FDA Orange Book
Generic for Integrilin
Integrilin contains eptifibatide. 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 Integrilin is eptifibatide. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Integrilin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 2MG/ML | Discontinued | None | 7 | AP |
| injectable, injection | 75MG/100ML | Discontinued | None | 7 | AP |
NDA 020718, held by MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic eptifibatide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 090854 | AP (A-rated, therapeutically equivalent) | June 12, 2015 | 2MG/ML |
| EUGIA PHARMA SPECIALITIES LTD | 206127 | AP (A-rated, therapeutically equivalent) | December 8, 2015 | 2MG/ML, 75MG/100ML |
| SAGENT PHARMACEUTICALS INC | 204693 | AP (A-rated, therapeutically equivalent) | March 7, 2018 | 2MG/ML, 75MG/100ML |
| MYLAN LABORATORIES LTD | 203258 | AP (A-rated, therapeutically equivalent) | July 20, 2018 | 2MG/ML, 75MG/100ML |
| BAXTER HEALTHCARE CORP | 208554 | AP (A-rated, therapeutically equivalent) | November 23, 2018 | 75MG/100ML |
| HAINAN POLY PHARM CO LTD | 209864 | AP (A-rated, therapeutically equivalent) | January 25, 2019 | 2MG/ML, 75MG/100ML |
| QUAGEN PHARMACEUTICALS LLC | 213081 | AP (A-rated, therapeutically equivalent) | September 7, 2021 | 2MG/ML, 75MG/100ML |
| MEITHEAL PHARMACEUTICALS INC | 213599 | AP (A-rated, therapeutically equivalent) | May 9, 2024 | 2MG/ML, 75MG/100ML |
Questions
Is there a generic for Integrilin?
Yes. The generic name for Integrilin is eptifibatide. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Integrilin?
The active ingredient in Integrilin is eptifibatide, 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.