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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Last Updated: December 7, 2019

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 five 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. Five 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
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:RXDosage:TABLET, DELAYED RELEASE;ORALStrength81MG;40MG
Approval Date:Sep 14, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 14, 2019
Regulatory Exclusivity Use:NEW COMBINATION
Patent:  Start TrialPatent Expiration:Feb 28, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS
Patent:  Start TrialPatent Expiration:Feb 28, 2023Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS

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Serving leading biopharmaceutical companies globally:

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