FDA Orange Book
Generic for Effient
Effient contains prasugrel. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Effient is prasugrel. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Effient products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE | Marketed (Rx) | AB | 6 | AB |
| tablet, oral | EQ 5MG BASE | Marketed (Rx) | AB | 6 | AB |
NDA 022307, held by COSETTE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic prasugrel
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 205927 | AB (A-rated, therapeutically equivalent) | July 12, 2017 | EQ 10MG BASE, EQ 5MG BASE |
| AUROBINDO PHARMA LTD | 205888 | AB (A-rated, therapeutically equivalent) | October 16, 2017 | EQ 10MG BASE, EQ 5MG BASE |
| PANACEA BIOTEC PHARMA LTD | 205897 | AB (A-rated, therapeutically equivalent) | October 16, 2017 | EQ 10MG BASE, EQ 5MG BASE |
| ACCORD HEALTHCARE INC | 205987 | AB (A-rated, therapeutically equivalent) | February 2, 2018 | EQ 10MG BASE, EQ 5MG BASE |
| HEC PHARM USA INC | 206021 | AB (A-rated, therapeutically equivalent) | January 16, 2019 | EQ 10MG BASE, EQ 5MG BASE |
| UNICHEM LABORATORIES LTD | 213315 | AB (A-rated, therapeutically equivalent) | August 28, 2023 | EQ 10MG BASE, EQ 5MG BASE |
Effient NDC codes
Questions
Is there a generic for Effient?
Yes. The generic name for Effient is prasugrel. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Effient?
The active ingredient in Effient is prasugrel, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.