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 |
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
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 | ||||
| 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 | 207946-005 | 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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Slovenia | 3744326 | ⤷ Sign Up | |
| Mexico | 2023006370 | REGIMENES DE DOSIFICACION ASOCIADOS CON FORMULACIONES INYECTABLES DE PALIPERIDONA DE LIBERACION PROLONGADA. (DOSING REGIMENS ASSOCIATED WITH EXTENDED RELEASE PALIPERIDONE INJECTABLE FORMULATIONS.) | ⤷ Sign Up |
| Japan | 7228503 | ⤷ Sign Up | |
| South Korea | 20230116013 | 서방형 팔리페리돈 주사용 제형과 관련된 투약 요법 | ⤷ Sign Up |
| Denmark | 0904081 | ⤷ Sign Up | |
| Japan | 6728221 | ⤷ Sign Up | |
| Slovakia | 284013 | ⤷ 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 |
|---|---|---|---|---|
| 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 | C00904081/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: PALIPERIDON PALMITATESTER; REGISTRATION NO/DATE: SWISSMEDIC 60466 20101215 |
| 0904081 | PA2011008,C0904081 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304 |
| 0904081 | PA2011008 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304 |
| 0904081 | CA 2011 00020 | Denmark | ⤷ Sign Up | |
| 0368388 | 07C0044 | France | ⤷ Sign Up | 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 |
| 0904081 | 416 | Finland | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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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