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Last Updated: November 21, 2019

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. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the NUZYRA profile page.

The generic ingredient in NUZYRA is omadacycline tosylate. One supplier is listed for this compound. 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.

Suppliers and Packaging for NDA: 209817
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NUZYRA omadacycline tosylate POWDER;INTRAVENOUS 209817 NDA Paratek Pharmaceuticals, Inc. 71715-001 71715-001-02 10 VIAL, GLASS in 1 CARTON (71715-001-02) > 10 mL in 1 VIAL, GLASS (71715-001-01)

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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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 verifification 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.