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
Sponsor | Phase |
---|---|
Region Capital Denmark | N/A |
Danish Region | N/A |
Grete Andersen, MD | 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 | 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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