Mexiletine hydrochloride - Generic Drug Details

What are the generic drug sources for mexiletine hydrochloride and what is the scope of patent protection?

Mexiletine hydrochloride is the generic ingredient in two branded drugs marketed by Ani Pharms, Annora Pharma, Carnegie, Chemistry Hlth, Crossmedika Sa, Novast Labs, Senores Pharms, Teva, Watson Labs, and Boehringer Ingelheim, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for mexiletine hydrochloride. Fourteen suppliers are listed for this compound.

Summary for mexiletine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	10
NDAs:	11
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	137
Clinical Trials:	31
Patent Applications:	1,541
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in mexiletine hydrochloride?	mexiletine hydrochloride excipients list
DailyMed Link:	mexiletine hydrochloride at DailyMed

Recent Clinical Trials for mexiletine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
ZiteLab	N/A
GCP-Copenhagen	N/A
Region Capital Denmark	N/A

See all mexiletine hydrochloride clinical trials

Pharmacology for mexiletine hydrochloride

Drug Class

Antiarrhythmic

Medical Subject Heading (MeSH) Categories for mexiletine hydrochloride

Anti-Arrhythmia Agents

Voltage-Gated Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for mexiletine hydrochloride

C01BB	Antiarrhythmics, class Ib
C01B	ANTIARRHYTHMICS, CLASS I AND III
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for mexiletine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chemistry Hlth	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	215876-002	Feb 27, 2023	AB	RX	No	No
Watson Labs	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	074865-003	Apr 13, 1998		DISCN	No	No
Teva	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	074377-002	May 16, 1995	AB	RX	No	No
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-002	Dec 30, 1985		DISCN	Yes	No
Teva	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	074377-001	May 16, 1995	AB	RX	No	No
Teva	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	074377-003	May 16, 1995	AB	RX	No	Yes
Watson Labs	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	074865-001	Apr 13, 1998		DISCN	No	No

Expired US Patents for mexiletine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-003	Dec 30, 1985
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-003	Dec 30, 1985
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-004	Dec 30, 1985
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-002	Dec 30, 1985
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-004	Dec 30, 1985
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-002	Dec 30, 1985