Neostigmine methylsulfate - Generic Drug Details

What are the generic drug sources for neostigmine methylsulfate and what is the scope of freedom to operate?

Neostigmine methylsulfate is the generic ingredient in three branded drugs marketed by Exela Pharma, Adaptis, Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Be Pharms, Caplin, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Meitheal, Sagent Pharms Inc, Umedica, and Avet Lifesciences, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for neostigmine methylsulfate. Twenty-five suppliers are listed for this compound.

Summary for neostigmine methylsulfate

US Patents:	0
Tradenames:	3
Applicants:	18
NDAs:	20
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	9
Patent Applications:	2,181
Drug Prices:	Drug price trends for neostigmine methylsulfate
What excipients (inactive ingredients) are in neostigmine methylsulfate?	neostigmine methylsulfate excipients list
DailyMed Link:	neostigmine methylsulfate at DailyMed

See drug prices for neostigmine methylsulfate

Recent Clinical Trials for neostigmine methylsulfate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Seoul National University Hospital	N/A
Alexandria University	Phase 4
Kasr El Aini Hospital	Phase 4

See all neostigmine methylsulfate clinical trials

Pharmacology for neostigmine methylsulfate

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for neostigmine methylsulfate

Cholinesterase Inhibitors

Parasympathomimetics

Anatomical Therapeutic Chemical (ATC) Classes for neostigmine methylsulfate

N07AA	Anticholinesterases
N07A	PARASYMPATHOMIMETICS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

S01EB	Parasympathomimetics
S01E	ANTIGLAUCOMA PREPARATIONS AND MIOTICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for neostigmine methylsulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Be Pharms	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	212512-002	May 13, 2019	AP	RX	No	No
Be Pharms	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	212512-001	May 13, 2019	AP	RX	No	No
Adaptis	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	210652-001	Oct 1, 2021	AP	RX	No	No
Endo Operations	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	208405-001	Apr 26, 2017	AP	RX	No	No
Amring Pharms	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	210989-002	Aug 22, 2018	AP	RX	No	No
Fresenius Kabi Usa	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	203629-001	Jan 8, 2015		RX	Yes	Yes
Dr Reddys	NEOSTIGMINE METHYLSULFATE	neostigmine methylsulfate	SOLUTION;INTRAVENOUS	216291-001	Jul 6, 2022	AP	RX	No	No

Neostigmine methylsulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Neostigmine Methylsulfate Injection

Market Size and Growth Projections

The global neostigmine methylsulfate injection market is poised for significant growth in the coming years. As of 2023, the market is valued at approximately US$ 156.7 million, and it is projected to reach US$ 213.3 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.5% during the forecast period[1][2].

Drivers of Market Growth

Several factors are driving the growth of the neostigmine methylsulfate injection market:

Increasing Prevalence of Neuromuscular Disorders

The rising prevalence of myasthenia gravis, Chronic Obstructive Pulmonary Disease (COPD), and other neuromuscular disorders is a significant driver. Neostigmine methylsulfate is used to treat these conditions by increasing muscle tone and reversing neuromuscular blockade[1][2].

Hospital Demand

The increasing demand for neostigmine methylsulfate injections in hospital settings, particularly for the reversal of non-depolarizing neuromuscular blocking agents after surgery, is another key factor. Hospital pharmacies are expected to grow rapidly due to the higher hospitalization rates for patients with myasthenia gravis and other related conditions[2].

Geriatric Population

The growing geriatric population, which is more prone to neurological conditions like myasthenia gravis, also contributes to the market growth. This demographic requires more frequent hospital treatments, including the use of neostigmine methylsulfate injections[2].

Regional Insights

North America

North America currently dominates the neostigmine methylsulfate injection market due to higher adoption rates of reversal agents and significant research and development activities. The region is expected to maintain its leading position, driven by increasing FDA approvals and robust healthcare infrastructure[1][2].

Asia Pacific

The Asia Pacific region is anticipated to witness the fastest growth during the forecast period. This growth is driven by rising anticholinesterase overdose cases, increasing healthcare expenditures in countries like China and India, and the growing need for neuromuscular blockade reversal in gastrointestinal surgeries[1].

Competitive Landscape

The market is highly competitive, with several major players including:

• Pfizer Inc.
• Fresenius Kabi AG
• Mylan N.V.
• Sandoz Inc.
• Bausch Health Companies Inc.
• Sun Pharmaceutical Industries Ltd.
• Hospira (now part of Pfizer)
• Akorn Pharmaceuticals
• Baxter International Inc.
• Hikma Pharmaceuticals
• Endo International[2].

Market Segmentation

By Application

The myasthenia gravis segment is a major contributor to the neostigmine methylsulfate injection market. Neostigmine methylsulfate is used to treat myasthenia gravis by increasing the availability of acetylcholine in the synapse, thereby improving muscle contraction[2].

By Distribution Channel

Hospital pharmacies are a significant distribution channel and are expected to grow rapidly due to the increasing hospitalization rates for patients requiring neostigmine methylsulfate injections[2].

Challenges and Restraints

Despite the growth prospects, the market faces several challenges:

Alternative Reversal Agents

The availability of alternative reversal agents like sugammadex sodium poses a significant threat to the market growth of neostigmine methylsulfate injections[1].

Regulatory Guidelines

Strict regulatory guidelines for drug approval can also hinder market expansion. Ensuring compliance with these regulations is crucial for market players[1].

Pricing Pressure and Research Funding

Pricing pressure and limited research funding for neostigmine methylsulfate are additional challenges. Market players need to navigate these issues to maintain their market position[1].

Opportunities and Trends

Expanding Therapeutic Indications

Increasing research aimed at expanding the therapeutic indications of neostigmine methylsulfate injections presents new opportunities for market growth. Collaborations with key opinion leaders and research institutes can help market players strengthen their product portfolios[1].

Biosimilars and Biologics

The rise of biosimilars and biologics has increased the demand for neostigmine methylsulfate injections. The cost-effectiveness of biosimilars has led to higher adoption rates, which in turn increases the need for neuromuscular blockade reversal agents like neostigmine methylsulfate[1].

Financial Performance and Key Players

Companies like Avadel Pharmaceuticals, which markets Bloxiverz (neostigmine methylsulfate injection), have seen significant financial activity related to this product. Bloxiverz was approved by the FDA in May 2013 and launched in July 2013, contributing to the company's revenue streams[3].

Recent Developments and Strategic Moves

Market players are engaging in various strategic activities such as new product launches, acquisitions, and partnerships to enhance their market presence. For instance, collaborations with research institutes and key opinion leaders are becoming more common to drive innovation and compliance with regulatory standards[1].

Key Takeaways

• The neostigmine methylsulfate injection market is projected to grow from US$ 156.7 million in 2023 to US$ 213.3 million by 2030.
• The market is driven by the increasing prevalence of neuromuscular disorders and the rising demand in hospital settings.
• North America dominates the market, but the Asia Pacific region is expected to witness the fastest growth.
• The market faces challenges from alternative reversal agents and strict regulatory guidelines.
• Expanding therapeutic indications and the rise of biosimilars present significant opportunities.

FAQs

What is the current market size of the neostigmine methylsulfate injection market?

The global neostigmine methylsulfate injection market size is valued at approximately US$ 156.7 million in 2023[1].

What is the projected growth rate of the neostigmine methylsulfate injection market?

The market is projected to grow at a CAGR of 4.5% from 2023 to 2030[1].

Which region dominates the neostigmine methylsulfate injection market?

North America currently dominates the neostigmine methylsulfate injection market due to higher adoption rates of reversal agents and significant research and development activities[1][2].

What are the major applications of neostigmine methylsulfate injections?

The major applications include the treatment of myasthenia gravis and the reversal of non-depolarizing neuromuscular blocking agents after surgery[2].

What are the key challenges facing the neostigmine methylsulfate injection market?

The key challenges include the availability of alternative reversal agents, strict regulatory guidelines, pricing pressure, and limited research funding[1].