.

Deeper Knowledge, Faster

  • Plan your formulary budget
  • Drug patents in 130+ countries
  • Set up watchlists for daily email updates

► See Plans & Pricing

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

Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Teva
Cantor Fitzgerald
Chinese Patent Office
Federal Trade Commission
Citi
Novartis
Healthtrust
Deloitte
McKinsey

Generated: July 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020733

« Back to Dashboard
NDA 020733 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: 020733

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020733

Suppliers and Packaging for NDA: 020733

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL 020733 NDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-004 35356-004-07 7 TABLET in 1 BOTTLE, PLASTIC (35356-004-07)
SUBOXONE
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL 020733 NDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-004 35356-004-30 30 TABLET in 1 BOTTLE, PLASTIC (35356-004-30)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrengthEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 8, 2002TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrengthEQ 8MG BASE;EQ 2MG BASE
Approval Date:Oct 8, 2002TE:RLD:Yes


Complete Access Available with Subscription
« Back to Dashboard

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

Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Julphar
Fuji
QuintilesIMS
McKesson
Moodys
Deloitte
Express Scripts
Chubb
Farmers Insurance

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot