FDA Orange Book · active-ingredient family
Amoxicillin; omeprazole magnesium; rifabutin
Amoxicillin; omeprazole magnesium; rifabutin is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TALICIA · NDA 213004
1
Brand (NDA)
0
Generics (ANDA)
7
Listed patents
2
Exclusivity periods
Brand (NDA) products · capsule, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TALICIARLD | TALICIA HOLDINGS | NDA 213004 | — | Nov 01, 2019 |
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 |
|---|---|---|---|
| 9603806 | Feb 12, 2034 | in 7 yr 9 mo | ProductU-2660 |
| 9498445 | Feb 12, 2034 | in 7 yr 9 mo | ProductU-2660 |
| 9050263 | Feb 12, 2034 | in 7 yr 9 mo | ProductU-2660 |
| 11135172 | Feb 12, 2034 | in 7 yr 9 mo | ProductU-2660 |
| 11931463 | Feb 12, 2034 | in 7 yr 9 mo | ProductU-3866 |
| 10238606 | Feb 12, 2034 | in 7 yr 9 mo | Product |
| 11878011 | May 27, 2042 | in 16 yr 2 mo | U-3816 |
Amoxicillin; omeprazole magnesium; rifabutin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
