FDA Orange Book · active-ingredient family
Thiotepa
Thiotepa is approved as 4 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TEPYLUTE · NDA 216984
4
Brand (NDA)
12
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, powder, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TEPYLUTERLD×2 | SHORLA | NDA 216984 | — | Jun 25, 2024 | |
| TEPADINARLD×4 | ADIENNE SA | NDA 208264 | AP | Jan 26, 2017 | |
| THIOPLEXRLD | IMMUNEX | NDA 020058 | — | Dec 22, 1994 | |
| THIOTEPA | IMMUNEX | NDA 011683 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| THIOTEPA | REGCON HOLDINGS | ANDA 217559 | AP | Aug 20, 2024 | |
| THIOTEPA×2 | MEITHEAL | ANDA 216037 | AP | Dec 26, 2023 | |
| THIOTEPA | HIKMA | ANDA 211755 | AP | Sep 05, 2023 | |
| THIOTEPA | REGCON HOLDINGS | ANDA 211831 | AP | Dec 08, 2021 | |
| THIOTEPA×2 | GLAND | ANDA 214222 | AP | Mar 08, 2021 | |
| THIOTEPA×2 | MSN | ANDA 213049 | AP | Mar 04, 2020 | |
| THIOTEPA | PENN LIFE | ANDA 208242 | AP | Jan 10, 2020 | |
| THIOTEPA | DR REDDYS | ANDA 210337 | AP | May 04, 2018 | |
| THIOTEPA | HENGRUI PHARMA | ANDA 209150 | — | May 04, 2018 | |
| THIOTEPA | FRESENIUS KABI USA | ANDA 075698 | — | Sep 20, 2001 | |
| THIOTEPA×2 | TEVA PARENTERAL | ANDA 075730 | — | Apr 20, 2001 | |
| THIOTEPA | WEST-WARD PHARMS INT | ANDA 075547 | AP | Apr 02, 2001 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9931458 | May 31, 2037 | in 11 yr 1 mo | Product |
| 12622921 | Aug 16, 2041 | in 15 yr 5 mo | U-4530 |
| 11975013 | Aug 16, 2041 | in 15 yr 5 mo | Product |
Thiotepa — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
