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Last Updated: March 28, 2024

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. There are two 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. Additional details are available on the aspirin; omeprazole profile page.
Summary for 205103
Tradename:YOSPRALA
Applicant:Genus Lifesciences
Ingredient:aspirin; omeprazole
Patents:2
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrength81MG;40MG
Approval Date:Sep 14, 2016TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 13, 2033Product Flag?Substance 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 TrialPatent Expiration:Jan 2, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:FOR SECONDARY PREVENTION OF CARDIOVASCULAR AND CEREBROVASCULAR EVENTS IN PATIENTS AT RISK OF DEVELOPING ASPIRIN-ASSOCIATED GASTRIC ULCERS

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrength325MG;40MG
Approval Date:Sep 14, 2016TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Mar 13, 2033Product Flag?Substance 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

Expired US Patents for NDA 205103

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 ⤷  Try a Trial ⤷  Try a Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 ⤷  Try a Trial ⤷  Try a Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 ⤷  Try a Trial ⤷  Try a Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 ⤷  Try a Trial ⤷  Try a Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 ⤷  Try a Trial ⤷  Try a Trial
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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