.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022410

« Back to Dashboard
NDA 022410 describes SUBOXONE, which is a drug marketed by Indivior Inc and is included in two NDAs. It is available from seven 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. Nineteen suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

Summary for NDA: 022410

Tradename:
SUBOXONE
Applicant:
Indivior Inc
Ingredient:
buprenorphine hydrochloride; naloxone hydrochloride
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:No
Patent:8,017,150Patent Expiration:Feb 13, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:8,475,832Patent 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:8,603,514Patent Expiration:Apr 3, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc