FDA Orange Book
Generic for Tygacil
Tygacil contains tigecycline. 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 Tygacil is tigecycline. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Tygacil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 50MG/VIAL | Marketed (Rx) | AP | 4 | AP |
NDA 021821, held by PF PRISM CV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tigecycline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 091620 | AP (A-rated, therapeutically equivalent) | May 27, 2015 | 50MG/VIAL |
| APOTEX INC | 204439 | AP (A-rated, therapeutically equivalent) | December 21, 2018 | 50MG/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 206335 | AP (A-rated, therapeutically equivalent) | June 11, 2019 | 50MG/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 214020 | AP (A-rated, therapeutically equivalent) | May 13, 2021 | 50MG/VIAL |
Tygacil patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9254328 | March 13, 2026 | Drug product | None | 021821 |
| 9694078 | March 13, 2026 | Drug product | None | 021821 |
| 10588975 | March 13, 2026 | Drug product | None | 021821 |
| 8975242 | October 24, 2028 | Drug product | None | 021821 |
| 7879828 | February 5, 2029 | Drug product | None | 021821 |
| 8372995 | October 8, 2030 | Drug product | None | 021821 |
Tygacil NDC codes
Questions
Is there a generic for Tygacil?
Yes. The generic name for Tygacil is tigecycline. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Tygacil?
The active ingredient in Tygacil is tigecycline, per the FDA Orange Book.
When does the Tygacil patent expire?
The last patent listed for Tygacil in the Orange Book expires October 8, 2030. 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.