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Last Updated: December 22, 2024

OMEPRAZOLE AND SODIUM BICARBONATE Drug Patent Profile


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Which patents cover Omeprazole And Sodium Bicarbonate, and what generic alternatives are available?

Omeprazole And Sodium Bicarbonate is a drug 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, and Zydus Pharms. and is included in fifteen NDAs.

The generic ingredient in OMEPRAZOLE AND SODIUM BICARBONATE is omeprazole; sodium bicarbonate. There are one hundred and thirty-one drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Omeprazole And Sodium Bicarbonate

A generic version of OMEPRAZOLE AND SODIUM BICARBONATE was approved as omeprazole; sodium bicarbonate by STRIDES PHARMA on April 19th, 2013.

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Summary for OMEPRAZOLE AND SODIUM BICARBONATE
US Patents:0
Applicants:11
NDAs:15
Finished Product Suppliers / Packagers: 24
Clinical Trials: 12
What excipients (inactive ingredients) are in OMEPRAZOLE AND SODIUM BICARBONATE?OMEPRAZOLE AND SODIUM BICARBONATE excipients list
DailyMed Link:OMEPRAZOLE AND SODIUM BICARBONATE at DailyMed
Drug patent expirations by year for OMEPRAZOLE AND SODIUM BICARBONATE
Recent Clinical Trials for OMEPRAZOLE AND SODIUM BICARBONATE

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

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

See all OMEPRAZOLE AND SODIUM BICARBONATE clinical trials

US Patents and Regulatory Information for OMEPRAZOLE AND SODIUM BICARBONATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ajanta Pharma Ltd OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204228-001 Jul 15, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Zydus Pharms OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 203290-001 May 25, 2018 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Strides Pharma OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 079182-002 Apr 19, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurolife Pharma Llc OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204922-002 Aug 19, 2016 AB RX 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
Sciegen Pharms Inc OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 207476-001 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

OMEPRAZOLE AND SODIUM BICARBONATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Omeprazole and Sodium Bicarbonate

Introduction

Omeprazole and sodium bicarbonate, a combination of a proton pump inhibitor (PPI) and an antacid, is a widely used medication for treating gastrointestinal disorders such as gastroesophageal reflux disease (GERD) and peptic ulcers. Here, we delve into the market dynamics and financial trajectory of this drug combination.

Market Size and Growth

The proton pump inhibitors (PPIs) market, which includes omeprazole and sodium bicarbonate, was valued at US$ 3.7 billion in 2023. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.0% from 2024 to 2034[1].

Key Drivers of Market Growth

Several factors are driving the growth of the omeprazole and sodium bicarbonate market:

Increasing Prevalence of Gastrointestinal Disorders

The rising number of patients suffering from GERD and peptic ulcers is a significant driver. For instance, GERD is common in infants, with its prevalence increasing to 41% between 3 and 4 months of age, which subsequently drives the demand for omeprazole-based drugs[1].

Product Launches and Approvals

Recent approvals and launches of new formulations, such as Azurity Pharmaceutical’s omeprazole and sodium bicarbonate for oral suspension, have boosted market growth. This product was approved by the U.S. FDA in September 2022 and reached commercial markets by 2023[1].

Growing Healthcare Expenditure

Increased healthcare expenditure and research & development activities by pharmaceutical companies are also propelling the market forward. The launch of novel drugs and the expansion of product portfolios by companies like Ajanta Pharma further contribute to this growth[3].

Market Segmentation

The market for omeprazole and sodium bicarbonate can be segmented in several ways:

By Drug Type

Omeprazole dominates the market in North America, holding a slightly higher market share compared to other PPIs like pantoprazole, esomeprazole, and lansoprazole[1].

By Indication Type

The primary indications for omeprazole and sodium bicarbonate are GERD and peptic ulcers. The market is forecasted to grow significantly in both segments due to the increasing prevalence of these conditions[1][3].

By End-user

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Retail pharmacies are a major distribution channel, given the widespread availability and ease of access to these medications[1].

Regional Analysis

The global market for omeprazole and sodium bicarbonate is analyzed across several regions:

North America

This region is dominated by the omeprazole segment, driven by a high number of prescriptions for acid reflux diseases and peptic ulcers. The U.S. and Canada are key markets within North America[1].

Europe

Europe also sees significant demand for omeprazole and sodium bicarbonate, with countries like Germany, the U.K., France, Italy, and Spain being major contributors to the regional market[1].

Asia Pacific

The Asia Pacific region is expected to grow rapidly due to increasing healthcare expenditure and a rising geriatric population, which is more prone to gastrointestinal disorders[1].

Market Challenges

Despite the growth, there are several challenges facing the market:

Alternative PPIs

The increasing adoption of alternative PPIs like pantoprazole, lansoprazole, and esomeprazole can hamper the market growth of omeprazole and sodium bicarbonate[3].

COVID-19 Impact

There is evidence suggesting that the use of PPIs, including omeprazole, may increase the risk of COVID-19 infection. This has been a market limitation, although the overall impact is still being studied[1].

Competitive Landscape

The global PPI market, including omeprazole and sodium bicarbonate, is fragmented with numerous players. Companies are engaging in partnerships and collaborations to strengthen their market position. For example, Ajanta Pharma has a robust portfolio with multiple ANDA approvals and is actively expanding its presence in the U.S. market[1][2].

Financial Trajectory

The financial trajectory of omeprazole and sodium bicarbonate is positive, driven by increasing demand and new product launches. Here are some key financial insights:

Revenue Growth

The market is expected to reach significant revenue by 2034, driven by a CAGR of 4.0% from 2024 to 2034[1].

New Product Launches

The launch of new formulations, such as the omeprazole and sodium bicarbonate oral suspension by Azurity, has contributed to revenue growth. Similar launches by other companies are expected to continue this trend[1][5].

Generic Competition

While generic versions of omeprazole and sodium bicarbonate are available, branded products still hold a significant market share due to their established reputation and ongoing research and development[2][5].

Key Takeaways

  • The omeprazole and sodium bicarbonate market is driven by the increasing prevalence of GERD and peptic ulcers.
  • New product launches and approvals are key growth drivers.
  • The market is segmented by drug type, indication, and end-user, with omeprazole dominating in North America.
  • Regional growth varies, with North America and Europe being significant markets.
  • Challenges include the adoption of alternative PPIs and potential COVID-19 risks.
  • The competitive landscape is fragmented, with companies engaging in partnerships and collaborations.

FAQs

Q: What is the projected CAGR for the proton pump inhibitors (PPIs) market from 2024 to 2034? A: The PPIs market is projected to grow at a CAGR of 4.0% from 2024 to 2034[1].

Q: Which region dominates the omeprazole market? A: North America dominates the omeprazole market, with the U.S. and Canada being key contributors[1].

Q: What are the primary indications for omeprazole and sodium bicarbonate? A: The primary indications are gastroesophageal reflux disease (GERD) and peptic ulcers[1][3].

Q: How has the COVID-19 pandemic impacted the omeprazole market? A: The use of PPIs, including omeprazole, has been associated with an increased risk of COVID-19 infection, which has been a market limitation[1].

Q: Which companies are key players in the omeprazole and sodium bicarbonate market? A: Companies like Azurity Pharmaceuticals and Ajanta Pharma are key players, with significant product launches and approvals contributing to market growth[1][2].

Sources

  1. Transparency Market Research - Proton Pump Inhibitors (PPIs) Market Size & Growth 2034
  2. BioSpace - Ajanta Pharma Announces The Approval And Launch Of Omeprazole And Sodium Bicarbonate Capsules
  3. Allied Market Research - Omeprazole Market Size and Share | Industry Growth 2030
  4. FDA - OFFICE OF CLINICAL PHARMACOLOGY REVIEW NDA
  5. Drug Patent Watch - KONVOMEP Drug Patent Profile

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