INVEGA SUSTENNA Drug Patent Profile
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Which patents cover Invega Sustenna, and when can generic versions of Invega Sustenna launch?
Invega Sustenna is a drug marketed by Janssen Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has thirty-five patent family members in twenty-six countries.
The generic ingredient in INVEGA SUSTENNA 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 Sustenna
Invega Sustenna was eligible for patent challenges on December 19, 2010.
There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (paliperidone palmitate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for INVEGA SUSTENNA
| International Patents: | 35 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 50 |
| Clinical Trials: | 11 |
| Patent Applications: | 169 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for INVEGA SUSTENNA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INVEGA SUSTENNA |
| What excipients (inactive ingredients) are in INVEGA SUSTENNA? | INVEGA SUSTENNA excipients list |
| DailyMed Link: | INVEGA SUSTENNA at DailyMed |
Recent Clinical Trials for INVEGA SUSTENNA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Evolution Research Group | Phase 1 |
| Alliance for Clinical Trials in Oncology | Phase 1 |
| Luye Pharma Group Ltd. | Phase 1 |
Pharmacology for INVEGA SUSTENNA
| Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for INVEGA SUSTENNA
Paragraph IV (Patent) Challenges for INVEGA SUSTENNA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| INVEGA SUSTENNA | Extended-release Injectable Suspension | paliperidone palmitate | 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL and 234 mg/1.5 mL | 022264 | 1 | 2017-11-21 |
US Patents and Regulatory Information for INVEGA SUSTENNA
INVEGA SUSTENNA is protected by four US patents.
Patents protecting INVEGA SUSTENNA
Dosing regimen associated with long acting injectable paliperidone esters
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS
Dosing regimen associated with long acting injectable paliperidone esters
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SCHIZOPHRENIA
Dosing regimen associated with long acting injectable paliperidone esters
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
Dosing regimen associated with long acting injectable paliperidone esters
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
| 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 SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-001 | Jul 31, 2009 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-002 | Jul 31, 2009 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-004 | Jul 31, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-005 | Jul 31, 2009 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-003 | Jul 31, 2009 | 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 |
Expired US Patents for INVEGA SUSTENNA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-005 | Jul 31, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-003 | Jul 31, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-001 | Jul 31, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-003 | Jul 31, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-002 | Jul 31, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Janssen Pharms | INVEGA SUSTENNA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 022264-005 | Jul 31, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for INVEGA SUSTENNA
See the table below for patents covering INVEGA SUSTENNA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 3274687 | ⤷ Try a Trial | |
| Eurasian Patent Organization | 000536 | ВОДНЫЕ СУСПЕНЗИИ СЛОЖНЫХ ЭФИРОВ ЖИРНОЙ КИСЛОТЫ 9-ГИДРОКСИРИСПЕРИДОНА (AQUEOUS SUSPENSIONS OF 9-HYDROXYRISPERIDONE FATTY ACID ESTERS) | ⤷ Try a Trial |
| Hong Kong | 1029045 | ⤷ Try a Trial | |
| Norway | 934271 | ⤷ Try a Trial | |
| Denmark | 2234617 | ⤷ Try a Trial | |
| Japan | H06211647 | COMPOSITION CONTAINING NANOPARTICLE AND ITS MANUFACTURE | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for INVEGA SUSTENNA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0904081 | SPC/GB11/044 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PALIPERIDONE PALMITATE; REGISTERED: UK EU/1/11/672/001 20110304; UK EU/1/11/672/002 20110304; UK EU/1/11/672/003 20110304; UK EU/1/11/672/004 20110304; UK EU/1/11/672/005 20110304; UK EU/1/11/672/006 20110304 |
| 0904081 | CA 2011 00020 | Denmark | ⤷ Try a Trial | |
| 0904081 | PA2011008,C0904081 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304 |
| 0904081 | 91842 | Luxembourg | ⤷ Try a Trial | 91842, EXPIRES: 20220512 |
| 0368388 | 91362 | Luxembourg | ⤷ Try a Trial | 91362, EXPIRES: 20141030 |
| 0368388 | 78/2007 | Austria | ⤷ Try a Trial | PRODUCT NAME: PALIPERIDON, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEMBAREN SALZES; REGISTRATION NO/DATE: EU/1/07/395/001-064 20070625 |
| >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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