GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE - Generic Drug Details

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

Glycopyrrolate; neostigmine methylsulfate is the generic ingredient in one branded drug marketed by Azurity and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE

US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE

Constraining patent/regulatory exclusivity:

11,110,054

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE

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

Sponsor	Phase
James J. Peters Veterans Affairs Medical Center	Phase 1

See all GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE clinical trials

Pharmacology for GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE

Drug Class	Anticholinergic Cholinergic Muscarinic Antagonist Cholinesterase Inhibitor
Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists Cholinesterase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for GLYCOPYRROLATE; 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 GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	PREVDUO	glycopyrrolate; neostigmine methylsulfate	SOLUTION;INTRAVENOUS	216903-001	Feb 23, 2023		RX	Yes	Yes	10,456,354		Y
Azurity	PREVDUO	glycopyrrolate; neostigmine methylsulfate	SOLUTION;INTRAVENOUS	216903-001	Feb 23, 2023		RX	Yes	Yes	11,938,217		Y
Azurity	PREVDUO	glycopyrrolate; neostigmine methylsulfate	SOLUTION;INTRAVENOUS	216903-001	Feb 23, 2023		RX	Yes	Yes	11,110,054		Y

GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Neostigmine Methylsulfate and Glycopyrrolate

Introduction

Neostigmine methylsulfate and glycopyrrolate are crucial medications used in the reversal of non-depolarizing neuromuscular blocking agents (NMBAs) after surgical procedures. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this market.

Market Size and Growth

The global neostigmine methylsulfate injection market is projected to experience significant growth. As of 2023, the market size is valued at US$ 156.7 million, and it is expected to reach US$ 213.3 million by 2030, registering a Compound Annual Growth Rate (CAGR) of 4.5% during the forecast period[1].

Market Drivers

Several factors are driving the growth of this market:

Increasing Prevalence of Neuromuscular Disorders

The rising prevalence of myasthenia gravis, Chronic Obstructive Pulmonary Disease (COPD), and other neuromuscular disorders is a key driver. These conditions often require the use of neostigmine methylsulfate for treatment and management[1].

Rising Demand in Hospital Settings

The increasing demand for neostigmine methylsulfate injections in hospital settings, particularly for reversing neuromuscular blockade after surgeries, is another significant factor[1].

Broader Biologics and Biosimilars Adoption

The surge in the adoption of biologics and biosimilars, which are often used in conjunction with neostigmine methylsulfate to reverse muscle blocking effects during operations, also contributes to market growth. For instance, global spending on biosimilars increased by 35% from 2020 to 2021, leading to increased access to biologic treatments and subsequently higher demand for neostigmine methylsulfate[1].

Regional Insights

The neostigmine methylsulfate injection market is currently dominated by North America, primarily due to higher adoption rates of reversal agents in this region. However, the Asia Pacific region is expected to witness the fastest growth during the forecast period. This growth is driven by rising anticholinesterase overdose cases and increasing healthcare expenditures in countries like China and India[1].

Product Benefits and Convenience

The development of fixed-dose combination products, such as the combination of neostigmine methylsulfate and glycopyrrolate, offers several benefits:

• Reduced Administration Steps: This combination reduces the number of administration steps compared to using individual products, making it more convenient for clinicians[4].
• Less Waste: The fixed-dose combination may result in less waste of neostigmine and glycopyrrolate, as it eliminates the need for multiple vials or prefilled syringes[4].

Pharmacology and Clinical Use

Neostigmine methylsulfate is a competitive cholinesterase inhibitor that increases acetylcholine levels in the synaptic cleft, thereby reversing the effects of non-depolarizing NMBAs. Glycopyrrolate, an anticholinergic agent, is administered concurrently to mitigate the muscarinic effects (such as bradycardia and excessive secretions) associated with neostigmine[3][4].

Market Restraints and Challenges

Despite the growth potential, the market faces several restraints:

• Availability of Alternative Agents: The presence of alternative reversal agents like sugammadex sodium poses a challenge[1].
• Strict Regulatory Guidelines: Stringent regulatory requirements for drug approval can hinder market growth[1].
• Pricing Pressure: Market players face pricing pressure, which can impact profitability[1].
• Limited Research Funding: The limited funding for research on neostigmine methylsulfate can also act as a barrier to innovation and expansion[1].

Opportunities and Trends

There are several opportunities and trends that could shape the future of this market:

• Expanding Therapeutic Indications: Increasing research aimed at expanding the therapeutic indications of neostigmine methylsulfate could create new opportunities[1].
• Growing Geriatric Population: The growing geriatric population, which is more vulnerable to anticholinesterase poisoning, presents a potential market opportunity[1].
• Collaborations and Partnerships: Collaborations with key opinion leaders and research institutes can help market players strengthen their product portfolios and address challenges[1].

Key Players

The market is dominated by several key 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.[1].

Recent Developments

Recent developments include the approval of new fixed-dose combination products like Prevduo, which combines neostigmine methylsulfate and glycopyrrolate. This product has been approved for the reversal of non-depolarizing NMBAs in patients two years of age and older, offering a convenient and efficient option for clinicians[4].

Geriatric and Pediatric Considerations

• Geriatric Patients: Elderly patients may require dose adjustments due to age-related kidney problems, but the medication is generally considered safe for this population[2].
• Pediatric Patients: The guidelines for pediatric patients (age >2 years) follow adult guidelines, and there are ongoing discussions and studies to support the use of these medications in younger patients[3][4].

Financial Trajectory

The financial trajectory of the neostigmine methylsulfate injection market is positive, driven by the increasing demand and expanding therapeutic uses. Here are some key financial highlights:

• Market Size in 2023: US$ 156.7 million
• Projected Market Size by 2030: US$ 213.3 million
• CAGR: 4.5% during the forecast period[1].

Key Takeaways

• The neostigmine methylsulfate injection market is growing due to increasing prevalence of neuromuscular disorders and rising demand in hospital settings.
• The Asia Pacific region is expected to witness the fastest growth.
• Fixed-dose combination products offer convenience and reduce waste.
• Market restraints include alternative agents, strict regulatory guidelines, and pricing pressure.
• Expanding therapeutic indications and growing geriatric population present opportunities.

FAQs

Q: What is the primary use of neostigmine methylsulfate and glycopyrrolate? A: Neostigmine methylsulfate and glycopyrrolate are used to reverse the effects of non-depolarizing neuromuscular blocking agents after surgery[3][4].

Q: Which region is expected to witness the fastest growth in the neostigmine methylsulfate injection market? A: The Asia Pacific region is expected to witness the fastest growth due to rising anticholinesterase overdose cases and increasing healthcare expenditures[1].

Q: What are the benefits of the fixed-dose combination product of neostigmine methylsulfate and glycopyrrolate? A: The fixed-dose combination reduces administration steps, minimizes waste, and provides a convenient option for clinicians[4].

Q: What are some of the challenges faced by the neostigmine methylsulfate injection market? A: The market faces challenges such as the availability of alternative reversal agents, strict regulatory guidelines, pricing pressure, and limited research funding[1].

Q: Who are the key players in the neostigmine methylsulfate injection market? A: Key players include Pfizer Inc., Fresenius Kabi AG, Mylan N.V., Sandoz Inc., and others[1].

Cited Sources

1. Coherent Market Insights: Neostigmine Methylsulfate Injection Market Size by 2030.
2. Mayo Clinic: Neostigmine methylsulfate and glycopyrrolate (intravenous route).
3. FDA: Office of Clinical Pharmacology Review—Neostigmine and Glycopyrrolate.
4. FDA: Prevduo (Neostigmine methylsulfate and glycopyrrolate injection).