FDA Orange Book · active-ingredient family
Prasugrel hydrochloride
Prasugrel hydrochloride is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EFFIENT · NDA 022307
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EFFIENTRLD×2 | COSETTE | NDA 022307 | AB | Jul 10, 2009 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRASUGREL HYDROCHLORIDE×2 | UNICHEM | ANDA 213315 | AB | Aug 28, 2023 | |
| PRASUGREL×2 | LUPIN | ANDA 205930 | — | Jan 09, 2023 | |
| PRASUGREL×2 | SENORES PHARMS | ANDA 205926 | — | Jul 07, 2020 | |
| PRASUGREL×2 | HEC PHARM | ANDA 206021 | AB | Jan 16, 2019 | |
| PRASUGREL×2 | AMNEAL PHARMS | ANDA 205913 | — | Jun 19, 2018 | |
| PRASUGREL×2 | ACCORD HLTHCARE | ANDA 205987 | AB | Feb 02, 2018 | |
| PRASUGREL×2 | AUROBINDO PHARMA | ANDA 205888 | AB | Oct 16, 2017 | |
| PRASUGREL×2 | CHARTWELL RX | ANDA 205790 | — | Oct 16, 2017 | |
| PRASUGREL×2 | PANACEA | ANDA 205897 | AB | Oct 16, 2017 | |
| PRASUGREL×2 | MYLAN | ANDA 205927 | AB | Jul 12, 2017 |
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.
Prasugrel hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
