ACIPHEX Drug Patent Profile

Which patents cover Aciphex, and what generic alternatives are available?

Aciphex is a drug marketed by Waylis Therap and Aytu and is included in two NDAs.

The generic ingredient in ACIPHEX is rabeprazole sodium. There are thirty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aciphex

A generic version of ACIPHEX was approved as rabeprazole sodium by CHARTWELL RX on November 8^th, 2013.

Summary for ACIPHEX

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	167
Clinical Trials:	22
Patent Applications:	4,335
Drug Prices:	Drug price information for ACIPHEX
What excipients (inactive ingredients) are in ACIPHEX?	ACIPHEX excipients list
DailyMed Link:	ACIPHEX at DailyMed

See drug prices for ACIPHEX

See drug sales revenues for ACIPHEX

Recent Clinical Trials for ACIPHEX

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

Sponsor	Phase
Pfizer	Phase 1
Janssen Research & Development, LLC	Phase 1
Eisai Inc.	Phase 1

See all ACIPHEX clinical trials

Pharmacology for ACIPHEX

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Proton Pump Inhibitors

US Patents and Regulatory Information for ACIPHEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-001	May 29, 2002		DISCN	Yes	No
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-002	Mar 26, 2013		DISCN	Yes	No
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-002	Aug 19, 1999	AB	RX	Yes	Yes

Expired US Patents for ACIPHEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-001	May 29, 2002	5,035,899
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	020973-002	Aug 19, 1999	5,035,899

International Patents for ACIPHEX

See the table below for patents covering ACIPHEX around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	239189
Denmark	575887
Germany	3752167

Supplementary Protection Certificates for ACIPHEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0268956	C990015	Netherlands		PRODUCT NAME: RABEPRAZOLI, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER RABEPRAZOLI NATRICUM; NATL REGISTRATION NO/DATE: RVG 23210-11 19981208; FIRST REGISTRATION: GB 10555/0008 AND 10555/0010 19980508
0268956	1999C0030	Belgium		PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
0268956	SPC/GB98/040	United Kingdom		PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508

Market Dynamics and Financial Trajectory for ACIPHEX (Rabeprazole Sodium)

Last updated: November 17, 2025

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Introduction

ACIPHEX (rabeprazole sodium) is a proton pump inhibitor (PPI) developed by Eisai Co., Ltd., and marketed primarily in the United States and other global markets. Approved by the U.S. Food and Drug Administration (FDA) in 1999, ACIPHEX is indicated for the treatment of gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and other acid-related disorders. Over the past two decades, its market performance has been shaped by evolving drug competition, regulatory landscapes, and shifting prescribing patterns. This report provides a comprehensive analysis of the current market dynamics and projects the financial trajectory for ACIPHEX within the global pharmaceutical landscape.

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Market Landscape and Competitive Environment

1. Historical Market Position

Initially, ACIPHEX gained significant market traction due to its efficacy, safety profile, and once-daily dosing convenience. During the early 2000s, PPIs represented a dominant class for acid suppression, with drugs such as omeprazole, esomeprazole, and pantoprazole capturing significant market share. ACIPHEX benefited from this growth, establishing a solid presence, especially in North America.

2. Competitive Dynamics

The PPI market is highly competitive, characterized by patent expirations, generic drug entry, and pricing pressures. ACIPHEX’s patent protections expired in the mid-2010s, leading to increased generic competition. Generic rabeprazole tablets entered markets across various geographies, resulting in substantial erosion of brand revenues. Notably:

• Generics Dominance: Generic rabeprazole now accounts for a significant proportion of prescriptions, often priced substantially lower than branded versions.
• Market Transition: Physicians shifted prescriptions toward cost-effective generic alternatives, reducing ACIPHEX's market share.

3. Regulatory and Patent Challenges

Post-patent expiration, Eisai faced generic competition in multiple markets, including the U.S., Japan, and Europe. Despite efforts to extend exclusivity through formulation patents, these measures proved less effective against generic proliferation, thereby constraining revenue potential. Moreover, regulatory environments in various countries influenced drug availability and pricing strategies.

Market Drivers and Trends Influencing ACIPHEX

1. Increasing Prevalence of Gastrointestinal Diseases

The global rise in GERD and other acid-related disorders continues to fuel demand for PPIs. According to the Global Burden of Disease Study, GERD affects approximately 10-20% of the Western population, with prevalence increasing worldwide. This trend sustains market demand for acid suppression therapies, although the specific impact on ACIPHEX is tempered by generic competition.

2. Evolving Prescribing Practices

Healthcare providers increasingly prioritize cost-effective treatments, favoring generics over branded medications. Although ACIPHEX maintains some prescriber loyalty due to perceived efficacy and tolerability, the overarching trend favors less expensive options, affecting its sales.

3. Patent Expirations and Generic Uptake

The expiration of key patents around 2014-2015 resulted in a sharp decline in ACIPHEX sales. The resultant surge in generic rabeprazole prescribing significantly impacts revenue streams, reducing profitability for the brand.

4. Market Segmentation and Specialty Drugs

In certain segments, such as Zollinger-Ellison syndrome, ACIPHEX retains niche value owing to specific safety profiles and formulation stability. However, newer therapies and combinations are emerging, challenging traditional PPI dominance.

Financial Trajectory

1. Revenue Trends Post-Patent Expiry

Following patent expiration, ACIPHEX experienced a steep decline:

• U.S. Market: Transition from a dominant brand to minimal sales levels. For instance, Eisai reported that domestic sales of ACIPHEX dropped from hundreds of millions annually pre-expiry to negligible amounts post-2015 [2].

• Global Markets: Similar declines observed in Europe and Japan, with local manufacturers and generics overtaking the brand.

2. Current Market Status

Today, ACIPHEX's commercial presence is primarily driven by legacy medication use, with limited promotional activities. In some regions, Eisai continues to license or distribute the drug for specific indications or formulations, but the overall financial contribution remains marginal.

3. Prospects and Future Revenue Opportunities

Potential future revenues hinge on:

• Niche Applications: Rare indications or formulations that are patent-protected or less substitutable.
• Combination Therapies: Co-formulations with other agents in development might provide incremental growth.
• Succession via Acquisition or Licensing: Strategies to leverage existing formulations for new indications could offer modest revenue streams.

4. Impact of Market Trends on Revenue

The global generic PPI market is forecast to grow modestly over the next decade, driven by increasing demand for acid-related disorder treatments and expanding healthcare access in emerging markets. However, this growth favors generic manufacturers, keeping brand-specific revenues low.

According to IQVIA data, the US market for PPIs in 2022 was valued at approximately USD 4 billion, with generics accounting for over 80% [3]. ACIPHEX's decline is emblematic of brands in this space, with most revenue concentrated prior to patent expiry.

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Strategic Outlook

1. Focus on Niche and Specialty Markets

Commercial strategies might shift toward specialized or orphan indications where patent protection or formulation advantages could be preserved, maintaining marginal revenue streams.

2. Development of Improved Formulations

Investments in new formulations, delivery mechanisms, or extended-release versions could provide differentiability, influencing future market trajectories.

3. Licensing and Partnership Opportunities

Partnerships with generic firms or licensing arrangements may revive activity, albeit limited to localized markets or specific indications.

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Key Market Risks and Challenges

• Intense Price Competition: The omnipresent threat of generics continuing to suppress prices and revenues.
• Regulatory Barriers: New formulation approvals or indication expansions could be delayed or complex.
• Therapeutic Shifts: Emerging therapies, such as potassium-competitive acid blockers (P-CABs), threaten to displace PPIs, including rabeprazole.

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Conclusion

The market dynamics for ACIPHEX underscore a once-dominant brand that has experienced significant revenue erosion due to patent expiry, generic competition, and evolving prescribing patterns. While its direct financial contribution has diminished substantially over the past decade, niche applications and strategic formulations may offer marginal opportunities. Broadly, the trajectory reflects a typical lifecycle pattern for branded drugs in mature markets—initial rapid growth, peak profitability, followed by decline and eventual commoditization.

Overall, ACIPHEX's future is unlikely to involve substantial revenue generation without innovation or strategic repositioning, typifying the lifecycle challenges faced by many first-generation PPIs.

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Key Takeaways

• Patent expiry significantly impacted ACIPHEX's revenue, leading to widespread generic substitution.
• Generic rabeprazole now dominates the PPI market, restricting brand profitability.
• Market trends favor cost-effective therapies, further challenging ACIPHEX’s market share.
• Niche applications or formulations could sustain minimal revenues amid strong generic competition.
• Future growth prospects depend on innovative formulations, rare indications, or licensing opportunities.

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FAQs

1. Why did ACIPHEX lose market share so rapidly after patent expiration?
Generic rabeprazole entered markets at a fraction of the brand price, leading prescribers and patients to switch due to cost considerations, resulting in swift declines in ACIPHEX sales.

2. Are there any ongoing efforts to reposition ACIPHEX in the market?
Currently, strategies revolve around niche uses or formulations. No significant new indications or reformulations are widely publicized, limiting repositioning opportunities.

3. How does ACIPHEX compare to other PPIs post-expiry?
While efficacy and safety profiles are comparable, market share tilts toward longer-established or more widely prescribed PPIs like omeprazole or esomeprazole, which have more extensive marketing and better patent protections.

4. What are the prospects for innovative formulations of rabeprazole?
Limited. Development of new formulations faces regulatory and cost barriers but represents a potential niche for differentiation.

5. Will emerging therapies threaten ACIPHEX’s remaining market?
Yes. The advent of P-CABs and other novel acid suppression agents could further diminish the role of traditional PPIs like ACIPHEX in future treatment algorithms.

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Sources:

[1] IQVIA, "Pharmaceutical Market Data," 2022.
[2] Eisai Co., Ltd. Annual Reports, 2015-2022.
[3] GlobalData, "PPI Market Analysis," 2022.