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Last Updated: March 16, 2025

PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE Drug Patent Profile


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Which patents cover Pantoprazole Sodium In 0.9% Sodium Chloride, and what generic alternatives are available?

Pantoprazole Sodium In 0.9% Sodium Chloride is a drug marketed by Baxter Hlthcare Corp and is included in one NDA.

The generic ingredient in PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Pantoprazole Sodium In 0.9% Sodium Chloride

A generic version of PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE was approved as pantoprazole sodium by DR REDDYS LABS LTD on January 19th, 2011.

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Summary for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Drug patent expirations by year for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Recent Clinical Trials for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE

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SponsorPhase
Alexandria UniversityPhase 3
Mansoura UniversityPhase 1/Phase 2
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE clinical trials

Pharmacology for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors

US Patents and Regulatory Information for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Baxter Hlthcare Corp PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE pantoprazole sodium SOLUTION;INTRAVENOUS 217512-001 Feb 14, 2024 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Baxter Hlthcare Corp PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE pantoprazole sodium SOLUTION;INTRAVENOUS 217512-002 Feb 14, 2024 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Baxter Hlthcare Corp PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE pantoprazole sodium SOLUTION;INTRAVENOUS 217512-003 Feb 14, 2024 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

Pantoprazole Sodium in 0.9% Sodium Chloride Injection: Market Dynamics and Financial Trajectory

Introduction

Pantoprazole sodium, a proton pump inhibitor (PPI), is widely used for the treatment of various gastrointestinal conditions. When administered in a 0.9% sodium chloride injection, it offers a convenient and effective intravenous option for patients. This article delves into the market dynamics and financial trajectory of pantoprazole sodium in 0.9% sodium chloride injection.

Indications and Usage

Pantoprazole sodium in 0.9% sodium chloride injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE) and for the treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome[1][3].

Market Size and Forecast

The global pantoprazole sodium market is expected to grow significantly over the forecast period of 2024-2031. According to market research, the pantoprazole sodium market is categorized based on geographical regions, with North America, Europe, Asia-Pacific, South America, and the Middle East and Africa being key segments. The market size is predicted to increase in value, measured in USD million, across these segments[5].

Historical Performance

In the past, pantoprazole sodium has shown strong market performance. For instance, in 2010, pantoprazole sodium delayed-release tablets had total U.S. sales of approximately $1.8 billion for the twelve months ending September 30, 2010[2].

Key Players

The market for pantoprazole sodium is dominated by several key players, including Pfizer, Dr. Reddy's Laboratories, Takeda GmbH, Teva Pharmaceutical, and others. These companies play a crucial role in the production, distribution, and marketing of pantoprazole sodium products[5].

Geographical Distribution

The market for pantoprazole sodium is spread across various geographical regions. Asia-Pacific is expected to be a significant growth area due to increasing healthcare expenditure and a growing patient population. North America and Europe also remain key markets due to their established healthcare systems and high demand for PPIs[5].

Financial Trajectory

The financial trajectory of pantoprazole sodium in 0.9% sodium chloride injection is positive, driven by increasing demand for effective treatments for GERD and other gastrointestinal conditions. The market is expected to grow from 2024 to 2031, with the base year being 2023. This growth is attributed to the expanding patient base, advancements in healthcare infrastructure, and the introduction of new formulations and delivery methods[5].

Competitive Landscape

The competitive landscape for pantoprazole sodium is highly competitive, with multiple generic and branded versions available. Companies like Dr. Reddy's Laboratories have successfully launched generic versions, which have contributed significantly to the market's growth. The competition is expected to remain fierce, driving innovation and potentially reducing prices[2][5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pantoprazole sodium. Regulatory approvals and guidelines set by health authorities such as the FDA are critical for the introduction and continued use of these products. For instance, pantoprazole sodium in 0.9% sodium chloride injection must be used in accordance with specific guidelines to ensure safety and efficacy[1][3].

Safety and Efficacy

The safety and efficacy of pantoprazole sodium in 0.9% sodium chloride injection have been established through various clinical trials. However, like all PPIs, it comes with potential side effects such as elevations of transaminases, hypomagnesemia, and an increased risk of fundic gland polyps with long-term use[1][3].

Administration and Preparation

The administration of pantoprazole sodium in 0.9% sodium chloride injection is straightforward, with the solution being administered intravenously over a period of approximately 15 minutes. The preparation involves reconstituting the lyophilized powder with 0.9% sodium chloride injection, and the solution must be stored and handled according to specific guidelines to maintain sterility and stability[1][4].

Stability and Storage

The stability of pantoprazole in 0.9% sodium chloride injection is pH-dependent, with the rate of degradation increasing with decreasing pH. The reconstituted solution has a pH of 9.0–10.5 and must be stored at room temperature for no more than two hours before use or further dilution[4].

Market Challenges

Despite the positive financial trajectory, the market for pantoprazole sodium faces several challenges. These include the risk of generic competition, regulatory hurdles, and potential side effects associated with long-term PPI use. Additionally, the market is sensitive to changes in healthcare policies and reimbursement rates[5].

Future Outlook

The future outlook for pantoprazole sodium in 0.9% sodium chloride injection is promising. With ongoing research and development, there is potential for new formulations and delivery methods that could further enhance the market. The growing demand for effective treatments for gastrointestinal conditions ensures a steady market for this drug[5].

Key Takeaways

  • Indications: Pantoprazole sodium in 0.9% sodium chloride injection is used for GERD with erosive esophagitis and pathological hypersecretory conditions.
  • Market Growth: The global market is expected to grow significantly from 2024 to 2031.
  • Key Players: Major pharmaceutical companies dominate the market.
  • Regulatory Environment: Strict guidelines govern the use and administration of the drug.
  • Safety and Efficacy: Established through clinical trials, but with potential side effects.
  • Administration and Preparation: Specific guidelines must be followed for reconstitution and administration.

FAQs

What are the primary indications for pantoprazole sodium in 0.9% sodium chloride injection?

Pantoprazole sodium in 0.9% sodium chloride injection is primarily indicated for the short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE) and for the treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome[1][3].

How is pantoprazole sodium in 0.9% sodium chloride injection administered?

The solution is administered intravenously over a period of approximately 15 minutes. It involves reconstituting the lyophilized powder with 0.9% sodium chloride injection and following specific storage and handling guidelines[1][4].

What are the potential side effects of pantoprazole sodium in 0.9% sodium chloride injection?

Potential side effects include elevations of transaminases, hypomagnesemia, and an increased risk of fundic gland polyps with long-term use[1][3].

Which companies are key players in the pantoprazole sodium market?

Key players include Pfizer, Dr. Reddy's Laboratories, Takeda GmbH, Teva Pharmaceutical, and others[5].

What is the expected market growth for pantoprazole sodium from 2024 to 2031?

The market is expected to grow significantly, driven by increasing demand for effective treatments for GERD and other gastrointestinal conditions. The market size is predicted to increase in value across various geographical segments[5].

Sources

  1. DailyMed: Pantoprazole sodium in 0.9% sodium chloride injection, solution.
  2. Dr. Reddy's: Launch of Pantoprazole Sodium delayed-released tablets.
  3. Baxter PI: Pantoprazole Sodium in 0.9% Sodium Chloride Injection.
  4. American Journal of Health-System Pharmacy: Stability of pantoprazole in 0.9% sodium chloride injection in polypropylene syringes.
  5. Market Research Intellect: Global Pantoprazole Sodium Market Size And Forecast.

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