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 Usa, 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-one 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:	21
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
Chartwell Rx	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	078964-001	Nov 8, 2013	AB	RX	No	No
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-001	Mar 26, 2013		DISCN	Yes	No
Teva Pharms Usa	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	076822-001	Nov 8, 2013		DISCN	No	No
Dr Reddys	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	076824-001	Nov 8, 2013	AB	RX	No	No
Lannett Co Inc	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	090678-001	Nov 8, 2013	AB	RX	No	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
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-002	Mar 26, 2013	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	5,045,552*PED

Market Dynamics and Financial Trajectory for Rabeprazole Sodium

Last updated: February 19, 2026

Rabeprazole sodium, an acid reducer used primarily to treat gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and other acid-related conditions, has sustained a steady demand since its approval. Its market trajectory is shaped by patent status, generic competition, regulatory landscape, and emerging therapeutic alternatives.

Current Market Overview

Rabeprazole sodium was first approved in India in 1994 (Lanz et al., 2017) and gained approval in the U.S. in 1999. Its global market value was approximately USD 1.2 billion in 2021, with an expected compound annual growth rate (CAGR) of 3.5% from 2022 to 2028 (Grand View Research, 2022). Key markets include North America, Europe, and Asia-Pacific, with India and China contributing significantly due to high GERD prevalence and emerging healthcare infrastructure.

Patent Status and Market Exclusivity

The original patent for rabeprazole sodium expired in multiple regions:

• United States: 2012
• European Union: 2015
• Japan: 2014

This expiration led to increased presence of generic versions, reducing prices and affecting revenue streams for originators. Patent challenges or extensions through formulation patents have limited the patent cliff's impact in certain markets until recent years.

Competitive Landscape

The market has transitioned from solely branded formulations to a significant presence of generics. Major manufacturers include:

• Eisai Co. (original developer)
• Teva Pharmaceuticals
• Mylan (now part of Viatris)
• Sun Pharma
• Cipla

Price erosion from generics has diminished average sales prices (ASPs) by approximately 45% since 2010 in the U.S. (FDA, 2022). However, branded products retain a niche in certain segments, especially in emerging markets where brand loyalty and physician prescribing habits persist.

Therapeutic and Regulatory Factors

Emerging therapies, such as potassium-competitive acid blockers (P-CABs) like vonoprazan, threaten rabeprazole’s market share due to faster onset and longer duration of action (Kahr et al., 2020). Regulatory approvals of novel agents driven by clinical trials that demonstrate superior efficacy and safety profiles may influence commercial dynamics.

In terms of approvals:

• In 2022, several generic versions received FDA approval following patent challenges.
• Regulatory pathways in China have streamlined generic approvals, further intensifying competition.

Financial Trajectory

Revenue projections reflect the market's evolution:	Year	Revenue (USD million)	Growth Rate	Notes
2021	1,200	--	Baseline year
2022	1,188	-1%	Slight decline due to increased generic competition
2023	1,173	-1.3%	Market saturation, slow decline
2025	1,045	-4.2%	Continued generic erosion, emerging alternatives debuting
2028	930	-4.8%	Potential stabilization as generics mature

The decline is primarily driven by patent expirations, pricing pressures, and the emergence of alternative therapies. Biopharmaceutical companies developing new formulations or delivery methods may offset revenue loss through niche markets.

Future Trends and Risks

Major risks include:

• Increased entry of generics following patent expiration.
• Regulatory hurdles surrounding new formulations or delivery systems.
• Competitive pressure from novel acid-suppressants with better efficacy profiles.
• Pricing controls in key markets such as India and Europe.

Opportunities may arise from:

• Developing extended-release formulations.
• Entering combination therapies to treat multi-pathology patients.
• Expanding in emerging markets with rising prevalence of acid-related disorders.

Key Takeaways

• Rabeprazole sodium markets are mature with declining revenues driven primarily by patent expirations and generic competition.
• The global revenue declined slightly post-2012 patent expiry, with a trend of slow erosion predicted through 2028.
• Emerging therapy competition, especially P-CABs, poses a long-term threat but also opportunities for differentiation.
• Strategic activity in formulation innovation and geographical expansion could mitigate revenue decline.

FAQs

Q1: How does patent expiration impact rabeprazole sodium sales?
A: Patent expiration allows generic manufacturers to produce cheaper versions, decreasing prices and revenues for original developers.

Q2: What biosimilar or alternative treatments threaten rabeprazole sodium?
A: Potassium-competitive acid blockers like vonoprazan offer rapid and sustained acid suppression, challenging PPI sales.

Q3: Are there patent extensions or new formulations still protecting rabeprazole sodium?
A: Some formulations and use patents may delay generics' entry, but most patent protections expired by 2015 in major markets.

Q4: Which markets are expanding for rabeprazole sodium?
A: Asia-Pacific, particularly India and China, represent growth opportunities due to rising GERD prevalence and healthcare outreach.

Q5: How might biopharmaceutical firms differentiate rabeprazole-based therapies moving forward?
A: Through novel delivery systems, combination therapies, or targeted formulations for specific patient populations.

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References

1. Lanz, R., Mertens, B., & Heidrich, B. (2017). Patent landscape of gastric acid suppressants. Journal of Drug Development and Industrial Pharmacy, 43(2), 185-192.
2. Grand View Research. (2022). Proton Pump Inhibitors Market Size, Share & Trends Analysis Report.
3. FDA. (2022). Annual Generic Drug Application Approvals.
4. Kahr, L., et al. (2020). Potassium-competitive acid blockers: A review of vonoprazan and clinical implications. Therapeutic Advances in Gastroenterology, 13, 1756284820927744.