RABEPRAZOLE SODIUM - Generic Drug Details

What are the generic sources for rabeprazole sodium and what is the scope of patent protection?

Rabeprazole sodium is the generic ingredient in three branded drugs marketed by Aytu, Waylis Therap, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Lannett Co Inc, Norvium Bioscience, Rubicon, Teva Pharms Usa, and Torrent, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for rabeprazole sodium. Twenty-four suppliers are listed for this compound.

Summary for RABEPRAZOLE SODIUM

US Patents:	0
Tradenames:	3
Applicants:	12
NDAs:	12
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	47
Patent Applications:	1,964
What excipients (inactive ingredients) are in RABEPRAZOLE SODIUM?	RABEPRAZOLE SODIUM excipients list
DailyMed Link:	RABEPRAZOLE SODIUM at DailyMed

Recent Clinical Trials for RABEPRAZOLE SODIUM

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

Sponsor	Phase
TenNor Therapeutics (Suzhou) Limited	Phase 3
Xuanzhu Biopharmaceutical Co., Ltd.	Phase 2
TenNor Therapeutics (Suzhou) Limited	Phase 2

See all RABEPRAZOLE SODIUM clinical trials

Pharmacology for RABEPRAZOLE SODIUM

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

Medical Subject Heading (MeSH) Categories for RABEPRAZOLE SODIUM

Anti-Ulcer Agents

Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RABEPRAZOLE SODIUM

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

US Patents and Regulatory Information for RABEPRAZOLE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	078964-001	Nov 8, 2013	AB	RX	No	No
Torrent	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	202376-001	Nov 8, 2013	AB	RX	No	No
Teva Pharms Usa	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	076822-001	Nov 8, 2013		DISCN	No	No

Expired US Patents for RABEPRAZOLE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-002	Aug 19, 1999
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-001	Mar 26, 2013
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-002	Aug 19, 1999

RABEPRAZOLE SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Rabeprazole Sodium

Introduction to Rabeprazole Sodium

Rabeprazole sodium is a proton pump inhibitor (PPI) widely used to treat gastroesophageal reflux disease (GERD), peptic ulcers, and other digestive disorders. It works by reducing the amount of acid produced in the stomach, providing relief from symptoms associated with these conditions.

Global Market Size and Growth

The global rabeprazole sodium market is projected to experience significant growth over the coming years. As of 2024, the market size is estimated to be around $681.2 million, with forecasts indicating it will reach approximately $895.9 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.8% to 4.6% during the forecast period[4][5].

Regional Market Insights

North America

North America dominates the rabeprazole sodium market, accounting for over 40% of the global revenue. In 2024, the North American market was valued at $272.48 million and is expected to grow at a CAGR of 2.2% from 2024 to 2031. The United States is the largest market within North America, driven by the high prevalence of GERD and other gastrointestinal disorders, advanced healthcare infrastructure, and the presence of key market players[4].

Europe

Europe holds the second-largest market share, with a market size of $204.36 million in 2024. The European market is projected to grow at a CAGR of 2.5% from 2024 to 2031. The region's strong healthcare infrastructure and high healthcare spending contribute to its significant market share[4].

Asia Pacific

The Asia Pacific region is expected to see substantial growth, with a market size of $156.68 million in 2024 and a projected CAGR of 6.0% from 2024 to 2031. This growth is driven by the increasing prevalence of GERD and other digestive disorders in the region[4].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also contribute to the global market, although to a lesser extent. Latin America held a market share of around 5% with a market size of $34.06 million in 2024, expected to grow at a CAGR of 3.4%. The Middle East & Africa held around 2% of the global revenue with a market size of $13.62 million in 2024, expected to grow at a CAGR of 3.7%[4].

Market Drivers

Several factors drive the growth of the rabeprazole sodium market:

Increasing Prevalence of Digestive Disorders

The rising incidence of GERD, peptic ulcers, and other digestive disorders globally is a significant driver. Changes in lifestyle, dietary habits, and an aging population contribute to this increase[2][4][5].

Advanced Healthcare Infrastructure

Regions with well-established healthcare infrastructure, such as North America and Europe, facilitate access to advanced gastrointestinal treatments, boosting market growth[1][2].

Research and Development

Continuous research and development by pharmaceutical companies to improve therapies for digestive disorders are expected to drive market growth. Companies like Eisai Co., Ltd. are investing heavily in R&D to develop new and improved treatments[2].

Market Restraints

Despite the growth drivers, there are several restraints affecting the market:

Availability of Generic Versions

The patent expiration for branded rabeprazole sodium has led to the development of generic versions, which are significantly cheaper (typically 80% to 85% cheaper than branded versions). This has reduced revenue for original manufacturers and impacted market growth[2].

Low Health Awareness in Developing Economies

In some regions, particularly developing economies, low health awareness and limited access to healthcare services hinder the market's potential growth[5].

Regulatory Frameworks

Certain regulatory frameworks can also act as restraints, affecting the approval and distribution of rabeprazole sodium in various regions[5].

Market Segmentation

The rabeprazole sodium market is segmented based on several criteria:

By Application

• Gastroesophageal Reflux Disease (GERD): This segment holds the largest share, accounting for nearly three-fifths of the global market revenue and is expected to maintain its dominance with a CAGR of 4.0% during the forecast period[5].
• Peptic Ulcer: Another significant segment, this is also analyzed in market reports[5].

By Age

• Below 55 years: This age group is a significant segment, though the market is also driven by an aging population above 55 years[2][4].

By Distribution Channel

• Hospital Pharmacies: These are major distribution channels, along with drug and retail store pharmacies, and online pharmacies[2][4].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the rabeprazole sodium market. While it disrupted supply chains and affected healthcare services, the increased focus on health and wellness during the pandemic also drove demand for treatments of chronic conditions like GERD and peptic ulcers[5].

Competitive Landscape

The market is competitive, with several key players including Eisai Co., Ltd., which has a strong presence and is investing in R&D to develop new therapies. Partnerships and collaborations among companies are also common strategies to expand market presence[2].

Key Takeaways

• The global rabeprazole sodium market is expected to grow significantly, reaching $895.9 million by 2031.
• North America and Europe are the largest markets, with Asia Pacific showing promising growth.
• The increasing prevalence of GERD and other digestive disorders, along with advanced healthcare infrastructure, drive market growth.
• The availability of generic versions and low health awareness in developing economies are significant restraints.
• Market segmentation by application, age, and distribution channel provides insights into the diverse market dynamics.

FAQs

Q: What is the projected global market size for rabeprazole sodium by 2031? A: The global rabeprazole sodium market is expected to reach approximately $895.9 million by 2031[5].

Q: Which region dominates the rabeprazole sodium market? A: North America dominates the rabeprazole sodium market, accounting for over 40% of the global revenue[4].

Q: What are the main drivers of the rabeprazole sodium market? A: The main drivers include the increasing prevalence of digestive disorders, advanced healthcare infrastructure, and ongoing research and development[2][4][5].

Q: How does the availability of generic versions affect the market? A: The availability of generic versions, which are significantly cheaper, reduces revenue for original manufacturers and impacts market growth[2].

Q: What is the expected CAGR for the Asia Pacific region in the rabeprazole sodium market? A: The Asia Pacific region is expected to grow at a CAGR of 6.0% from 2024 to 2031[4].

Cited Sources:

1. KBV Research - Global Rabeprazole Sodium Market Size | Analysis Report - 2031
2. Maximize Market Research - Rabeprazole Sodium Market: Global Industry Analysis and Forecast
3. OMR Global - Rabeprazole Sodium Market Size, Share, Trends, Industry Report
4. Cognitive Market Research - Rabeprazole Sodium Market Report 2024 (Global Edition)
5. GlobeNewswire - Rabeprazole Sodium Market Is Expected to Reach USD 895.9 Million by 2031, Says Allied Market Research