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Details for New Drug Application (NDA): 206426
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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:
Dosage:
SOLUTION;INTRAVENOUS |
*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 | Seqirus USA 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: | Sep 20, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | Start Trial | Patent Expiration: | Feb 12, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN PATIENTS 2 YEARS AND OLDER | ||||||||
| Patent: | Start Trial | Patent Expiration: | Dec 16, 2023 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Expired US Patents for NDA 206426
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Biocryst | RAPIVAB | peramivir | SOLUTION;INTRAVENOUS | 206426-001 | Dec 19, 2014 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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