Details for New Drug Application (NDA): 218230
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NDA 218230 describes BLUJEPA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the BLUJEPA profile page.
The generic ingredient in BLUJEPA is gepotidacin mesylate. One supplier is listed for this compound. Additional details are available on the gepotidacin mesylate profile page.
The generic ingredient in BLUJEPA is gepotidacin mesylate. One supplier is listed for this compound. Additional details are available on the gepotidacin mesylate profile page.
Summary for 218230
| Tradename: | BLUJEPA |
| Applicant: | Glaxosmithkline |
| Ingredient: | gepotidacin mesylate |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218230
Generic Entry Date for 218230*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW 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: 218230
Suppliers and Packaging for NDA: 218230
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BLUJEPA | gepotidacin mesylate | TABLET;ORAL | 218230 | NDA | GlaxoSmithKline LLC | 0173-0922 | 0173-0922-38 | 8 TABLET, FILM COATED in 1 BOTTLE (0173-0922-38) |
| BLUJEPA | gepotidacin mesylate | TABLET;ORAL | 218230 | NDA | GlaxoSmithKline LLC | 0173-0922 | 0173-0922-45 | 20 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 750MG BASE | ||||
| Approval Date: | Mar 25, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 25, 2035 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Mar 25, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Dec 11, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF UNCOMPLICATED UROGENITAL GONORRHEA CAUSED BY SUSCEPTIBLESTRAINS OF NEISSERIA GONORRHOEAE IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WEIGHING AT LEAST 45 KILOGRAMS WHO HAVE LIMITED OR NO ALTERNATIVE OPTIONS | ||||||||
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