DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 022416
NDA 022416 describes APTIOM, which is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the APTIOM profile page.
The generic ingredient in APTIOM is eslicarbazepine acetate. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.
The generic ingredient in APTIOM is eslicarbazepine acetate. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.
Summary for 022416
| Tradename: | APTIOM |
| Applicant: | Sunovion Pharms Inc |
| Ingredient: | eslicarbazepine acetate |
| Patents: | 7 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022416
| Mechanism of Action | Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 022416
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416 | NDA | Sunovion Pharmaceuticals Inc. | 63402-202 | N | 63402-202-28 |
| APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416 | NDA | Sunovion Pharmaceuticals Inc. | 63402-202 | N | 63402-202-30 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Nov 8, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 27, 2018 | ||||||||
| Regulatory Exclusivity Use: | 1600MG DAILY FOR PATIENTS ON ADJUNCTIVE THERAPY WHO DID NOT ACHIEVE A SATISFACTORY RESPONSE ON 1200MG DAILY DOSE | ||||||||
| Regulatory Exclusivity Expiration: | Aug 27, 2018 | ||||||||
| Regulatory Exclusivity Use: | FOR THE ADDITION OF THE INDICATION FOR MONOTHERAPY TREATMENT IN PARTIAL-ONSET SEIZURES IN ADULTS. | ||||||||
| Regulatory Exclusivity Expiration: | Nov 8, 2018 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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