DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 206426
NDA 206426 describes RAPIVAB, which is a drug marketed by Biocryst and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the RAPIVAB profile page.
The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the peramivir profile page.
The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the peramivir profile page.
Generic Entry Opportunity Date for 206426
Generic Entry Date for 206426*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION Dosage:
SOLUTION;IV (INFUSION) |
*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.
Suppliers and Packaging for NDA: 206426
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RAPIVAB | peramivir | SOLUTION;INTRAVENOUS | 206426 | NDA | bioCSL Inc. | 61364-181 | 61364-181-03 | 3 VIAL, GLASS in 1 CARTON (61364-181-03) > 20 mL in 1 VIAL, GLASS (61364-181-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 200MG/20ML (10MG/ML) | ||||
| Approval Date: | Dec 19, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 19, 2019 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Sep 20, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Nov 5, 2019 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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