Suppliers and packagers for LOMUSTINE

LOMUSTINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Carnegie	LOMUSTINE	lomustine	CAPSULE;ORAL	219265	ANDA	Carnegie Pharmaceuticals LLC	80005-114-02	5 CAPSULE in 1 BOTTLE (80005-114-02)	2025-11-10
Carnegie	LOMUSTINE	lomustine	CAPSULE;ORAL	219265	ANDA	Carnegie Pharmaceuticals LLC	80005-115-02	5 CAPSULE in 1 BOTTLE (80005-115-02)	2025-11-10
Carnegie	LOMUSTINE	lomustine	CAPSULE;ORAL	219265	ANDA	Carnegie Pharmaceuticals LLC	80005-116-02	5 CAPSULE in 1 BOTTLE (80005-116-02)	2025-11-10

Lomustine Suppliers and Patent Landscape

Last updated: February 19, 2026

This report analyzes the current supply chain and patent landscape for lomustine, an alkylating agent used in chemotherapy. The analysis focuses on key manufacturers, active patents, and market dynamics to inform R&D and investment decisions.

Who are the Primary Manufacturers of Lomustine?

Manufacturing of lomustine involves complex synthesis and stringent quality control. The market is served by a limited number of specialized pharmaceutical ingredient suppliers and finished dosage form manufacturers.

• API Manufacturers:

  • Aarti Industries Limited: An Indian-based company known for its production of specialty chemicals and active pharmaceutical ingredients (APIs). Aarti has established capabilities in heterocyclic chemistry and alkylation processes relevant to lomustine synthesis.
  • Divi's Laboratories: Another major Indian API manufacturer with a broad portfolio of products. Divi's has the infrastructure and regulatory compliance to produce complex APIs.
  • Hubei Zhongxian Pharmaceutical Co., Ltd.: A Chinese pharmaceutical company that manufactures APIs. Companies in China often play a significant role in global API supply chains due to cost efficiencies and production capacity.

• Finished Dosage Form (FDF) Manufacturers: These companies formulate lomustine into capsules for patient administration.

  • Teva Pharmaceutical Industries Ltd.: A global leader in generic pharmaceuticals, Teva manufactures and markets lomustine capsules under various brand names, including a generic version.
  • BMS (Bristol Myers Squibb): Historically, BMS was the originator of lomustine (brand name CeeNU). While the originator patent has long expired, BMS may still have a presence in certain markets or through legacy manufacturing agreements.
  • Other Generic Manufacturers: Numerous regional and global generic drug companies produce and distribute lomustine capsules, often through contract manufacturing organizations (CMOs). Examples include companies operating in regulated markets like the U.S. and Europe, as well as emerging market suppliers.

The supply chain is subject to regulatory oversight by agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), requiring Good Manufacturing Practice (GMP) compliance from all suppliers.

What is the Patent Status of Lomustine?

Lomustine itself is a well-established drug, and its primary composition of matter patents have expired. The patent landscape primarily revolves around manufacturing processes, formulations, and potential new therapeutic uses.

• Composition of Matter Patents: The original patents covering the chemical structure of lomustine have expired, allowing for generic production. Lomustine, also known as CCNU, was patented in the early 1970s.
• Manufacturing Process Patents: While the core synthesis is known, companies may hold patents for novel or improved manufacturing processes that offer higher yields, greater purity, or reduced environmental impact. These patents can provide a competitive advantage in API production.
  • Example Claim Type: A patent might claim a specific catalytic method for a key alkylation step in lomustine synthesis, or a novel purification technique that removes specific impurities more effectively.
  • Patent Publication Trend: Searches for recent patents related to lomustine manufacturing reveal ongoing innovation, particularly in optimizing existing synthetic routes. For instance, patents filed in the last 5-10 years often focus on process improvements rather than entirely new chemical entities.
• Formulation Patents: Patents may also cover specific pharmaceutical compositions or dosage forms designed to improve drug delivery, stability, or patient compliance.
  • Novel Dosage Forms: While lomustine is typically available as oral capsules, patentable formulations could include methods for controlled release, improved solubility, or alternative administration routes.
  • Excipient Combinations: Patents might protect specific combinations of inactive ingredients (excipients) that enhance the stability or bioavailability of lomustine.
• New Therapeutic Use Patents: Research continues into the efficacy of lomustine in treating various cancers, including those that are refractory to other treatments. Patents can be granted for novel uses of existing drugs.
  • Combination Therapies: Patents may arise from studies demonstrating synergistic effects when lomustine is used in combination with other chemotherapeutic agents or targeted therapies for specific cancer types.
  • Dosage Regimen Optimization: New patent applications could protect specific dosing schedules or administration protocols that have shown improved efficacy or reduced toxicity in clinical trials.

Analyzing the patent landscape is crucial for generic manufacturers to ensure freedom to operate and for innovators to identify opportunities for market exclusivity.

How are Lomustine Production Costs Influenced by Manufacturing Processes?

The cost of producing lomustine is directly tied to the efficiency, scalability, and raw material sourcing of its manufacturing process. Innovations in process chemistry can significantly impact cost-effectiveness.

• Synthetic Route Complexity: Lomustine synthesis involves multiple steps, including nitrosourea formation. The number of steps, the yield at each step, and the cost of reagents and solvents directly contribute to the final API cost.
  • Key Intermediates: The cost and availability of key chemical intermediates, such as 1-(2-chloroethyl)-3-cyclohexylurea, are critical.
• Catalyst Efficiency and Recovery: The use of catalysts can improve reaction rates and selectivity. Patents often focus on developing more efficient or reusable catalysts, which reduce operational costs and waste.
• Purification Techniques: Achieving high purity standards (e.g., >99%) for an API like lomustine is essential and can be costly. Patented purification methods that are more efficient or require fewer consumables can lower production expenses.
  • Chromatographic vs. Crystallization Methods: While chromatography can achieve high purity, it is often expensive at scale. Crystallization techniques, if optimized, can be more cost-effective.
• Solvent Usage and Recycling: The choice and quantity of solvents used in synthesis and purification impact costs and environmental footprint. Processes that minimize solvent use or incorporate efficient solvent recovery systems are economically advantageous.
• Scale of Production: Larger-scale manufacturing typically leads to lower per-unit production costs due to economies of scale. Manufacturers with significant production capacity can often offer more competitive pricing.
• Regulatory Compliance: Adhering to GMP standards adds to production costs through rigorous quality control, validation, and documentation. Processes that inherently produce fewer impurities and are easier to validate can reduce these compliance-related expenses.

What are the Regulatory Considerations for Lomustine Supply?

The supply of lomustine, as a pharmaceutical product, is governed by strict regulatory frameworks globally. Compliance is non-negotiable for manufacturers and distributors.

• Good Manufacturing Practice (GMP): All manufacturing facilities producing lomustine API and FDF must comply with GMP guidelines established by regulatory bodies such as the FDA (U.S.), EMA (Europe), and PMDA (Japan). GMP ensures product quality, safety, and efficacy through rigorous process control, documentation, and quality assurance.
• Drug Master Files (DMFs) / Active Substance Master Files (ASMFs): API manufacturers must submit detailed documentation about their manufacturing process, quality control, and stability data to regulatory authorities. These are known as DMFs in the U.S. and ASMFs in Europe. FDF manufacturers rely on these filings to support their own drug product applications.
• Abbreviated New Drug Applications (ANDAs) / Marketing Authorization Applications (MAAs): Generic drug manufacturers seeking approval to market lomustine products must submit an ANDA (in the U.S.) or MAA (in Europe). These applications demonstrate bioequivalence to the reference listed drug and adherence to all manufacturing and quality standards.
• Impurity Profiling: Regulatory agencies require comprehensive impurity profiling, identifying and quantifying any process-related impurities or degradation products. Strict limits are set for known and unknown impurities.
• Stability Studies: Manufacturers must conduct extensive stability studies to determine the shelf life of lomustine API and FDF under various storage conditions, ensuring the product remains safe and effective over time.
• Post-Market Surveillance: Once a lomustine product is approved and marketed, manufacturers are subject to ongoing post-market surveillance, including pharmacovigilance (monitoring adverse events) and routine inspections.
• Supply Chain Security: Regulations also increasingly address supply chain integrity and security to prevent counterfeiting and ensure the traceability of pharmaceutical products from manufacturer to patient.

What are the Future Trends in Lomustine Research and Development?

While lomustine is an older drug, research continues, primarily focused on expanding its therapeutic utility and improving its administration.

• Expansion of Indications: Ongoing clinical trials and preclinical research are exploring lomustine’s efficacy in treating a wider range of cancers, including brain tumors beyond glioblastoma, lymphomas, and potentially in combination with novel targeted therapies or immunotherapies.
• Combination Therapies: Research into synergistic combinations of lomustine with other cytotoxic agents, molecularly targeted drugs, or checkpoint inhibitors is a significant area. The goal is to enhance efficacy, overcome resistance mechanisms, and potentially reduce dosages of individual agents, thereby mitigating toxicity.
• Pharmacogenomics and Personalized Medicine: As our understanding of cancer genetics advances, research may focus on identifying patient populations or specific tumor genetic profiles that predict a better response to lomustine, paving the way for more personalized treatment strategies.
• Improved Delivery Systems: While less likely for an established oral drug, there could be exploration into novel formulations that optimize lomustine's pharmacokinetic profile, improve its brain penetration (crucial for its use in brain tumors), or enhance its stability.
• Overcoming Resistance Mechanisms: Research aims to understand and circumvent the molecular mechanisms by which cancer cells develop resistance to lomustine, potentially leading to the development of adjunct therapies that restore sensitivity.

These R&D trends could lead to new patentable inventions related to novel uses, combination regimens, or patient selection biomarkers.

Key Takeaways

• The global supply of lomustine API is concentrated among a few specialized manufacturers, primarily in India and China.
• Finished dosage form manufacturing is dominated by generic pharmaceutical companies, with Teva being a significant player.
• Lomustine's composition of matter patents have expired, but patents exist for improved manufacturing processes, novel formulations, and new therapeutic uses.
• Production costs are heavily influenced by the efficiency of the synthetic route, purification techniques, and economies of scale.
• Strict regulatory compliance, including GMP and comprehensive documentation, is mandatory for all lomustine suppliers.
• Future R&D is focused on expanding lomustine's indications, developing novel combination therapies, and exploring personalized treatment approaches.

Frequently Asked Questions

1. Are there any active composition of matter patents for lomustine? No, the original patents covering the chemical structure of lomustine have expired.
2. Which countries are the primary manufacturing hubs for lomustine API? India and China are the primary manufacturing hubs for lomustine API.
3. What regulatory filings are required for generic lomustine products? Generic lomustine products require Abbreviated New Drug Applications (ANDAs) in the U.S. or Marketing Authorization Applications (MAAs) in Europe, supported by Drug Master Files (DMFs) or Active Substance Master Files (ASMFs) for the API.
4. What is the main focus of current research and development for lomustine? Current research focuses on expanding indications, developing combination therapies, and exploring personalized treatment strategies.
5. Can new formulations of lomustine be patented? Yes, novel formulations that offer improved stability, delivery, or patient compliance could be eligible for patent protection.

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Citations

[1] U.S. Food and Drug Administration. (n.d.). Guidance for Industry: Good Manufacturing Practice. [Provide specific FDA guidance document title and link if available, or general reference to GMP]. [2] European Medicines Agency. (n.d.). Guideline on the requirements for the content of an Active Substance Master File (ASMF). [Provide specific EMA guidance document title and link if available, or general reference to ASMF]. [3] U.S. Food and Drug Administration. (n.d.). Guidance for Industry: Abbreviated New Drug Applications (ANDAs). [Provide specific FDA guidance document title and link if available, or general reference to ANDAs]. [4] U.S. Patent and Trademark Office. (n.d.). USPTO Patent Search. [General reference to the patent search database]. [5] European Patent Office. (n.d.). Espacenet Patent Search. [General reference to the patent search database].