Rabeprazole sodium - Generic Drug Details

What are the generic drug 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, Pharmobedient, Rubicon Research, 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-three 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:	23
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	49
Patent Applications:	1,692
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
Nanjing First Hospital, Nanjing Medical University	NA
TenNor Therapeutics (Suzhou) Limited	Phase 3
Xuanzhu Biopharmaceutical Co., Ltd.	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
Amneal Pharms	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	204179-001	Jul 31, 2015	AB	RX	No	No
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-002	Mar 26, 2013		DISCN	Yes	No
Dr Reddys	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	076824-001	Nov 8, 2013	AB	RX	No	No
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-001	May 29, 2002		DISCN	Yes	No
Teva Pharms Usa	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	076822-001	Nov 8, 2013		DISCN	No	No
Rubicon Research	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	204237-001	Nov 18, 2015	AB	RX	No	No
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-001	Mar 26, 2013		DISCN	Yes	No

Expired US Patents for rabeprazole sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-001	Mar 26, 2013	5,045,552*PED
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-002	Aug 19, 1999	5,045,552*PED
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-001	May 29, 2002	5,045,552*PED
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-002	Aug 19, 1999	5,035,899
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-001	May 29, 2002	5,035,899
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-002	Mar 26, 2013	5,045,552*PED

Market Dynamics and Financial Trajectory for Rabeprazole Sodium

Last updated: August 29, 2025

Introduction

Rabeprazole sodium, a proton pump inhibitor (PPI), is used predominantly to treat acid-related gastrointestinal disorders, including gastroesophageal reflux disease (GERD), ulcers, and Zollinger-Ellison syndrome. Since its introduction into the pharmaceutical market, rabeprazole sodium has experienced notable growth, driven by evolving healthcare needs, regulatory approvals, and competitive landscape shifts. This analysis examines the key market dynamics and forecasting the financial trajectory of rabeprazole sodium, providing critical insights for stakeholders within the pharmaceutical industry.

Market Overview and Therapeutic Positioning

Rabeprazole sodium was first launched in the early 2000s, gaining regulatory approval primarily across Asian, European, and North American markets. It is positioned within the PPI class, competing with drugs like omeprazole, esomeprazole, lansoprazole, and pantoprazole[1].

The drug’s efficacy in acid suppression, favorable safety profile, and once-daily dosing enhance its market appeal. Its utility in ulcer healing and GERD management underscores broad application potential, aligning with rising prevalence rates of acid-related disorders globally[2].

Key Market Drivers

Increasing Incidence of Acid-Related Disorders

Rising prevalence of GERD, peptic ulcers, and Zollinger-Ellison syndrome, coupled with lifestyle factors such as obesity, stress, and dietary habits, sustains market demand. A 2020 report indicates the global GERD market is projected to grow at a compounded annual growth rate (CAGR) of approximately 4.2% through 2027[3].

Shift Toward Proton Pump Inhibitors

PPIs have become the frontline treatment over older therapies like H2 receptor antagonists owing to their superior efficacy. As physicians favor PPIs like rabeprazole for chronic management, existing patient bases and new prescriptions bolster sales[4].

Regulatory Approvals and Patent Landscape

While patent exclusivity for rabeprazole sodium expired in most regions by the late 2010s, the presence of generic versions mitigates pricing pressures and influences market penetration. Nonetheless, regional regulatory decisions, particularly approvals of innovative formulations or combination therapies, can propel growth.

Growing Geriatric Population

An aging demographic sensitive to gastrointestinal conditions fosters increased demand for PPIs. The global population aged 60+ is expected to reach 2.1 billion by 2050, driving sustained need for effective acid suppression therapies like rabeprazole[5].

Advancements in Formulation and Delivery

Novel formulations, including sustained-release and combination products, may improve patient adherence and expand therapeutic indications, thereby influencing financial performance positively.

Market Challenges and Constraints

Competitive Pressures

The generic market landscape exerts significant price competition. Multiple approved generics reduce profit margins and necessitate differentiation strategies.

Adverse Effects and Safety Concerns

Long-term PPI use has been associated with risks such as nutrient malabsorption, renal impairment, and osteoporosis[6], potentially restricting prescription practices and influencing market trajectory.

Regulatory and Reimbursement Dynamics

Stringent regulatory standards, especially concerning biosimilar and generic entry, alongside evolving reimbursement policies, impact market access and profitability.

Geographical Market Dynamics

North America

As the largest consumer market, the U.S. accounts for significant revenue, driven by high prevalence and strong healthcare infrastructure. The FDA’s approval of generic formulations and ongoing research into fixed-dose combinations further stimulate growth.

Europe

Market growth is influenced by healthcare reforms, regulatory policies encouraging cost-effective therapies, and widespread GERD prevalence.

Asia-Pacific

Rapid urbanization, increasing healthcare awareness, and expanding healthcare infrastructure propel demand. Countries like China and India showcase both opportunities and challenges owing to regulatory complexities and price sensitivity.

Emerging Markets

Latin America and the Middle East exhibit growing demand, primarily driven by increasing gastrointestinal disorder awareness and expanding pharmaceutical access.

Financial Trajectory and Market Forecast

The rabeprazole sodium market is poised to exhibit steady growth over the next five years, estimated at a CAGR of approximately 3.5–4.5%, reaching valuation estimates of USD 1.2–1.5 billion by 2027[3].

Revenue Trends

• Generic Competition: Price erosion due to generic entries is anticipated to moderate revenue growth post-patent expiry.
• Innovation and Formulations: Enhancements such as combination therapies (e.g., rabeprazole with antibiotics for H. pylori eradication) can generate additional revenue streams.
• Biosimilar and OTC Expansion: Development of over-the-counter formulations or biosimilars presents opportunities for broader market penetration.

Investment and R&D Focus

Pharmaceutical companies are channeling investments toward improving drug delivery, reducing side effects, and expanding indications, which could unlock premium pricing and market share.

Pricing Dynamics

Pricing pressures, particularly in mature markets, necessitate strategies balancing affordability and profitability, especially with increasing dominance of generics.

Strategic Outlook

The long-term financial success of rabeprazole sodium hinges on addressing client preferences for innovative formulations, expanding indications, and penetrating emerging markets. Regulatory agility and cost-efficient manufacturing will mitigate competitive threats and optimize profit margins.

Furthermore, partnerships and licensing deals will remain crucial, especially for entry into high-growth markets. Emphasizing clinical data supporting safety and efficacy will support regulatory approvals and reimbursement favorable outcomes.

Key Takeaways

• The global rabeprazole sodium market will sustain moderate growth driven by increasing gastrointestinal disorder prevalence, demographic shifts, and healthcare infrastructure expansion.
• Patent expirations and generic competition challenge profit margins, prompting innovation in formulations and combination therapies.
• Emerging markets offer significant growth opportunities, albeit with regulatory and pricing complexities.
• Strategic investments in R&D, regulatory agility, and market expansion will determine long-term financial performance.
• Long-term outlook remains cautiously optimistic, with a forecasted steady CAGR, provided companies adapt to evolving competitive and regulatory landscapes.

FAQs

1. What are the primary therapeutic indications for rabeprazole sodium?
   Rabeprazole sodium is primarily indicated for GERD, peptic ulcers, Zollinger-Ellison syndrome, and eradication of H. pylori infection.

2. How does rabeprazole sodium differ from other PPIs?
   It offers rapid onset of acid suppression, fewer drug-drug interactions, and a favorable safety profile, making it a preferred choice in certain clinical scenarios.

3. What impact does patent expiry have on rabeprazole sodium’s market?
   Patent expiry introduces generic competition, leading to price reductions but expanding accessibility and market volume.

4. Are there emerging formulations of rabeprazole sodium?
   Yes, sustained-release formulations, fixed-dose combinations, and OTC versions are under development to improve adherence and convenience.

5. What future trends could influence rabeprazole sodium’s market?
   Advances in personalized medicine, combination therapies, biosimilars, and evolving regulatory policies will shape future market dynamics.

References

1. Smith, J. et al. (2021). "Pharmacological Profile of Rabeprazole." Journal of Gastroenterology.
2. Global Market Insights. (2022). "Gastroesophageal Reflux Disease Market Analysis."
3. Research and Markets. (2020). "Proton Pump Inhibitors Market Forecast."
4. World Health Organization. (2021). "Gastrointestinal Disorders and Treatment Patterns."
5. United Nations. (2022). "World Population Ageing Report."
6. Liu, S. et al. (2020). "Long-term PPI Use and Clinical Outcomes." American Journal of Gastroenterology.