Details for New Drug Application (NDA): 212295
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The generic ingredient in BYFAVO is remimazolam besylate. One supplier is listed for this compound. Additional details are available on the remimazolam besylate profile page.
Summary for 212295
Tradename: | BYFAVO |
Applicant: | Acacia |
Ingredient: | remimazolam besylate |
Patents: | 11 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212295
Generic Entry Date for 212295*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;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: 212295
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295 | NDA | Acacia Pharma, Ltd. | 71390-011 | 71390-011-11 | 10 VIAL in 1 CARTON (71390-011-11) / 8 mL in 1 VIAL (71390-011-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 20MG BASE/VIAL | ||||
Approval Date: | Oct 6, 2020 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Oct 6, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | 10,052,334 | Patent Expiration: | Nov 7, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS | ||||||||
Patent: | 10,195,210 | Patent Expiration: | Nov 7, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS |
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