OXCARBAZEPINE | N021014 | NOVARTIS PHARMACEUTICALS CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Jubliant Generics Limited FDA-2017-P-7033 · 7 docket documents Jubilant Generics Limited submitted this petition under section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting the FDA determine that Oxcarbazepine Oral Tablet 450 mg (dual scored) is suitable for consideration in an ANDA, with TRILEPTAL Tablets (150, 300, and 600 mg) under NDA 0 | Other | 2017-12-29 | Granted | Jubliant Generics Limited |
Citizen Petition from Supernus Pharmaceuticals (Ropes and Gray, LLP) FDA-2015-P-2830 · 22 docket documents Supernus Pharmaceuticals filed this citizen petition pursuant to Section 505 of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 10.30 requesting that FDA establish specific bioequivalence parameters, including partial area under the curve measurements at 0-T and T-t with 90-125% confidence | 505(q) | 2015-08-10 | Denied | Supernus Pharmaceuticals (Ropes and Gray, LLP) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$19.27
per ea
Lowest NADAC/Unit
$5.72
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00078045705TRILEPTAL 600 MG TABLET | $19.27 | EA | Brand | $0.3080 | 2026-06-17 |
| 00078033705TRILEPTAL 300 MG TABLET | $10.45 | EA | Brand | $0.1664 | 2026-06-17 |
| 00078045605TRILEPTAL 150 MG TABLET | $5.72 | EA | Brand | $0.1036 | 2026-01-07 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.