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INVEGA TRINZA Drug Profile
When do Invega Trinza patents expire, and what generic alternatives are available?
Invega Trinza is a drug marketed by Janssen Pharms and is included in one NDA. There is one patent protecting this drug.
This drug has eleven patent family members in eleven countries.
The generic ingredient in INVEGA TRINZA 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.
US ANDA Litigation and Generic Entry Outlook for Invega Trinza
Invega Trinza was eligible for patent challenges on December 31, 1968.
Indicators of Generic Entry
Summary for INVEGA TRINZA
| International Patents: | 11 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 14 |
| Patent Applications: | 16 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for INVEGA TRINZA |
| DailyMed Link: | INVEGA TRINZA at DailyMed |
Pharmacology for INVEGA TRINZA
| Drug Class | Atypical Antipsychotic |
Synonyms for INVEGA TRINZA
| (9RS)-3-(2-(4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl)ethyl)-2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido(1,2-a)pyrimidin-9-yl hexadecanoate |
| 199739-10-1 |
| 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-9-yl hexadecanoate |
| 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-9-yl hexadecanoate |
| 9-Hydroxyrisperidone Palmitate |
| AKOS030526057 |
| BCP08473 |
| CHEBI:83808 |
| CHEMBL2107360 |
| FT-0673476 |
| Hexadecanoic Acid 3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido[1,2-a]pyrimidin-9-yl Ester |
| Hexadecanoic acid, 3-(2-(4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl)ethyl)-6,7,8,9-tetrahydro-2-methyl-4-oxo-4H-pyrido(1,2-a)pyrimidin-9-yl ester |
| JNS 010 |
| Paliperidone Palmitate |
| Paliperidone Palmitate [USAN] |
| PALPERIDONE PALMITATE |
| R8P8USM8FR |
| Ro 92670 |
| RO92670 |
| SCHEMBL12415674 |
| SCHEMBL1871384 |
| Trinza |
| UNII-R8P8USM8FR |
US Patents and Regulatory Information for INVEGA TRINZA
| 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 TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-001 | May 18, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-004 | May 18, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-002 | May 18, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-003 | May 18, 2015 | RX | Yes | No | Start Trial | Start Trial | Start 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 TRINZA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-003 | May 18, 2015 | Start Trial | Start Trial |
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-001 | May 18, 2015 | Start Trial | Start Trial |
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-002 | May 18, 2015 | Start Trial | Start Trial |
| Janssen Pharms | INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946-004 | May 18, 2015 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for INVEGA TRINZA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 3280416 | Start Trial |
| Canada | 2925908 | Start Trial |
| Brazil | 112017021383 | Start Trial |
| Taiwan | 201642863 | Start Trial |
| Ukraine | 118732 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for INVEGA TRINZA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0904081 | 2011/021 | Ireland | Start Trial | PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304 |
| 0904081 | 11C0035 | France | Start Trial | PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304 |
| 0368388 | SPC/GB07/065 | United Kingdom | Start Trial | 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 |
| 0368388 | 07C0044 | France | Start 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 |
| 0904081 | SPC/GB11/044 | United Kingdom | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
