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PROBUPHINE

NDA

BUPRENORPHINE HYDROCHLORIDE | N204442 | REACX PHARMACEUTICALS 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

10 letters from Drugs@FDA

Date	Submission	Document
Dec 29, 2025	SUPPL -15	View Letter (PDF)
Dec 19, 2023	SUPPL -14	View Letter (PDF)
Mar 24, 2023	SUPPL -13	View Letter (PDF)
Jun 21, 2022	SUPPL -12	View Letter (PDF)
Mar 8, 2021	SUPPL -11	View Letter (PDF)
Oct 9, 2019	SUPPL -9	View Letter (PDF)
Nov 6, 2018	SUPPL -7	View Letter (PDF)
Feb 2, 2018	SUPPL -6	View Letter (PDF)
Apr 21, 2017	SUPPL -3	View Letter (PDF)
May 26, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 80MG BASE/IMPLANT

RLD

0 patents0 exclusivities▴

IMPLANT;IMPLANTATION | Approved: May 26, 2016

No patent or exclusivity listings for this strength.