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Generated: November 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211109

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NDA 211109 describes XERAVA, which is a drug marketed by Tetraphase Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the XERAVA profile page.

The generic ingredient in XERAVA is eravacycline dihydrochloride. One supplier is listed for this compound. Additional details are available on the eravacycline dihydrochloride profile page.
Summary for 211109
Tradename:XERAVA
Applicant:Tetraphase Pharms
Ingredient:eravacycline dihydrochloride
Patents:0
Generic Entry Opportunity Date for 211109
Generic Entry Date for 211109*:
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: 211109
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XERAVA eravacycline dihydrochloride POWDER;INTRAVENOUS 211109 NDA Tetraphase Pharmaceuticals, Inc. 71773-050 71773-050-05 1 VIAL, GLASS in 1 CARTON (71773-050-05) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
XERAVA eravacycline dihydrochloride POWDER;INTRAVENOUS 211109 NDA Tetraphase Pharmaceuticals, Inc. 71773-050 71773-050-12 12 VIAL, GLASS in 1 CARTON (71773-050-12) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 50MG BASE/VIAL
Approval Date:Aug 27, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 27, 2028
Regulatory Exclusivity Use:GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:Aug 27, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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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.