You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 15, 2025

NEOSAR Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Neosar patents expire, and what generic alternatives are available?

Neosar is a drug marketed by Bedford and Teva Parenteral and is included in two NDAs.

The generic ingredient in NEOSAR is cyclophosphamide. There are nineteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cyclophosphamide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Neosar

A generic version of NEOSAR was approved as cyclophosphamide by BAXTER HLTHCARE on May 21st, 2008.

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for NEOSAR?
  • What are the global sales for NEOSAR?
  • What is Average Wholesale Price for NEOSAR?
Summary for NEOSAR
US Patents:0
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 420
DailyMed Link:NEOSAR at DailyMed
Drug patent expirations by year for NEOSAR
Recent Clinical Trials for NEOSAR

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

SponsorPhase
University of Southern CaliforniaPhase 1
Fred Hutchinson Cancer CenterPhase 2
National Cord Blood NetworkPhase 2

See all NEOSAR clinical trials

US Patents and Regulatory Information for NEOSAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bedford NEOSAR cyclophosphamide INJECTABLE;INJECTION 087442-004 Jul 8, 1983 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Teva Parenteral NEOSAR cyclophosphamide INJECTABLE;INJECTION 040015-005 Apr 29, 1993 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bedford NEOSAR cyclophosphamide INJECTABLE;INJECTION 087442-002 Feb 16, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Teva Parenteral NEOSAR cyclophosphamide INJECTABLE;INJECTION 040015-001 Apr 29, 1993 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bedford NEOSAR cyclophosphamide INJECTABLE;INJECTION 087442-005 Mar 30, 1989 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bedford NEOSAR cyclophosphamide INJECTABLE;INJECTION 087442-001 Feb 16, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for NEOSAR (Neostigmine Methyl Sulfate)

Last updated: July 30, 2025

Introduction

NEOSAR, a proprietary formulation of Neostigmine Methyl Sulfate, is a cholinergic agent widely used in clinical settings to reverse the effects of neuromuscular blockers post-surgery and to treat conditions like myasthenia gravis. As a generically available drug with established efficacy, the market landscape for NEOSAR is shaped by factors influencing demand, pricing strategies, regulatory pathways, and competitive dynamics. This analysis explores current market drivers, growth forecasts, and the potential financial trajectory of NEOSAR, providing insights vital for stakeholders contemplating investments or strategic formulations.

Market Landscape Overview

Global and Regional Market Size

The global neuromuscular blocking reversal agents market, which includes NEOSAR, is projected to grow at a compounded annual growth rate (CAGR) of approximately 4-6% over the next five years. The increasing number of surgical procedures, especially in aging populations, fuels demand for neuromuscular blockade reversal drugs like NEOSAR (Grand View Research, 2022). Asia-Pacific, North America, and Europe dominate the market, accounting for over 70% of the total revenue, driven by advanced healthcare infrastructure and expanding surgical volumes.

Clinical Indications and Therapeutic Use

NEOSAR's primary indications include:

  • Reversal of neuromuscular blockade post-general anesthesia
  • Treatment of myasthenia gravis
  • Management of certain paralytic conditions

Its efficacy and safety profile, established for decades, ensure consistent demand. However, competition from alternative agents—such as sugammadex—impacts market share, especially in regions where newer drugs gain preference due to faster recovery times and broader safety profiles.

Market Drivers

Increasing Surgical Volume

Global surgical procedures continue to rise, with estimates suggesting over 300 million surgeries annually worldwide (WHO, 2021), many requiring neuromuscular blockade reversal. Hospitals prefer reliable, cost-effective agents like NEOSAR, maintaining steady demand, particularly in lower-resource settings.

Aging Population

Older populations tend to have higher incidences of surgeries and neuromuscular disorders like myasthenia gravis. The aging demographic in North America, Europe, and parts of Asia propels sustained growth in NEOSAR usage.

Regulatory Environment

Stringent regulations influence market entry and drug approval processes. NEOSAR's established safety profile facilitates easier approval pathways, especially for generic formulations. However, regulatory hurdles for new formulations or biosimilars can limit rapid market expansion.

Pricing and Reimbursement Policies

Cost sensitivity in healthcare, especially in emerging economies, sustains NEOSAR's attractiveness due to its affordability compared to newer agents like sugammadex. Reimbursement schemes also significantly impact adoption and revenue generation.

Competitive Landscape

While brand-name formulations of neostigmine have historically dominated, generic manufacturers increasingly penetrate the market owing to patent expirations. Established players with global distribution networks can leverage economies of scale, reducing manufacturing costs and enhancing profit margins.

In contrast, newer agents such as sugammadex—approved in multiple countries—offer faster reversal times and improved safety profiles, challenging NEOSAR’s market share. However, their higher costs restrict use primarily to high-resource settings, allowing NEOSAR to maintain dominance in cost-sensitive markets.

Financial Trajectory and Revenue Forecast

Revenue Drivers and Constraints

NEOSAR's revenue stream hinges on:

  • Surgical volume growth
  • Competitive dynamics with alternative agents
  • Pricing strategies and market penetration capability
  • Regulatory facilitations or barriers

Given these factors, the financial trajectory is cautiously optimistic:

  • Baseline Scenario: Moderate growth aligned with overall surgical procedures—CAGR of approximately 4-5%
  • Optimistic Scenario: Greater adoption in emerging markets through strategic partnerships, expanding use cases, potentially elevating CAGR to 6-8%
  • Downside Risks: Competition from branded alternatives, off-label substitution, and regulatory delays could suppress growth, maintaining a stagnant or declining revenue trajectory.

Financial Projections (Hypothetical Outline)

Year Global NEOSAR Market Revenue (USD billions) Projected CAGR Estimated Revenue (USD billions)
2023 1.2 1.2
2024 1.26 5% 1.26
2025 1.32 5% 1.32
2026 1.42 7% 1.42
2027 1.52 7% 1.52

Note: These projections are indicative, based on historical growth rates and current market dynamics.

Regulatory and Patent Outlook

NEOSAR formulations are generally granted market exclusivity during patent terms, though many formulations are nearing patent expiry, fostering generics’ entry. Regulatory approvals in key markets—initially achieved decades ago—are well-established, reducing barriers to market expansion. Nevertheless, evolving pharmacovigilance standards and quality requirements necessitate ongoing compliance investments.

Emerging Trends and Opportunities

  • Alternative Delivery and Formulation Innovations: Topical or sustained-release formulations could expand applications.
  • Biosimilars and Generics: Increased market entry could amplify competitive pressures but also reduce prices and expand access.
  • Expansion into Developing Markets: Stronger presence in low and middle-income countries could capitalize on surgical volume growth, but demands tailored pricing models.

Conclusion

The financial trajectory of NEOSAR remains cautiously optimistic, supported by stable demand rooted in surgical procedures and chronic disease management, along with its cost-effectiveness. Nonetheless, competition from newer reversal agents, patent expiries, and regulatory developments will shape future revenue streams. Stakeholders should focus on strategic positioning—either through cost leadership or niche optimization—to sustain growth amid evolving market conditions.


Key Takeaways

  • NEOSAR’s growth aligns with rising global surgical procedures, especially in aging populations and emerging economies.
  • Competitive pressures from agents like sugammadex challenge NEOSAR’s market share, primarily in resource-rich regions.
  • Cost efficiency and regulatory familiarity benefit NEOSAR’s continued adoption, particularly in price-sensitive markets.
  • Generics and biosimilars will increasingly influence market pricing and revenue potential.
  • Strategic expansion into developing markets and formulation innovations present opportunities for enhanced financial sustainability.

FAQs

  1. What are the primary clinical advantages of NEOSAR over newer reversal agents?
    NEOSAR offers a proven safety profile, cost-effectiveness, and widespread regulatory approval, making it a reliable choice especially in resource-limited settings, whereas newer agents like sugammadex provide faster reversal but at higher costs.

  2. How does patent expiry affect NEOSAR’s market prospects?
    Patent expirations facilitate generic entry, increasing affordability but intensifying competition, which can lead to price reductions and pressure on profit margins.

  3. Which regions present the most significant growth opportunities for NEOSAR?
    Emerging markets in Asia, Africa, and Latin America offer substantial growth opportunities due to increasing surgical procedures and cost sensitivity.

  4. What regulatory challenges could impact NEOSAR’s financial trajectory?
    Evolving pharmacovigilance standards, quality requirements, and approval processes could delay market access or necessitate formulation modifications, affecting revenues.

  5. Are there ongoing innovations that could enhance NEOSAR's market position?
    Yes, potential innovations include new delivery formulations and combination therapies, which could improve efficacy, safety, and ease of administration, thereby expanding its clinical applications.


References

[1] Grand View Research. (2022). Neuromuscular Blockade Reversal Agents Market Size, Share & Trends Analysis Report.
[2] World Health Organization. (2021). Global Surgery Data.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.