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, Crossmedika Sa, Leading, Novast Labs, Senores Pharms, Teva, Watson Labs, and Zenara. 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.
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Questions you can ask:
- What is the 5 year forecast for MEXILETINE HYDROCHLORIDE?
- What are the global sales for MEXILETINE HYDROCHLORIDE?
- What is Average Wholesale Price for MEXILETINE HYDROCHLORIDE?
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 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zenara | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride | CAPSULE;ORAL | 215315-001 | Aug 26, 2022 | 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 | |||
| Ani Pharms | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride | CAPSULE;ORAL | 074450-001 | May 16, 1996 | 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 | |||
| Watson Labs | MEXILETINE HYDROCHLORIDE | mexiletine hydrochloride | CAPSULE;ORAL | 074711-002 | Feb 26, 1997 | DISCN | 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 |
