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, Crossmedika Sa, Leading, Novast Labs, Senores Pharms, Teva, Watson Labs, Zenara, 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
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
Region Capital Denmark	N/A
Danish Region	N/A
Grete Andersen, MD	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
Watson Labs	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	074711-002	Feb 26, 1997		DISCN	No	No
Novast Labs	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	214352-001	Jan 25, 2021	AB	RX	No	No
Novast Labs	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	214352-002	Jan 25, 2021	AB	RX	No	No
Crossmedika Sa	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	213500-001	Jul 22, 2020	AB	RX	No	No
Senores Pharms	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	214089-002	Oct 1, 2021	AB	RX	No	No
Ani Pharms	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	074450-001	May 16, 1996	AB	RX	No	No
Teva	MEXILETINE HYDROCHLORIDE	mexiletine hydrochloride	CAPSULE;ORAL	074377-003	May 16, 1995	AB	RX	No	Yes

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	018873-002	Dec 30, 1985
Boehringer Ingelheim	MEXITIL	mexiletine hydrochloride	CAPSULE;ORAL	018873-004	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