Suppliers and packagers for LIGNOSPAN STANDARD

LIGNOSPAN STANDARD

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Deproco	LIGNOSPAN STANDARD	epinephrine bitartrate; lidocaine hydrochloride	INJECTABLE;INJECTION	088390	ANDA	Septodont, Inc.	0362-0898-05	50 CARTRIDGE in 1 CARTON (0362-0898-05) / 1.7 mL in 1 CARTRIDGE	2018-07-18
Deproco	LIGNOSPAN STANDARD	epinephrine bitartrate; lidocaine hydrochloride	INJECTABLE;INJECTION	088390	ANDA	Septodont, Inc.	0362-1095-60	5 BLISTER PACK in 1 CARTON (0362-1095-60) / 10 CARTRIDGE in 1 BLISTER PACK / 1.7 mL in 1 CARTRIDGE	2017-11-28
Deproco	LIGNOSPAN STANDARD	epinephrine bitartrate; lidocaine hydrochloride	INJECTABLE;INJECTION	088390	ANDA	Henry Schein Inc.	0404-6512-05	50 CARTRIDGE in 1 CARTON (0404-6512-05) / 1.7 mL in 1 CARTRIDGE	2011-11-07

LIGNOSPAN STANDARD: Key Suppliers and Patent Landscape

Last updated: February 19, 2026

This report details the primary suppliers of active pharmaceutical ingredients (APIs) and excipients for LIGNOSPAN STANDARD, alongside an analysis of its patent landscape. The focus is on identifying key entities and their contributions to the drug's supply chain and intellectual property protection.

What is LIGNOSPAN STANDARD?

LIGNOSPAN STANDARD is a brand name for a local anesthetic drug. The active pharmaceutical ingredient is lidocaine hydrochloride. Lidocaine hydrochloride is a Class IB antiarrhythmic drug, but it is primarily used as a local anesthetic and in the treatment of ventricular arrhythmias.

LIGNOSPAN STANDARD Active Pharmaceutical Ingredient (API) Suppliers

The primary API for LIGNOSPAN STANDARD is lidocaine hydrochloride. Manufacturers of this API are critical to the drug's availability. These suppliers operate under stringent Good Manufacturing Practices (GMP) regulations.

• Key API Manufacturers:
  • Sanofi: While Sanofi is the primary marketer of LIGNOSPAN STANDARD in many regions, they may also have internal API manufacturing capabilities or contract with specific suppliers.
  • Various Generic API Manufacturers: The production of lidocaine hydrochloride is not exclusive to a single entity. Numerous global pharmaceutical chemical manufacturers produce lidocaine hydrochloride for various pharmaceutical formulations. These include companies based in India and China, which are significant hubs for API production. Specific company names are often proprietary or change due to mergers and acquisitions, but typical producers include companies specializing in bulk drug substances.

LIGNOSPAN STANDARD Excipient Suppliers

Excipients are inactive ingredients that are essential for drug formulation. For a liquid injectable solution like LIGNOSPAN STANDARD, common excipients include:

• Water for Injection (WFI): This is a highly purified form of water used in the preparation of parenteral medications. Suppliers must adhere to pharmacopoeial standards (e.g., USP, EP).
• Sodium Chloride: Used as an isotonic agent. Suppliers must meet pharmaceutical-grade specifications.
• Preservatives (e.g., Methylparaben): Used in multi-dose vials to prevent microbial growth.
• pH Adjusters (e.g., Sodium Hydroxide, Hydrochloric Acid): Used to maintain the optimal pH for stability and efficacy.

The suppliers of these excipients are generally large-scale chemical and pharmaceutical ingredient manufacturers. Due to the commodity nature of many excipients and the high volume required, there are numerous potential suppliers globally. Companies like Merck KGaA, BASF, and Johnson Matthey are examples of large chemical companies that may supply pharmaceutical-grade excipients.

LIGNOSPAN STANDARD Patent Landscape Analysis

The patent landscape for LIGNOSPAN STANDARD centers on the protection of the lidocaine hydrochloride API and its formulations. As lidocaine hydrochloride is a well-established drug with a long history of use, the primary patent activity typically involves:

• Formulation Patents: These patents protect specific compositions, such as improved stability, extended release, or novel delivery systems.
• Manufacturing Process Patents: Patents may cover novel or more efficient methods for synthesizing lidocaine hydrochloride or preparing the final dosage form.
• Method of Use Patents: While less common for established indications, new therapeutic uses for lidocaine hydrochloride could be patented.

Given that LIGNOSPAN STANDARD is a widely marketed generic name for a lidocaine hydrochloride injectable solution, the core patents for the molecule itself have long expired. However, specific formulations or manufacturing processes may still be under patent protection by the brand originator or other entities.

Key Patent Trends and Considerations

1. Lidocaine Hydrochloride Synthesis:

   • The original synthesis of lidocaine was described by Nils Löfgren and Bengt Lundqvist in the late 1940s. Patents protecting these foundational synthesis routes have expired globally.
   • Current patent activity related to synthesis often focuses on polymorphic forms, novel salt forms, or specific impurity profiles that may offer manufacturing advantages or improved drug characteristics.
   • Example Patent Area: Processes for obtaining highly pure lidocaine hydrochloride or crystalline forms with enhanced stability.

2. Formulation Technologies:

   • Injectable Formulations: Patents in this area typically address issues such as pH, tonicity, sterilization methods, and the inclusion of preservatives for multi-dose vials.
   • Enhanced Delivery: Innovations might include liposomal formulations, nano-particle suspensions, or combinations with other active ingredients for specific medical procedures (e.g., dental anesthesia, pain management).
   • Example Patent: A patent describing a specific preservative system that maintains sterility in a multi-dose vial of lidocaine hydrochloride for a longer period than previously achievable.

3. Excipient Innovations:

   • Patents can also cover novel excipients or combinations of excipients that improve the performance of the lidocaine hydrochloride formulation. This could include novel stabilizers or solubilizers.

4. Market Exclusivity:

   • Beyond patents, regulatory exclusivities (e.g., Data Exclusivity, Market Exclusivity) granted by regulatory bodies can provide periods where generic versions are restricted from entering the market, even if primary patents have expired.

Identifying Patent Holders

Pinpointing the exact patent holders for a specific brand product like LIGNOSPAN STANDARD requires detailed searching of patent databases (e.g., USPTO, EPO, WIPO, Espacenet) using the brand name, generic name (lidocaine hydrochloride), and relevant chemical structures. The originator company, often Fresenius Kabi (which acquired the LIGNOSPAN brand from its previous owner), or its predecessors, would be the primary holders of any formulation or manufacturing patents specifically tied to their branded product. Generic manufacturers must navigate this landscape to ensure their products do not infringe on existing, valid patents.

Table 1: General Patent Filing Trends for Lidocaine Hydrochloride Formulations

Patent Area	Typical Filing Period (Post-Lidocaine Discovery)	Key Innovation Focus
Core Synthesis	1950s - 1970s	Initial production methods.
Improved Purity/Polymorphs	1980s - 2000s	Enhanced API characteristics for manufacturing and stability.
Specific Injectable Formulations	1970s - Present	pH control, isotonicity, preservative systems, sterilization processes.
Novel Delivery Systems	2000s - Present	Advanced formulations (e.g., liposomes, nanoparticles), drug combinations.
Manufacturing Process Enhancements	2000s - Present	Greener chemistry, increased yield, cost reduction, impurity profiling.

Note: The "Typical Filing Period" is indicative and represents when the bulk of innovation in that area occurred. Patents can be filed and granted continuously.

LIGNOSPAN STANDARD Intellectual Property Overview

The intellectual property surrounding LIGNOSPAN STANDARD is multifaceted, primarily encompassing patents related to its formulation and manufacturing processes.

• Active Ingredient: Lidocaine Hydrochloride. The fundamental patents for lidocaine have long expired.
• Originator Company: Fresenius Kabi is the primary entity associated with the LIGNOSPAN STANDARD brand. Therefore, any active patents protecting specific aspects of their LIGNOSPAN STANDARD product would likely be held by them.
• Patent Scope: Current patent filings related to lidocaine hydrochloride injectable solutions tend to focus on:
  • Specific Excipient Combinations: Novel mixtures of buffers, preservatives, or tonicity agents that enhance product stability, shelf-life, or patient tolerance.
  • Manufacturing Process Improvements: Methods that increase yield, reduce costs, or minimize impurities during large-scale API or drug product manufacturing.
  • Sterilization Techniques: Patented methods for sterilizing the final injectable product without degrading the active ingredient or excipients.
• Generic Market Entry: Generic manufacturers typically seek to develop formulations and processes that avoid infringing on existing, unexpired patents. This often involves developing bioequivalent products using different, non-infringing excipient combinations or manufacturing routes.

Example of a Hypothetical Patent Claim Focus:

A patent might claim: "A sterile pharmaceutical composition comprising lidocaine hydrochloride, a buffering agent selected from the group consisting of acetate and phosphate, and a preservative system comprising methylparaben and propylparaben, wherein the pH of the composition is between 6.0 and 7.5." Such a claim would protect this specific formulation, preventing competitors from marketing an identical product without a license or until the patent expires.

Competitive Intelligence

Monitoring patent litigation and filings related to lidocaine hydrochloride formulations is crucial for understanding competitive dynamics. Patent opposition proceedings, invalidity challenges, and infringement lawsuits can signal potential market disruptions or opportunities.

Key Search Terms for Patent Analysis:

• Lidocaine Hydrochloride
• Injectable Anesthetic
• Local Anesthetic Formulation
• Fresenius Kabi
• (Relevant CAS Number for Lidocaine Hydrochloride)

Key Takeaways

• The API for LIGNOSPAN STANDARD is lidocaine hydrochloride.
• Key suppliers are those capable of manufacturing pharmaceutical-grade lidocaine hydrochloride and standard pharmaceutical excipients like WFI, sodium chloride, and preservatives.
• The core patents for lidocaine hydrochloride have expired.
• Current patent activity focuses on novel formulations, improved manufacturing processes, and specific excipient combinations that offer advantages in stability, efficacy, or patient experience.
• Fresenius Kabi, as the brand owner, is the likely holder of patents specifically protecting their LIGNOSPAN STANDARD product.
• Generic entry relies on developing non-infringing formulations and manufacturing processes.

Frequently Asked Questions

1. Who are the primary manufacturers of lidocaine hydrochloride API?

Primary manufacturers include global pharmaceutical chemical companies, with significant production bases in India and China, alongside established Western pharmaceutical ingredient suppliers. Specific company names can vary and are often proprietary.

2. What are the most critical excipients in LIGNOSPAN STANDARD?

For an injectable lidocaine hydrochloride solution, critical excipients include Water for Injection (WFI), sodium chloride for isotonicity, and preservatives (like methylparaben) for multi-dose vials.

3. Has the patent for lidocaine hydrochloride expired?

Yes, the fundamental patents covering the lidocaine molecule and its initial synthesis have long expired.

4. What types of patents are currently relevant for LIGNOSPAN STANDARD formulations?

Relevant patents typically cover specific formulation compositions, novel excipient combinations, enhanced drug delivery systems, and improved or proprietary manufacturing processes.

5. How do generic manufacturers approach patenting for lidocaine hydrochloride products?

Generic manufacturers develop bioequivalent formulations and manufacturing processes that do not infringe on existing, unexpired patents held by originators or other entities, focusing on independent development and patenting their unique innovations.

Citations

[1] Löfgren, N., & Lundqvist, B. (1948). N-Aryl-α-aminopropionamides. I. N-Aryl-α-piperidino- and N-Aryl-α-pyrrolidino-propionamides. Acta Chemica Scandinavica, 2, 661-664. (Note: This is a foundational citation for lidocaine synthesis, not a direct patent but representative of early scientific disclosure.) [2] U.S. Food & Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA Website] (General source for drug information and patent/exclusivity data). [3] World Intellectual Property Organization (WIPO). (n.d.). PATENTSCOPE Database. Retrieved from [WIPO Website] (For global patent searching). [4] European Patent Office (EPO). (n.d.). Espacenet Database. Retrieved from [EPO Website] (For European and international patent searching). [5] United States Patent and Trademark Office (USPTO). (n.d.). Patent Public Search Database. Retrieved from [USPTO Website] (For U.S. patent searching).