PHENTERMINE HYDROCHLORIDE; TOPIRAMATE | N022580 | VIVUS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
VIVUS, INC. v. DR. REDDY'S LABORATORIES, S.A. et al 8 patentsANDA 208175phentermine and topiramate extended-release | D.N.J. | 2015-04-15 | Terminated 2017-09-06 | — |
VIVUS, INC. v. ACTAVIS LABORATORIES FL, INC. 6 patentsANDA 204982phentermine and topiramate extended-release | D.N.J. | 2014-06-12 | Terminated 2017-07-07 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lannett Company, Inc. - Citizen Petition FDA-2012-P-0052 Lannett Company, Inc. filed this petition under Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require manufacturers of Phentermine HCl products to add a warning to package insert labeling stating that coadministration with topiramate has not been demonstrated | Other | 2012-01-24 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$3.06
per ea
Lowest NADAC/Unit
$2.70
per ea
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 66993078130PHENTERMINE-TOPIRAMATE ER 7.5-46 MG CAPSULE | $3.06 | EA | Generic | — | 2026-10-21 |
| 66993078230PHENTERMINE-TOPIRAMATE ER 11.25-69 MG CAPSULE | $3.02 | EA | Generic | — | 2026-10-21 |
| 66993078030PHENTERMINE-TOPIRAMATE ER 3.75-23 MG CAPSULE | $2.99 | EA | Generic | — | 2026-10-21 |
| 66993078330PHENTERMINE-TOPIRAMATE ER 15-92 MG CAPSULE | $2.70 | EA | Generic | — | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.