FDA Orange Book · active-ingredient family
Eptifibatide
Eptifibatide is approved as 1 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:INTEGRILIN · NDA 020718
1
Brand (NDA)
15
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| INTEGRILINRLD×2 | MSD SUB MERCK | NDA 020718 | — | May 18, 1998 |
Generic (ANDA) products (15)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EPTIFIBATIDE×2 | MEITHEAL | ANDA 213599 | AP | May 09, 2024 | |
| EPTIFIBATIDE×2 | SHUANGCHENG | ANDA 213081 | AP | Sep 07, 2021 | |
| EPTIFIBATIDE×2 | HYBIO | ANDA 207864 | — | Mar 20, 2020 | |
| EPTIFIBATIDE×2 | USV | ANDA 204361 | — | Mar 14, 2019 | |
| EPTIFIBATIDE | USV | ANDA 204362 | — | Mar 11, 2019 | |
| EPTIFIBATIDE×2 | SLATE RUN PHARMA | ANDA 209864 | AP | Jan 25, 2019 | |
| EPTIFIBATIDE×2 | BAXTER HLTHCARE CORP | ANDA 208554 | — | Nov 23, 2018 | |
| EPTIFIBATIDE×2 | MYLAN LABS LTD | ANDA 203258 | AP | Jul 20, 2018 | |
| EPTIFIBATIDE×2 | SAGENT PHARMS INC | ANDA 204693 | AP | Mar 07, 2018 | |
| EPTIFIBATIDE×2 | ACCORD HLTHCARE | ANDA 205557 | — | Nov 06, 2017 | |
| EPTIFIBATIDE×2 | RISING | ANDA 204589 | — | Apr 18, 2017 | |
| EPTIFIBATIDE×2 | AMNEAL PHARMS | ANDA 205581 | — | Dec 08, 2016 | |
| EPTIFIBATIDE×2 | EUGIA PHARMA | ANDA 206127 | AP | Dec 08, 2015 | |
| EPTIFIBATIDE | TEVA PHARMS USA | ANDA 090854 | AP | Jun 12, 2015 | |
| EPTIFIBATIDE | TEVA PHARMS USA | ANDA 091555 | — | Jun 05, 2015 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Eptifibatide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
