Details for New Drug Application (NDA): 211673
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NDA 211673 describes XENLETA, which is a drug marketed by Hong Kong and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the XENLETA profile page.
The generic ingredient in XENLETA is lefamulin acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the lefamulin acetate profile page.
The generic ingredient in XENLETA is lefamulin acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the lefamulin acetate profile page.
Summary for 211673
| Tradename: | XENLETA |
| Applicant: | Hong Kong |
| Ingredient: | lefamulin acetate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211673
Generic Entry Date for 211673*:
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.
Pharmacology for NDA: 211673
| Mechanism of Action | Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors Acidifying Activity Calcium Chelating Activity |
| Physiological Effect | Decreased Coagulation Factor Activity |
Suppliers and Packaging for NDA: 211673
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673 | NDA | Meitheal Pharmaceuticals Inc. | 71288-039 | 71288-039-16 | 6 VIAL, SINGLE-USE in 1 CARTON (71288-039-16) / 15 mL in 1 VIAL, SINGLE-USE (71288-039-15) |
| XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673 | NDA | Meitheal Pharmaceuticals Inc. | 71288-040 | 71288-040-65 | 6 BAG in 1 CARTON (71288-040-65) / 270 mL in 1 BAG (71288-040-64) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 150MG BASE/15ML (EQ 10MG BASE/ML) | ||||
| Approval Date: | Aug 19, 2019 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 19, 2029 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Aug 19, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 14, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 211673
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Hong Kong | XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673-001 | Aug 19, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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