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 |
|---|---|
| Grete Andersen, MD | N/A |
| Lupin Atlantis Holdings S.A. | N/A |
| ZiteLab | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Leading | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride | CAPSULE;ORAL | 215876-002 | Feb 27, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zenara | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride | CAPSULE;ORAL | 215315-002 | Aug 26, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zenara | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride | CAPSULE;ORAL | 215315-001 | Aug 26, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride | CAPSULE;ORAL | 074865-003 | Apr 13, 1998 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Senores Pharms | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride | CAPSULE;ORAL | 214089-002 | Oct 1, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Senores Pharms | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride | CAPSULE;ORAL | 214089-003 | Oct 1, 2021 | 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 | 018873-002 | 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 |
| 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 |
| Boehringer Ingelheim | MEXITIL | mexiletine hydrochloride | CAPSULE;ORAL | 018873-002 | 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.
ISSN: 2162-2639
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