BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | N204242 | EDENBRIDGE PHARMACEUTICALS LLC DBA DEXCEL PHARMA USA
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2017-06-14 | Terminated 2019-01-10 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Wiley Rein LLP FDA-2015-P-1752 · 5 docket documents Wiley Rein LLP, on behalf of a client, petitioned the FDA on May 14, 2015, requesting a determination that ZUBSOLV (buprenorphine and naloxone sublingual tablets), 11.4 mg/2.9 mg base, approved under NDA 204242 in December 2014, was voluntarily withdrawn from the market but not for safety or efficac | 505(q) | 2015-05-19 | Withdrawn | Wiley Rein LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$21.04
per ea
Lowest NADAC/Unit
$5.26
per ea
Brand NDCs
6
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 54123011430ZUBSOLV 11.4-2.9 MG TABLET SL | $21.04 | EA | Brand | — | 2026-06-17 |
| 54123098630ZUBSOLV 8.6-2.1 MG TABLET SL | $15.82 | EA | Brand | — | 2026-06-17 |
| 54123095730ZUBSOLV 5.7-1.4 MG TABLET SL | $10.55 | EA | Brand | — | 2026-06-17 |
| 54123092930ZUBSOLV 2.9-0.71 MG TABLET SL | $10.53 | EA | Brand | — | 2026-06-17 |
| 54123090730ZUBSOLV 0.7-0.18 MG TABLET SL | $5.27 | EA | Brand | — | 2026-06-17 |
| 54123091430ZUBSOLV 1.4-0.36 MG TABLET SL | $5.26 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.