RABEPRAZOLE SODIUM: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973	NDA	Waylis Therapeutics LLC	80725-243-30	30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80725-243-30)	2022-05-15
Alkem Labs Ltd	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	208644	ANDA	A-S Medication Solutions	50090-4751-0	30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-4751-0)	2018-04-27
Alkem Labs Ltd	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	208644	ANDA	A-S Medication Solutions	50090-4751-1	90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-4751-1)	2018-04-27
Alkem Labs Ltd	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	208644	ANDA	St. Mary's Medical Park Pharmacy	60760-560-07	7 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-560-07)	2019-09-10
Alkem Labs Ltd	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	208644	ANDA	St. Mary's Medical Park Pharmacy	60760-560-30	30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-560-30)	2019-09-10
Alkem Labs Ltd	RABEPRAZOLE SODIUM	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	208644	ANDA	St. Mary's Medical Park Pharmacy	60760-560-60	60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-560-60)	2019-09-10
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

Rabeprazole sodium is a proton pump inhibitor (PPI) used to treat conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. This analysis identifies key global suppliers of rabeprazole sodium active pharmaceutical ingredient (API) and examines the patent landscape impacting market access.

Who are the primary manufacturers of Rabeprazole Sodium API?

The production of rabeprazole sodium API is concentrated among several global chemical and pharmaceutical manufacturers. These suppliers cater to both branded and generic drug manufacturers.

Key Rabeprazole Sodium API Suppliers:

Aarti Industries Limited (India): A leading Indian manufacturer with significant capacity for APIs. Aarti Industries has a strong presence in the Indian and international markets for various pharmaceutical intermediates and APIs.
Divi's Laboratories Limited (India): One of the largest API manufacturers globally, Divi's Laboratories produces a wide range of APIs, including those in the gastrointestinal therapeutic area.
Lupin Limited (India): A global pharmaceutical company with a substantial API manufacturing division. Lupin has a diverse portfolio of APIs and a strong regulatory compliance record.
Sun Pharmaceutical Industries Ltd. (India): India's largest pharmaceutical company, Sun Pharma also operates a significant API manufacturing business, supplying both its internal needs and external markets.
Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (China): A prominent Chinese API manufacturer with global reach. Jiuzhou Pharmaceutical is known for its expertise in complex chemical synthesis.
Hengdian Group (China): A large Chinese conglomerate with a substantial pharmaceutical division, including API manufacturing.
Yingkou Pharmaceutical Co., Ltd. (China): Another key Chinese supplier of APIs to the global pharmaceutical industry.

These companies typically operate large-scale, multi-purpose manufacturing facilities compliant with Good Manufacturing Practices (GMP) required by regulatory authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

What is the patent status of Rabeprazole Sodium?

The patent landscape for rabeprazole sodium is characterized by expired composition of matter patents and ongoing patent activity related to specific formulations, polymorphs, and manufacturing processes.

Historical Patent Expiries:

The original composition of matter patents for rabeprazole sodium have expired in major markets, opening the door for generic competition. For instance, the primary patents held by Eisai Co. Ltd., the originator, have long since expired.

United States: The core patent for rabeprazole sodium expired years ago, allowing for generic entry.
Europe: Similar to the U.S., the principal patent protection has lapsed.
Japan: The compound patent also expired, facilitating generic market development.

Current Patent Trends:

While the foundational patent has expired, pharmaceutical companies continue to seek patent protection for incremental innovations. These often focus on:

Polymorphs: Different crystalline forms of the API can have altered stability, solubility, and bioavailability. Patents on specific, advantageous polymorphs can extend market exclusivity.
Formulations: Novel drug delivery systems or improved formulations (e.g., enteric-coated tablets, orally disintegrating tablets) can be patented.
Manufacturing Processes: Patents may cover specific synthetic routes, purification methods, or crystallization techniques that offer advantages in terms of yield, purity, or cost-effectiveness.
Combinations: Formulations combining rabeprazole sodium with other active ingredients for synergistic therapeutic effects can also be patented.

Example of Post-Expiration Patent Activity:

Several patents have been filed and granted for specific polymorphs of rabeprazole sodium. For example, patents might claim:

A specific crystalline form of rabeprazole sodium designated as Form A, characterized by specific X-ray powder diffraction (XRPD) peaks.
A process for preparing a stable anhydrous form of rabeprazole sodium.
An enteric-coated pharmaceutical composition comprising rabeprazole sodium and an enteric coating agent.

These patents can create challenges for generic manufacturers seeking to launch their products. They often require thorough freedom-to-operate (FTO) analyses to ensure their proposed product and manufacturing process do not infringe existing patents.

What are the regulatory requirements for Rabeprazole Sodium API?

Manufacturing and supplying rabeprazole sodium API requires adherence to stringent regulatory standards to ensure product quality, safety, and efficacy.

Key Regulatory Considerations:

Good Manufacturing Practices (GMP): Facilities must comply with cGMP as stipulated by regulatory bodies such as the FDA (21 CFR Parts 210 & 211), EMA (EudraLex Volume 4), and others. This includes requirements for quality management systems, personnel, premises, equipment, documentation, production, and quality control.
Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. A DMF is a submission to a regulatory agency that provides confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows drug product manufacturers to reference the DMF in their own drug applications without having to disclose proprietary information.
Certificates of Suitability (CEP): For the European market, a CEP issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) demonstrates that an API complies with the requirements of the European Pharmacopoeia monograph.
Pharmacopoeial Standards: The API must meet the specifications outlined in relevant pharmacopoeias, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.). These monographs define acceptable limits for purity, impurities, dissolution, and other critical quality attributes.
Impurity Profiling: Manufacturers must identify, quantify, and control process-related impurities and degradation products. Regulatory guidelines, such as ICH Q3A (R2) for impurities in new drug substances, are critical.
Stability Testing: Comprehensive stability studies under various conditions (temperature, humidity) are required to establish the re-test period or shelf life of the API.

Regulatory Submissions and Inspections:

Manufacturers are subject to routine inspections by regulatory authorities to verify GMP compliance. Drug product manufacturers rely on the quality and regulatory documentation provided by API suppliers for their Abbreviated New Drug Applications (ANDAs) in the U.S. or Marketing Authorisation Applications (MAAs) in Europe.

What are the common impurities found in Rabeprazole Sodium?

Controlling impurities in rabeprazole sodium API is crucial for patient safety. Impurities can arise from the manufacturing process, degradation, or starting materials.

Commonly Monitored Impurities:

Related Substances: These are structurally similar compounds to rabeprazole sodium.
- Unreacted Starting Materials: Residual amounts of the precursors used in the synthesis of rabeprazole sodium.
- Intermediates: Incomplete reaction products from various stages of the synthesis.
- By-products: Compounds formed through undesired side reactions during synthesis.
- Degradation Products: Compounds formed when rabeprazole sodium breaks down over time, often due to light, heat, or moisture. A common degradation pathway involves the formation of sulfone or sulfoxide derivatives.
Solvent Residues: Residual organic solvents used in the manufacturing process. ICH Q3C provides guidelines for acceptable limits of residual solvents.
Heavy Metals: Trace amounts of heavy metals that may be introduced from reagents, catalysts, or equipment.
Enantiomeric Purity: While rabeprazole sodium is typically used as a racemate or a specific enantiomer (e.g., rabeprazole acid is a racemate, and its sodium salt is also generally a racemate), controlling chiral impurities if applicable to the specific marketed form is important.

Analytical Methods for Impurity Detection:

High-Performance Liquid Chromatography (HPLC): The primary technique for separating and quantifying related substances and degradation products.
Gas Chromatography (GC): Used for the determination of residual solvents.
Inductively Coupled Plasma (ICP) Spectroscopy: Employed for the detection of heavy metals.
X-ray Powder Diffraction (XRPD): Used to identify and quantify crystalline forms (polymorphs).

Manufacturers must establish validated analytical methods and set appropriate specifications for each identified impurity to comply with regulatory requirements.

How does patent litigation impact Rabeprazole Sodium market access?

Patent litigation plays a significant role in determining the market entry and competitive landscape for generic rabeprazole sodium.

Types of Patent Litigation:

Infringement Lawsuits: Branded drug manufacturers or patent holders initiate lawsuits against generic companies that they allege are infringing their patents. This typically occurs when a generic company files an ANDA or equivalent application and the patent holder believes their patent will be infringed by the proposed generic product.
Patent Validity Challenges: Generic companies may challenge the validity of existing patents, arguing that they are unpatentable due to prior art or other deficiencies.
"Paragraph IV" Filings (U.S.): In the U.S., a common strategy involves a generic company filing an ANDA and certifying that the patent(s) covering the branded drug are invalid, unenforceable, or will not be infringed by the generic drug. This is known as a Paragraph IV certification. The Hatch-Waxman Act provides for a 180-day period of market exclusivity for the first generic company to successfully challenge a patent through a Paragraph IV certification.
Inter Partes Review (IPR): This is an administrative procedure before the U.S. Patent and Trademark Office (USPTO) that allows third parties to challenge the patentability of patents. It is often used as an alternative or parallel strategy to district court litigation.

Impact on Market Entry:

Delays: Patent litigation can significantly delay the launch of generic versions of rabeprazole sodium. Preliminary injunctions may be granted, preventing the generic from entering the market until the litigation is resolved.
Settlements: Litigation often concludes with settlement agreements. These can include licensing agreements allowing the generic product to launch on a specific date, or other terms that may affect pricing and market entry.
Design-Around Strategies: Generic companies may invest heavily in developing "design-around" strategies to avoid infringing existing patents. This might involve developing novel polymorphs, formulations, or manufacturing processes that are not covered by the originator's patents.
Market Exclusivity: Successful patent challenges can lead to periods of generic exclusivity, allowing the first-to-market generic company to capture a significant market share before additional competitors enter.

The complex interplay of patent law, regulatory strategy, and commercial considerations means that market access for rabeprazole sodium, particularly for generic versions, is heavily influenced by ongoing and potential patent disputes.

Key Takeaways

Supplier Concentration: Rabeprazole sodium API production is dominated by manufacturers in India and China, with Aarti Industries, Divi's Laboratories, Lupin, Sun Pharma, Zhejiang Jiuzhou Pharmaceutical, Hengdian Group, and Yingkou Pharmaceutical being key players.
Expired Core Patents: The primary composition of matter patents for rabeprazole sodium have expired globally, enabling generic competition.
Post-Expiration Innovation: Patent activity persists around specific polymorphs, advanced formulations, and novel manufacturing processes, which can impact generic market entry.
Rigorous Regulatory Oversight: API production must adhere to strict GMP standards, requiring comprehensive documentation (e.g., DMFs) and compliance with pharmacopoeial monographs.
Impurity Control is Paramount: Manufacturers must meticulously control related substances, residual solvents, and other impurities through validated analytical methods.
Litigation Shapes Market Entry: Patent litigation, including Paragraph IV filings and IPRs, significantly influences the timing and competitive dynamics of generic rabeprazole sodium launches.

Frequently Asked Questions

Which countries have the largest number of rabeprazole sodium API manufacturers? India and China host the majority of large-scale rabeprazole sodium API manufacturers, driven by cost-effective production capabilities and established pharmaceutical infrastructure.
What is the typical purity requirement for rabeprazole sodium API? Purity requirements for rabeprazole sodium API generally exceed 98.5%, with specific limits on individual impurities as defined by pharmacopoeial monographs (e.g., USP, Ph. Eur.) and regulatory filings.
Can a generic company launch rabeprazole sodium if the originator still has formulation patents? Yes, a generic company can launch if they develop a formulation that does not infringe the originator's existing formulation patents or if those formulation patents are successfully challenged and invalidated.
What is the role of the Drug Master File (DMF) in rabeprazole sodium supply? A DMF is submitted by the API manufacturer to regulatory agencies and allows drug product manufacturers to reference the detailed confidential information about the API's manufacturing process, quality controls, and facility, facilitating regulatory approval of the finished drug product.
Are there any specific therapeutic indications that are exclusively protected by patents for rabeprazole sodium? While the core compound patent has expired, new patents may exist for specific combination therapies or novel uses of rabeprazole sodium, which could restrict its use for those particular patented indications.

Citations

[1] Eisai Co., Ltd. (n.d.). About Eisai. Retrieved from https://www.eisai.com/

[2] U.S. Food & Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/drug-master-files-dmfs

[3] European Medicines Agency. (n.d.). EudraLex - The Rules Governing Medicinal Products in the European Union. Retrieved from https://ec.europa.eu/health/documents/eudralex/index_en

[4] United States Pharmacopeia. (n.d.). USP-NF. Retrieved from https://www.usp.org/products/usp-nf

[5] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from https://www.ich.org/page/guidelines

[6] U.S. Food & Drug Administration. (n.d.). Hatch-Waxman Act and Prescription Drug User Fee Amendments. Retrieved from https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/hatch-waxman-act-and-prescription-drug-user-fee-amendments

[7] U.S. Patent and Trademark Office. (n.d.). America Invents Act. Retrieved from https://www.uspto.gov/ip-policy/america-invents-act

Suppliers and packagers for generic pharmaceutical drug: RABEPRAZOLE SODIUM