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Paliperidone palmitate - Generic Drug Details

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Paliperidone palmitate is the generic ingredient in two branded drugs marketed by Janssen Pharms and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are thirty drug master file entries for paliperidone palmitate. Two suppliers are listed for this compound.

Summary for Generic Name: paliperidone palmitate

Tradenames:2
Patents:2
Applicants:1
NDAs:2
Drug Master File Entries: see list30
Suppliers / Packaging: see list2
Formulation / Manufacturing:see details

Pharmacology for Ingredient: paliperidone palmitate

Clinical Trials for: paliperidone palmitate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
INVEGA TRINZA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207946-001May 18, 2015RXNo<disabled><disabled>
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-002Jul 31, 2009RXNo6,077,843*PED<disabled>Y<disabled>
Janssen Pharms
INVEGA TRINZA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207946-004May 18, 2015RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: paliperidone palmitate

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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 Ingredient: paliperidone palmitate

Country Document Number Estimated Expiration
Taiwan487572<disabled in preview>
New Zealand330369<disabled in preview>
Austria208619<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: PALIPERIDONE PALMITATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB07/065United Kingdom<disabled>PRODUCT NAME: PALIPERIDONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/395/001 20070625; UK EU/1/07/395/002 20070625; UK EU/1/07/395/003 20070625; UK EU/1/07/395/004 20070625; UK EU/1/07/395/005 20070625; UK EU/1/07/395/006 20070625; UK EU/1/07/395/007 20070625; UK EU/1/07/395/008 20070625; UK EU/1/07/395/009 20070625; UK EU/1/07/395/010 20070625; UK EU/1/07/395/011 20070625; UK EU/1/07/395/012 20070625; UK EU/1/07/395/013 20070625; UK EU/1/07/395/014 20070625; UK EU/1/07/395/015 20070625; UK EU/1/07/395/016 20070625; UK EU/1/07/395/017 20070625; UK EU/1/07/395/018 20070625; UK EU/1/07/395/019 20070625; UK EU/1/07/395/020 20070625; UK EU/1/07/395/021
C0035France<disabled>PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304
90023-0Sweden<disabled>PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304
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