Orange Book product · Brand (NDA)
TYGACIL
TIGECYCLINE
At a glance
Jun 15, 2005
Approved
Brand (NDA)
Application
AP
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 15, 2005
21 yr 4 mo ago
Patent 10588975 expires
Listed drug product patent expiration.
Mar 13, 2026
3 mo ago
Patent 9254328 expires
Listed drug product patent expiration.
Mar 13, 2026
3 mo ago
Patent 9694078 expires
Listed drug product patent expiration.
Mar 13, 2026
3 mo ago
Today
Patent 8975242 expires
Listed drug product patent expiration.
Oct 24, 2028
in 2 yr 5 mo
Patent 7879828 expires
Listed drug product patent expiration.
Feb 05, 2029
in 2 yr 8 mo
Patent 8372995 expires
Listed drug product patent expiration.
Oct 08, 2030
in 4 yr 4 mo
Pharmaceutical detail
Active ingredient
TIGECYCLINE
Strength
50MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
AP
Application
NDA 021821
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.
- 2018TIGECYCLINEBrand (NDA)
NDA 211158 · AMNEAL
- 2018TIGECYCLINEBrand (NDA)
NDA 208744 · ACCORD HLTHCARE INC
- 2016TIGECYCLINEBrand (NDA)
NDA 205645 · FRESENIUS KABI USA
- 2021TIGECYCLINEGeneric (ANDA)
ANDA 214020 · MEITHEAL
- 2019TIGECYCLINEGeneric (ANDA)
ANDA 205722 · XELLIA PHARMS APS
- 2019TIGECYCLINEGeneric (ANDA)
ANDA 206335 · EUGIA PHARMA
- 2018TIGECYCLINEGeneric (ANDA)
ANDA 204439 · APOTEX
- 2015TIGECYCLINEGeneric (ANDA)
ANDA 091620 · SANDOZ
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10588975 | Mar 13, 2026 | 3 mo ago | Product |
| 9254328 | Mar 13, 2026 | 3 mo ago | Product |
| 9694078 | Mar 13, 2026 | 3 mo ago | Product |
| 8975242 | Oct 24, 2028 | in 2 yr 5 mo | Product |
| 7879828 | Feb 05, 2029 | in 2 yr 8 mo | Product |
| 8372995 | Oct 08, 2030 | in 4 yr 4 mo | Product |
