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Last Updated: December 22, 2024

OMEPRAZOLE; SODIUM BICARBONATE - Generic Drug Details


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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

SponsorPhase
BioPharma Services, IncPhase 1
Food and Drug Administration (FDA)Phase 1
Ajou University School of MedicinePhase 1

See all OMEPRAZOLE; SODIUM BICARBONATE clinical trials

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Strides Pharma OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 078966-001 May 25, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Anda Repository OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 212587-002 Apr 30, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Salix ZEGERID omeprazole; sodium bicarbonate CAPSULE;ORAL 021849-002 Feb 27, 2006 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sciegen Pharms Inc OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 207476-002 Dec 6, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Subscribe ⤷  Subscribe
Riley Consumer ZEGERID OTC omeprazole; sodium bicarbonate CAPSULE;ORAL 022281-001 Dec 1, 2009 ⤷  Subscribe ⤷  Subscribe
Salix ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-001 Jun 15, 2004 ⤷  Subscribe ⤷  Subscribe
Salix ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-002 Dec 21, 2004 ⤷  Subscribe ⤷  Subscribe
Salix ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-002 Dec 21, 2004 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for OMEPRAZOLE; SODIUM BICARBONATE

Country Patent Number Title Estimated Expiration
Mexico 2022000623 ⤷  Subscribe
Canada 3147586 ⤷  Subscribe
Canada 3147586 COMPOSITIONS ET KITS POUR SUSPENSION D'OMEPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION) ⤷  Subscribe
European Patent Office 3999066 COMPOSITIONS ET KITS POUR SUSPENSION D'OMÉPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION) ⤷  Subscribe
European Patent Office 3999066 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OMEPRAZOLE; SODIUM BICARBONATE

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

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].

More… ↓

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.