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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Baxter
Cerilliant
Fish and Richardson
Fuji
Moodys
Mallinckrodt
Dow
Cipla

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207946

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NDA 207946 describes INVEGA TRINZA, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the INVEGA TRINZA profile page.

The generic ingredient in INVEGA TRINZA is paliperidone palmitate. There are thirty-six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
Summary for 207946
Tradename:INVEGA TRINZA
Applicant:Janssen Pharms
Ingredient:paliperidone palmitate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207946
Suppliers and Packaging for NDA: 207946
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946 NDA Janssen Pharmaceuticals, Inc 50458-606 N 50458-606-01
INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946 NDA Janssen Pharmaceuticals, Inc 50458-607 N 50458-607-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrength273MG/0.875ML (273MG/0.875ML)
Approval Date:May 18, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:May 18, 2018
Regulatory Exclusivity Use:NEW PRODUCT

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrength410MG/1.315ML (311.79MG/ML)
Approval Date:May 18, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:May 18, 2018
Regulatory Exclusivity Use:NEW PRODUCT

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrength546MG/1.75ML (312MG/ML)
Approval Date:May 18, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:May 18, 2018
Regulatory Exclusivity Use:NEW PRODUCT

Expired US Patents for NDA 207946

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-003 May 18, 2015 ➤ Sign Up ➤ Sign Up
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-001 May 18, 2015 ➤ Sign Up ➤ Sign Up
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-004 May 18, 2015 ➤ Sign Up ➤ Sign Up
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-002 May 18, 2015 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
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Daiichi Sankyo
Express Scripts
Healthtrust
Accenture
Teva
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Johnson and Johnson

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