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Generated: January 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020272

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NDA 020272 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-eight suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 020272
Tradename:RISPERDAL
Applicant:Janssen Pharms
Ingredient:risperidone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020272
Medical Subject Heading (MeSH) Categories for 020272
Suppliers and Packaging for NDA: 020272
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERDAL risperidone TABLET;ORAL 020272 NDA Rebel Distributors Corp 21695-113 21695-113-15 15 TABLET in 1 BOTTLE (21695-113-15)
RISPERDAL risperidone TABLET;ORAL 020272 NDA Rebel Distributors Corp 21695-115 21695-115-30 30 TABLET in 1 BOTTLE (21695-115-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Dec 29, 1993TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Dec 29, 1993TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Dec 29, 1993TE:ABRLD:Yes

Expired US Patents for NDA 020272

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL risperidone TABLET;ORAL 020272-001 Dec 29, 1993 ➤ Sign Up ➤ Sign Up
Janssen Pharms RISPERDAL risperidone TABLET;ORAL 020272-004 Dec 29, 1993 ➤ Sign Up ➤ Sign Up
Janssen Pharms RISPERDAL risperidone TABLET;ORAL 020272-008 May 10, 1999 ➤ Sign Up ➤ Sign Up
Janssen Pharms RISPERDAL risperidone TABLET;ORAL 020272-002 Dec 29, 1993 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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