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Last Updated: May 11, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205103

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NDA 205103 describes YOSPRALA, which is a drug marketed by Genus Lifesciences and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the YOSPRALA profile page.

The generic ingredient in YOSPRALA is aspirin; omeprazole. There are twenty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the aspirin; omeprazole profile page.
Summary for 205103
Tradename:YOSPRALA
Applicant:Genus Lifesciences
Ingredient:aspirin; omeprazole
Patents:5
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 205103
Generic Entry Date for 205103*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, DELAYED RELEASE;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.

Suppliers and Packaging for NDA: 205103
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103 NDA Genus Lifesciences Inc. 64950-424 64950-424-30 30 TABLET, FILM COATED in 1 BOTTLE (64950-424-30)
YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103 NDA Genus Lifesciences Inc. 64950-424 64950-424-90 90 TABLET, FILM COATED in 1 BOTTLE (64950-424-90)
Paragraph IV (Patent) Challenges for 205103
Tradename Dosage Ingredient NDA Submissiondate
YOSPRALA TABLET, DELAYED RELEASE;ORAL aspirin; omeprazole 205103 2016-10-14

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrength81MG;40MG
Approval Date:Sep 14, 2016TE:RLD:Yes
Patent:  Get Started for $10Patent Expiration:Feb 28, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:  Get Started for $10Patent Expiration:Feb 28, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:  Get Started for $10Patent Expiration:May 31, 2022Product Flag?YSubstance Flag?Delist Request?

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