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 thirty-two patent family members in fourteen 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
Summary for INVEGA HAFYERA
International Patents: | 32 |
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 |
Pharmacology for INVEGA HAFYERA
Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for INVEGA HAFYERA
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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 | ||||
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2020090498 | 長時間作用型注射可能パリペリドンエステルの抜かした投与量のための投与レジメン (DOSING REGIMEN FOR MISSED DOSES FOR LONG-ACTING INJECTABLE PALIPERIDONE ESTERS) | ⤷ Sign Up |
South Korea | 102606678 | ⤷ Sign Up | |
Morocco | 53511 | SCHÉMA DE TRAITEMENT EN CAS DE DOSES OUBLIÉES POUR DES ESTERS DE PALIPÉRIDONE INJECTABLES À ACTION PROLONGÉE | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INVEGA HAFYERA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0904081 | C00904081/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: PALIPERIDON PALMITATESTER; REGISTRATION NO/DATE: SWISSMEDIC 60466 20101215 |
0904081 | 1190023-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304 |
0904081 | 91842 | Luxembourg | ⤷ Sign Up | 91842, EXPIRES: 20220512 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |