FDA Orange Book · active-ingredient family
Tigecycline
Tigecycline is approved as 4 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TIGECYCLINE · NDA 205645
4
Brand (NDA)
5
Generics (ANDA)
7
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TIGECYCLINERLD | FRESENIUS KABI USA | NDA 205645 | — | Dec 01, 2016 | |
| TYGACILRLD | PF PRISM CV | NDA 021821 | AP | Jun 15, 2005 | |
| TIGECYCLINE | AMNEAL | NDA 211158 | AP | Aug 02, 2018 | |
| TIGECYCLINE | ACCORD HLTHCARE INC | NDA 208744 | — | Jan 18, 2018 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TIGECYCLINE | MEITHEAL | ANDA 214020 | AP | May 13, 2021 | |
| TIGECYCLINE | XELLIA PHARMS APS | ANDA 205722 | — | Oct 18, 2019 | |
| TIGECYCLINE | EUGIA PHARMA | ANDA 206335 | AP | Jun 11, 2019 | |
| TIGECYCLINE | APOTEX | ANDA 204439 | AP | Dec 21, 2018 | |
| TIGECYCLINE | SANDOZ | ANDA 091620 | AP | May 27, 2015 |
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9254328 | Mar 13, 2026 | 3 mo ago | Product |
| 9694078 | Mar 13, 2026 | 3 mo ago | Product |
| 10588975 | 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 |
| 9855335 | Apr 07, 2033 | in 6 yr 11 mo | Product |
Tigecycline — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
