4 yr 9 mo
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11197822 | Nov 09, 2026 | in 5 mo | Product |
| 11413296 | Nov 09, 2026 | in 5 mo | Product |
| 8497258 | Nov 09, 2026 | in 5 mo | U-3820 |
| 8679545 | Nov 09, 2026 | in 5 mo | Product |
| 8975243 | Nov 09, 2026 | in 5 mo | U-3820 |
| 9119863 | Nov 09, 2026 | in 5 mo | U-3820 |
| 11357859 | Nov 12, 2028 | in 2 yr 5 mo | U-3820 |
| 10293052 | Nov 22, 2028 | in 2 yr 6 mo | Product |
| 9050368 | Aug 01, 2029 | in 3 yr 2 mo | Product |
| 8324192 | Aug 03, 2029 | in 3 yr 2 mo | U-3820 |
| 11260064 | Jan 10, 2039 | in 12 yr 9 mo | Product |
| 11564934 | Jan 10, 2039 | in 12 yr 9 mo | U-3820 |
