FDA Orange Book
Generic for Evoxac
Evoxac contains cevimeline. 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 Evoxac is cevimeline. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Evoxac products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 30MG | Marketed (Rx) | AB | 8 | AB |
NDA 020989, 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 cevimeline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 091591 | AB (A-rated, therapeutically equivalent) | July 8, 2013 | 30MG |
| RISING PHARMA HOLDINGS INC | 203775 | AB (A-rated, therapeutically equivalent) | June 4, 2014 | 30MG |
| NOVEL LABORATORIES INC | 204746 | AB (A-rated, therapeutically equivalent) | December 30, 2016 | 30MG |
| RUBICON RESEARCH LTD | 216682 | AB (A-rated, therapeutically equivalent) | April 6, 2023 | 30MG |
| AUROBINDO PHARMA LTD | 215056 | AB (A-rated, therapeutically equivalent) | April 18, 2023 | 30MG |
| BIONPHARMA INC | 218290 | AB (A-rated, therapeutically equivalent) | November 8, 2023 | 30MG |
| MACLEODS PHARMACEUTICALS LTD | 206808 | AB (A-rated, therapeutically equivalent) | September 20, 2024 | 30MG |
| ZYDUS LIFESCIENCES GLOBAL FZE | 220267 | AB (A-rated, therapeutically equivalent) | March 11, 2026 | 30MG |
Evoxac NDC codes
Questions
Is there a generic for Evoxac?
Yes. The generic name for Evoxac is cevimeline. 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 Evoxac?
The active ingredient in Evoxac is cevimeline, 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.