➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts

Last Updated: July 13, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209819

Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 209819 describes SUBLOCADE, which is a drug marketed by Indivior Inc and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the SUBLOCADE profile page.

The generic ingredient in SUBLOCADE is buprenorphine. There are twenty-nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.
Summary for 209819
Applicant:Indivior Inc
Formulation / Manufacturing:see details
Pharmacology for NDA: 209819
Mechanism of ActionPartial Opioid Agonists
Medical Subject Heading (MeSH) Categories for 209819
Suppliers and Packaging for NDA: 209819
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819 NDA Indivior Inc. 12496-0100 12496-0100-1 1 POUCH in 1 CARTON (12496-0100-1) > 1 SYRINGE in 1 POUCH (12496-0100-2) > 1 SOLUTION in 1 SYRINGE (12496-0100-5)
SUBLOCADE buprenorphine SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS 209819 NDA Indivior Inc. 12496-0300 12496-0300-1 1 POUCH in 1 CARTON (12496-0300-1) > 1 SYRINGE in 1 POUCH (12496-0300-2) > 1 SOLUTION in 1 SYRINGE (12496-0300-5)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION, EXTENDED RELEASE;SUBCUTANEOUSStrength100MG/0.5ML (100MG/0.5ML)
Approval Date:Nov 30, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 30, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Jun 6, 2031Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 25, 2031Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson

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 verification 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.