Orange Book product · Brand (NDA)
TARPEYO
BUDESONIDE
At a glance
Dec 15, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 15, 2021
4 yr 7 mo ago
Today
Exclusivity ends · ODE-389
Orphan-drug exclusivity (7 years)
Dec 15, 2028
in 2 yr 6 mo
Patent 8491932 expires
Listed drug product patent expiration.
May 07, 2029
in 2 yr 11 mo
Patent 8491932 expires
Listed drug product patent expiration.
May 07, 2029
in 2 yr 11 mo
Exclusivity ends · ODE-464
Orphan-drug exclusivity (7 years)
Dec 20, 2030
in 4 yr 7 mo
Patent 11896719 expires
Listed method-of-use patent (U-3810) expiration.
Jan 23, 2043
in 16 yr 10 mo
Patent 12171882 expires
Listed method-of-use patent (U-4085) expiration.
Jan 23, 2043
in 16 yr 10 mo
Patent 12171882 expires
Listed method-of-use patent (U-4086) expiration.
Jan 23, 2043
in 16 yr 10 mo
Patent 12171883 expires
Listed drug product patent expiration.
Jan 23, 2043
in 16 yr 10 mo
Patent 12311057 expires
Listed drug product patent expiration.
Jan 23, 2043
in 16 yr 10 mo
Patent 12311057 expires
Listed drug product patent expiration.
Jan 23, 2043
in 16 yr 10 mo
Patent 12311057 expires
Listed drug product patent expiration.
Jan 23, 2043
in 16 yr 10 mo
Pharmaceutical detail
Active ingredient
BUDESONIDE
Strength
4MG
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 215935
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.
- 2024EOHILIABrand (NDA)
NDA 213976 · TAKEDA PHARMS USA
- 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)
- ODE-389Orphan-drug exclusivity (7 years)
Dec 15, 2028
in 2 yr 6 mo
- ODE-464Orphan-drug exclusivity (7 years)
Dec 20, 2030
in 4 yr 7 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8491932 | May 07, 2029 | in 2 yr 11 mo | ProductU-3269 |
| 8491932 | May 07, 2029 | in 2 yr 11 mo | ProductU-3781 |
| 11896719 | Jan 23, 2043 | in 16 yr 10 mo | U-3810 |
| 12171882 | Jan 23, 2043 | in 16 yr 10 mo | U-4085 |
| 12171882 | Jan 23, 2043 | in 16 yr 10 mo | U-4086 |
| 12171883 | Jan 23, 2043 | in 16 yr 10 mo | Product |
| 12311057 | Jan 23, 2043 | in 16 yr 10 mo | ProductU-4085 |
| 12311057 | Jan 23, 2043 | in 16 yr 10 mo | ProductU-4086 |
| 12311057 | Jan 23, 2043 | in 16 yr 10 mo | ProductU-4204 |
