FDA Orange Book
Generic for Aromasin
Aromasin contains exemestane. 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 Aromasin is exemestane. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Aromasin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 25MG | Marketed (Rx) | AB | 7 | AB |
NDA 020753, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic exemestane
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDINGS INC | 203315 | AB (A-rated, therapeutically equivalent) | March 10, 2017 | 25MG |
| UPSHER SMITH LABORATORIES LLC | 209208 | AB (A-rated, therapeutically equivalent) | July 26, 2017 | 25MG |
| CIPLA LTD | 210323 | AB (A-rated, therapeutically equivalent) | April 27, 2018 | 25MG |
| ZYDUS PHARMACEUTICALS USA INC | 202602 | AB (A-rated, therapeutically equivalent) | October 3, 2018 | 25MG |
| BRECKENRIDGE PHARMACEUTICAL INC | 211031 | AB (A-rated, therapeutically equivalent) | February 21, 2019 | 25MG |
| QILU PHARMACEUTICAL CO LTD | 213547 | AB (A-rated, therapeutically equivalent) | April 13, 2020 | 25MG |
| EUGIA PHARMA SPECIALITIES LTD | 216454 | AB (A-rated, therapeutically equivalent) | May 20, 2022 | 25MG |
Aromasin NDC codes
Questions
Is there a generic for Aromasin?
Yes. The generic name for Aromasin is exemestane. 7 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 Aromasin?
The active ingredient in Aromasin is exemestane, 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.