BUPRENORPHINE HYDROCHLORIDE | N207932 | BIODELIVERY SCIENCES INTERNATIONAL INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
BioDelivery Sciences International, Inc. et al v. Alvogen Pb Research & Development LLC et al 3 patentsANDA 211594, 220582buprenorphine | D. Del. | 2025-07-24 | Active | — |
| D. Del. | 2022-09-12 | Active | — | |
Aquestive Therapeutics, Inc. v. BioDelivery Sciences International, Inc. 1 patentbuprenorphine hydrochloride | E.D.N.C. | 2019-11-11 | Terminated 2023-03-09 | — |
BIODELIVERY SCIENCES INTERNATIONAL, INC. et al v. CHEMO RESEARCH, S.L. et al 3 patentsANDA 212036buprenorphine buccal film | D.N.J. | 2019-03-15 | Terminated 2019-04-26 | — |
BioDelivery Sciences International, Inc. et al v. Chemo Research, S.L. et al 3 patentsANDA 212036buprenorphine | D. Del. | 2019-03-01 | Terminated 2020-09-18 | — |
Aquestive Therapeutics, Inc. v. Biodelivery Sciences International, Inc. 1 patentbuprenorphine hydrochloride | E.D.N.C. | 2018-10-30 | Terminated 2019-08-07 | — |
BioDelivery Sciences International, Inc. et al v. Alvogen Pb Research & Development LLC et al 3 patentsANDA 211594buprenorphine | D. Del. | 2018-09-07 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Collegium Pharmaceutical, Inc. FDA-2026-P-4762 · 36 docket documents Collegium Pharmaceutical, Inc. filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that FDA require ANDA 220582 submitted by Alvogen Inc. for a generic version of BELBUCA (buprenorphine hydrochloride) buccal film to be supported by new in vivo bioequi | 505(q) | 2026-05-01 | Open | Collegium Pharmaceutical, Inc. |
Citizen Petition from BioDelivery Sciences International, Inc. FDA-2021-P-1142 · 3 docket documents BioDelivery Sciences International, Inc. filed this citizen petition on October 20, 2021, requesting that the FDA require applicants submitting ANDAs or 505(b)(2) NDAs for generic buprenorphine buccal film products referencing BELBUCA as the reference listed drug to provide comparative clinical safe | 505(q) | 2021-10-21 | Denied | BioDelivery Sciences International, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$18.60
per ea
Lowest NADAC/Unit
$7.54
per ea
Brand NDCs
7
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 59385002760BELBUCA 900 MCG FILM | $18.60 | EA | Brand | — | 2026-06-17 |
| 59385002660BELBUCA 750 MCG FILM | $18.08 | EA | Brand | — | 2026-06-17 |
| 59385002560BELBUCA 600 MCG FILM | $17.21 | EA | Brand | — | 2026-06-17 |
| 59385002460BELBUCA 450 MCG FILM | $16.13 | EA | Brand | — | 2026-06-17 |
| 59385002360BELBUCA 300 MCG FILM | $11.84 | EA | Brand | — | 2026-06-17 |
| 59385002260BELBUCA 150 MCG FILM | $7.56 | EA | Brand | — | 2026-06-17 |
| 59385002160BELBUCA 75 MCG FILM | $7.54 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.