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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Moodys
McKinsey
Daiichi Sankyo
UBS
Boehringer Ingelheim
Express Scripts
Cerilliant
Argus Health

Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021444

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NDA 021444 describes RISPERDAL, which is a drug marketed by Janssen Pharms and is included in four NDAs. It is available from seven 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. Fifty-five suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 021444
Tradename:RISPERDAL
Applicant:Janssen Pharms
Ingredient:risperidone
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021444
Medical Subject Heading (MeSH) Categories for 021444
Suppliers and Packaging for NDA: 021444
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444 NDA Janssen Pharmaceuticals, Inc. 50458-395 N 50458-395-28
RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444 NDA Janssen Pharmaceutical, Inc. 50458-601 N 50458-601-28

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.5MG
Approval Date:Apr 2, 2003TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength1MG
Approval Date:Apr 2, 2003TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength2MG
Approval Date:Apr 2, 2003TE:ABRLD:Yes

Expired US Patents for NDA 021444

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-002 Apr 2, 2003 ➤ Sign Up ➤ Sign Up
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-001 Apr 2, 2003 ➤ Sign Up ➤ Sign Up
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-001 Apr 2, 2003 ➤ Sign Up ➤ Sign Up
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-005 Dec 23, 2004 ➤ 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:

Fish and Richardson
McKesson
Cantor Fitzgerald
McKinsey
Teva
Chubb
US Army
UBS
Mallinckrodt

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