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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205103

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NDA 205103 describes YOSPRALA, which is a drug marketed by Aralez Pharms and is included in one NDA. It is available from one supplier. There are four 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-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the aspirin; omeprazole profile page.
Summary for 205103
Tradename:YOSPRALA
Applicant:Aralez Pharms
Ingredient:aspirin; omeprazole
Patents:4
Formulation / Manufacturing:see details
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 Aralez Pharmaceuticals Us Inc. 70347-081 N 70347-081-30
YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103 NDA Aralez Pharmaceuticals Us Inc. 70347-081 N 70347-081-90

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:➤ Try a Free 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:➤ Try a Free 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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