Is there a generic for Omeprazole; sodium bicarbonate?

Yes. The FDA Orange Book lists 16 approved generic (ANDA) applications for Omeprazole; sodium bicarbonate, referencing the brand KONVOMEP. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Omeprazole; sodium bicarbonate?

KONVOMEP (NDA 213593, AZURITY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Omeprazole; sodium bicarbonate?

The Orange Book lists 8 patents against Omeprazole; sodium bicarbonate products, with the earliest listed expiry in 2039. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Omeprazole; sodium bicarbonate are approved?

Omeprazole; sodium bicarbonate is approved in the following dosage forms: capsule, for suspension.

FDA Orange Book · active-ingredient family

Omeprazole; sodium bicarbonate

Omeprazole; sodium bicarbonate is approved as 5 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:KONVOMEP · NDA 213593

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, for suspension

Product	Applicant	Application	TE	Approved
KONVOMEPRLD	AZURITY	NDA 213593	—	Aug 30, 2022
ZEGERID OTCRLD	RILEY CONSUMER	NDA 022283	—	Jun 17, 2013
ZEGERID OTCRLD	RILEY CONSUMER	NDA 022281	—	Dec 01, 2009
ZEGERIDRLD×2	SALIX	NDA 021849	—	Feb 27, 2006
ZEGERIDRLD×2	SALIX	NDA 021636	—	Jun 15, 2004

Generic (ANDA) products (16)

Product	Applicant	Application	TE	Approved
OMEPRAZOLE AND SODIUM BICARBONATE×2	NOVITIUM PHARMA	ANDA 219161	AB	Dec 10, 2025
OMEPRAZOLE AND SODIUM BICARBONATE	DR REDDYS	ANDA 217784	—	May 09, 2024
OMEPRAZOLE AND SODIUM BICARBONATE×2	ANDA REPOSITORY	ANDA 212587	AB	Apr 30, 2020
OMEPRAZOLE AND SODIUM BICARBONATE×2	ZYDUS PHARMS	ANDA 203290	AB	May 25, 2018
OMEPRAZOLE AND SODIUM BICARBONATE	ZYDUS	ANDA 203345	—	Mar 16, 2018
OMEPRAZOLE AND SODIUM BICARBONATE×2	SCIEGEN PHARMS	ANDA 207476	AB	Dec 06, 2016
OMEPRAZOLE AND SODIUM BICARBONATE	AUROBINDO PHARMA	ANDA 204923	—	Nov 07, 2016
OMEPRAZOLE AND SODIUM BICARBONATE×2	AUROLIFE PHARMA LLC	ANDA 204922	AB	Aug 19, 2016
OMEPRAZOLE AND SODIUM BICARBONATE×2	AJANTA PHARMA LTD	ANDA 205545	AB	Jul 27, 2016
OMEPRAZOLE AND SODIUM BICARBONATE×2	AJANTA PHARMA LTD	ANDA 204228	AB	Jul 15, 2016
OMEPRAZOLE AND SODIUM BICARBONATE	CHARTWELL RX	ANDA 204137	—	Jul 15, 2016
OMEPRAZOLE AND SODIUM BICARBONATE×2	DR REDDYS	ANDA 204068	AB	Jul 15, 2016
OMEPRAZOLE AND SODIUM BICARBONATE	PERRIGO R AND D	ANDA 201361	—	Jul 15, 2016
OMEPRAZOLE AND SODIUM BICARBONATE	STRIDES PHARMA INTL	ANDA 201946	—	Jul 15, 2016
OMEPRAZOLE AND SODIUM BICARBONATE×2	STRIDES PHARMA INTL	ANDA 079182	AB	Apr 19, 2013
OMEPRAZOLE AND SODIUM BICARBONATE×2	STRIDES PHARMA INTL	ANDA 078966	—	May 25, 2010

Listed patents (8)

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

Omeprazole; sodium bicarbonate — frequently asked questions

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

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