Details for New Drug Application (NDA): 211672
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NDA 211672 describes XENLETA, which is a drug marketed by Nabriva and is included in two NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the XENLETA profile page.
The generic ingredient in XENLETA is lefamulin acetate. 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. One supplier is listed for this compound. Additional details are available on the lefamulin acetate profile page.
Summary for 211672
| Tradename: | XENLETA |
| Applicant: | Nabriva |
| Ingredient: | lefamulin acetate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211672
Generic Entry Date for 211672*:
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.
Suppliers and Packaging for NDA: 211672
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XENLETA | lefamulin acetate | TABLET;ORAL | 211672 | NDA | Nabriva Therapeutics US, Inc. | 72000-110 | 72000-110-10 | 10 TABLET, COATED in 1 BLISTER PACK (72000-110-10) |
| XENLETA | lefamulin acetate | TABLET;ORAL | 211672 | NDA | Nabriva Therapeutics US, Inc. | 72000-110 | 72000-110-30 | 30 TABLET, COATED in 1 BOTTLE (72000-110-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 600MG BASE | ||||
| 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: | ⤷ Try a Trial | Patent Expiration: | Jan 16, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 211672
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Nabriva | XENLETA | lefamulin acetate | TABLET;ORAL | 211672-001 | Aug 19, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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