Suppliers and packagers for CEVIMELINE HYDROCHLORIDE

CEVIMELINE HYDROCHLORIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	215056	ANDA	Aurobindo Pharma Limited	59651-422-01	100 CAPSULE in 1 BOTTLE (59651-422-01)	2023-04-18
Aurobindo Pharma	CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	215056	ANDA	Aurobindo Pharma Limited	59651-422-05	500 CAPSULE in 1 BOTTLE (59651-422-05)	2023-04-18
Aurobindo Pharma	CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	215056	ANDA	Bryant Ranch Prepack	72162-2563-1	100 CAPSULE in 1 BOTTLE (72162-2563-1)	2023-04-18
Bionpharma	CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	218290	ANDA	Bionpharma Inc	69452-316-20	100 CAPSULE in 1 BOTTLE (69452-316-20)	2024-01-17
Hikma	CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	091591	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0334-25	100 CAPSULE in 1 BOTTLE (0054-0334-25)	2013-07-08
Hikma	CEVIMELINE HYDROCHLORIDE	cevimeline hydrochloride	CAPSULE;ORAL	091591	ANDA	Bryant Ranch Prepack	71335-2264-1	30 CAPSULE in 1 BOTTLE (71335-2264-1)	2013-07-08

CEVIMELINE HYDROCHLORIDE: SUPPLIER LANDSCAPE AND PATENT ANALYSIS

Last updated: February 19, 2026

This report details the suppliers and patent landscape for CEVIMELINE HYDROCHLORIDE, a muscarinic agonist used to treat dry mouth associated with Sjögren's syndrome. Key suppliers are identified, and patent expirations and potential new entrants are analyzed.

What is CEVIMELINE HYDROCHLORIDE?

Cevimeline hydrochloride, marketed as Evoxac, is a prescription medication used to increase saliva production in individuals suffering from dry mouth (xerostomia) due to Sjögren's syndrome. It functions as a cholinergic agonist, specifically targeting M1 and M3 muscarinic receptors in salivary glands, thereby stimulating salivary secretion. The active pharmaceutical ingredient (API) is cevimeline hydrochloride, with the chemical formula C13H22ClNOS and a molecular weight of 275.85 g/mol [1]. The drug is typically administered orally in capsule form.

Who are the Key Suppliers of CEVIMELINE HYDROCHLORIDE?

The supply chain for cevimeline hydrochloride involves both active pharmaceutical ingredient (API) manufacturers and finished dosage form (FDF) producers. Several companies are involved in the production and distribution of cevimeline hydrochloride, catering to both branded and generic markets.

API Manufacturers

API manufacturers are responsible for synthesizing the bulk cevimeline hydrochloride. The quality and reliability of these suppliers are critical for FDF manufacturers.

• Sun Pharmaceutical Industries Ltd.: Sun Pharma is a significant player in the generic pharmaceutical market and is known to manufacture cevimeline hydrochloride API. They supply to their own FDF production and potentially to other generic manufacturers.
• Other Generic API Producers: While specific details on all API suppliers are proprietary, several generic API manufacturers globally, particularly in India and China, likely produce cevimeline hydrochloride. These suppliers often operate on a contract manufacturing basis. Identifying these suppliers often requires direct engagement and qualification processes by FDF companies.

Finished Dosage Form (FDF) Manufacturers

FDF manufacturers formulate the API into the final dosage form (capsules) ready for patient use.

• Daiichi Sankyo Company, Limited (Original Marketer): Daiichi Sankyo, through its subsidiary Daiichi Sankyo, Inc., was the original marketer of Evoxac in the United States. While the branded product's market presence may be reduced due to generic competition, Daiichi Sankyo remains a key entity in the drug's history and regulatory filings.
• Apotex Inc.: Apotex is a prominent generic pharmaceutical company that has historically manufactured and marketed generic versions of cevimeline hydrochloride capsules in various markets, including the United States.
• Breckenridge Pharmaceutical, Inc.: Breckenridge Pharmaceutical has been involved in the Abbreviated New Drug Application (ANDA) process and market introduction of generic cevimeline hydrochloride products.
• Chartwell RX, LLC: Chartwell RX is another entity that has received ANDA approvals and launched generic cevimeline hydrochloride.
• Other Generic FDF Manufacturers: Numerous generic pharmaceutical companies worldwide produce cevimeline hydrochloride capsules, often through contract manufacturing organizations (CMOs) or by sourcing API from various global suppliers. These companies typically focus on obtaining ANDA approvals in target markets.

What is the Patent Landscape for CEVIMELINE HYDROCHLORIDE?

The patent landscape for cevimeline hydrochloride is characterized by its original composition of matter patents and subsequent patents covering formulations, manufacturing processes, and uses. The expiration of key patents has paved the way for generic competition.

Key Patents and Expirations

The original patents protecting cevimeline hydrochloride have largely expired, opening the market to generic alternatives.

• Composition of Matter Patents: The foundational patents covering the cevimeline molecule itself have long expired. For example, U.S. Patent No. 4,507,473, which covers cevimeline and its salts, expired in the early 2000s. This was a critical patent that granted market exclusivity for the original innovator product.
• Formulation and Manufacturing Patents: Innovator companies often file secondary patents related to specific formulations (e.g., capsule stability, dissolution profiles) and improved manufacturing processes. These patents can provide extended exclusivity periods. However, as of current information, major formulation and process patents that would significantly extend exclusivity beyond the composition of matter patent term have not demonstrably blocked generic entry for an extended period.
• Exclusivity Periods: The Hatch-Waxman Act in the United States provides periods of market exclusivity for new drugs. For cevimeline hydrochloride (Evoxac), the primary exclusivity periods have concluded. The U.S. Food and Drug Administration (FDA) Orange Book lists patents and exclusivity for approved drugs. For Evoxac, the relevant patents and their expiration dates indicate that generic versions have been able to enter the market.

Generic Entry and Market Dynamics

The expiration of key patents has led to significant generic competition.

• ANDA Approvals: The FDA has approved numerous Abbreviated New Drug Applications (ANDAs) for cevimeline hydrochloride capsules. This signifies that generic manufacturers have demonstrated bioequivalence to the reference listed drug (Evoxac).
• Price Erosion: As is typical with generic entry, the introduction of multiple generic competitors has resulted in substantial price erosion for cevimeline hydrochloride capsules. This increases accessibility for patients but reduces revenue for individual manufacturers.
• Patent Litigation: While the primary composition of matter patents are expired, disputes can arise over secondary patents. However, there is no widespread public record of significant, ongoing patent litigation that is currently preventing generic supply of cevimeline hydrochloride.

What are the Regulatory Considerations?

Regulatory approval is paramount for both API and FDF suppliers. Compliance with Good Manufacturing Practices (GMP) is a standard requirement.

FDA Oversight and GMP Compliance

The U.S. Food and Drug Administration (FDA) plays a critical role in approving drugs and overseeing manufacturing.

• ANDA Approval: Manufacturers seeking to market generic cevimeline hydrochloride must file an ANDA with the FDA, demonstrating that their product is therapeutically equivalent to the reference listed drug.
• Facility Inspections: FDA conducts regular inspections of manufacturing facilities for both API and FDF production to ensure compliance with current Good Manufacturing Practices (cGMP). This includes rigorous quality control, process validation, and documentation standards.
• Drug Master Files (DMFs): API manufacturers typically submit Drug Master Files (DMFs) to the FDA. These confidential documents contain detailed information about the API manufacturing process, facilities, and quality controls. FDF manufacturers can then reference these DMFs in their ANDAs, streamlining the approval process.
• Quality Agreements: FDF manufacturers and API suppliers enter into quality agreements that define the responsibilities of each party concerning the quality of the API and the finished drug product.

Global Regulatory Standards

Beyond the FDA, manufacturers must adhere to the regulatory requirements of other major markets.

• European Medicines Agency (EMA): Manufacturers supplying to the European market must comply with EMA regulations, including GMP standards recognized by the EMA.
• Other Health Authorities: Health Canada, Japan's Pharmaceuticals and Medical Devices Agency (PMDA), and other national regulatory bodies have their own requirements for drug approval and manufacturing.

How to Select and Qualify CEVIMELINE HYDROCHLORIDE Suppliers?

Selecting and qualifying suppliers for cevimeline hydrochloride requires a systematic approach focused on quality, reliability, and compliance.

Supplier Qualification Process

A robust qualification process mitigates risks associated with supply chain disruptions and quality issues.

1. Initial Screening:
   • Review company background, financial stability, and track record.
   • Assess existing regulatory approvals (e.g., FDA inspection history, DMF filings).
   • Determine production capacity and ability to meet demand.
2. Quality Assessment:
   • Evaluate Quality Management System (QMS) adherence to ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients).
   • Review batch release testing data and stability study results.
   • Assess change control procedures and deviation management.
3. On-Site Audit:
   • Conduct a comprehensive audit of manufacturing facilities covering all aspects of GMP.
   • Verify process validation and critical process parameters.
   • Inspect laboratory controls and analytical method validation.
4. Contractual Agreements:
   • Establish clear supply agreements outlining quality standards, delivery schedules, pricing, and intellectual property protection.
   • Define responsibilities for regulatory filings and compliance.

Key Considerations for Suppliers

When evaluating potential suppliers, several factors are paramount.

• API Purity and Impurity Profile: Consistent API purity and a well-characterized impurity profile are essential. Any significant deviations can impact the safety and efficacy of the finished product.
• Supply Chain Security and Redundancy: Assess the supplier's ability to maintain consistent supply, including contingency plans for disruptions (e.g., raw material shortages, natural disasters, geopolitical issues). Dual sourcing for critical raw materials or APIs can be a strategic advantage.
• Regulatory Compliance History: A supplier with a history of successful FDA inspections and no significant regulatory actions is preferable.
• Technical Support: The supplier should provide robust technical support, including assistance with regulatory filings and troubleshooting.

What are the Future Trends and Opportunities?

The market for cevimeline hydrochloride is mature, with established generic competition. Future trends are likely to focus on cost optimization and potential niche applications.

Market Maturity and Competition

The generic nature of the market implies intense price competition and a focus on operational efficiency.

• Cost Optimization: Manufacturers will continue to seek ways to reduce production costs through process improvements and efficient sourcing of raw materials.
• Supply Chain Resilience: Increased focus on building resilient supply chains to mitigate the impact of global disruptions. This may involve near-shoring or friend-shoring strategies for critical components.

Potential Niche Opportunities

While the primary indication is Sjögren's syndrome, research into other potential uses or improved delivery mechanisms could emerge.

• Off-Label Use: Physicians may utilize cevimeline hydrochloride for other conditions causing xerostomia, although formal regulatory approval for these uses is unlikely without new clinical trials.
• Drug Delivery Innovations: While unlikely to be a major focus for a mature drug, novel drug delivery systems or combination therapies could theoretically emerge, though these would require significant R&D investment and new patentable subject matter.

Key Takeaways

• Cevimeline hydrochloride suppliers include API manufacturers like Sun Pharma and generic FDF producers such as Apotex and Breckenridge Pharmaceutical.
• The patent landscape is characterized by expired composition of matter patents, allowing for significant generic competition.
• Regulatory compliance, particularly FDA GMP standards, is critical for all suppliers.
• Supplier selection necessitates thorough quality assessment, on-site audits, and robust contractual agreements.
• The market is mature with a strong focus on cost optimization and supply chain resilience.

FAQs

1. Are there any new patents being filed for cevimeline hydrochloride? While original composition of matter patents have expired, new patents may be filed for novel formulations, manufacturing processes, or specific therapeutic uses. However, these are unlikely to grant broad market exclusivity similar to the original patent.

2. What is the typical lead time for qualifying a new API supplier for cevimeline hydrochloride? Qualifying a new API supplier typically takes 6 to 12 months, involving initial screening, quality assessments, and on-site audits.

3. How does the purity of cevimeline hydrochloride API affect the finished drug product? The purity and impurity profile of the API directly impact the safety, efficacy, and stability of the finished drug product. Strict control over impurities is mandated by regulatory authorities.

4. What are the primary risks associated with sourcing cevimeline hydrochloride API from overseas suppliers? Risks include geopolitical instability, longer lead times, potential for quality control variations, and challenges in conducting on-site audits.

5. Does the demand for cevimeline hydrochloride fluctuate seasonally? Demand for cevimeline hydrochloride is primarily driven by the prevalence of Sjögren's syndrome and is not typically subject to significant seasonal fluctuations.

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Citations

[1] U.S. National Library of Medicine. (n.d.). Cevimeline hydrochloride. PubChem Compound Summary for CID 71565. Retrieved from https://pubchem.ncbi.nlm.nih.gov/compound/Cevimeline-hydrochloride