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Generated: November 17, 2017

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Paliperidone palmitate - Generic Drug Details

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What are the generic sources for paliperidone palmitate and what is the scope of paliperidone palmitate patent protection?

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

Paliperidone palmitate has sixty-nine patent family members in thirty-nine countries and thirteen supplementary protection certificates in ten countries.

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

Pharmacology for paliperidone palmitate

Medical Subject Heading (MeSH) Categories for paliperidone palmitate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-001Jul 31, 2009RXYesNo► Subscribe► Subscribe ► Subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-005Jul 31, 2009RXYesNo► Subscribe► SubscribeY► Subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-005Jul 31, 2009RXYesNo► Subscribe► SubscribeY► Subscribe
Janssen Pharms
INVEGA TRINZA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207946-003May 18, 2015RXYesNo► Subscribe► SubscribeY► Subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-004Jul 31, 2009RXYesYes► Subscribe► Subscribe ► Subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-005Jul 31, 2009RXYesNo► Subscribe► Subscribe► Subscribe
Janssen Pharms
INVEGA TRINZA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207946-001May 18, 2015RXYesNo► Subscribe► SubscribeY► Subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-002Jul 31, 2009RXYesNo► Subscribe► SubscribeY► Subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-002Jul 31, 2009RXYesNo► Subscribe► SubscribeY► Subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-001Jul 31, 2009RXYesNo► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: paliperidone palmitate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
INVEGA TRINZA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207946-004May 18, 2015► Subscribe► Subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-005Jul 31, 2009► Subscribe► Subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-004Jul 31, 2009► Subscribe► Subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-002Jul 31, 2009► Subscribe► Subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-002Jul 31, 2009► Subscribe► Subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-004Jul 31, 2009► Subscribe► Subscribe
Janssen Pharms
INVEGA TRINZA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR207946-001May 18, 2015► Subscribe► Subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-003Jul 31, 2009► Subscribe► Subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-001Jul 31, 2009► Subscribe► Subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-002Jul 31, 2009► Subscribe► Subscribe
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International Patent Family for Ingredient: paliperidone palmitate

Country Document Number Estimated Expiration
European Patent Office0904081► Subscribe
Australia2955997► Subscribe
Slovenia904081► Subscribe
Bulgaria102443► Subscribe
Hong Kong1223850► Subscribe
Ukraine99163► Subscribe
BrazilPI0821408► Subscribe
Australia2008340101► Subscribe
Norway315931► Subscribe
Eurasian Patent Organization020697► 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: PALIPERIDONE PALMITATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/044United Kingdom► SubscribePRODUCT 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
2011008Lithuania► SubscribePRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304
C0044France► SubscribePRODUCT NAME: PALIPERIDONE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/395/01 DU 20070626; REGISTRATION NO/DATE AT EEC: EU/1/07/395/01 DU 20070625
11/021Ireland► SubscribePRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
90023-0Sweden► SubscribePRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304
0904081/01Switzerland► SubscribePRODUCT NAME: PALIPERIDON PALMITATESTER; REGISTRATION NO/DATE: SWISSMEDIC 60466 20101215
842Luxembourg► Subscribe91842, EXPIRES: 20220512
00491Netherlands► SubscribePRODUCT NAME: PALIPERIDONPALMITAAT; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
6Finland► Subscribe
C/GB07/065United Kingdom► SubscribePRODUCT 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
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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Healthtrust
AstraZeneca
McKinsey
Cantor Fitzgerald
Covington
Medtronic
Daiichi Sankyo
Chubb
Harvard Business School

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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