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Last Updated: November 24, 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
Grete Andersen, MDN/A
Lupin Atlantis Holdings S.A.N/A
ZiteLabN/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
Boehringer Ingelheim MEXITIL mexiletine hydrochloride CAPSULE;ORAL 018873-004 Dec 30, 1985 DISCN Yes 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
Watson Labs MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE;ORAL 074865-001 Apr 13, 1998 DISCN 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 018873-002 Dec 30, 1985 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim MEXITIL mexiletine hydrochloride CAPSULE;ORAL 018873-003 Dec 30, 1985 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim MEXITIL mexiletine hydrochloride CAPSULE;ORAL 018873-004 Dec 30, 1985 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.