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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
US Department of Justice
Johnson and Johnson
McKesson
Julphar
Merck
UBS
Farmers Insurance
Argus Health

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020588

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NDA 020588 describes RISPERDAL, which is a drug marketed by Janssen Pharms and is included in four NDAs. It is available from six suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the RISPERDAL profile page.

The generic ingredient in RISPERDAL is risperidone. There are thirty drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 020588
Tradename:RISPERDAL
Applicant:Janssen Pharms
Ingredient:risperidone
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020588
Medical Subject Heading (MeSH) Categories for 020588
Suppliers and Packaging for NDA: 020588
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERDAL risperidone SOLUTION;ORAL 020588 NDA Janssen Pharmaceuticals, Inc. 50458-305 N 50458-305-03
RISPERDAL risperidone SOLUTION;ORAL 020588 NDA Janssen Pharmaceutical, Inc. 50458-596 N 50458-596-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Jun 10, 1996TE:AARLD:Yes

Expired US Patents for NDA 020588

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL risperidone SOLUTION;ORAL 020588-001 Jun 10, 1996 ➤ Sign Up ➤ Sign Up
Janssen Pharms RISPERDAL risperidone SOLUTION;ORAL 020588-001 Jun 10, 1996 ➤ Sign Up ➤ Sign Up
Janssen Pharms RISPERDAL risperidone SOLUTION;ORAL 020588-001 Jun 10, 1996 ➤ Sign Up ➤ Sign Up
Janssen Pharms RISPERDAL risperidone SOLUTION;ORAL 020588-001 Jun 10, 1996 ➤ 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:

AstraZeneca
Chubb
US Army
Merck
Express Scripts
Fish and Richardson
Queensland Health
Accenture
Teva

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