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-four 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:	2
Raw Ingredient (Bulk) Api Vendors:	213
Clinical Trials:	22
Patent Applications:	3,487
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	020973-002	Aug 19, 1999	5,045,552*PED
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-002	Aug 19, 1999	5,035,899
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-001	May 29, 2002	5,045,552*PED

International Patents for ACIPHEX

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

Country	Patent Number	Title	Estimated Expiration
Hungary	203200	PROCESS FOR PRODUCING ORAL PHARMACEUTICAL COMPOSITIONS COMPRISING ACID-SENSITIVE BENZIMIDAZOLE DERIVATIVES
Japan	H0674272
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
Japan	2576843
Greece	3003389

Supplementary Protection Certificates for ACIPHEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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

ACIPHEX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of AcipHex (Rabeprazole Sodium)

Introduction to AcipHex

AcipHex, also known as rabeprazole sodium, is a proton pump inhibitor (PPI) used to treat various gastrointestinal diseases, including gastroesophageal reflux disease (GERD), ulcers, and Zollinger-Ellison syndrome. Here, we delve into the market dynamics and financial trajectory of this drug.

Global Market Size and Growth

The global rabeprazole sodium market is projected to reach USD 895.9 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.8% from 2022 to 2031[1][4].

Regional Market Analysis

North America

North America accounted for a significant share of the rabeprazole sodium market in 2021 and is expected to maintain its dominance during the forecast period. This is due to the well-established healthcare infrastructure, high purchasing power, and the presence of major pharmaceutical companies in the region. The high awareness of health issues and the availability of efficient treatment options also contribute to the market growth in this region[1][4].

Asia-Pacific

The Asia-Pacific region is expected to grow at the highest rate during the forecast period. Factors driving this growth include the presence of numerous pharmaceutical companies, increasing disposable incomes, and a large population with growing healthcare needs. Countries like China and India are key contributors due to their large populations and rising medicine expenditures. The abundance of raw materials and the growth of contract manufacturing organizations in this region also provide lucrative opportunities for market players[1][4].

Market Drivers

• Increasing Prevalence of Gastrointestinal Diseases: The rise in GERD and other gastrointestinal diseases, particularly among the aging population, is a significant driver. Improved diagnostic procedures such as pH monitoring and impedance monitoring have also increased the diagnosis rate of these diseases[4].
• Health Awareness and Lifestyle: Growing health awareness and the adoption of healthy lifestyles are driving the demand for rabeprazole sodium. This trend is particularly pronounced in regions with improving economic conditions[1][4].
• Pharmaceutical Infrastructure: The presence of well-established pharmaceutical companies and the availability of raw materials in regions like Asia-Pacific are crucial for market growth[1].

Competitive Analysis

The rabeprazole sodium market is highly competitive, with several key players:

• Woodward Pharma: Notably, Woodward Pharma acquired the rights to sell AcipHex delayed-release tablets in the U.S. from Eisai Co., Ltd. in November 2021[1].
• Other Key Players: Companies such as Alembic Pharmaceuticals Ltd, Cadila Pharmaceuticals Ltd, Cipla Ltd, Dr. Reddy's Laboratories Ltd, Elikem Pharmaceuticals Pvt Ltd, Jasco Labs Private Limited, Intas Pharmaceutical Ltd., Sun Pharmaceutical Industries Ltd., and Torrent Pharmaceuticals Ltd. are also significant players in this market[1].

Financial Performance and Acquisitions

• Revenue Growth: The global rabeprazole sodium market was valued at $615.72 million in 2021 and is estimated to reach $895.85 million by 2031, indicating a steady growth trajectory[1].
• Acquisitions and Partnerships: The acquisition of AcipHex by Woodward Pharma is a notable example of market activity. Such transactions help in expanding market reach and enhancing product portfolios[1].

Impact of Market Dynamics on Financial Trajectory

• Growth Opportunities: The Asia-Pacific region offers high growth opportunities due to its large population, increasing healthcare spending, and the presence of domestic pharmaceutical companies. This region's growth is expected to significantly contribute to the overall financial trajectory of the rabeprazole sodium market[1][4].
• Competition and Market Share: The competitive landscape, with multiple players and potential new entrants, especially in the Asia-Pacific region, will influence the financial performance of companies involved. Strategic acquisitions and partnerships will be crucial in maintaining market share and driving revenue growth[1].

Challenges and Risks

• Competition from New Entrants: The entry of new competitors, especially in the Asia-Pacific region, can pose a challenge to existing market players. This competition can lead to price pressures and reduced market share[1][4].
• Regulatory and Economic Factors: Economic instability, changes in regulatory policies, and fluctuations in raw material prices can impact the financial performance of companies in the rabeprazole sodium market[2][3].

Key Takeaways

• The global rabeprazole sodium market is expected to grow significantly, driven by increasing health awareness and the prevalence of gastrointestinal diseases.
• North America and Asia-Pacific are key regions, with the latter expected to grow at the highest rate.
• Strategic acquisitions and partnerships are crucial for market players to maintain their competitive edge.
• The market is highly competitive, with several key players vying for market share.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of rabeprazole sodium by 2031? A: The global rabeprazole sodium market is projected to reach USD 895.9 million by 2031[1].

Q: Which region is expected to grow at the highest rate in the rabeprazole sodium market? A: The Asia-Pacific region is expected to grow at the highest rate during the forecast period[1][4].

Q: What are the key drivers of the rabeprazole sodium market? A: Key drivers include the increasing prevalence of gastrointestinal diseases, growing health awareness, and the presence of well-established pharmaceutical infrastructure[1][4].

Q: Who are the major players in the rabeprazole sodium market? A: Major players include Woodward Pharma, Alembic Pharmaceuticals Ltd, Cadila Pharmaceuticals Ltd, Cipla Ltd, and others[1].

Q: What is the impact of acquisitions on the rabeprazole sodium market? A: Acquisitions, such as Woodward Pharma's acquisition of AcipHex, help in expanding market reach and enhancing product portfolios, contributing to the overall growth of the market[1].

Sources Cited

1. Allied Market Research: Rabeprazole Sodium Market Size, Share | Report By 2031.
2. Avadel Pharmaceuticals PLC: Annual Report for the Year Ended 31 December 2023.
3. Avadel Pharmaceuticals PLC: Product sales and services revenues.
4. InsightAce Analytic: Rabeprazole Sodium Market Size, Scope and Future Growth Analysis.