FDA Orange Book · active-ingredient family
Exemestane
Exemestane is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AROMASIN · NDA 020753
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AROMASINRLD | PFIZER | NDA 020753 | AB | Oct 21, 1999 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EXEMESTANE | EUGIA PHARMA | ANDA 216454 | AB | May 20, 2022 | |
| EXEMESTANE | QILU | ANDA 213547 | AB | Apr 13, 2020 | |
| EXEMESTANE | DR REDDYS LABS SA | ANDA 208764 | — | Aug 08, 2019 | |
| EXEMESTANE | BRECKENRIDGE | ANDA 211031 | AB | Feb 21, 2019 | |
| EXEMESTANE | AMNEAL PHARMS | ANDA 206421 | — | Dec 28, 2018 | |
| EXEMESTANE | ZYDUS PHARMS | ANDA 202602 | AB | Oct 03, 2018 | |
| EXEMESTANE | CIPLA | ANDA 210323 | AB | Apr 27, 2018 | |
| EXEMESTANE | UPSHER SMITH LABS | ANDA 209208 | AB | Jul 26, 2017 | |
| EXEMESTANE | RISING | ANDA 203315 | AB | Mar 10, 2017 | |
| EXEMESTANE | ALVOGEN | ANDA 200898 | — | Jul 28, 2014 | |
| EXEMESTANE | HIKMA | ANDA 077431 | — | Apr 01, 2011 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Exemestane — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
