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RISPERDAL Drug Profile

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Risperdal is a drug marketed by Janssen Pharms and is included in four NDAs. It is available from seven suppliers. There are eight patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-four patent family members in twenty-seven countries.

The generic ingredient in RISPERDAL is risperidone. There are twenty-nine drug master file entries for this compound. Sixty-three suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the risperidone profile page.

Summary for Tradename: RISPERDAL

Patents:8
Applicants:1
NDAs:4
Suppliers / Packagers: see list7
Drug Prices: :see details

Pharmacology for Tradename: RISPERDAL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-002Oct 29, 2003RXNo6,596,316*PED► subscribeY► subscribe
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-002Oct 29, 2003RXNo5,916,598*PED► subscribeY► subscribe
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-002Oct 29, 2003RXNo6,667,061*PED► subscribeY► subscribe
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Expired Patents for Tradename: RISPERDAL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
RISPERDAL
risperidone
TABLET, ORALLY DISINTEGRATING;ORAL021444-002Apr 2, 20035,648,093*PED► subscribe
Janssen Pharms
RISPERDAL
risperidone
TABLET, ORALLY DISINTEGRATING;ORAL021444-005Dec 23, 20044,804,663*PED► subscribe
Janssen Pharms
RISPERDAL
risperidone
TABLET;ORAL020272-004Dec 29, 19934,804,663*PED► subscribe
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Paragraph IV activity for: RISPERDAL

Drugname Dosage Strength RLD Submissiondate
risperidoneOrally Disintegrating Tablets0.25 mgRisperdal4/11/2005
risperidoneOrally Disintegrating Tablets3 mg and 4 mgRisperdal3/23/2005

International Patent Family for Tradename: RISPERDAL

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9748383► subscribe
Czech Republic297261► subscribe
Slovakia173798► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: RISPERDAL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0008Belgium► subscribePRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
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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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