FDA Orange Book · active-ingredient family
Ceftaroline fosamil
Ceftaroline fosamil is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TEFLARO · NDA 200327
1
Brand (NDA)
1
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TEFLARORLD×2 | ABBVIE | NDA 200327 | AP | Oct 29, 2010 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFTAROLINE FOSAMIL×2 | APOTEX | ANDA 208075 | AP | Sep 21, 2021 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9629861 | Sep 21, 2030 | in 4 yr 4 mo | Product |
| 8247400 | Feb 10, 2031 | in 4 yr 9 mo | ProductU-282 |
Ceftaroline fosamil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
