Serving 500+ biopharmaceutical companies globally:
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Serving 500+ biopharmaceutical companies globally:
Generated: September 26, 2017
| Tradename: | 1 |
| Applicant: | 1 |
| Ingredient: | 1 |
| Patents: | 5 |
| Formulation / Manufacturing: | see details |
| Mechanism of Action | Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors |
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
| 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 | 63402-202-30 | 30 TABLET in 1 BOTTLE (63402-202-30) |
APTIOM |
eslicarbazepine acetate |
TABLET;ORAL | 022416 | NDA | Sunovion Pharmaceuticals Inc. | 63402-204 | 63402-204-28 | 4 BLISTER PACK in 1 CARTON (63402-204-28) > 7 TABLET in 1 BLISTER PACK (63402-204-07) |
| 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 | ||||||||
Serving 500+ biopharmaceutical companies globally:
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 verifification 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.
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