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Last Updated: November 4, 2024

Mexiletine hydrochloride - Generic Drug Details


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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

SponsorPhase
Region Capital DenmarkN/A
Danish RegionN/A
Grete Andersen, MDN/A

See all mexiletine hydrochloride clinical trials

Pharmacology for mexiletine hydrochloride
Drug ClassAntiarrhythmic
Medical Subject Heading (MeSH) Categories for mexiletine hydrochloride
Anatomical Therapeutic Chemical (ATC) Classes for mexiletine hydrochloride

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novast Labs MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 214352-001 Jan 25, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novast Labs MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 214352-002 Jan 25, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Crossmedika Sa MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 213500-001 Jul 22, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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