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 | — |
Aquestive Therapeutics, Inc. v. BioDelivery Sciences International, Inc. 1 patentbuprenorphine hydrochloride | NCED | 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 | Active | — |
Aquestive Therapeutics, Inc. v. Biodelivery Sciences International, Inc. 1 patentbuprenorphine hydrochloride | NCED | 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 Collegium Pharmaceutical, Inc. filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.94 regarding ANDA 220582 submitted by Alvogen Inc. for a generic version of BELBUCA (buprenorphine hydrochloride) buccal film. Collegium requests that FDA require A | 505(q) | 2026-05-01 | Open | Collegium Pharmaceutical |
Source: Regulations.gov. FDA citizen petitions matched by application number.