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Eslicarbazepine acetateis the generic ingredient in one branded drug marketed by Sunovion Pharms Inc and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.
Eslicarbazepine acetate has one hundred and twenty patent family members in thirty countries.
There are twelve drug master file entries for eslicarbazepine acetate. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for eslicarbazepine acetate
|Drug Master File Entries:||12|
|Suppliers / Packagers:||1|
|Bulk Api Vendors:||62|
|Formulation / Manufacturing:||see details|
|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
|Whanin Pharmaceutical Company||Phase 1|
|Stanford University||Phase 4|
Generic filers with tentative approvals for ESLICARBAZEPINE ACETATE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for eslicarbazepine acetate
|Mechanism of Action||Cytochrome P450 3A4 Inducers |
Cytochrome P450 2C19 Inhibitors
|Physiological Effect||Decreased Central Nervous System Disorganized Electrical Activity |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Sunovion Pharms Inc||APTIOM||eslicarbazepine acetate||TABLET;ORAL||022416-004||Nov 8, 2013||RX||Yes||Yes||Start Trial||Start Trial||Y||Start Trial|
|Sunovion Pharms Inc||APTIOM||eslicarbazepine acetate||TABLET;ORAL||022416-001||Nov 8, 2013||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|Sunovion Pharms Inc||APTIOM||eslicarbazepine acetate||TABLET;ORAL||022416-003||Nov 8, 2013||RX||Yes||No||Start Trial||Start Trial||Y||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|0751129||CA 2009 00023||Denmark||Start Trial|
|0751129||09C0040||France||Start Trial||PRODUCT NAME: ESLICARBAZEPINE ACETATE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/514/001 DU 20090421; REGISTRATION NO/DATE AT EEC: EU/1/09/514/001 DU 20090421|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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