FDA Orange Book · active-ingredient family
Epinastine hydrochloride
Epinastine 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:ELESTAT · NDA 021565
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ELESTATRLD | ALLERGAN | NDA 021565 | — | Oct 16, 2003 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EPINASTINE HYDROCHLORIDE | EPIC PHARMA LLC | ANDA 204055 | — | May 05, 2017 | |
| EPINASTINE HYDROCHLORIDE | CHARTWELL RX | ANDA 203384 | — | Dec 07, 2016 | |
| EPINASTINE HYDROCHLORIDE | APOTEX | ANDA 090919 | — | Oct 31, 2011 | |
| EPINASTINE HYDROCHLORIDE | SOMERSET THERAPS LLC | ANDA 090951 | — | Oct 31, 2011 | |
| EPINASTINE HYDROCHLORIDE | SUN PHARM INDS | ANDA 091626 | — | Oct 31, 2011 | |
| EPINASTINE HYDROCHLORIDE | PHARMOBEDIENT | ANDA 090870 | — | Mar 14, 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.
Epinastine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
