Details for New Drug Application (NDA): 208610
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NDA 208610 describes BAXDELA, which is a drug marketed by Melinta and is included in two NDAs. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the BAXDELA profile page.
The generic ingredient in BAXDELA is delafloxacin meglumine. One supplier is listed for this compound. Additional details are available on the delafloxacin meglumine profile page.
The generic ingredient in BAXDELA is delafloxacin meglumine. One supplier is listed for this compound. Additional details are available on the delafloxacin meglumine profile page.
Summary for 208610
| Tradename: | BAXDELA |
| Applicant: | Melinta |
| Ingredient: | delafloxacin meglumine |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208610
Generic Entry Date for 208610*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*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.
Pharmacology for NDA: 208610
Suppliers and Packaging for NDA: 208610
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BAXDELA | delafloxacin meglumine | TABLET;ORAL | 208610 | NDA | Melinta Therapeutics, LLC | 70842-101 | 70842-101-01 | 1 BOTTLE in 1 CARTON (70842-101-01) / 20 TABLET in 1 BOTTLE |
| BAXDELA | delafloxacin meglumine | TABLET;ORAL | 208610 | NDA | Melinta Therapeutics, LLC | 70842-101 | 70842-101-02 | 2 BLISTER PACK in 1 CARTON (70842-101-02) / 10 TABLET in 1 BLISTER PACK (70842-101-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 450MG BASE | ||||
| Approval Date: | Jun 19, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 19, 2027 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Jun 19, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Oct 24, 2022 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA (CABP) CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS | ||||||||
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