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INVEGA TRINZA Drug Profile
» See Plans and Pricing
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 twenty-nine patent family members in twenty-three 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
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 5, 2036. This may change due to patent challenges or generic licensing.
There has been one patent litigation case 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.
Indicators of Generic Entry
Summary for INVEGA TRINZA
| International Patents: | 29 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 30 |
| Patent Applications: | 156 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for INVEGA TRINZA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INVEGA TRINZA |
| What excipients (inactive ingredients) are in INVEGA TRINZA? | INVEGA TRINZA excipients list |
| DailyMed Link: | INVEGA TRINZA at DailyMed |
Generic Entry Opportunity Date for INVEGA TRINZA
Generic Entry Date for INVEGA TRINZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for INVEGA TRINZA
| Drug Class | Atypical Antipsychotic |
Paragraph IV (Patent) Challenges for INVEGA TRINZA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| INVEGA TRINZA | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | paliperidone palmitate | 207946 | 2020-06-24 |
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 | 207946-001 | 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 | 207946-003 | 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 |
|---|---|---|
| Hungary | 9901319 | Start Trial |
| Norway | 981984 | Start Trial |
| Japan | 6728221 | Start Trial |
| Czech Republic | 9801401 | Start Trial |
| China | 1093762 | Start Trial |
| Australia | 715572 | 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 | 1190023-0 | Sweden | Start Trial | PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304 |
| 0904081 | C300491 | Netherlands | Start Trial | PRODUCT NAME: PALIPERIDONPALMITAAT; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304 |
| 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 | PA2011008,C0904081 | Lithuania | Start Trial | PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304 |
| 0904081 | PA2011008 | Lithuania | Start Trial | PRODUCT NAME: PALIPERIDONI PALMITAS; REGISTRATION NO/DATE: EU/1/11/672/001 - EU/1/11/672/006 20110304 |
| 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 |
