Omeprazole; sodium bicarbonate - Generic Drug Details

What are the generic drug sources for omeprazole; sodium bicarbonate and what is the scope of patent protection?

Omeprazole; sodium bicarbonate is the generic ingredient in four branded drugs marketed by Ajanta Pharma Ltd, Anda Repository, Aurobindo Pharma, Aurolife Pharma Llc, Chartwell Rx, Dr Reddys, Perrigo R And D, Sciegen Pharms Inc, Strides Pharma, Zydus, Zydus Pharms, Salix, Riley Consumer, and Azurity, and is included in twenty NDAs. There are six patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Omeprazole; sodium bicarbonate has five patent family members in five countries.

Twenty-seven suppliers are listed for this compound.

Summary for omeprazole; sodium bicarbonate

International Patents:	5
US Patents:	6
Tradenames:	4
Applicants:	14
NDAs:	20
Finished Product Suppliers / Packagers:	27
Clinical Trials:	12
DailyMed Link:	omeprazole; sodium bicarbonate at DailyMed

Recent Clinical Trials for omeprazole; sodium bicarbonate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Food and Drug Administration (FDA)	Phase 1
BioPharma Services, Inc	Phase 1
Ajou University School of Medicine	Phase 1

See all omeprazole; sodium bicarbonate clinical trials

Pharmacology for omeprazole; sodium bicarbonate

Drug Class	Proton Pump Inhibitor Osmotic Laxative
Mechanism of Action	Alkalinizing Activity Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Anatomical Therapeutic Chemical (ATC) Classes for omeprazole; sodium bicarbonate

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

B05CB	Salt solutions
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for OMEPRAZOLE; SODIUM BICARBONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZEGERID OTC	Capsules	omeprazole; sodium bicarbonate	20 mg/1100 mg	022281	1	2010-04-20
ZEGERID	Powder for Oral Suspension	omeprazole; sodium bicarbonate	20mg/1680mg per packet	021636	1	2007-11-13
ZEGERID	Powder for Oral Suspension	omeprazole; sodium bicarbonate	40 mg/1680 mg per packet	021636	1	2007-08-24
ZEGERID	Capsules	omeprazole; sodium bicarbonate	20 mg/1100 mg and 40 mg/1100 mg	021849	1	2007-04-30

US Patents and Regulatory Information for omeprazole; sodium bicarbonate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	201946-001	Jul 15, 2016		DISCN	No	No
Strides Pharma	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	078966-001	May 25, 2010		DISCN	No	No
Anda Repository	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	212587-002	Apr 30, 2020	AB	RX	No	No
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-002	Feb 27, 2006		DISCN	Yes	No
Sciegen Pharms Inc	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	207476-002	Dec 6, 2016	AB	RX	No	No
Azurity	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes	10,751,333		Y
Zydus Pharms	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	203290-001	May 25, 2018	AB	RX	No	No

Expired US Patents for omeprazole; sodium bicarbonate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004	6,780,882
Riley Consumer	ZEGERID OTC	omeprazole; sodium bicarbonate	CAPSULE;ORAL	022281-001	Dec 1, 2009	6,645,988
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004	6,780,882
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004	6,645,988
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-002	Dec 21, 2004	7,399,772
Salix	ZEGERID	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	021636-001	Jun 15, 2004	6,489,346
Salix	ZEGERID	omeprazole; sodium bicarbonate	CAPSULE;ORAL	021849-002	Feb 27, 2006	6,489,346

International Patents for omeprazole; sodium bicarbonate

Country	Patent Number	Title	Estimated Expiration
Mexico	2022000623
Canada	3147586
Canada	3147586	COMPOSITIONS ET KITS POUR SUSPENSION D'OMEPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION)
European Patent Office	3999066	COMPOSITIONS ET KITS POUR SUSPENSION D'OMÉPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION)
European Patent Office	3999066
World Intellectual Property Organization (WIPO)	2021011669
Mexico	2022000623	COMPOSICIONES Y KITS PARA UNA SUSPENSION DE OMEPRAZOL. (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION.)

Supplementary Protection Certificates for omeprazole; sodium bicarbonate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105

Omeprazole; sodium bicarbonate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Omeprazole and Sodium Bicarbonate

Introduction

Omeprazole, combined with sodium bicarbonate, is a widely used proton pump inhibitor (PPI) for treating various gastrointestinal disorders. This combination has seen significant market growth and is expected to continue its upward trajectory due to several key factors.

Market Size and Growth

The omeprazole market, which includes formulations with sodium bicarbonate, was valued at USD 1.06 billion in 2023. It is projected to grow at a CAGR of more than 6.4% from 2024 to 2036, reaching USD 2.38 billion by the end of 2036[3].

Key Drivers of Market Growth

Increasing Prevalence of Chronic Diseases

The global rise in chronic diseases such as gastroesophageal reflux disease (GERD), peptic ulcers, and Helicobacter pylori infections is a significant driver of the omeprazole market. According to the World Health Organization (WHO), chronic diseases are expected to account for 90% of all global fatalities by 2050, which will boost the demand for omeprazole[3].

Product Launches and Approvals

Recent approvals and launches of omeprazole and sodium bicarbonate formulations have contributed to market growth. For example, the U.S. FDA approved Azurity Pharmaceutical’s omeprazole and sodium bicarbonate for oral suspension in 2022, which entered commercial markets in 2023[1].

Strong Product Pipeline

The strong product pipeline of new PPI drugs, including omeprazole and sodium bicarbonate combinations, is expected to drive market growth. Companies like RedHill Biopharma have shown positive results in clinical trials for H. pylori elimination therapy using omeprazole, further increasing demand[3].

Market Segmentation

By Drug Type

The omeprazole segment, particularly the combination with sodium bicarbonate, dominates the PPI market in North America. Omeprazole holds a slightly higher market share compared to other PPIs like pantoprazole and esomeprazole due to its high prescription rate[1].

By Indication Type

Omeprazole and sodium bicarbonate are indicated for various conditions, including GERD, duodenal ulcers, gastric ulcers, and erosive esophagitis. The treatment of GERD and peptic ulcers are major drivers of the market[2][3].

By Dosage Form

The capsule segment is expected to propel the omeprazole market growth, occupying around 52% of the market share by 2036. Capsules are preferred due to their ease of use and higher bioavailability when combined with sodium bicarbonate[3].

By End-User

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Retail pharmacies are a significant channel due to the widespread availability of omeprazole and sodium bicarbonate formulations[1].

Regional Analysis

North America

North America is a dominant region for the omeprazole and sodium bicarbonate market, driven by the high incidence of acid reflux diseases and peptic ulcers. The U.S. and Canada are key markets, with omeprazole being the most prescribed PPI in these countries[1].

Europe

Europe also presents a significant market for omeprazole and sodium bicarbonate, with countries like Germany, the U.K., France, Italy, and Spain contributing substantially to the regional market[1].

Asia Pacific

The Asia Pacific region is expected to grow rapidly due to increasing healthcare spending and a rising prevalence of gastrointestinal diseases. Countries like India, China, and Indonesia are driving this growth[1].

Challenges and Limitations

Safety Concerns

The use of proton pump inhibitors, including omeprazole, has been associated with increased risks of COVID-19 infection and other adverse effects such as acute interstitial nephritis and vitamin B-12 deficiency. These safety concerns can limit market growth[1].

Pediatric Use

The use of omeprazole with sodium bicarbonate in pediatric patients is undesirable due to safety concerns, which restricts the market potential in this demographic[4].

Competitive Landscape

The global omeprazole and sodium bicarbonate market is fragmented with several key players. Companies are engaging in partnerships and collaborations to gain a strong foothold in the market. For instance, Ajanta Pharma USA Inc. launched omeprazole and sodium bicarbonate capsules, adding to the competitive landscape[5].

Financial Trajectory

Revenue Projections

The omeprazole market is expected to grow from USD 1.06 billion in 2023 to USD 2.38 billion by 2036, with a CAGR of more than 6.4%. This growth is driven by increasing demand, new product launches, and a strong product pipeline[3].

Investment and R&D

Companies are investing heavily in research and development to improve the efficacy and safety of omeprazole and sodium bicarbonate formulations. This investment is expected to yield positive returns as the market expands.

Key Takeaways

• The omeprazole and sodium bicarbonate market is driven by the increasing prevalence of chronic gastrointestinal diseases.
• New product launches and approvals are significant growth drivers.
• The capsule segment is expected to dominate the market due to its ease of use and higher bioavailability.
• Safety concerns and limitations in pediatric use are key challenges.
• The market is fragmented with several key players engaging in partnerships and collaborations.

FAQs

What is the projected market size of omeprazole by 2036?

The omeprazole market is expected to reach USD 2.38 billion by 2036, growing at a CAGR of more than 6.4% from 2024 to 2036[3].

What are the primary indications for omeprazole and sodium bicarbonate?

The primary indications include GERD, duodenal ulcers, gastric ulcers, and erosive esophagitis[2].

Which region dominates the omeprazole and sodium bicarbonate market?

North America is the dominant region, driven by the high incidence of acid reflux diseases and peptic ulcers[1].

What are the safety concerns associated with omeprazole use?

Safety concerns include increased risks of COVID-19 infection, acute interstitial nephritis, and vitamin B-12 deficiency[1].

Why is the use of omeprazole with sodium bicarbonate undesirable in pediatric patients?

The use is undesirable due to safety concerns, particularly the presence of sodium bicarbonate which can facilitate dissolution and absorption but poses risks in children aged 0-2 years[4].

Which companies are key players in the omeprazole and sodium bicarbonate market?

Key players include Azurity Pharmaceutical, RedHill Biopharma, and Ajanta Pharma USA Inc., among others[1][3][5].