MEXILETINE HYDROCHLORIDE Drug Patent Profile
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Which patents cover Mexiletine Hydrochloride, and when can generic versions of Mexiletine Hydrochloride launch?
Mexiletine Hydrochloride is a drug marketed by Ani Pharms, Annora Pharma, Carnegie, Chemistry Hlth, Crossmedika Sa, Novast Labs, Senores Pharms, Teva, and Watson Labs. and is included in ten NDAs.
The generic ingredient in MEXILETINE HYDROCHLORIDE 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 Hydrochloride
A generic version of MEXILETINE HYDROCHLORIDE was approved as mexiletine hydrochloride by TEVA on May 16th, 1995.
Summary for MEXILETINE HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 9 |
NDAs: | 10 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 137 |
Clinical Trials: | 31 |
Patent Applications: | 1,058 |
Formulation / Manufacturing: | see details |
DailyMed Link: | MEXILETINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for MEXILETINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Lupin Atlantis Holdings S.A. | N/A |
ZiteLab | N/A |
GCP-Copenhagen | N/A |
Pharmacology for MEXILETINE HYDROCHLORIDE
Drug Class | Antiarrhythmic |
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 | 074865-002 | Apr 13, 1998 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Watson Labs | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride | CAPSULE;ORAL | 074711-003 | Feb 26, 1997 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Ani Pharms | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride | CAPSULE;ORAL | 074450-001 | May 16, 1996 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novast Labs | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride | CAPSULE;ORAL | 214352-003 | Jan 25, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |