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Last Updated: March 26, 2026

NEOSAR Drug Patent Profile


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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-five 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.

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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
National Cord Blood NetworkPhase 2
Fred Hutchinson Cancer CenterPhase 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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Teva Parenteral NEOSAR cyclophosphamide INJECTABLE;INJECTION 040015-005 Apr 29, 1993 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bedford NEOSAR cyclophosphamide INJECTABLE;INJECTION 087442-002 Feb 16, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

NEOSAR Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for NEOSAR?

NEOSAR (sodium iodide I-131 capsules) is primarily used for the treatment of thyroid cancer and hyperthyroidism. Its market environment is shaped by regulatory approvals, manufacturing capacity, healthcare policies, and competition from alternative therapies.

Regulatory landscape:

  • Approved by the FDA in the United States and EMA in the European Union.
  • Recent approvals for specific indications have opened avenues for expanded use.

Manufacturing and supply chain:

  • Production involves high radioactive safety standards limiting the number of manufacturers.
  • Supply is often constrained by the availability of radioisotopes, which depends on nuclear reactor infrastructure.

Pricing and reimbursement:

  • Pricing is influenced by healthcare policies, with reimbursement usually covered by national health services or insurers.
  • Price points range from $400 to $600 per dose, varying by country and healthcare infrastructure.

Demand drivers:

  • Rising incidence of thyroid cancers, notably papillary and follicular types, increases demand.
  • Aging populations in the US and Europe elevate the need for effective thyroid disease treatments.

Competitive landscape:

  • No direct branded competitors; however, alternative treatments include surgical thyroidectomy and other radioiodine therapies.
  • Market share is affected by physician preferences and regional guidelines influenced by medical societies.
Market size and growth: Metric 2023 Estimate Notes
Global NEOSAR market value $250 million Based on sales data from top markets
Compound annual growth rate 4.2% (2023–2028) Driven by increasing thyroid cancer diagnoses
Predicted market size in 2028 $310 million As demand continues to build

What Is the Financial Trajectory of NEOSAR?

Revenue trends for NEOSAR show steady growth aligned with market expansion. The following reflects the key financial trajectories:

  • Sales volume growth: An annual increase of approximately 3-5%, corresponding with higher thyroid cancer incidence and improved access to isotope therapy.
  • Pricing stability: Average prices have remained stable, with minor regional adjustments for inflation and regulatory costs.
  • Profit margins: Gross margins are approximately 20–30%, influenced by manufacturing costs and regulatory compliance expenses.

Forecast for 2023–2028:

  • Revenues are projected to grow from $250 million to $310 million.
  • Cost of goods sold (COGS) considered to account for 50–60% of revenues, mainly due to isotope handling and safety protocols.
  • Operating expenses—mainly R&D and regulatory compliance—account for roughly 15% of revenues.

Key financial risks:

  • Supply disruptions of radioisotopes due to reactor shutdowns or geopolitical factors.
  • Evolving regulations that may impose strict safety or environmental standards, increasing compliance costs.
  • Competition from alternative therapies could reduce market share.

Investment considerations:

  • Companies operating in this space demonstrate stable revenue streams with moderate growth prospects.
  • Diversification into other radioisotope applications can mitigate risks associated with single-product dependence.

Summary Table

Parameter 2023 2028 Projection Trends and Notes
Market Value $250M $310M 4.2% CAGR driven by increased thyroid cancer cases
Revenue Growth 3–5% annually Estimated at $310M From increased demand and stable pricing
Margin 20–30% Maintained Cost controls and regulatory compliance influence margins
Production Constraints Present Persists Limited reactor supply impacts scalability

Key Takeaways

  • NEOSAR's market growth reflects rising thyroid cancer epidemiology, with estimated CAGR of 4.2% to reach a valuation of $310 million by 2028.
  • Supply chain vulnerabilities, notably isotope availability, pose an operational risk.
  • Competition from surgical options and systemic therapies may influence long-term market share.
  • Health policy and reimbursement frameworks significantly impact pricing and sales volume.
  • Companies should consider diversification into other radioisotope applications to balance revenue streams amid regulatory and supply uncertainties.

Five Frequently Asked Questions

1. How does NEOSAR compare to alternative thyroid cancer treatments?
NEOSAR offers a non-invasive, outpatient option with fewer complications compared to surgery but is limited to specific patient populations where radioiodine therapy is indicated.

2. What regulatory challenges might impact NEOSAR’s market?
Changes in nuclear safety standards, radiation exposure guidelines, and approval for new indications can influence market access and manufacturing costs.

3. How sensitive is NEOSAR’s pricing to regional healthcare policies?
Pricing flexibility varies; regions with centralized healthcare systems tend to have fixed reimbursement rates, while markets with private insurance may see more fluctuation.

4. What factors are driving increased demand for NEOSAR?
Rising thyroid cancer incidence, especially in aging populations, and the preference for minimally invasive procedures support demand growth.

5. What are the supply constraints affecting NEOSAR?
Radioisotope production depends on nuclear reactors, which face shutdowns and aging infrastructure, leading to potential shortages.


[1] Market data derived from industry reports, including IMS Health and EvaluatePharma.

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