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Generated: August 22, 2017

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 five suppliers. There are three 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-eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

Summary for NDA: 022410

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:3
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 12496-1202-3 30 POUCH in 1 CARTON (12496-1202-3) > 1 FILM, SOLUBLE in 1 POUCH (12496-1202-1)
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
FILM;BUCCAL, SUBLINGUAL 022410 NDA Indivior Inc. 12496-1204 12496-1204-3 30 POUCH in 1 CARTON (12496-1204-3) > 1 FILM, SOLUBLE in 1 POUCH (12496-1204-1)

Summary 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:► SubscribePatent Expiration:Feb 13, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent 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:► SubscribePatent Expiration:Apr 3, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION


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Serving 500+ biopharmaceutical companies globally:

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