FDA Orange Book
Generic for Teflaro
Teflaro contains ceftaroline fosamil. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Teflaro is ceftaroline fosamil. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Teflaro products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 400MG/VIAL | Marketed (Rx) | AP | 1 | AP |
| powder, intravenous | 600MG/VIAL | Marketed (Rx) | AP | 1 | AP |
NDA 200327, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ceftaroline fosamil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 208075 | AP (A-rated, therapeutically equivalent) | September 21, 2021 | 400MG/VIAL, 600MG/VIAL |
Teflaro patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9629861 | September 21, 2030 | Drug product | None | 200327 |
| 8247400 | February 10, 2031 | Drug product | U-282 | 200327 |
Teflaro NDC codes
Questions
Is there a generic for Teflaro?
Yes. The generic name for Teflaro is ceftaroline fosamil. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Teflaro?
The active ingredient in Teflaro is ceftaroline fosamil, per the FDA Orange Book.
When does the Teflaro patent expire?
The last patent listed for Teflaro in the Orange Book expires February 10, 2031. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.