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Last Updated: December 22, 2024

NEOSTIGMINE METHYSULFATE Drug Patent Profile


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Which patents cover Neostigmine Methysulfate, and when can generic versions of Neostigmine Methysulfate launch?

Neostigmine Methysulfate is a drug marketed by Avet Lifesciences and is included in one NDA.

The generic ingredient in NEOSTIGMINE METHYSULFATE is neostigmine methylsulfate. There are nine drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Neostigmine Methysulfate

A generic version of NEOSTIGMINE METHYSULFATE was approved as neostigmine methylsulfate by FRESENIUS KABI USA on January 8th, 2015.

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Summary for NEOSTIGMINE METHYSULFATE
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:NEOSTIGMINE METHYSULFATE at DailyMed
Drug patent expirations by year for NEOSTIGMINE METHYSULFATE
Pharmacology for NEOSTIGMINE METHYSULFATE

US Patents and Regulatory Information for NEOSTIGMINE METHYSULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Avet Lifesciences NEOSTIGMINE METHYSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 208230-001 Nov 25, 2022 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Avet Lifesciences NEOSTIGMINE METHYSULFATE neostigmine methylsulfate SOLUTION;INTRAVENOUS 208230-002 Nov 25, 2022 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

NEOSTIGMINE METHYSULFATE Market Analysis and Financial Projection Experimental

Neostigmine Methylsulfate Market Dynamics and Financial Trajectory

Introduction to Neostigmine Methylsulfate

Neostigmine methylsulfate is a reversible cholinesterase inhibitor used primarily in the treatment of myasthenia gravis and as an antidote for non-depolarizing neuromuscular blocking agents. It works by inhibiting the acetylcholinesterase enzyme, thereby prolonging the action of acetylcholine and increasing neuromuscular transmission and muscle strength[2][5].

Market Size and Growth Projections

The global neostigmine methylsulfate injection market has been experiencing significant growth and is expected to continue this trend. As of 2022, the market size was valued at USD 156.54 million. Projections indicate that it will reach USD 228.43 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.4% during the forecast period from 2023 to 2031[2][3].

Segmentation of the Market

The neostigmine methylsulfate market is segmented based on several key factors:

By Type

  • The market is categorized into different purity levels, such as purity ≥98% and purity ≥99%[1].

By Application

  • The primary applications include injection solutions, reagents, and other uses. The myasthenia gravis segment is a major contributor to the market[2][5].

By Distribution Channel

  • Hospital pharmacies are expected to grow rapidly, driven by increasing hospitalizations for myasthenia gravis treatment and the reversal of neuromuscular blockade[2].

By Geographical Region

  • North America holds a significant revenue share due to increasing research and development and rising FDA approvals for various competitors[2].

Key Drivers of the Market

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

Increasing Geriatric Population

The elderly are more susceptible to neurological conditions like myasthenia gravis, which frequently requires treatment with neostigmine methylsulfate injections. This demographic shift is a significant driver of market growth[2][5].

Rising Medical Expenditures

Increased healthcare spending is expected to fuel the demand for neostigmine methylsulfate injections, particularly in regions with advanced healthcare systems[5].

Advancements in Veterinary Medicine

The use of neostigmine methylsulfate in veterinary medicine, especially for treating neuromuscular diseases in animals, presents new commercial opportunities and is expected to contribute to market growth[5].

Challenges and Restraints

Despite the positive growth trajectory, there are several challenges that could impact the market:

Lack of Knowledge and Diagnosis

Limited awareness and diagnosis of myasthenia gravis and other conditions treated with neostigmine methylsulfate can hamper market growth. Early detection and proper diagnosis are crucial for the effective use of this drug[5].

Regulatory Hurdles

Stringent regulatory requirements and the need for FDA approvals can slow down market growth. However, recent approvals and ongoing research are expected to mitigate this to some extent[2].

Major Key Players

The neostigmine methylsulfate injection market is dominated by several key players:

  • 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].

Regional Market Analysis

North America

This region is expected to record the maximum market share in terms of revenue. The presence of major pharmaceutical companies, increasing research and development, and rising FDA approvals are key factors driving growth in this region[2].

Europe and Asia-Pacific

These regions are also expected to see significant growth, driven by increasing healthcare expenditures and a growing geriatric population[2].

Financial Performance and Projections

The financial performance of the neostigmine methylsulfate market is robust, with a projected CAGR of 4.4% to 4.5% from 2023 to 2031. Here are some key financial metrics:

  • 2022 Market Size: USD 156.54 million
  • 2031 Projected Market Size: USD 228.43 million
  • CAGR: 4.4% to 4.5% during the forecast period[2][5].

Conclusion

The neostigmine methylsulfate market is poised for significant growth driven by an increasing geriatric population, rising medical expenditures, and advancements in veterinary medicine. Despite challenges such as lack of knowledge and diagnosis, the market is expected to expand substantially over the forecast period.

Key Takeaways

  • The neostigmine methylsulfate injection market is valued at USD 156.54 million in 2022 and is projected to reach USD 228.43 million by 2031.
  • The market is driven by an increasing geriatric population and rising medical expenditures.
  • North America holds a significant revenue share due to increasing research and development and FDA approvals.
  • Major key players include Pfizer Inc., Fresenius Kabi AG, and Mylan N.V.
  • The market faces challenges such as lack of knowledge and diagnosis.

Frequently Asked Questions (FAQs)

Q: What is the primary use of neostigmine methylsulfate? A: Neostigmine methylsulfate is primarily used in the treatment of myasthenia gravis and as an antidote for non-depolarizing neuromuscular blocking agents[2][5].

Q: What is the projected CAGR of the neostigmine methylsulfate injection market from 2023 to 2031? A: The projected CAGR is 4.4% to 4.5% during the forecast period[2][5].

Q: Which region holds the maximum market share in the neostigmine methylsulfate injection market? A: North America holds the maximum market share due to increasing research and development and rising FDA approvals[2].

Q: What are the major challenges facing the neostigmine methylsulfate market? A: The major challenges include lack of knowledge and diagnosis, and regulatory hurdles[5].

Q: Who are the major key players in the neostigmine methylsulfate injection market? A: Major key players include Pfizer Inc., Fresenius Kabi AG, Mylan N.V., and others[2].

Sources Cited

  1. Market Research Intellect, "Neostigmine Methylsulfate Market Size, Scope And Forecast Report".
  2. InsightAce Analytic, "Neostigmine Methylsulfate Injection Market Share, Size, Growth and ...".
  3. InsightAce Analytic, "Neostigmine Methylsulfate Injection Market Share, Size, Growth and ...".
  4. Avadel Pharmaceuticals PLC, "st - Avadel Pharmaceuticals PLC".
  5. Coherent Market Insights, "Neostigmine Methylsulfate Injection Market, By Dosage, By ...".

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