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Paliperidone - Generic Drug Details

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Paliperidone is the generic ingredient in four branded drugs marketed by Mylan Pharms Inc, Actavis Labs Fl Inc, and Janssen Pharms, and is included in five NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: paliperidone

Tradenames:4
Patents:3
Applicants:3
NDAs:5
Drug Master File Entries: see list34
Suppliers / Packagers: see list9
Bulk Api Vendors: see list75
Clinical Trials: see list31
Patent Applications: see list270
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:paliperidone at DailyMed

Pharmacology for Ingredient: paliperidone

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-003Jul 31, 2009RXYesNo9,439,906► subscribe ► subscribe
Janssen Pharms
INVEGA SUSTENNA
paliperidone palmitate
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR022264-005Jul 31, 2009RXYesNo9,439,906► subscribe ► subscribe
Mylan Pharms Inc
PALIPERIDONE
paliperidone
TABLET, EXTENDED RELEASE;ORAL203802-004Sep 24, 2015RXNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: paliperidone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
INVEGA
paliperidone
TABLET, EXTENDED RELEASE;ORAL021999-001Dec 19, 20065,158,952*PED► subscribe
Janssen Pharms
INVEGA
paliperidone
TABLET, EXTENDED RELEASE;ORAL021999-004Dec 19, 20065,158,952*PED► subscribe
Janssen Pharms
INVEGA
paliperidone
TABLET, EXTENDED RELEASE;ORAL021999-006Aug 26, 20085,158,952*PED► subscribe
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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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