FDA Orange Book · active-ingredient family
Mexiletine hydrochloride
Mexiletine hydrochloride 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:MEXITIL · NDA 018873
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MEXITILRLD×3 | BOEHRINGER INGELHEIM | NDA 018873 | — | Dec 30, 1985 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MEXILETINE HYDROCHLORIDE×3 | MACLEODS PHARMS LTD | ANDA 219987 | AB | Mar 23, 2026 | |
| MEXILETINE HYDROCHLORIDE×3 | QUAGEN | ANDA 215876 | AB | Feb 27, 2023 | |
| MEXILETINE HYDROCHLORIDE×3 | ANNORA PHARMA | ANDA 216463 | AB | Nov 09, 2022 | |
| MEXILETINE HYDROCHLORIDE×3 | RISING | ANDA 215315 | AB | Aug 26, 2022 | |
| MEXILETINE HYDROCHLORIDE×3 | SENORES PHARMS | ANDA 214089 | AB | Oct 01, 2021 | |
| MEXILETINE HYDROCHLORIDE×3 | INGENUS PHARMS LLC | ANDA 214352 | AB | Jan 25, 2021 | |
| MEXILETINE HYDROCHLORIDE×3 | CROSSMEDIKA SA | ANDA 213500 | AB | Jul 22, 2020 | |
| MEXILETINE HYDROCHLORIDE×3 | WATSON LABS | ANDA 074865 | — | Apr 13, 1998 | |
| MEXILETINE HYDROCHLORIDE×3 | WATSON LABS | ANDA 074711 | — | Feb 26, 1997 | |
| MEXILETINE HYDROCHLORIDE×3 | ANI PHARMS | ANDA 074450 | AB | May 16, 1996 | |
| MEXILETINE HYDROCHLORIDE×3 | TEVA | ANDA 074377 | AB | May 16, 1995 |
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.
Mexiletine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
