FDA Orange Book
Generic for Evista
Evista contains raloxifene. 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 Evista is raloxifene. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Evista products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 60MG | Marketed (Rx) | AB | 8 | AB |
NDA 020815, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic raloxifene
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 078193 | AB (A-rated, therapeutically equivalent) | March 4, 2014 | 60MG |
| INVAGEN PHARMACEUTICALS INC | 090842 | AB (A-rated, therapeutically equivalent) | September 24, 2014 | 60MG |
| WATSON LABORATORIES INC | 200825 | AB (A-rated, therapeutically equivalent) | January 21, 2015 | 60MG |
| AUROBINDO PHARMA LTD | 204310 | AB (A-rated, therapeutically equivalent) | August 28, 2015 | 60MG |
| GLENMARK PHARMACEUTICALS LTD | 204491 | AB (A-rated, therapeutically equivalent) | March 22, 2016 | 60MG |
| AMNEAL PHARMACEUTICALS | 208206 | AB (A-rated, therapeutically equivalent) | April 8, 2016 | 60MG |
| SCIEGEN PHARMACEUTICALS INC | 206384 | AB (A-rated, therapeutically equivalent) | October 12, 2016 | 60MG |
| CADILA PHARMACEUTICALS LTD | 211324 | AB (A-rated, therapeutically equivalent) | August 18, 2020 | 60MG |
Evista NDC codes
Questions
Is there a generic for Evista?
Yes. The generic name for Evista is raloxifene. 8 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 Evista?
The active ingredient in Evista is raloxifene, 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.