Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: September 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210854

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NDA 210854 describes XOFLUZA, which is a drug marketed by Genentech Inc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the XOFLUZA profile page.

The generic ingredient in XOFLUZA is baloxavir marboxil. Two suppliers are listed for this compound. Additional details are available on the baloxavir marboxil profile page.
Summary for 210854
Tradename:XOFLUZA
Applicant:Genentech Inc
Ingredient:baloxavir marboxil
Patents:3
Generic Entry Opportunity Date for 210854
Generic Entry Date for 210854*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*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.

Pharmacology for NDA: 210854
Suppliers and Packaging for NDA: 210854
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XOFLUZA baloxavir marboxil TABLET;ORAL 210854 NDA A-S Medication Solutions 50090-4102 50090-4102-0 1 BLISTER PACK in 1 CARTON (50090-4102-0) > 2 TABLET, FILM COATED in 1 BLISTER PACK
XOFLUZA baloxavir marboxil TABLET;ORAL 210854 NDA A-S Medication Solutions 50090-4104 50090-4104-0 1 BLISTER PACK in 1 CARTON (50090-4104-0) > 2 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 24, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 24, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:May 5, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Sep 21, 2031Product Flag?YSubstance Flag?YDelist Request?

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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.