Details for New Drug Application (NDA): 207946
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NDA 207946 describes INVEGA TRINZA, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the INVEGA TRINZA profile page.
The generic ingredient in INVEGA TRINZA is paliperidone palmitate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
The generic ingredient in INVEGA TRINZA is paliperidone palmitate. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
Summary for 207946
| Tradename: | INVEGA TRINZA |
| Applicant: | Janssen Pharms |
| Ingredient: | paliperidone palmitate |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207946
Generic Entry Date for 207946*:
Constraining patent/regulatory exclusivity:
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 NDA: 207946
Medical Subject Heading (MeSH) Categories for 207946
Suppliers and Packaging for NDA: 207946
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INVEGA HAFYERA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946 | NDA | Janssen Pharmaceuticals, Inc | 50458-606 | 50458-606-01 | 1 SYRINGE in 1 KIT (50458-606-01) / 1 mL in 1 SYRINGE |
| INVEGA TRINZA | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 207946 | NDA | Janssen Pharmaceuticals, Inc | 50458-606 | 50458-606-01 | 1 SYRINGE in 1 KIT (50458-606-01) / 1 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 273MG/0.875ML (273MG/0.875ML) | ||||
| Approval Date: | May 18, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 5, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 5, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 410MG/1.315ML (311.79MG/ML) | ||||
| Approval Date: | May 18, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 5, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO | ||||||||
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