FDA Orange Book · active-ingredient family
Alosetron hydrochloride
Alosetron hydrochloride is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LOTRONEX · NDA 021107
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOTRONEXRLD×2 | LEGACY PHARMA | NDA 021107 | AB | Dec 23, 2003 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALOSETRON HYDROCHLORIDE×2 | MANKIND PHARMA | ANDA 213614 | AB | Sep 09, 2020 | |
| ALOSETRON HYDROCHLORIDE×2 | HIBROW HLTHCARE | ANDA 211621 | AB | Sep 16, 2019 | |
| ALOSETRON HYDROCHLORIDE×2 | RISING | ANDA 209180 | AB | Jan 14, 2019 | |
| ALOSETRON HYDROCHLORIDE×2 | PH HEALTH | ANDA 206113 | — | Feb 23, 2018 | |
| ALOSETRON HYDROCHLORIDE×2 | AMNEAL PHARMS | ANDA 206647 | AB | Dec 22, 2016 | |
| ALOSETRON HYDROCHLORIDE×2 | HIKMA | ANDA 200652 | — | May 04, 2015 |
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.
Alosetron hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
