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Serving leading biopharmaceutical companies globally:

Cipla
Harvard Business School
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Chinese Patent Office
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Moodys
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Generated: December 14, 2017

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

Summary for 021444

Tradename:1
Applicant:1
Ingredient:1
Patents:1
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. 50458-315 50458-315-30 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50458-315-30)
RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444 NDA Janssen Pharmaceuticals, Inc. 50458-315 50458-315-28 7 BLISTER PACK in 1 BOX (50458-315-28) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.5MG
Approval Date:Apr 2, 2003TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Dec 10, 2017Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength1MG
Approval Date:Apr 2, 2003TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Dec 10, 2017Product Flag?Substance Flag?Delist Request?Y

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength2MG
Approval Date:Apr 2, 2003TE:ABRLD:Yes
Patent:► SubscribePatent Expiration:Dec 10, 2017Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021444

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen PharmsRISPERDALrisperidoneTABLET, ORALLY DISINTEGRATING;ORAL021444-005Dec 23, 2004► Subscribe► Subscribe
Janssen PharmsRISPERDALrisperidoneTABLET, ORALLY DISINTEGRATING;ORAL021444-005Dec 23, 2004► Subscribe► Subscribe
Janssen PharmsRISPERDALrisperidoneTABLET, ORALLY DISINTEGRATING;ORAL021444-002Apr 2, 2003► Subscribe► Subscribe
Janssen PharmsRISPERDALrisperidoneTABLET, ORALLY DISINTEGRATING;ORAL021444-004Dec 23, 2004► Subscribe► Subscribe
Janssen PharmsRISPERDALrisperidoneTABLET, ORALLY DISINTEGRATING;ORAL021444-003Apr 2, 2003► Subscribe► Subscribe
Janssen PharmsRISPERDALrisperidoneTABLET, ORALLY DISINTEGRATING;ORAL021444-001Apr 2, 2003► Subscribe► Subscribe
Janssen PharmsRISPERDALrisperidoneTABLET, ORALLY DISINTEGRATING;ORAL021444-002Apr 2, 2003► Subscribe► Subscribe
Janssen PharmsRISPERDALrisperidoneTABLET, ORALLY DISINTEGRATING;ORAL021444-005Dec 23, 2004► Subscribe► Subscribe
Janssen PharmsRISPERDALrisperidoneTABLET, ORALLY DISINTEGRATING;ORAL021444-004Dec 23, 2004► Subscribe► Subscribe
Janssen PharmsRISPERDALrisperidoneTABLET, ORALLY DISINTEGRATING;ORAL021444-003Apr 2, 2003► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Dow
Express Scripts
Fish and Richardson
Johnson and Johnson
Covington
US Army
Moodys
Teva
Chubb
QuintilesIMS

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