Details for New Drug Application (NDA): 216974
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NDA 216974 describes XACDURO (COPACKAGED), which is a drug marketed by Entasis Therap 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 XACDURO (COPACKAGED) profile page.
The generic ingredient in XACDURO (COPACKAGED) is durlobactam sodium; durlobactam sodium; sulbactam sodium. One supplier is listed for this compound. Additional details are available on the durlobactam sodium; durlobactam sodium; sulbactam sodium profile page.
The generic ingredient in XACDURO (COPACKAGED) is durlobactam sodium; durlobactam sodium; sulbactam sodium. One supplier is listed for this compound. Additional details are available on the durlobactam sodium; durlobactam sodium; sulbactam sodium profile page.
Summary for 216974
| Tradename: | XACDURO (COPACKAGED) |
| Applicant: | Entasis Therap |
| Ingredient: | durlobactam sodium; durlobactam sodium; sulbactam sodium |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216974
Generic Entry Date for 216974*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW 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: 216974
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XACDURO (COPACKAGED) | durlobactam sodium; durlobactam sodium; sulbactam sodium | POWDER;INTRAVENOUS | 216974 | NDA | La Jolla Pharmaceutical Company | 68547-111 | 68547-111-10 | 1 KIT in 1 CARTON (68547-111-10) * 5 mL in 1 VIAL, SINGLE-DOSE (68547-211-20) * 2.5 mL in 1 VIAL, SINGLE-DOSE (68547-311-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL | ||||
| Approval Date: | May 23, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 23, 2033 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | May 23, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,376,499 | Patent Expiration: | Nov 17, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP) | ||||||||
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