Details for New Drug Application (NDA): 022416
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NDA 022416 describes APTIOM, which is a drug marketed by Sumitomo Pharma Am and is included in one NDA. It is available from one supplier. There are eleven 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. Two suppliers are 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. Two suppliers are listed for this compound. Additional details are available on the eslicarbazepine acetate profile page.
Summary for 022416
| Tradename: | APTIOM |
| Applicant: | Sumitomo Pharma Am |
| Ingredient: | eslicarbazepine acetate |
| Patents: | 11 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022416
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Cytochrome P450 3A4 Inducers |
| 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 | Sumitomo Pharma America, 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 | Sumitomo Pharma America, Inc. | 63402-202 | 63402-202-30 | 30 TABLET in 1 BOTTLE (63402-202-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Nov 8, 2013 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 6, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PARTIAL-ONSET SEIZURES | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 6, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PARTIAL-ONSET SEIZURES IN A PATIENT WITH REFRACTORY PARTIAL-ONSET SEIZURES | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 6, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PARTIAL-ONSET SEIZURES | ||||||||
Expired US Patents for NDA 022416
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sumitomo Pharma Am | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-001 | Nov 8, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sumitomo Pharma Am | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-003 | Nov 8, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sumitomo Pharma Am | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-002 | Nov 8, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Sumitomo Pharma Am | APTIOM | eslicarbazepine acetate | TABLET;ORAL | 022416-004 | Nov 8, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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