Orange Book product · Brand (NDA)

KONVOMEP

OMEPRAZOLE; SODIUM BICARBONATE

Brand (NDA)NDA 213593RX AZURITY

Aug 30, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 30, 2022
3 yr 10 mo ago
Today
Patent 10751333 expires
Listed drug product patent expiration.
Jul 16, 2039
in 13 yr 3 mo
Patent 11103492 expires
Listed drug product patent expiration.
Jul 16, 2039
in 13 yr 3 mo
Patent 11633478 expires
Listed drug product patent expiration.
Jul 16, 2039
in 13 yr 3 mo
Patent 11911473 expires
Listed method-of-use patent (U-623) expiration.
Jul 16, 2039
in 13 yr 3 mo
Patent 11911473 expires
Listed method-of-use patent (U-624) expiration.
Jul 16, 2039
in 13 yr 3 mo
Patent 12042539 expires
Listed drug product patent expiration.
Jul 16, 2039
in 13 yr 3 mo
Patent 12329752 expires
Listed drug product patent expiration.
Jul 16, 2039
in 13 yr 3 mo
Patent 12440566 expires
Listed drug product patent expiration.
Jul 16, 2039
in 13 yr 3 mo
Patent 11771686 expires
Listed method-of-use patent (U-623) expiration.
Mar 01, 2040
in 13 yr 11 mo

Active ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Strength

2MG/ML;84MG/ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 213593

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10751333	Jul 16, 2039	in 13 yr 3 mo	Product
11103492	Jul 16, 2039	in 13 yr 3 mo	Product
11633478	Jul 16, 2039	in 13 yr 3 mo	Product
11911473	Jul 16, 2039	in 13 yr 3 mo	U-623
11911473	Jul 16, 2039	in 13 yr 3 mo	U-624
12042539	Jul 16, 2039	in 13 yr 3 mo	Product
12329752	Jul 16, 2039	in 13 yr 3 mo	Product
12440566	Jul 16, 2039	in 13 yr 3 mo	Product
11771686	Mar 01, 2040	in 13 yr 11 mo	U-623