Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Cipla
US Department of Justice
Queensland Health
Argus Health
Fish and Richardson
McKinsey
Johnson and Johnson

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205103

« Back to Dashboard

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 70347-081-90
YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103 NDA Aralez Pharmaceuticals Us Inc. 70347-081 N 70347-081-30

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:➤ Sign UpPatent 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:➤ Sign UpPatent 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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Teva
Chinese Patent Office
Argus Health
Johnson and Johnson
Moodys
US Army
Accenture
Merck
Medtronic

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.