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Last Updated: July 15, 2024

Details for New Drug Application (NDA): 209819


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NDA 209819 describes SUBLOCADE, which is a drug marketed by Indivior and is included in one NDA. It is available from one supplier. There are twelve 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. Nine suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.
Summary for 209819
Tradename:SUBLOCADE
Applicant:Indivior
Ingredient:buprenorphine
Patents:12
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
Patent:⤷  Sign UpPatent Expiration:Jun 6, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER
Patent:⤷  Sign UpPatent Expiration:Jun 25, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jun 6, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER

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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.