Details for New Drug Application (NDA): 212295
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NDA 212295 describes BYFAVO, which is a drug marketed by Acacia and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the BYFAVO profile page.
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.
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: | ⤷ Get Started Free | 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: | ⤷ Get Started Free | 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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