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Generated: January 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210655

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NDA 210655 describes PERSERIS KIT, which is a drug marketed by Indivior Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the PERSERIS KIT profile page.

The generic ingredient in PERSERIS KIT is risperidone. There are thirty drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 210655
Tradename:PERSERIS KIT
Applicant:Indivior Inc
Ingredient:risperidone
Patents:5
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 210655
Suppliers and Packaging for NDA: 210655
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PERSERIS KIT risperidone FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 210655 NDA Indivior Inc. 12496-0090 12496-0090-1 1 KIT in 1 CARTON (12496-0090-1) * 1 SYRINGE in 1 POUCH > 1.2 mL in 1 SYRINGE * 1 SYRINGE in 1 POUCH (12496-0589-2) > 1 mL in 1 SYRINGE (12496-0589-5)
PERSERIS KIT risperidone FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS 210655 NDA Indivior Inc. 12496-0120 12496-0120-1 1 KIT in 1 CARTON (12496-0120-1) * 1 SYRINGE in 1 POUCH > 1.2 mL in 1 SYRINGE * 1 SYRINGE in 1 POUCH (12496-0776-2) > 1 mL in 1 SYRINGE (12496-0776-5)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUSStrength90MG
Approval Date:Jul 27, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 27, 2021
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:Feb 13, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Sep 26, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:ADMINISTRATION OF RISPERIDONE

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McKesson
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