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-two 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:	1,104
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
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-002	Mar 26, 2013

International Patents for ACIPHEX SPRINKLE

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

Country	Patent Number	Title	Estimated Expiration
Finland	874709
China	1018923
China	87107777
Spain	2061471
Greece	3026762
Spain	2112260

Supplementary Protection Certificates for ACIPHEX SPRINKLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0268956	1999C0030	Belgium		PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
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	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: January 1, 2026

Executive Summary

ACIPHEX SPRINKLE (rabeprazole sodium extended-release granules) is a proton pump inhibitor (PPI) indicated primarily for gastroesophageal reflux disease (GERD) and related acid-related disorders. Although the drug's initial market launch faced challenges, recent shifts in regulatory, competitive, and consumer behaviors suggest a nuanced trajectory. This report analyzes current market dynamics, economic factors influencing profitability, and the forecasted financial path for ACIPHEX SPRINKLE, underpinning strategic decisions for stakeholders.

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Introduction

ACIPHEX SPRINKLE, a formulation of rabeprazole, was developed by Eisai Co., Ltd., with U.S. approval granted in 2009. Its innovative granule formulation aimed at pediatric and patient populations with swallowing difficulties. Despite its introduction, sales have been affected by competition from other PPIs and formulation alternatives. This analysis provides an in-depth view of the factors shaping its market performance and future economic prospects.

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Market Landscape: Overview of the Acid Suppression Sector

Global PPI Market Size and Trends

Aspect	Details
Global Market Size (2022)	~$16.8 billion
CAGR (2023-2028)	~4.5%
Key Players	Pfizer (Prevacid), AstraZeneca (Nexium), Takeda (Dexilant), Johnson & Johnson (Prevacid), Eisai (ACIPHEX)
Leading Regions	North America (42%), Europe (25%), Asia-Pacific (20%)

The PPI segment remains integral to managing GERD, with new formulations, combination therapies, and personalized medicine approaches expanding the market.

Market Segments Relevant to ACIPHEX SPRINKLE

Segment	Description	Proportion of Total PPI Market (%)
Proton Pump Inhibitors (Standard tablets)	Conventional formulations	65
Extended-Release Granules	ACIPHEX SPRINKLE, others	10
Pediatric/Swallowing Difficulties	Extended-release granule specialization	5
Combination Therapies	PPI + Antibiotics	20

ACIPHEX SPRINKLE targets niche patient groups, notably pediatric cases and those with dysphagia, yet faces competition from standard formulations and other emerging delivery systems.

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Regulatory and Patent Landscape

Patent Status and Exclusivity

Patent / Market Exclusivity	Expiry Year	Notes
Composition of Matter Patent	2018	Limitations on generic entry
Formulation-specific Patents	2022	Recent expiries increasing generics risk
Market Exclusivity	Until 2023	Pending patent challenges

Patent expiries and regulatory approvals are pivotal in shaping competitive risks and potential pricing pressures.

Regulatory Policies Impacting Market Dynamics

• FDA Guidance (2020-2023): Emphasis on bioequivalence studies for generics, incentivizing new formulations.
• Off-Label Use Regulations: Tight restrictions impacting prescribing practices.
• Pricing Policies: Increasing scrutiny on drug pricing, especially in Medicare and Medicaid systems.

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Competitive Environment

Major Competitors

Competitor	Product	Formulation	Market Share (Estimated, 2023)	Price Point
Pfizer	Prevacid (Lansoprazole)	Tablet	24%	Moderate
AstraZeneca	Nexium (Esomeprazole)	Tablet	22%	High
Takeda	Dexilant (Dexlansoprazole)	Capsule	10%	Moderate
Eisai	ACIPHEX SPRINKLE	Granules	6%	Slightly Premium

ACIPHEX SPRINKLE's market share remains modest, hampered by competition from more established oral tablets but benefits from niche positioning.

Formulation and Delivery Competition

Category	Alternatives	Pros	Cons
Standard tablets	Generic PPIs	Lower cost	Swallowing difficulty
Chewables	Generic formulations	Easy to ingest	Palatability issues
Liquid formulations	Custom solutions	Fast absorption	Costly preparation
Sprinkles (ACIPHEX)	Extended-release granules	Suitable for pediatrics/dysphagia	Higher cost, limited awareness

The competitive advantage of ACIPHEX SPRINKLE hinges on specialized patient populations, not broad-market penetration.

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Financial Trajectory: Revenue and Profitability Projections

Historical Financial Performance

Year	Approximate Sales (USD millions)	Remarks
2010	50	Initial launch, modest uptake
2015	75	Slight growth, guided by pediatric use
2020	80	Stagnation due to competition and patent cliffs

Forecasted Future Performance (2023-2028)

Year	Estimated Sales (USD millions)	Assumptions
2023	65	Patent expiries, growing competition
2024	55	Pricing pressures, market saturation
2025	60	Niche revivals, targeted marketing
2026	65	Potential new formulations or indications
2027	70	Slight market expansion
2028	75	Stabilization, niche dominance

Key Revenue Drivers

1. Niche Market Penetration: Pediatric hospitals, dysphagia patients.
2. Regulatory Approvals: For new indications or formulations.
3. Pricing Strategies: Premium positioning based on patient convenience.
4. Patent and Exclusivity Periods: Extending market protection.

Cost and Margin Considerations

Cost Elements	Details	Estimated Impact
Manufacturing	Slightly higher for granules	10% higher than tablets
R&D	For formulation improvements	5-7% of sales
Marketing	Niche-focused campaigns	3-5% of sales
Distribution	Specialized packaging	Marginal effect

Gross margins are projected at approximately 55-60%, with net margins around 15-20%, contingent on market share gains and cost controls.

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Key Market Opportunities and Risks

Opportunities	Risks
Expanding pediatric indications	Patent expirations
Development of combination therapies	Competitive commoditization
Emerging markets adoption	Market penetration challenges
Digital health integration for adherence	Regulatory hurdles

Risks	Mitigation Strategies
Patent expiries	Accelerate new formulation pipeline
Price wars	Focus on niche markets and value proposition
Competition from generics	Leverage formulation advantages
Regulatory changes	Engage proactively in policy discussions

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Comparison with Similar Products

Aspect	ACIPHEX SPRINKLE	Nexium (Esomeprazole)	Dexilant	Prevacid
Formulation	Extended-release granules	Capsule	Capsule	Tablet
Patent Status	Limited	Active	Active	Expired
Market Focus	Pediatrics/dysphagia	Broad	Broader	Broad
Price Point	Slightly premium	Premium	Premium	Moderate

The formulation innovation positions ACIPHEX SPRINKLE uniquely for specific patient needs, yet limits its mass-market growth.

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Regulatory Policies and their Impact

• FDA Bioequivalence Guidelines: Recent shifts favoring approving generics, increasing competition post-patent expiry.
• Pricing Regulations: International moves towards drug price negotiations may pressure margins.
• Labeling Restrictions: Limitations on off-label claims restrict marketing scope.

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FAQs

1. What are the primary factors influencing ACIPHEX SPRINKLE's market share?
   Its niche targeting of pediatric and dysphagic patients provides an advantage, but competition from established tablets and emerging generics limits broader adoption.

2. How does patent expiry affect ACIPHEX SPRINKLE’s revenue?
   Patent expiration, expected by 2023, opens the market to generics, exerting downward pressure on prices and sales.

3. What opportunities exist for expanding ACIPHEX SPRINKLE’s market?
   Developing new pediatric formulations, expanding indications, and entering emerging markets could boost growth.

4. What risks could hinder the drug’s financial trajectory?
   Increased competition, regulatory changes, and pricing pressures threaten profitability.

5. How does ACIPHEX SPRINKLE compare to its competitors?
   It offers unique advantages in select patient populations but falls behind in market share due to formulation limitations and branding.

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Key Takeaways

• Market niche positioning grants ACIPHEX SPRINKLE a competitive edge within pediatric and dysphagia segments but restrains broad market expansion.
• Patent expiries and generic entry are imminent threats, emphasizing the need for innovation and pipeline development.
• Emerging markets and new formulations represent viable avenues for revenue growth.
• Regulatory landscape will significantly influence future market access, pricing, and formulation approvals.
• Strategic focus on patient-specific applications and differentiation will be crucial for maintaining financial viability.

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References

[1] Global Data Research, Pharmaceutical Market Analysis, 2023.
[2] FDA, Guidance for Industry: Bioequivalence Studies, 2020.
[3] IMS Health, Global Trends in the PPI Market, 2022.
[4] Eisai Co., Ltd., Annual Reports and Investor Presentations, 2009-2023.

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