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BUPRENEX

NDA

BUPRENORPHINE HYDROCHLORIDE | N018401 | INDIVIOR INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Odin Pharmaceuticals LLC FDA-2023-P-4223 Odin Pharmaceuticals LLC filed this petition on September 27, 2023, pursuant to sections 505(j) and 505(w) of the FDC Act and implementing regulations, requesting that the FDA determine whether BUPRENEX (Buprenorphine Hydrochloride) Injection, 0.3 mg/mL, approved under NDA 018401 and held by Indivio	505(q)	2023-09-28	Withdrawn	Odin Pharmaceuticals LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

4 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Neuromodulation and Cognitive Training in Opioid Use Disorder NCT03773523	N/A	Active	University of Minnesota	30	2019-08-01 → 2027-05-15
Buprenorphine Implementation at Syringe Service Programs to Reduce Overdoses NCT07631598	N/A	Not Yet Recruiting	Montefiore Medical Center	512	2026-08-10 → 2028-06
Using Clinical Decision Support to Provide Social Risk-Informed Care for Opioid Use Disorder in the Emergency Department NCT06872190	N/A	Recruiting	University of California, San Francisco	300	2025-04-20 → 2027-07
tAN for PTSD and OUD in Buprenorphine Therapy NCT06130501	N/A	Completed	University of Cincinnati	20	2024-07-01 → 2026-06-04

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part B Spending

CMS physician-administered drug spending for Buprenex (2023)

Total Spending

$863.20

Total Claims

194

Beneficiaries

160

ASP Price

—

HCPCS: J0592 — Injection, buprenorphine hydrochloride, 0.1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain14 active DMFs4 inactive

13 active API suppliers hold Drug Master Files for this ingredient.

ASPEN OSS BVBUPRENORPHINE HYDROCHLORIDE

DMF 70991987

TAPI NL BVBUPRENORPHINE HYDROCHLORIDE

DMF 164192003

MACFARLAN SMITH LTDBUPRENORPHINE HYDROCHLORIDE

DMF 191092006

SIEGFRIED LTDBUPRENORPHINE HYDROCHLORIDE

DMF 210602007

SUN PHARMACEUTICAL INDUSTRIES LTDBUPRENORPHINE HYDROCHLORIDE USP

DMF 228562009

UNICHEM LABORATORIES LTDBUPRENORPHINE HYDROCHLORIDE USP

DMF 228872009

NORAMCO LLCBUPRENORPHINE HYDROCHLORIDE (R036869) DRUG SUBSTANCE

DMF 236832010

AREVIPHARMA GMBHBUPRENORPHINE HYDROCHLORIDE

DMF 245942011

SPECGX LLCBUPRENORPHINE HYDROCHLORIDE USP, CODE 3210

DMF 249272012

SIEGFRIED USA LLCBUPRENORPHINE HYDROCHLORIDE USP

DMF 255072011

CAMBREX CHARLES CITY INCBUPRENORPHINE HYDROCHLORIDE

DMF 337992023

CHATTEM CHEMICALS INCBUPRENORPHINE HYDROCHLORIDE USP

DMF 351922021

SIEGFRIED AGBUPRENORPHINE HYDROCHLORIDE

DMF 388392024

AREVIPHARMA GMBHBUPRENORPHINE HYDROCHLORIDE

DMF 401952024

MACFARLAN SMITH LTDInactiveBUPRENORPHINE HYDROCHLORIDE

DMF 73431988

SALARS SPAInactiveBUPRENORPHINE HYDROCHLORIDE

DMF 76841988

UNICHEM LABORATORIES LTDInactiveBUPRENORPHINE HYDROCHLORIDE

DMF 79231989

RESONANCE LABORATORIES PVT LTDInactiveBUPRENORPHINE HYDROCHLORIDE (BPNH)

DMF 237562010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Dec 19, 2023	SUPPL -27	View Letter (PDF)
Jun 21, 2022	SUPPL -26	View Letter (PDF)
Oct 9, 2019	SUPPL -25	View Letter (PDF)
Dec 19, 2016	SUPPL -22	View Letter (PDF)
Jun 22, 2003	SUPPL -15	View Letter (PDF)
Mar 8, 2002	SUPPL -14	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.