ESLICARBAZEPINE ACETATE Drug Patent Profile
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When do Eslicarbazepine Acetate patents expire, and what generic alternatives are available?
Eslicarbazepine Acetate is a drug marketed by Alkem Labs Ltd, Apotex, Dr Reddys, Hetero Labs Ltd V, Lupin Ltd, and Torrent. and is included in six NDAs.
The generic ingredient in ESLICARBAZEPINE ACETATE is eslicarbazepine acetate. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Eslicarbazepine Acetate
A generic version of ESLICARBAZEPINE ACETATE was approved as eslicarbazepine acetate by DR REDDYS on June 29th, 2021.
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Summary for ESLICARBAZEPINE ACETATE
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 78 |
| Clinical Trials: | 51 |
| Patent Applications: | 226 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ESLICARBAZEPINE ACETATE |
| DailyMed Link: | ESLICARBAZEPINE ACETATE at DailyMed |
Recent Clinical Trials for ESLICARBAZEPINE ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Whanin Pharmaceutical Company | Phase 1 |
| Stanford University | Phase 4 |
| Sunovion | Phase 4 |
Pharmacology for ESLICARBAZEPINE ACETATE
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Anatomical Therapeutic Chemical (ATC) Classes for ESLICARBAZEPINE ACETATE
Paragraph IV (Patent) Challenges for ESLICARBAZEPINE ACETATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| APTIOM | Tablets | eslicarbazepine acetate | 200 mg, 400 mg, 600 mg and 800 mg | 022416 | 7 | 2017-11-08 |
US Patents and Regulatory Information for ESLICARBAZEPINE ACETATE
EU/EMA Drug Approvals for ESLICARBAZEPINE ACETATE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| BIAL - Portela & Ca, S.A. | Zebinix | eslicarbazepine acetate | EMEA/H/C/000988 Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation. |
Authorised | no | no | no | 2009-04-21 | |
| BIAL - Portela Ca, S.A. | Exalief | eslicarbazepine acetate | EMEA/H/C/000987 Exalief is indicated as adjunctive therapy in adults with partial-onset seizures with or without secondary generalisation. |
Withdrawn | no | no | no | 2009-04-21 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
