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 · 4 docket documents 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
$3.41
per ea
Lowest NADAC/Unit
$3.03
per ea
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 66993078330PHENTERMINE-TOPIRAMATE ER 15-92 MG CAPSULE | $3.41 | EA | Generic | — | 2026-06-17 |
| 66993078130PHENTERMINE-TOPIRAMATE ER 7.5-46 MG CAPSULE | $3.37 | EA | Generic | — | 2026-06-17 |
| 66993078030PHENTERMINE-TOPIRAMATE ER 3.75-23 MG CAPSULE | $3.30 | EA | Generic | — | 2026-06-17 |
| 66993078230PHENTERMINE-TOPIRAMATE ER 11.25-69 MG CAPSULE | $3.03 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.