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INVEGA SUSTENNA Drug Profile

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Invega Sustenna is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug.

This drug has forty-six patent family members in thirty-six countries.

The generic ingredient in INVEGA SUSTENNA is paliperidone palmitate. There are thirty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.

Summary for Tradename: INVEGA SUSTENNA

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: INVEGA SUSTENNA

Clinical Trials for: INVEGA SUSTENNA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-001Jul 31, 2009RXNo6,555,544*PED<disabled>Y<disabled>
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-005Jul 31, 2009RXNo6,077,843*PED<disabled>Y<disabled>
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-002Jul 31, 2009RXNo<disabled><disabled>
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Expired Patents for Tradename: INVEGA SUSTENNA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-002Jul 31, 20095,254,556*PED<disabled>
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-001Jul 31, 20095,254,556*PED<disabled>
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-003Jul 31, 20095,254,556*PED<disabled>
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International Patent Family for Tradename: INVEGA SUSTENNA

Country Document Number Estimated Expiration
Portugal904081<disabled in preview>
China1093762<disabled in preview>
Hungary9901319<disabled in preview>
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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: INVEGA SUSTENNA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0904081/01Switzerland<disabled>PRODUCT NAME: PALIPERIDON PALMITATESTER; REGISTRATION NO/DATE: SWISSMEDIC 60466 20101215
2011008Lithuania<disabled>PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304
C/GB11/044United Kingdom<disabled>PRODUCT NAME: PALIPERIDONE PALMITATE; REGISTERED: UK EU/1/11/672/001 20110304; UK EU/1/11/672/002 20110304; UK EU/1/11/672/003 20110304; UK EU/1/11/672/004 20110304; UK EU/1/11/672/005 20110304; UK EU/1/11/672/006 20110304
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