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Generated: July 23, 2017

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 eight 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-nine suppliers are listed for this compound. Additional details are available on the risperidone profile page.

Summary for NDA: 020588

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 50458-305-03 30 mL in 1 BOTTLE (50458-305-03)
RISPERDAL
risperidone
SOLUTION;ORAL 020588 NDA Janssen Pharmaceutical, Inc. 50458-596 50458-596-01 30 mL in 1 BOTTLE (50458-596-01)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 020588

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
RISPERDAL
risperidone
SOLUTION;ORAL020588-001Jun 10, 19964,804,663*PED► Subscribe
Janssen Pharms
RISPERDAL
risperidone
SOLUTION;ORAL020588-001Jun 10, 19965,616,587*PED► Subscribe
Janssen Pharms
RISPERDAL
risperidone
SOLUTION;ORAL020588-001Jun 10, 1996RE39181*PED► Subscribe
Janssen Pharms
RISPERDAL
risperidone
SOLUTION;ORAL020588-001Jun 10, 19965,453,425*PED► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Moodys
Fish and Richardson
Daiichi Sankyo
Baxter
Cerilliant
Healthtrust
Novartis
Federal Trade Commission
Cantor Fitzgerald
Merck

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 verifification 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.

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