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-one 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	5,035,899
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-001	May 29, 2002	5,045,552*PED
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	174366
European Patent Office	0268956	Dérivés de pyridine, leurs compositions pharmaceutiques, leur utilisation pour la fabrication de médicaments ayant une valeur thérapeutique ou préventive, et un procédé pour leur préparation (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)
Japan	H01290628	INTERNAL DRUG PREPARATION OF COMPOUND UNSTABLE TO ACID
Germany	19975035
European Patent Office	0342522	PERORAL PREPARATION OF AN ACID-UNSTABLE COMPOUND
Japan	2544567

Supplementary Protection Certificates for ACIPHEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for ACIPHEX

Last updated: February 20, 2026

Summary:
ACIPHEX (rabeprazole sodium) is a proton pump inhibitor (PPI) initially marketed to treat gastroesophageal reflux disease (GERD) and related conditions. Its market presence has declined due to patent expiration, generic competition, and shifts in prescribing practices. Current forecasts suggest continued erosion in sales volume with limited potential for recovery, barring new indications or formulations.

Market Overview and Historical Context

• Introduction:
  ACIPHEX was approved by the FDA in 1999 for GERD and related disorders. It was acquired by Evoloce Inc. from GSK in 2009. The drug maintained a significant presence through the early 2010s, with annual sales peaking around $600 million in the U.S.

• Patent and Generic Entry:
  GSK’s patent expired in the U.S. in 2014, leading to immediate generic competition. Generic versions entered the market in 2015, resulting in steep sales declines. Brand sales diminished to below $50 million by 2020.

• Market Shares:
  The PPI segment is highly competitive, dominated by omeprazole, esomeprazole, and pantoprazole. ACIPHEX’s market share fell from over 20% pre-patent expiry to less than 1% post-generic entry.

Market Dynamics

Patent Expiration and Generic Competition

The key factor affecting ACIPHEX’s financial outlook. Generic manufacturers significantly reduced prices, leading to rapid erosion of revenue. The entry of multiple generics within a year of patent expiry intensified market share loss.

Prescribing Trends and Off-Label Use

Physicians increasingly prefer OTC PPIs or newer formulations with reduced side effects. ACIPHEX has not introduced a new formulation or indication to sustain prescriber interest, limiting its share.

Regulatory and Patent Extensions

In 2007, GSK secured pediatric exclusivity prolonging patent coverage until 2014; no further extensions were granted. No new patents were obtained to extend exclusivity beyond that.

Market Segments and Demand

The U.S. remains the primary market. The demand for prescription PPIs has declined with the rise of OTC options. The segment is expected to contract further as generics dominate supply channels.

Financial Trajectory

Year	Estimated U.S. Sales	Global Sales	Key Factors Impacting Revenue
2014	~$600 million	Estimated ~$800 million	Patent protection ends, peak sales year
2015	<$100 million	<$200 million	First generic approvals, sales drop
2016–2018	<$50 million	<$100 million	Continued generic competition
2019–2022	<$10 million	<$50 million	Market saturation, OTC shift

• Forecasting:
  Sales are projected to decline further, approaching negligible levels by 2025, absent new indications or delivery methods.

• Revenue Streams:
  The majority of revenue stemmed from prescription formulations. OTC products and new delivery systems have not been developed for ACIPHEX; thus, no significant revenue streams are expected outside of existing generic competition.

Impact of External Factors

• Pricing pressure: Harsh discounts and tiered pricing strategies by generics and PBMs.
• Healthcare policies: Shift towards cost-effective therapies reduces the prescription volume for older PPIs.
• Market shifts: Emerging alternatives, including novel acid suppression agents and biologics, do not target the same indications but influence overall market size decline.

Strategic Considerations

• Product Lifecycle Management:
  Without new formulations or indications, ACIPHEX’s future sales rely on residual prescriptions. Development of new delivery methods or combination therapies may temporarily sustain revenues.

• Partnership Opportunities:
  Licensing or co-marketing agreements with OTC or generic companies could extend product relevance.

• Exit Strategies:
  Given the sales trajectory, divestment or discontinuation could be considered to mitigate sunk costs.

Conclusion

ACIPHEX’s market is characterized by sharp decline driven by patent expiry, generic competition, and evolving prescribing habits. Its financial contribution has diminished to minimal levels and is forecasted to remain so unless strategic reforms are implemented. Companies considering ACIPHEX should evaluate opportunities for reformulation, new indications, or exit.

Key Takeaways

• US peak sales reached approximately $600 million in 2014; sales have declined over 90% since patent expiry.
• Generic competition and OTC availability have undercut prescription sales.
• No significant pipeline or reformulation initiatives are publicly announced as of 2023.
• Future revenue depends on product repositioning or lifecycle management strategies.
• The market outlook remains negative without innovation or new indications.

FAQs

1. Why did ACIPHEX’s sales decline sharply after 2014?
Generic entry following patent expiration in 2014 led to rapid price erosion and market share loss, reducing sales from over $600 million to minimal levels.

2. Could ACIPHEX regain market share with new formulations?
Likely not, given dominant generic competition and shifting prescriber and patient preferences towards OTC PPIs or innovative therapies.

3. Are there any ongoing efforts to develop new indications for ACIPHEX?
Public records do not indicate current efforts; focus appears to have shifted to other pipeline assets.

4. How does ACIPHEX compare to competitors like Prilosec or Nexium?
Prilosec (omeprazole) and Nexium (esomeprazole) maintain larger market shares due to broader marketing and patent protections, although they face similar generic challenges.

5. Is there any opportunity for licensing or partnering?
Potential exists if a partner aims to develop new formulations or combination therapies, but no such deals are publicly announced.

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References:

[1] U.S. Food and Drug Administration. (2023). FDA Approval History of Rabeprazole Sodium.
[2] IQVIA. (2022). US Prescription Drug Market Data.
[3] EvaluatePharma. (2022). Global Sales Data for Proton Pump Inhibitors.