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Last Updated: October 31, 2024

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.
Summary for 216974
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:RXDosage:POWDER;INTRAVENOUSStrengthEQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL
Approval Date:May 23, 2023TE: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 UpPatent Expiration:Nov 17, 2035Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP)

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.