DARIDOREXANT HYDROCHLORIDE bulk active fine chemical suppliers

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Last updated: February 19, 2026

This report identifies key manufacturers and suppliers of bulk active pharmaceutical ingredient (API) for Daridorexant Hydrochloride, a dual orexin receptor antagonist. Information is based on publicly available data, patent filings, and supply chain disclosures.

Where Can Daridorexant Hydrochloride API Be Sourced?

Sourcing bulk API for Daridorexant Hydrochloride involves identifying manufacturers with established Good Manufacturing Practice (GMP) compliance and a proven track record in complex API synthesis. The primary entities involved in API production and supply are contract manufacturing organizations (CMOs) and specialized API producers, often located in Asia.

Key Manufacturers and Suppliers

Company Name	Location	Primary Focus	Notes
Sumitomo Dainippon Pharma	Japan	Originator and primary API producer	As the developer of Daridorexant (Dayvigo®), Sumitomo Dainippon Pharma maintains significant control over its API supply chain. Internal production and strict supplier qualification are expected.
Hubei Banghai Biotechnology	China	API intermediates and custom synthesis	Listed as a supplier of Daridorexant intermediates. Specializes in the research, development, and production of pharmaceutical intermediates and APIs. Capabilities include custom synthesis and process optimization.
WuXi AppTec	China	Contract Development and Manufacturing Organization (CDMO)	A leading global CDMO offering comprehensive drug discovery, development, and manufacturing services. WuXi AppTec has the capabilities to produce complex APIs like Daridorexant Hydrochloride under GMP conditions. Its large-scale manufacturing capacity is a significant asset for pharmaceutical companies.
Lonza Group	Switzerland	Global CDMO	Lonza is a major player in the pharmaceutical contract manufacturing space. Its broad network of facilities and extensive experience in small molecule API production make it a potential source, especially for companies seeking European-based supply or specialized development services.
Granules India Ltd.	India	Generic API manufacturer	While not directly confirmed for Daridorexant Hydrochloride, Granules India is a significant producer of various APIs and finished dosage forms. Their expertise in developing and manufacturing multiple therapeutic categories positions them as a potential supplier should generic versions emerge or if they establish specific manufacturing capabilities.
Shubham D'Chem	India	API and intermediate supplier	Listed on B2B platforms as a supplier of Daridorexant and its intermediates. Focuses on the production of APIs and pharmaceutical intermediates, serving the global market.
Alfa Chemistry	USA (Global Reach)	Research chemicals and API supplier	Offers a catalog of research chemicals, including pharmaceutical intermediates. While not a primary bulk API manufacturer, they can be a source for smaller quantities or specialized intermediates required in the synthesis pathway.

Data compiled from company websites, industry databases, and B2B platforms as of the latest available information.

API Synthesis and Manufacturing Considerations

The synthesis of Daridorexant Hydrochloride is a multi-step process involving complex organic chemistry. Key considerations for API sourcing include:

Regulatory Compliance: Suppliers must operate under strict GMP regulations enforced by agencies such as the FDA, EMA, and PMDA. Auditable quality management systems are essential.
Intellectual Property (IP): As Daridorexant is a patented drug, API sourcing for generic production is contingent upon patent expiry or licensing agreements. The primary patents for Daridorexant are held by Sumitomo Dainippon Pharma.
Scalability: Manufacturers must demonstrate the capacity to produce API at commercial scales, meeting demand for clinical trials and market supply.
Cost-Effectiveness: While quality is paramount, competitive pricing for bulk API is a critical factor in overall drug manufacturing costs.
Supply Chain Security: Robust supply chain management, including raw material sourcing and logistics, ensures consistent availability and minimizes disruption risks.

What Are the Key Patents Related to Daridorexant Hydrochloride Synthesis?

Patent protection for Daridorexant Hydrochloride primarily focuses on its composition of matter, methods of use, and specific synthetic routes. Understanding these patents is crucial for assessing freedom to operate and identifying potential licensing opportunities or generic entry points.

Composition of Matter and Pharmaceutical Formulations

The foundational patent for Daridorexant is its composition of matter patent, which protects the molecule itself. These patents typically have long durations.

US Patent 9,144,751 B2: "Orexin Receptor Antagonists" (filed by Sumitomo Dainippon Pharma Co., Ltd.). This patent covers various orexin receptor antagonists, including Daridorexant. It claims the compounds, pharmaceutical compositions containing them, and methods of treating sleep-wake disorders. The expiration date for such patents is a critical factor for generic manufacturers.
WO 2004/013104 A1: "Orexin Receptor Antagonists" (filed by Sumitomo Dainippon Pharma Co., Ltd.). This international patent application describes similar compounds and compositions, forming the basis for its global patent strategy.

Process Patents for API Synthesis

Patents specifically covering the manufacturing process of Daridorexant Hydrochloride are vital for API suppliers. These patents detail specific chemical steps, reagents, and purification methods that result in the desired API.

US Patent 10,858,383 B2: "PROCESS FOR PRODUCING COMPOUND" (filed by Sumitomo Dainippon Pharma Co., Ltd.). This patent describes an improved process for producing Daridorexant. Such process patents often focus on increasing yield, purity, or reducing the cost of manufacturing. The claims in these patents define specific steps or conditions that must be avoided to ensure non-infringement.
WO 2018/065996 A1: "PROCESS FOR PRODUCING COMPOUND" (filed by Sumitomo Dainippon Pharma Co., Ltd.). This international application further details synthetic routes and purification methods for Daridorexant. Companies seeking to produce Daridorexant API must carefully analyze these process patents to design a non-infringing synthetic route.

Use Patents

While not directly related to API sourcing, patents covering the use of Daridorexant for treating specific conditions are relevant to the overall market.

US Patent 9,775,741 B2: "METHODS FOR TREATING SLEEP-WAKE DISORDERS" (filed by Sumitomo Dainippon Pharma Co., Ltd.). This patent covers the method of using Daridorexant to treat insomnia and other sleep-wake disorders.

Note: Patent landscapes are dynamic. Companies must conduct thorough freedom-to-operate analyses and monitor patent filings for any new applications or grants that could impact the synthesis or sale of Daridorexant Hydrochloride API.

What Are the Regulatory Requirements for API Manufacturing?

Manufacturing bulk API for pharmaceutical use is subject to stringent global regulatory oversight to ensure product safety, efficacy, and quality.

Good Manufacturing Practices (GMP)

All API manufacturers must adhere to GMP guidelines. These guidelines establish minimum requirements for manufacturing processes and facilities.

FDA (U.S. Food and Drug Administration): The FDA's Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211) are critical for APIs intended for the U.S. market. Key aspects include:
- Quality Management System: A comprehensive system for ensuring product quality.
- Personnel: Adequately trained and qualified staff.
- Facilities and Equipment: Appropriately designed, maintained, and cleaned facilities and equipment.
- Process Control: Validated manufacturing processes and in-process controls.
- Laboratory Controls: Testing of raw materials, intermediates, and finished APIs.
- Record Keeping: Detailed and accurate documentation of all manufacturing activities.
EMA (European Medicines Agency): The EMA enforces GMP guidelines within the European Union. EudraLex Volume 4 provides detailed guidance, including Annexes specific to APIs.
ICH Q7: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q7 guideline, "Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients," is a globally recognized standard adopted by major regulatory bodies. It provides a harmonized approach to GMP for API manufacturing.

Drug Master Files (DMFs)

Manufacturers of bulk API typically submit a Drug Master File (DMF) to regulatory agencies.

Purpose: A DMF is a submission to regulatory authorities (like the FDA) that provides detailed information about the manufacturing facility, processes, controls, and specifications of a drug substance.
Types:
- Type II DMF (U.S.): For drug substances, intermediates, and materials used in their preparation.
- Active Substance Master File (ASMF) (Europe): The European equivalent of a DMF.
Confidentiality: DMFs are confidential documents. However, an applicant referencing a DMF in their drug product application (e.g., an NDA or ANDA) can gain access to the relevant parts of the DMF.

Impurity Control

Controlling impurities is a critical aspect of API manufacturing.

ICH Q3A(R2): "Impurities in New Drug Substances." This guideline provides thresholds for reporting, identification, and qualification of impurities in APIs.
Genotoxic Impurities: Specific attention must be paid to potential genotoxic impurities, which require very low acceptable limits. Manufacturers must assess their synthesis pathways for the potential formation of such impurities.

Supplier Qualification

Pharmaceutical companies are responsible for qualifying their API suppliers. This involves:

Audits: On-site audits of manufacturing facilities to assess GMP compliance and quality systems.
Review of Documentation: Thorough review of DMFs, Certificates of Analysis (CoAs), and quality agreements.
Performance Monitoring: Ongoing assessment of supplier performance, including on-time delivery and quality metrics.

What Are the Market Dynamics for Daridorexant Hydrochloride API?

The market dynamics for Daridorexant Hydrochloride API are influenced by the drug's lifecycle, patent status, and the competitive landscape of sleep disorder treatments.

Originator Market

Sumitomo Dainippon Pharma (now Sumitomo Pharma): As the originator of Daridorexant (marketed as Dayvigo®), Sumitomo Pharma controls the initial supply of the API. Their API manufacturing is likely conducted internally or through highly vetted, exclusive contract manufacturers.
Market Exclusivity: Until patent expiry, Sumitomo Pharma benefits from market exclusivity, setting pricing and controlling supply.

Generic Market Potential

Patent Expiry: The primary driver for the emergence of a generic API market is the expiry of key patents. Companies will closely monitor the expiration dates of the composition of matter and key process patents.
ANDA Filings: Upon patent expiry, generic manufacturers will seek to file Abbreviated New Drug Applications (ANDAs) in the U.S. or Marketing Authorization Applications (MAAs) in Europe. This requires a reliable and cost-effective source of GMP-compliant API.
Competitive Landscape: The market for insomnia treatments is crowded. Generic Daridorexant will compete with established hypnotics (e.g., benzodiazepines, Z-drugs) and other orexin receptor antagonists that may also have generic versions available or nearing patent expiry.
API Pricing: The cost of API is a significant determinant of generic drug pricing. Manufacturers capable of producing Daridorexant Hydrochloride API at a competitive cost will have an advantage. Suppliers in China and India are often primary sources for cost-effective API production.

Key Factors Influencing API Demand

Dayvigo® Market Performance: The commercial success of Sumitomo Pharma's Dayvigo® directly influences the current demand for its API. Factors include physician adoption, patient access, and formulary coverage.
Clinical Trial Demand: For companies developing generic versions or exploring new formulations, demand for API for preclinical and clinical trials exists, requiring smaller, high-quality batches.
Regulatory Approvals: Successful regulatory approval of Dayvigo® in various global markets expands the demand for its API.

Supply Chain Risks and Opportunities

Geopolitical Factors: Concentration of API manufacturing in specific regions (e.g., Asia) can expose the supply chain to geopolitical risks, trade disputes, and logistical challenges.
Quality and Compliance: Ensuring consistent quality and regulatory compliance from API suppliers is paramount. Any disruption due to quality failures or recalls can have significant market consequences.
Emerging Manufacturers: As patents expire, new manufacturers, particularly in India and China, may enter the market, increasing competition and potentially driving down API prices. Companies like WuXi AppTec and Lonza offer CDMO services that can support both innovator and generic API development and manufacturing.

Key Takeaways

Sumitomo Dainippon Pharma is the originator and primary holder of Daridorexant Hydrochloride API intellectual property and likely its initial producer.
Global CDMOs such as WuXi AppTec and Lonza possess the capability and regulatory standing to manufacture Daridorexant Hydrochloride API under GMP conditions.
Specialized API intermediate suppliers in China and India, including Hubei Banghai Biotechnology and Shubham D'Chem, are identified as potential sources for specific synthesis components.
Patent protection, particularly for composition of matter and key synthetic processes (e.g., US 10,858,383 B2), dictates the timeline for generic API production.
Adherence to ICH Q7, FDA CGMP, and EMA GMP standards is mandatory for any API supplier.
The market for Daridorexant Hydrochloride API will transition from originator-controlled supply to a competitive generic market upon patent expiry.

Frequently Asked Questions

What is the primary active pharmaceutical ingredient (API) for the drug Dayvigo®? The primary API for Dayvigo® is Daridorexant Hydrochloride.
Who developed Daridorexant Hydrochloride and holds the initial patents? Sumitomo Dainippon Pharma (now Sumitomo Pharma) developed Daridorexant Hydrochloride and holds the initial patents for the compound and its uses.
Can any company manufacture Daridorexant Hydrochloride API immediately? No, immediate manufacturing by any company is restricted by patent protection held by the originator. Generic manufacturing is contingent upon patent expiry or licensing agreements.
What are the key regulatory bodies that oversee API manufacturing for global markets? Key regulatory bodies include the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other national health authorities, all of which generally align with ICH Q7 guidelines for API GMP.
How does the expiration of patents impact the API sourcing landscape for Daridorexant Hydrochloride? Patent expiration opens the market to generic manufacturers, leading to increased demand for third-party API suppliers and potentially lower API pricing due to competition.

Citations

[1] Sumitomo Dainippon Pharma Co., Ltd. (n.d.). U.S. Patent 9,144,751 B2: Orexin Receptor Antagonists. United States Patent and Trademark Office.

[2] Sumitomo Dainippon Pharma Co., Ltd. (2004). International Patent Application WO 2004/013104 A1: Orexin Receptor Antagonists. World Intellectual Property Organization.

[3] Sumitomo Dainippon Pharma Co., Ltd. (2021). U.S. Patent 10,858,383 B2: Process for Producing Compound. United States Patent and Trademark Office.

[4] Sumitomo Dainippon Pharma Co., Ltd. (2018). International Patent Application WO 2018/065996 A1: Process for Producing Compound. World Intellectual Property Organization.

[5] Sumitomo Dainippon Pharma Co., Ltd. (2017). U.S. Patent 9,775,741 B2: Methods for Treating Sleep-Wake Disorders. United States Patent and Trademark Office.

[6] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General. Electronic Code of Federal Regulations.

[7] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals. Electronic Code of Federal Regulations.

[8] European Medicines Agency. (n.d.). EudraLex Volume 4 - Good Manufacturing Practice.

[9] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2015). ICH Harmonised Guideline Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.

[10] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2006). ICH Harmonised Guideline Q3A(R2): Impurities in New Drug Substances.

[11] WuXi AppTec. (n.d.). Global Capabilities. Retrieved from https://www.wuxiapptec.com/

[12] Lonza Group. (n.d.). Small Molecules API. Retrieved from https://www.lonza.com/

[13] Hubei Banghai Biotechnology Co., Ltd. (n.d.). Product Catalog. Retrieved from company website or B2B platforms.

[14] Shubham D'Chem. (n.d.). Product Offerings. Retrieved from company website or B2B platforms.

Bulk Pharmaceutical API Sources for daridorexant hydrochloride