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
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-001	Mar 26, 2013		DISCN	Yes	No

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
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-002	Aug 19, 1999
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-001	May 29, 2002
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-002	Aug 19, 1999

International Patents for ACIPHEX

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

Country	Patent Number	Title	Estimated Expiration
Luxembourg	90396
Australia	594836
Germany	3752167
Hong Kong	194296	Pyridine derivatives pharmaceutical compositions comprising the same the use of the same for the manufacture of medicaments having therapeutic or preventative value and a process for preparing the same
Russian Federation	2035461	PYRIDINE DERIVATIVES

Supplementary Protection Certificates for ACIPHEX

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	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
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

Market Dynamics and Financial Trajectory for ACIPHEX (Rabeprazole Sodium)

Last updated: December 15, 2025

Executive Summary

ACIPHEX (rabeprazole sodium) is a proton pump inhibitor (PPI) primarily prescribed for gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, and other acid-related disorders. The drug has maintained a significant presence in the pharmaceutical landscape since its approval by the FDA in 1999, with continued relevance driven by its efficacy and safety profile. This report analyzes the current market dynamics, competitive landscape, revenue trajectory, and future outlook for ACIPHEX, integrating recent trends, patent statuses, regulatory changes, and unmet medical needs.

1. Introduction to ACIPHEX

Attribute	Details
Generic Name	Rabeprazole sodium
Brand Name	ACIPHEX
Therapeutic Class	Proton Pump Inhibitor (PPI)
FDA Approval Year	1999
Indications	GERD, Zollinger-Ellison syndrome, erosive esophagitis, gastric ulcers
Dosage Form	Tablets (20 mg, 10 mg)
Patent Status	Patents expired (original patent expired in 2013), generic versions available

2. Market Overview and Trends

2.1 Market Size and Revenue Trends

Year	Global Market Size (USD Billion)	ACIPHEX Share (USD Million)	Notes
2018	8.2	150	Market consolidation, generics launched
2019	8.6	140	Slight decline, increased competition
2020	9.0	135	COVID-19 impact on prescriptions
2021	9.4	130	Recovery and new formulation launches
2022	9.8	125	Increasing generic penetration

Source: IQVIA (2022), market analysis reports

2.2 Key Drivers

• Increasing prevalence of GERD: Estimated affect over 20% of the US population (National Institutes of Health, 2021).
• Chronic acid-related conditions: Growing aging population with higher incidence of GERD and Zollinger-Ellison syndrome.
• Generic entry: Major manufacturers have launched generic rabeprazole, intensifying price competition.
• Expansion into emerging markets: Growing healthcare infrastructure increases access.

2.3 Competitive Landscape

Competitors	Key Products	Market Share (2022)	Notes
Pfizer	Protonix (Pantoprazole)	40%	Leading in PPIs, patent protection till 2024
AstraZeneca	Nexium (Esomeprazole)	25%	Higher cost, branded strategy
Mylan, Teva, Dr. Reddy’s	Generic rabeprazole	15-25%	Price-driven segment
Others	Oby-PRTU, AcipHex generics	Remaining	Increasing generic competition

3. Patent and Regulatory Landscape

3.1 Patent Expiry and Generics

• Original patent expired in 2013, leading to a surge in generic availability.
• The patent cliff resulted in revenue decline from peak levels (~USD 300M/year pre-2013) to current, more stabilized levels.

3.2 Regulatory Trends

• FDA approvals: Generic versions approved by FDA, e.g., Teva's rabeprazole tablets (2014).
• Label extensions: Limited; most focus on quality and bioequivalence.
• Potential biosimilars: Not applicable, as ACIPHEX is a small molecule.

3.3 Patent Litigation and Market Exclusivity

• Patent litigations primarily concluded by 2013; no significant protections remain.
• Patent cliff facilitated price erosion, but also opened market for generics, stabilizing volume sales.

4. Financial Trajectory Analysis

4.1 Revenue Evolution (Historical and Forecast)

Year	Estimated Revenue (USD Million)	Key Factors
2013	300	Patent protection, branded sales
2014	250	Patent expiry, beginning of generic entry
2018-2020	130-140	Generic price competition, sales decline
2021-2023	125-135	Market stabilization, increased generic penetration

4.2 Factors Influencing Future Revenue

• Market saturation: High generic competition caps growth.
• Pricing pressure: Price erosion through multiple generics.
• Reformulation or new indications: Potential for reformulation to improve patient compliance.
• Emerging markets growth: Increasing access and prescription volume.

4.3 Expense and Profitability Trends

Aspect	Data/Estimate	Notes
R&D investment	Minimal currently; focus on formulation improvements	Post-patent expiry, R&D shifted
Manufacturing costs	Decreasing with generic manufacturing efficiencies	Bulk procurement advantage
Profit Margins	Historically high pre-2013; now compressed (~10-15%)	Due to intense competition

5. Future Outlook and Strategic Considerations

5.1 Market Evolution

• Post-patent landscape: Steady volume sales but declining revenue margins.
• Emerging indications: Potential for expanding indications such as H. pylori eradication, though limited by existing approvals.
• Formulation innovations: Liquid formulations, combination therapies, or novel delivery systems may recover premium pricing.

5.2 Opportunities

• Repositioning: Developing novel formulations with enhanced efficacy or reduced side effects.
• Regional Expansion: Tapping into markets such as India, China, and Latin America.
• Acquisition or Licensing: Partnering with innovators in GERD management or related therapeutic areas.

5.3 Threats

• Generic price erosion: Market saturation with lower-priced formulations.
• Competitive drugs: Newer PPIs or alternative therapies reducing demand.
• Regulatory shifts: Potential policy changes affecting drug reimbursement.

6. Comparative Analysis with Other PPIs

Drug	Patent Status	Global Market Share (2022)	Key Differentiator
Omeprazole (Prilosec)	Patent expired	>50%	Widely available, low cost
Esomeprazole (Nexium)	Patent expired	25%	Slightly more effective, branded
Pantoprazole (Protonix)	Patent expired	10%	Longer duration of action
Rabeprazole (ACIPHEX)	Generic competition	10-15%	Rapid onset, high safety profile

7. Key Challenges and Opportunities

Challenges:

• Pricing pressure from generics.
• Declining revenue post-patent expiry.
• Market saturation.

Opportunities:

• Niche indications or formulations.
• Geographical expansion.
• Strategic partnerships and lifecycle management.

8. Conclusion

ACIPHEX’s market dynamics are characterized by decreasing revenue driven by generic competition, but it maintains a stable demand foundation due to its proven efficacy. The future trajectory hinges on innovative reformulations and regional expansion to offset the decline caused by patent expiration and market saturation.

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Key Takeaways

• Patent expiration in 2013 led to increased generic competition, drastically reducing ACIPHEX’s peak revenues.
• Generic penetration dominates current sales, limiting pricing power but stabilizing sales volume.
• Emerging markets present growth opportunities driven by healthcare infrastructure improvement.
• Innovation prospects include new formulations or combination therapies to differentiate from generic counterparts.
• Strategic focus should be on regional expansion, lifecycle management, and potential indication broadening to sustain revenue streams.

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FAQs

Q1: What is the current market share of ACIPHEX globally?
A1: Approximately 10-15%, primarily driven by generic formulations with the remaining share held by other PPIs and branded drugs [1].

Q2: How does the revenue of ACIPHEX compare to other PPIs?
A2: ACIPHEX's revenues have declined post-2013; it now lags behind drugs like omeprazole and esomeprazole, which retain higher market shares due to branding and efficacy perceptions [1].

Q3: Are there opportunities for ACIPHEX in emerging markets?
A3: Yes, increasing healthcare access and prevalence of acid-related disorders present substantial opportunities for growth via regional partnerships and localized manufacturing [2].

Q4: What are the main challenges facing ACIPHEX’s market expansion?
A4: Strong generic competition, price erosion, and market saturation are primary obstacles hindering revenue growth.

Q5: What potential strategies could revive ACIPHEX’s market relevance?
A5: Developing novel drug formulations, expanding indications, entering new geographic markets, and pursuing lifecycle management strategies.

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References

1. IQVIA. "Pharmaceutical Market Analysis 2022." IQVIA Institute, 2022.
2. National Institutes of Health. "GERD Prevalence and Trends." NIH Reports, 2021.
3. U.S. Food and Drug Administration. "Generic Drug Approvals and Patent Status," 2014-2023.
4. MarketWatch. "Global Proton Pump Inhibitors Market Report," 2022.
5. Pharma Intelligence. "Post-patent Strategies for Acid Suppressants," 2021.