FDA Orange Book · active-ingredient family
Raloxifene hydrochloride
Raloxifene hydrochloride is approved as 1 brand and 8 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EVISTA · NDA 020815
1
Brand (NDA)
8
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EVISTARLD | LILLY | NDA 020815 | AB | Dec 09, 1997 |
Generic (ANDA) products (8)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RALOXIFENE HYDROCHLORIDE | CADILA PHARMS LTD | ANDA 211324 | AB | Aug 18, 2020 | |
| RALOXIFENE HYDROCHLORIDE | SCIEGEN PHARMS | ANDA 206384 | AB | Oct 12, 2016 | |
| RALOXIFENE HYDROCHLORIDE | AMNEAL PHARMS | ANDA 208206 | AB | Apr 08, 2016 | |
| RALOXIFENE HYDROCHLORIDE | GLENMARK PHARMS LTD | ANDA 204491 | AB | Mar 22, 2016 | |
| RALOXIFENE HYDROCHLORIDE | AUROBINDO PHARMA | ANDA 204310 | AB | Aug 28, 2015 | |
| RALOXIFENE HYDROCHLORIDE | WATSON LABS INC | ANDA 200825 | AB | Jan 21, 2015 | |
| RALOXIFENE HYDROCHLORIDE | INVAGEN PHARMS | ANDA 090842 | AB | Sep 24, 2014 | |
| RALOXIFENE HYDROCHLORIDE | TEVA PHARMS USA | ANDA 078193 | AB | Mar 04, 2014 |
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.
Raloxifene hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
