Market Analysis of Succinylcholine Chloride in the USA: Opportunities and Patent Landscape

Overview

Succinylcholine Chloride has been present in the US market since 1952, with 1 approved drug currently available. It serves as a depolarizing neuromuscular blocker used in anesthesia procedures. The drug has maintained its clinical relevance for over 70 years, with the most recent approval in 2021 for Hikma Pharmaceuticals' solution formulation. The long-standing presence in the market indicates its established clinical utility despite the emergence of newer neuromuscular blocking agents.

Detailed Description

Drug Information

Succinylcholine Chloride was originally developed by Sandoz, Inc. and has been approved in the USA since 1952. It is currently marketed by multiple companies with various formulations.

** Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

Structure

Patent Barrier Analysis

Registration Patent Analysis

There is one active FDA Orange Book patent for Succinylcholine Chloride, which is held by Hikma Pharmaceuticals USA, Inc. This patent appears to be device-related rather than covering the compound itself.

Other Patent Barrier Analysis

There are several non-original patents related to succinylcholine, many of which are inactive or expired PCT applications. However, there are two active US patents that could present potential barriers.

Several inactive patents exist from various companies worldwide:

Clinical Results

Based on FDA Label Clinical Insight:

Pharmacodynamic Studies:

• Succinylcholine acts as a depolarizing neuromuscular blocker by binding to cholinergic receptors at the motor end plate, resulting in initial muscle fasciculations followed by flaccid paralysis.
• The drug has a rapid onset of action (less than 1 minute after IV administration) and short duration of paralysis (approximately 4 to 6 minutes).
• Succinylcholine is rapidly hydrolyzed to succinylmonocholine and further metabolized to succinic acid and choline .

Drug Interaction Studies:

• Experiments have shown that certain drugs (promazine, non-penicillin antibiotics, β-adrenergic blockers) can enhance the neuromuscular blocking action of succinylcholine either by directly interacting with neuromuscular transmission or by reducing plasma cholinesterase activity.

Malignant Hyperthermia Studies:

• Ex-vivo experiments and case reports have explored the role of polymorphisms in the ryr1 and cacna1s genes in malignant hyperthermia susceptibility.
• Clinical observations of malignant hyperthermia in patients administered succinylcholine (including pediatric cases) have contributed to understanding of risk factors.

Safety Concerns:

• Multiple case reports, especially in pediatric patients, describe severe adverse reactions including hyperkalemic rhabdomyolysis and cardiac arrest following succinylcholine administration.
• No long-term animal studies have been performed to evaluate carcinogenic potential, genotoxicity, or impact on fertility.

Infringement Cases

Based on the results from the Generic Drug Infringement News tool, there are no reported patent infringement incidents involving Succinylcholine Chloride.

Policy and Regulatory Risk Warning

After a comprehensive search, Succinylcholine Chloride has no market exclusivity or data protection period in the USA. The compound itself has been in the market since 1952, far exceeding any regulatory exclusivity periods. The only potential regulatory barriers would be related to specific formulations, devices, or delivery methods covered by current patents.

Market Entry Assessment & Recommendations

Based on the analysis of Succinylcholine Chloride in the USA market:

Patent Landscape Assessment:

• The compound itself is not patent protected, as it has been in use since 1952.
• The primary patent barriers are device-related (US12295932B2, expiring in 2041) and formulation/new use patents (US20230091021A1, expiring in 2042).
• Generic manufacturers should focus on developing formulations and delivery systems that do not infringe on these specific patents.

Market Opportunity:

• Despite being an older drug, succinylcholine remains clinically relevant in anesthesia practice, indicating a stable market.
• The recent approval in 2021 (Hikma Pharmaceuticals) suggests continued market demand.
• Potential for developing improved formulations with better stability or safety profiles.

Strategic Recommendations:

• For generics: Develop alternative delivery systems or formulations that circumvent existing device and formulation patents.
• For innovators: Focus on addressing known safety concerns (e.g., malignant hyperthermia risk, hyperkalemia) through improved formulations or combination products.
• Consider developing extended-release formulations or combinations with agents that mitigate adverse effects.

Regulatory Strategy:

• The 505(b)(2) pathway could be leveraged for new formulations or combinations that improve upon the existing product.
• Conduct thorough freedom-to-operate analyses focused on delivery systems and formulations rather than the active ingredient itself.

Competitive Advantage Opportunities:

• Develop formulations with improved stability at room temperature.
• Create products with reduced risk of malignant hyperthermia or hyperkalemia.
• Explore novel delivery systems for more controlled administration in emergency settings.

The succinylcholine market represents an opportunity for both generic competition and innovation through improved formulations and delivery systems, with the main barriers being device and formulation patents rather than compound patents.