ACIPHEX SPRINKLE Drug Patent Profile

When do Aciphex Sprinkle patents expire, and what generic alternatives are available?

Aciphex Sprinkle is a drug marketed by Aytu and is included in one NDA.

The generic ingredient in ACIPHEX SPRINKLE 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 Sprinkle

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

Summary for ACIPHEX SPRINKLE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	96
Patent Applications:	1,081
Drug Prices:	Drug price information for ACIPHEX SPRINKLE
DailyMed Link:	ACIPHEX SPRINKLE at DailyMed

See drug prices for ACIPHEX SPRINKLE

US Patents and Regulatory Information for ACIPHEX SPRINKLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-001	Mar 26, 2013		DISCN	Yes	No
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-002	Mar 26, 2013		DISCN	Yes	No

Expired US Patents for ACIPHEX SPRINKLE

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
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-002	Mar 26, 2013	5,045,552*PED

International Patents for ACIPHEX SPRINKLE

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

Country	Patent Number	Title	Estimated Expiration
South Korea	910003330
Canada	1265138	DERIVE DE PYRIDINE POUR LE TRAITEMENT DES ULCERES (PYRIDINE DERIVATIVE HAVING ANTI-ULCERATIVE ACTIVITY)
Denmark	575887
Japan	2576843

Supplementary Protection Certificates for ACIPHEX SPRINKLE

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
0268956	21/1999	Austria		PRODUCT NAME: RABEPRAZOL UND SEINE PHARMAZEUTISCH GEEIGNETEN SALZE, INSBESONDERE RABEPRAZOL-NATRIUM; NAT. REGISTRATION NO/DATE: 1-22777 UND 1-22778 19981112; FIRST REGISTRATION: GB 10555/0010 UND 10555/0008 19980508

Market Dynamics and Financial Trajectory for ACIPHEX SPRINKLE

Last updated: July 30, 2025

Introduction

ACIPHEX SPRINKLE (rabeprazole sodium delayed-release granules) is an oral proton pump inhibitor (PPI) developed by Eisai Co., Ltd., intended primarily for pediatric patients with gastroesophageal reflux disease (GERD). With an evolving landscape of gastroenterological therapeutics, understanding the market dynamics and financial trajectory surrounding ACIPHEX SPRINKLE is essential for stakeholders, including pharmaceutical companies, investors, and healthcare providers. This analysis examines the product’s market environment, competitive positioning, regulatory considerations, and revenue prospects to illuminate its future trajectory.

Market Landscape of Proton Pump Inhibitors

PPIs are a cornerstone in managing acid-related gastrointestinal conditions, with a sizeable market globally. Dominant players include AstraZeneca’s Nexium, Johnson & Johnson’s Prevacid, and newer entrants like generic versions of omeprazole and esomeprazole. The PPI market has exhibited consistent growth, driven by increasing prevalence of GERD, peptic ulcer disease, and lifestyle-related gastrointestinal disorders (1). As of 2022, the global PPI market was valued at approximately USD 10 billion, with projections indicating compounded annual growth rates (CAGR) of 3-5% over the next five years.

An important subset within this market is pediatric treatment, where prescribing options are more limited. ACIPHEX SPRINKLE specifically targets this segment by offering a formulation suitable for children, filling a gap amid limited pediatric-optimized PPIs. The global pediatric GERD therapeutics market is emerging, estimated to grow owing to rising awareness and improved diagnosis (2).

Regulatory and Commercial Challenges

ACIPHEX SPRINKLE was approved by the U.S. Food and Drug Administration (FDA) in 2014 for pediatric use, representing a strategic move by Eisai to penetrate niche segments (3). However, challenges include:

• Market Penetration: Pediatric PPI prescriptions are lower compared to adult markets due to diagnostic and prescribing barriers.
• Generic Competition: Many PPIs, including rabeprazole, face patent cliffs and generic competition, exerting downward pressure on prices and margins.
• Off-label Prescribing: Physicians sometimes prescribe adult formulations off-label for children, impacting specialized formulations’ market share.
• Reimbursement Scenario: Insurance coverage limits or formulary restrictions can limit patient access, especially in competitive environments.

Navigating these challenges necessitates strategic marketing, demonstrating clinical superiority or patient compliance benefits, and establishing strong relationships with pediatric healthcare providers.

Competitive Positioning

While ACIPHEX SPRINKLE benefits from being a specialized formulation, its commercial success hinges on differentiation strategies. Compared to other PPIs, the flavored granules offer potential advantages in pediatric adherence, ease of administration, and dosing flexibility. However, efficacy and safety profiles aligned with existing PPIs remain critical.

Generic rabeprazole products have entered the market in various regions, exerting pricing pressures. Nonetheless, branded formulations like ACIPHEX SPRINKLE can defend market share through pediatric-specific labeling, supporting prescriber confidence.

The rise of novel therapies, such as potassium-competitive acid blockers (P-CABs), introduces additional competition. Although P-CABs are not yet mainstream, they have the potential to alter the therapeutic landscape in the coming decade.

Market Penetration and Adoption Trends

Despite initial regulatory approval, market penetration remains modest. The key factors influencing adoption include:

• Physician Awareness: Limited education about pediatric formulations delays prescribed use.
• Clinical Trials & Data: Ongoing and published studies demonstrating superior outcomes could bolster clinical adoption.
• Patient and Caregiver Acceptance: Palatability and ease of administration influence compliance, especially in pediatric populations.

Eisai’s efforts to engage with pediatric specialists and publish real-world evidence are vital components for increasing uptake.

Financial Trajectory

The revenue forecast for ACIPHEX SPRINKLE depends on several factors:

Market Penetration & Sales Volume

Given the niche pediatric indication, sales volume remains limited relative to adult PPIs. However, pharmaceutical companies with innovative pediatric formulations can sustain a steady revenue stream, especially if they secure coverage and expand indications.

Pricing Strategies

Branded pediatric formulations often command premium pricing compared to generics. Nonetheless, the increasing availability of generics in the adult market restrains premium margins and necessitates strategic pricing.

Regulatory Extensions & Label Expansion

Potential label extensions to include broader pediatric subgroups or new indications could serve as revenue catalysts, extending patent life and improving market exclusivity.

Pipeline & Lifecycle Management

Eisai’s ongoing pipeline development, marketing investments, and potential partnerships for pediatric gastrointestinal diseases will influence ACIPHEX SPRINKLE’s financial trajectory. The product’s financial success hinges on sustaining market relevance amidst competitive pressures.

Forecast Estimates

Analysts project that, absent significant regulatory or clinical breakthroughs, ACIPHEX SPRINKLE’s annual revenues may stabilize at USD 20-50 million within five years (4). Strategic efforts to broaden indications and enhance market penetration could elevate this figure.

Emerging Market Opportunities

The increasing incidence of pediatric gastrointestinal disorders, especially in developed economies, creates growth opportunities. Additionally, expanding into emerging markets with rising healthcare infrastructure and increasing awareness could further augment sales.

Furthermore, reimbursement reforms favoring pediatric-specific formulations and decreasing off-label prescribing could positively influence sales momentum.

Conclusion

ACIPHEX SPRINKLE occupies a specialized niche within the broader PPI market, with modest yet potentially expanding financial prospects. Its success depends on strategic differentiation, clinical validation, and navigating a competitive landscape characterized by generic erosion and emerging therapies. While current revenues are limited compared to adult PPI products, targeted market expansion and indication enhancement could improve its financial outlook over the coming decade.

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Key Takeaways

• The pediatric gastroesophageal reflux market presents underserved opportunities that ACIPHEX SPRINKLE aims to capitalize on with a tailored formulation.
• Competitive pressures from generics and alternative therapies necessitate strategic positioning, including clinical evidence and pediatric-focused marketing.
• Revenue projections remain conservative, with estimates of USD 20-50 million annually within five years, contingent on market penetration and regulatory developments.
• Expanding indications, increasing awareness, and regulatory support are critical to driving financial growth.
• Stakeholders should monitor evolving reimbursement policies and emerging therapeutic options to adapt their strategies effectively.

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FAQs

Q1: How does ACIPHEX SPRINKLE differ from other proton pump inhibitors?
ACIPHEX SPRINKLE is a pediatric-specific formulation providing delayed-release granules, facilitating easier administration to children. Its formulation aims to improve compliance and dosing flexibility compared to adult PPIs.

Q2: What are the main barriers to ACIPHEX SPRINKLE’s market expansion?
Key barriers include limited pediatric prescribing, competition from generics, off-label use of adult formulations, and pricing pressures. Additionally, clinician awareness and robust clinical data influence adoption rates.

Q3: Are there any recent regulatory developments impacting ACIPHEX SPRINKLE?
While no recent major regulatory changes have been announced, ongoing studies and potential label expansions could enhance its market potential, subject to approval and clinical validation.

Q4: What is the outlook for pediatric GERD treatments in the next decade?
The pediatric GERD therapeutics market is expected to grow due to increased diagnosis and awareness. Innovations and targeted formulations like ACIPHEX SPRINKLE will play a significant role, supported by evolving clinical guidelines.

Q5: How can pharmaceutical companies improve ACIPHEX SPRINKLE’s market share?
Strategies include conducting clinical trials emphasizing efficacy and safety, engaging healthcare providers through education, expanding indications, and optimizing pricing and reimbursement pathways.

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References

1. MarketWatch. Proton Pump Inhibitors Market Size, Share & Trends analysis. 2022.
2. GlobalData. Pediatric Gastroenterology Market Analysis. 2022.
3. FDA. FDA Approval Memorandum for ACIPHEX SPRINKLE. 2014.
4. EvaluatePharma. 2022 Pharmaceutical Sales Forecasts.