You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210303


✉ Email this page to a colleague

« Back to Dashboard


NDA 210303 describes ZEMDRI, which is a drug marketed by Cipla Usa and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug. Additional details are available on the ZEMDRI profile page.

The generic ingredient in ZEMDRI is plazomicin sulfate. Three suppliers are listed for this compound. Additional details are available on the plazomicin sulfate profile page.
Summary for 210303
Tradename:ZEMDRI
Applicant:Cipla Usa
Ingredient:plazomicin sulfate
Patents:4
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210303
Generic Entry Date for 210303*:
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.

Suppliers and Packaging for NDA: 210303
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZEMDRI plazomicin sulfate SOLUTION;INTRAVENOUS 210303 NDA Cipla USA Inc. 69097-820 69097-820-96 10 VIAL in 1 CARTON (69097-820-96) / 10 mL in 1 VIAL (69097-820-37)
ZEMDRI plazomicin sulfate SOLUTION;INTRAVENOUS 210303 NDA Achaogen, Inc. 71045-010 71045-010-02 10 VIAL in 1 CARTON (71045-010-02) / 10 mL in 1 VIAL (71045-010-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrengthEQ 500MG BASE/10ML (EQ 50MG BASE/ML)
Approval Date:Jun 25, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 25, 2028
Regulatory Exclusivity Use:GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:Jun 25, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:Jun 2, 2031Product Flag?Substance Flag?YDelist Request?
Patented Use:METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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.