INVEGA HAFYERA Drug Patent Profile

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Which patents cover Invega Hafyera, and when can generic versions of Invega Hafyera launch?

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 thirty-one patent family members in thirteen 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 two 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:	31
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

Anatomical Therapeutic Chemical (ATC) Classes for INVEGA HAFYERA

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA BY ADMINISTERING A DOSE UP TO TWO WEEKS BEFORE OR THREE WEEKS AFTER THE SCHEDULED SIX-MONTH DOSE

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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

NEW STRENGTH
Exclusivity Expiration: ⤷ Try a Trial

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-005	Aug 30, 2021		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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
Denmark	3280416		⤷ Try a Trial
China	116528837	用于确保棕榈酸帕潘立酮制剂再悬浮的方法 (Method for ensuring resuspension of paliperidone palmitate formulations)	⤷ Try a Trial
China	1093762		⤷ Try a Trial
European Patent Office	4025188	SCHÉMAS POSOLOGIQUES ASSOCIÉS À DES FORMULATIONS INJECTABLES DE PALIPÉRIDONE À LIBÉRATION PROLONGÉE (DOSING REGIMENS ASSOCIATED WITH EXTENDED RELEASE PALIPERIDONE INJECTABLE FORMULATIONS)	⤷ Try a Trial
>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
0904081	C00904081/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: PALIPERIDON PALMITATESTER; REGISTRATION NO/DATE: SWISSMEDIC 60466 20101215
0904081	PA2011008	Lithuania	⤷ Try a Trial	PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304
0904081	1190023-0	Sweden	⤷ Try a Trial	PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304
0368388	07C0044	France	⤷ Try a Trial	PRODUCT 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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description