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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022410

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NDA 022410 describes SUBOXONE, which is a drug marketed by Indivior Inc and is included in two NDAs. It is available from four suppliers. There are six patents protecting this drug and three Paragraph IV challenges. Additional details are available on the SUBOXONE profile page.

The generic ingredient in SUBOXONE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for 022410
Tradename:SUBOXONE
Applicant:Indivior Inc
Ingredient:buprenorphine hydrochloride; naloxone hydrochloride
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 022410
Suppliers and Packaging for NDA: 022410
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410 NDA Indivior Inc. 12496-1202 N 12496-1202-3
SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 022410 NDA Indivior Inc. 12496-1204 N 12496-1204-3

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FILM;BUCCAL, SUBLINGUALStrengthEQ 2MG BASE;EQ 0.5MG BASE
Approval Date:Aug 30, 2010TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 13, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Mar 26, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
Patent:➤ Sign UpPatent Expiration:Apr 3, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION

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