Details for New Drug Application (NDA): 210303
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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: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | ||||
Approval Date: | Jun 25, 2018 | TE: | 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 Up | Patent Expiration: | Jun 2, 2031 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patented Use: | METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS |
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