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Last Updated: July 5, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209817


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NDA 209817 describes NUZYRA, which is a drug marketed by Paratek Pharms Inc and is included in two NDAs. There are ten patents protecting this drug. Additional details are available on the NUZYRA profile page.

The generic ingredient in NUZYRA is omadacycline tosylate. Additional details are available on the omadacycline tosylate profile page.
Summary for 209817
Tradename:NUZYRA
Applicant:Paratek Pharms Inc
Ingredient:omadacycline tosylate
Patents:7
Generic Entry Opportunity Date for 209817
Generic Entry Date for 209817*:
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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 100MG BASE/VIAL
Approval Date:Oct 2, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 2, 2028
Regulatory Exclusivity Use:GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:Oct 2, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Mar 5, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTION

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