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Details for New Drug Application (NDA): 022416
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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 twelve 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 twelve 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 |
Generic Entry Opportunity Date for 022416
Generic Entry Date for 022416*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 | 63402-202-28 | 4 BLISTER PACK in 1 CARTON (63402-202-28) > 7 TABLET in 1 BLISTER PACK (63402-202-07) |
| APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416 | NDA | Sunovion Pharmaceuticals Inc. | 63402-202 | 63402-202-30 | 30 TABLET in 1 BOTTLE (63402-202-30) |
Paragraph IV (Patent) Challenges for 022416
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| APTIOM | TABLET;ORAL | eslicarbazepine acetate | 022416 | 2017-11-08 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Nov 8, 2013 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Jun 27, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PARTIAL-ONSET SEIZURES | ||||||||
| Patent: | Start Trial | Patent Expiration: | Apr 17, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Apr 21, 2026 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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