Details for New Drug Application (NDA): 216974
✉ Email this page to a colleague
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 | LaJolla 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: | ⤷ Sign Up | 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) |
Complete Access Available with Subscription