➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Colorcon
Boehringer Ingelheim
Baxter
Harvard Business School

Last Updated: July 13, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021346


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 021346 describes RISPERDAL CONSTA, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the RISPERDAL CONSTA profile page.

The generic ingredient in RISPERDAL CONSTA is risperidone. There are thirty drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 021346
Tradename:RISPERDAL CONSTA
Applicant:Janssen Pharms
Ingredient:risperidone
Patents:1
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021346
Suppliers and Packaging for NDA: 021346
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346 NDA Janssen Pharmaceuticals, Inc. 50458-306 50458-306-11 1 KIT in 1 BOX (50458-306-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE
RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346 NDA Janssen Pharmaceuticals, Inc. 50458-307 50458-307-11 1 KIT in 1 BOX (50458-307-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrength25MG/VIAL
Approval Date:Oct 29, 2003TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Nov 25, 2020Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrength37.5MG/VIAL
Approval Date:Oct 29, 2003TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Nov 25, 2020Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrength50MG/VIAL
Approval Date:Oct 29, 2003TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Nov 25, 2020Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021346

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003   Start Trial   Start Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003   Start Trial   Start Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-004 Apr 12, 2007   Start Trial   Start Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003   Start Trial   Start Trial
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Dow
Colorcon
Express Scripts
McKinsey
Moodys
Medtronic

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.