invega hafyera Drug Patent Profile

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Which patents cover Invega Hafyera, and what generic alternatives are available?

Invega Hafyera is a drug marketed by Janssen Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has forty-eight patent family members in nineteen countries.

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

DrugPatentWatch^® Generic Entry Outlook for Invega Hafyera

There are three tentative approvals for the generic drug (paliperidone palmitate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for invega hafyera

International Patents:	48
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	50
Patent Applications:	133
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for invega hafyera
What excipients (inactive ingredients) are in invega hafyera?	invega hafyera excipients list
DailyMed Link:	invega hafyera at DailyMed

Drug patent expirations by year for invega hafyera

Pharmacology for invega hafyera

Drug Class	Atypical Antipsychotic

US Patents and Regulatory Information for invega hafyera

invega hafyera is protected by three US patents and one FDA Regulatory Exclusivity.

Patents protecting invega hafyera

Dosing regimens associated with extended release paliperidone injectable formulations
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Patented Use: REINITIATION OF SCHIZOPHRENIA TREATMENT WHEREIN MORE THAN 6 MONTHS 3 WEEKS BUT LESS THAN 8 MONTHS HAVE ELAPSED SINCE THE LAST DOSE

Dosing regimens associated with extended release paliperidone injectable formulations
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Patented Use: TREATMENT OF SCHIZOPHRENIA BY ADMINISTERING A DOSE UP TO TWO WEEKS BEFORE OR THREE WEEKS AFTER THE SCHEDULED SIX-MONTH DOSE

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Patented Use: TREATMENT OF SCHIZOPHRENIA BY ADMINISTRATION OF A SIX-MONTH PALIPERIDONE PALMITATE INJECTABLE SUSPENSION FILLED SYRINGE THAT HAS BEEN SHIPPED AND STORED IN A HORIZONAL POSITION

FDA Regulatory Exclusivity protecting invega hafyera

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Glossary

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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 HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-005	Aug 30, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-005	Aug 30, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for invega hafyera

See the table below for patents covering invega hafyera around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	7422277		⤷ Sign Up
Israel	303251	משטרי מינון הקשורים לפורמולציות להזרקה של פליפרידון עם שחרור מושהה (Dosing regimens associated with extended release paliperidone injectable formulations)	⤷ Sign Up
Taiwan	202222318	Dosing regimens associated with extended release paliperidone injectable formulations	⤷ Sign Up
Canada	3203567	PROCEDES DESTINES A ASSURER LA RESUSPENSION DE FORMULATIONS DE PALMITATE DE PALIPERIDONE (METHODS FOR ENSURING RESUSPENSION OF PALIPERIDONE PALMITATE FORMULATIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for invega hafyera

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0368388	SPC/GB07/065	United Kingdom	⤷ Sign Up	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
0904081	1190023-0	Sweden	⤷ Sign Up	PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304
0904081	11C0035	France	⤷ Sign Up	PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304
0904081	416	Finland	⤷ Sign Up
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description