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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
Drug Prices:see low prices

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 SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-005Jul 31, 2009RXNoNov 12, 2017
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-002Jul 31, 2009RXNo6,077,843*PEDNov 12, 2017Y
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-003Jul 31, 2009RXNo6,555,544*PEDMay 10, 2019Y
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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;INTRAMUSCULAR022264-003Jul 31, 20095,352,459*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;INTRAMUSCULAR022264-004Jul 31, 20095,352,459*PED<disabled>
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International Patent Family for Ingredient: paliperidone palmitate

Country Document Number Estimated Expiration
Israel124551<disabled in preview>
Portugal904081<disabled in preview>
Cyprus2270<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
6Finland<disabled>
2011008,C0904081Lithuania<disabled>PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304
11/021Ireland<disabled>PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
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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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