Details for New Drug Application (NDA): 218590
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NDA 218590 describes ZURNAI (AUTOINJECTOR), which is a drug marketed by Knoa 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 ZURNAI (AUTOINJECTOR) profile page.
The generic ingredient in ZURNAI (AUTOINJECTOR) is nalmefene hydrochloride. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the nalmefene hydrochloride profile page.
The generic ingredient in ZURNAI (AUTOINJECTOR) is nalmefene hydrochloride. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the nalmefene hydrochloride profile page.
Summary for 218590
| Tradename: | ZURNAI (AUTOINJECTOR) |
| Applicant: | Knoa Pharma |
| Ingredient: | nalmefene hydrochloride |
| Patents: | 2 |
Pharmacology for NDA: 218590
| Mechanism of Action | Opioid Antagonists |
Suppliers and Packaging for NDA: 218590
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZURNAI (AUTOINJECTOR) | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 218590 | NDA | Knoa Pharma LLC | 59011-962 | 59011-962-01 | 1 SYRINGE, GLASS in 1 CARTON (59011-962-01) / .5 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Strength | EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML) | ||||
| Approval Date: | Aug 7, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 7, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 5, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 5, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATING OPIOID OVERDOSE | ||||||||
Expired US Patents for NDA 218590
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Knoa Pharma | ZURNAI (AUTOINJECTOR) | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 218590-001 | Aug 7, 2024 | ⤷ Start Trial | ⤷ Start Trial |
| Knoa Pharma | ZURNAI (AUTOINJECTOR) | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 218590-001 | Aug 7, 2024 | ⤷ Start Trial | ⤷ Start Trial |
| Knoa Pharma | ZURNAI (AUTOINJECTOR) | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 218590-001 | Aug 7, 2024 | ⤷ Start Trial | ⤷ Start Trial |
| Knoa Pharma | ZURNAI (AUTOINJECTOR) | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 218590-001 | Aug 7, 2024 | ⤷ Start Trial | ⤷ Start Trial |
| Knoa Pharma | ZURNAI (AUTOINJECTOR) | nalmefene hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 218590-001 | Aug 7, 2024 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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