Details for New Drug Application (NDA): 216352
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NDA 216352 describes ERZOFRI, which is a drug marketed by Luye Innomind Pharma and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ERZOFRI profile page.
The generic ingredient in ERZOFRI is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
The generic ingredient in ERZOFRI is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.
Summary for 216352
| Tradename: | ERZOFRI |
| Applicant: | Luye Innomind Pharma |
| Ingredient: | paliperidone palmitate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216352
Generic Entry Date for 216352*:
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: 216352
Medical Subject Heading (MeSH) Categories for 216352
Suppliers and Packaging for NDA: 216352
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ERZOFRI | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 216352 | NDA | Shandong Luye Pharmaceutical Co., Ltd. | 72526-105 | 72526-105-11 | 1 SYRINGE, GLASS in 1 KIT (72526-105-11) / .25 mL in 1 SYRINGE, GLASS |
| ERZOFRI | paliperidone palmitate | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 216352 | NDA | Shandong Luye Pharmaceutical Co., Ltd. | 72526-106 | 72526-106-11 | 1 SYRINGE, GLASS in 1 KIT (72526-106-11) / .5 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 39MG/0.25ML (39MG/0.25ML) | ||||
| Approval Date: | Jul 26, 2024 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Sep 24, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S) | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Sep 24, 2039 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S) | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Oct 26, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING AN INITIAL DOSE OF PALIPERIDONE PALMITATE FOLLOWED BY MONTHLY DOSE(S) | ||||||||
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