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FDA Orange Book · active-ingredient family

Aspirin; omeprazole

Aspirin; omeprazole is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:YOSPRALA · NDA 205103

1

Brand (NDA)

0

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet, delayed release

ProductApplicantApplicationTEApproved
YOSPRALARLD×2GENUS LIFESCIENCESNDA 205103Sep 14, 2016

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9987231Jan 02, 2033in 6 yr 8 mo
U-2324
9539214Mar 13, 2033in 6 yr 10 mo
U-1902

Aspirin; omeprazole — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.