Suppliers and packagers for XYZAL

XYZAL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chattem Sanofi	XYZAL	levocetirizine dihydrochloride	TABLET;ORAL	022064	NDA	Chattem, Inc.	41167-5803-9	90 TABLET, FILM COATED in 1 BOTTLE (41167-5803-9)	2017-07-24
Chattem Sanofi	XYZAL	levocetirizine dihydrochloride	TABLET;ORAL	022064	NDA	Chattem, Inc.	41167-5804-5	1 BOTTLE in 1 CARTON (41167-5804-5) / 148 mL in 1 BOTTLE	2017-07-24

Xyzal Suppliers: Manufacturing and Distribution Landscape

Last updated: February 19, 2026

This analysis identifies key suppliers involved in the manufacturing and distribution of Xyzal (levocetirizine dihydrochloride), a second-generation H1 antihistamine. The landscape is characterized by active pharmaceutical ingredient (API) manufacturers, finished dosage form (FDF) producers, and extensive distribution networks, reflecting the global nature of pharmaceutical supply chains. Key patent expirations and the subsequent rise of generic competition have influenced supplier dynamics and market access.

Who Manufactures the Active Pharmaceutical Ingredient (API) for Xyzal?

The primary API for Xyzal is levocetirizine dihydrochloride. Its synthesis involves multiple chemical steps, and production is concentrated among specialized API manufacturers.

• Original API Source: Sanofi (formerly Aventis) was the originator. Post-patent expiry, multiple manufacturers now produce levocetirizine dihydrochloride.
• Key API Manufacturers: While specific suppliers can be proprietary and subject to change based on contracts and regulatory approvals, general categories of API producers include:
  • Large-scale generic API manufacturers: Companies with significant capacity for bulk chemical synthesis often supply multiple generic drug producers. These entities are typically located in regions with established pharmaceutical chemical industries, such as India and China, alongside some European and North American producers.
  • Contract Development and Manufacturing Organizations (CDMOs): Specialized CDMOs may produce levocetirizine dihydrochloride under contract for various pharmaceutical companies. These organizations possess advanced chemical synthesis capabilities and adhere to strict Good Manufacturing Practices (GMP).
• Regulatory Compliance: API manufacturers must comply with stringent regulatory standards set by bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This includes adhering to ICH guidelines for quality, safety, and efficacy. API production sites undergo regular inspections to ensure GMP compliance.

What Companies Produce Finished Dosage Forms (FDFs) of Xyzal?

Finished dosage forms, primarily oral tablets and oral solutions, are manufactured by pharmaceutical companies that formulate the API into the final drug product. This stage involves blending the API with excipients, granulation, compression (for tablets), or dissolution and bottling (for solutions), followed by packaging.

• Originator: Sanofi markets the branded Xyzal.
• Generic Manufacturers: The expiration of key patents for Xyzal has led to the introduction of numerous generic versions. These companies source levocetirizine dihydrochloride API from third-party manufacturers and produce their own FDFs.
  • Example Generic Product Names: Availability varies by region, but examples include Levocetirizine HCl (various brands), Cetirizine HCl (though this is a different drug, often confused, Xyzal is levocetirizine), and others.
  • Manufacturing Locations: FDF manufacturing occurs globally, with significant production hubs in North America, Europe, India, and China. Companies often operate multiple manufacturing facilities to ensure supply chain resilience.
  • Product Formulations:
    • Tablets: Typically available in strengths of 5 mg. Excipients commonly include microcrystalline cellulose, lactose monohydrate, maize starch, colloidal anhydrous silica, povidone, and magnesium stearate.
    • Oral Solution: Available in various concentrations, often around 0.5 mg/mL. Excipients can include sorbitol solution, glycerol, sodium citrate dihydrate, methylparahydroxybenzoate, propylparahydroxybenzoate, sodium saccharin, purified water, and flavorings.
• Quality Control: FDF manufacturers implement rigorous quality control measures, including in-process checks and finished product testing, to ensure the identity, strength, quality, and purity of the drug product.

Who Distributes Xyzal and Its Generic Equivalents?

The distribution of Xyzal and its generic counterparts involves a complex network of wholesalers, distributors, and pharmacies.

• Primary Wholesalers/Distributors: These companies purchase large quantities of drug products from manufacturers and supply them to pharmacies, hospitals, and other healthcare providers.
  • Major US Wholesalers: McKesson, Cardinal Health, and AmerisourceBergen are dominant players in the U.S. pharmaceutical distribution market.
  • Major European Distributors: Companies like Alliance Healthcare (a Walgreens Boots Alliance company), Celesio (now part of McKesson Europe), and Phoenix Pharmahandel operate significant distribution networks across Europe.
• Retail Pharmacies: These are the point of dispensing to the end consumer. They purchase from wholesalers.
• Hospital Pharmacies: Hospitals manage their own internal pharmacies, often sourcing directly from manufacturers or major wholesalers.
• Specialty Distributors: For specific product needs or patient populations, specialty distributors may also play a role.
• Logistics and Cold Chain: While levocetirizine dihydrochloride is generally stable at room temperature, appropriate storage and handling conditions are maintained throughout the distribution chain to preserve product integrity. Temperature monitoring and tracking systems are employed.
• Regulatory Oversight: Distribution practices are subject to regulations such as the Drug Supply Chain Security Act (DSCSA) in the U.S., which aims to create an electronic, interoperable system to identify and trace certain marketed prescription drugs. Similar track-and-trace regulations exist in other major markets.

What is the Patent Landscape for Xyzal (Levocetirizine Dihydrochloride)?

The patent landscape for Xyzal has significantly shifted from originator protection to a more competitive generic environment.

• Composition of Matter Patent: The fundamental patent covering levocetirizine itself has expired. This is the most critical patent, granting exclusive rights to the chemical entity.
  • Original Patent Holder: UCB Pharma (now part of UCB).
  • Expiration: The U.S. composition of matter patent for levocetirizine expired around 2007-2008, though extensions and additional patents for specific forms or uses might have had later expiry dates. For example, U.S. Patent No. 6,545,026, related to levocetirizine, had an expiry around 2020, but its impact on generic entry was diminished by the expiry of earlier, more foundational patents.
• Formulation and Polymorph Patents: Patents related to specific pharmaceutical formulations, crystalline forms (polymorphs), or manufacturing processes can provide secondary protection. These patents often become the focus of litigation in the generic drug space.
  • Example: Patents covering specific crystal forms might be challenged by generic companies if they can demonstrate their product is non-infringing or that the patented form is not essential to the drug's efficacy or safety.
• Method of Use Patents: Patents covering new medical uses for levocetirizine could exist, but their impact on the market for established indications (allergic rhinitis, urticaria) is less pronounced after the primary patents lapse.
• Generic Entry: The expiry of key patents has enabled generic manufacturers to launch their own versions of levocetirizine dihydrochloride, leading to price competition and increased market access. The first generic versions entered the U.S. market around 2017.
• Patent Litigation: Disputes over patent validity, inventorship, and infringement are common as generic companies seek to enter the market. These litigations often involve complex scientific and legal arguments regarding chemical synthesis, crystalline structures, and bioequivalence.

Key Players in the Xyzal Supply Chain

Identifying specific companies involved in each stage can be fluid due to contract manufacturing and shifting market dynamics. However, general categories and notable participants can be outlined.

• API Manufacturers (Examples of types, not specific product suppliers):
  • Global API Giants: Companies like Dr. Reddy's Laboratories, Sun Pharmaceutical Industries, Cipla, and Teva Pharmaceutical Industries are major API producers. Many Chinese manufacturers, such as Zhejiang NHU Co., Ltd., also produce APIs.
  • Specialized Chemical Synthesizers: Smaller, niche companies focused on specific complex organic syntheses may also be involved.
• Finished Dosage Form (FDF) Manufacturers:
  • Originator: Sanofi.
  • Major Generic Companies (U.S. Market Focus): Teva Pharmaceuticals USA, Inc., Sandoz Inc. (a Novartis company), Mylan N.V. (now part of Viatris), Aurobindo Pharma USA, Inc., and Actavis (now part of Teva).
  • Global Generic Players: Beyond those listed above, companies like Apotex,Torrent Pharmaceuticals, and others are active globally.
• Distributors (U.S. Focus):
  • McKesson Corporation
  • Cardinal Health, Inc.
  • AmerisourceBergen Corporation (now Cencora)
• Distributors (European Focus):
  • Alliance Healthcare
  • Phoenix Pharmahandel
  • Celesio (part of McKesson Europe)
• Regulatory Bodies:
  • U.S. Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)
  • Pharmaceutical and Medical Devices Agency (PMDA) - Japan
  • Therapeutic Goods Administration (TGA) - Australia

Market Dynamics and Supply Chain Considerations

The supply chain for Xyzal, particularly its generic versions, is influenced by several factors:

• Generic Competition: The high volume of generic competition after patent expiry has led to significant price erosion. This necessitates efficient manufacturing and supply chain management for profitability.
• API Sourcing: Pharmaceutical companies often source APIs from multiple suppliers to mitigate risks related to quality, supply disruptions, and price volatility. Geographic diversification of API sources is common.
• Quality Assurance and Compliance: Maintaining consistent quality across API and FDF manufacturing is paramount. Audits of suppliers and rigorous in-house testing are standard procedures. Regulatory non-compliance can lead to severe supply disruptions and financial penalties.
• Supply Chain Security: Concerns about counterfeit drugs and diversion have increased the focus on track-and-trace systems and supply chain integrity.
• Geopolitical Factors: Trade policies, international relations, and global events (e.g., pandemics) can impact the availability and cost of raw materials and finished products, affecting supply chain stability.
• Environmental, Social, and Governance (ESG) Factors: Increasing scrutiny on the environmental impact of chemical synthesis and ethical labor practices influences supplier selection and manufacturing processes.

Key Takeaways

• The Xyzal supply chain involves distinct API manufacturers, FDF producers, and distribution networks.
• Following patent expirations, the market for levocetirizine dihydrochloride is dominated by generic competition, with numerous API and FDF suppliers globally.
• Key API production centers are located in Asia (India, China) and Europe.
• Major pharmaceutical distributors in the U.S. (McKesson, Cardinal Health, Cencora) and Europe (Alliance Healthcare, Phoenix Pharmahandel) manage the flow of finished products to pharmacies and healthcare providers.
• Patent litigation, particularly around formulation and polymorph patents, continues to shape the competitive landscape for generic levocetirizine.
• Supply chain resilience, quality control, and regulatory compliance are critical for all participants.

FAQs

1. Which companies hold the primary patents for Xyzal? The primary composition of matter patents for levocetirizine were originally held by UCB Pharma. These patents have since expired, paving the way for generic competition.
2. Where are the majority of levocetirizine dihydrochloride APIs manufactured? A significant portion of levocetirizine dihydrochloride API production is concentrated in manufacturing hubs located in India and China, with some production also occurring in Europe.
3. What are the main finished dosage forms of Xyzal available in the market? The most common finished dosage forms of Xyzal and its generic equivalents are oral tablets (typically 5 mg) and oral solutions (varying concentrations, often around 0.5 mg/mL).
4. How has the expiration of Xyzal patents impacted its availability and pricing? The expiration of key patents has led to a substantial increase in the number of generic manufacturers producing levocetirizine dihydrochloride. This has resulted in increased market availability and significant price reductions compared to the branded product.
5. What regulatory considerations are paramount for Xyzal suppliers? All suppliers, from API manufacturers to FDF producers and distributors, must adhere to stringent Good Manufacturing Practices (GMP) and comply with regulations set by bodies like the FDA and EMA. This includes maintaining product quality, ensuring supply chain integrity, and fulfilling reporting requirements.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Patent Term Restoration and Exclusivity. Retrieved from [FDA Website Information on Patents] (Note: Specific patent details and expiry dates are publicly accessible through FDA databases and patent office records, not typically a single document for all). [2] European Medicines Agency. (n.d.). Public Assessment Reports. Retrieved from [EMA Website for Product Information] (Note: Specific active ingredient supplier details are often confidential business information). [3] Pharmaceutical industry reports and market analysis databases (e.g., IQVIA, Statista). (Proprietary Data). [4] Company financial reports and investor relations materials for major pharmaceutical manufacturers and distributors. (Publicly available via company websites).