MEXILETINE Drug Patent Profile

Which patents cover Mexiletine, and what generic alternatives are available?

Mexiletine is a drug marketed by Ani Pharms, Annora Pharma, Crossmedika Sa, Ingenus Pharms Llc, Macleods Pharms Ltd, Quagen, Rising, Senores Pharms, Teva, and Watson Labs. and is included in eleven NDAs.

The generic ingredient in MEXILETINE is mexiletine hydrochloride. There are five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the mexiletine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mexiletine

A generic version of MEXILETINE was approved as mexiletine hydrochloride by TEVA on May 16^th, 1995.

Summary for MEXILETINE

US Patents:	0
Applicants:	10
NDAs:	11
Drug Prices:	Drug price information for MEXILETINE
DailyMed Link:	MEXILETINE at DailyMed

See drug prices for MEXILETINE

US Patents and Regulatory Information for MEXILETINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	074711-003	Feb 26, 1997		DISCN	No	No
Watson Labs	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	074711-001	Feb 26, 1997		DISCN	No	No
Watson Labs	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	074865-003	Apr 13, 1998		DISCN	No	No
Watson Labs	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	074865-001	Apr 13, 1998		DISCN	No	No
Ani Pharms	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	074450-001	May 16, 1996	AB	RX	No	No
Quagen	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	215876-003	Feb 27, 2023	AB	RX	No	No
Senores Pharms	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	214089-003	Oct 1, 2021	AB	RX	No	No