Orange Book product · Brand (NDA)
TALICIA
AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN
At a glance
Nov 01, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 01, 2019
6 yr 9 mo ago
Exclusivity ends · NP
New product exclusivity (3 years)
Nov 01, 2022
3 yr 8 mo ago
Today
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Nov 01, 2027
in 1 yr 5 mo
Patent 10238606 expires
Listed drug product patent expiration.
Feb 12, 2034
in 7 yr 9 mo
Patent 11135172 expires
Listed drug product patent expiration.
Feb 12, 2034
in 7 yr 9 mo
Patent 11931463 expires
Listed drug product patent expiration.
Feb 12, 2034
in 7 yr 9 mo
Patent 9050263 expires
Listed drug product patent expiration.
Feb 12, 2034
in 7 yr 9 mo
Patent 9498445 expires
Listed drug product patent expiration.
Feb 12, 2034
in 7 yr 9 mo
Patent 9603806 expires
Listed drug product patent expiration.
Feb 12, 2034
in 7 yr 9 mo
Patent 11878011 expires
Listed method-of-use patent (U-3816) expiration.
May 27, 2042
in 16 yr 2 mo
Pharmaceutical detail
Active ingredient
AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN
Strength
250MG;EQ 10MG BASE;12.5MG
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 213004
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)
Nov 01, 2022
3 yr 8 mo ago
- GAINQualified infectious disease product exclusivity (adds 5 years)
Nov 01, 2027
in 1 yr 5 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10238606 | Feb 12, 2034 | in 7 yr 9 mo | Product |
| 11135172 | Feb 12, 2034 | in 7 yr 9 mo | ProductU-2660 |
| 11931463 | Feb 12, 2034 | in 7 yr 9 mo | ProductU-3866 |
| 9050263 | Feb 12, 2034 | in 7 yr 9 mo | ProductU-2660 |
| 9498445 | Feb 12, 2034 | in 7 yr 9 mo | ProductU-2660 |
| 9603806 | Feb 12, 2034 | in 7 yr 9 mo | ProductU-2660 |
| 11878011 | May 27, 2042 | in 16 yr 2 mo | U-3816 |

