Last Updated: June 17, 2026

MUSTARGEN Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Mustargen is a drug marketed by Recordati Rare and is included in one NDA.

The generic ingredient in MUSTARGEN is mechlorethamine hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the mechlorethamine hydrochloride profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for MUSTARGEN?
  • What are the global sales for MUSTARGEN?
  • What is Average Wholesale Price for MUSTARGEN?
Summary for MUSTARGEN
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for MUSTARGEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Recordati Rare MUSTARGEN mechlorethamine hydrochloride INJECTABLE;INJECTION 006695-001 Approved Prior to Jan 1, 1982 DISCN Yes 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

Investment Scenario and Fundamentals Analysis of Mustargen (Mechlorethamine)

Last updated: February 27, 2026

What is Mustargen?

Mustargen (mechlorethamine) is an alkylating agent primarily used in chemotherapy. It treats Hodgkin lymphoma, non-Hodgkin lymphoma, and some other cancers. It is available as an injection, with limited oral formulation options.

Market Overview

The global cancer therapeutics market was valued at approximately $161 billion in 2022, with chemotherapy agents contributing a significant share. Mustargen represents a niche product within the chemotherapy segment, primarily used in combo regimens for hematological cancers.

Competitive Landscape

Mustargen faces limited direct competition within its use cases due to its specific application in lymphoma protocols. However, it competes with other alkylating agents such as cyclophosphamide, chlorambucil, and newer targeted therapies that may replace traditional chemotherapy in certain settings.

Key Competing Drugs Market Position Administration Method Approval Status Price Range (per dose)
Cyclophosphamide Widely used Oral, IV Globally $40–$80
Bendamustine Growing in use IV US, EU $200–$300
Cyclophosphamide + Rituximab Standard in certain regimens IV US, EU $150–$250

Mustargen is off patent, with no recent major patent activity, positioning it as a generic drug with limited pricing power.

Regulatory & Supply Dynamics

The drug has longstanding approval status from the FDA and EMA, with no recent regulatory changes. Manufacturing involves complex handling due to its cytotoxic nature, constraining supply to specialized facilities.

Investment Fundamentals

Revenue prospects

  • Limited to niche indications, restricting growth potential.
  • Therapeutic positioning as a legacy chemotherapy drug diminishes its influence in markets prioritizing targeted therapies.
  • Pricing fluctuations are minimal; no patent exclusivity provides no pricing leverage.

Cost structure

  • Manufacturing and distribution costs are relatively high, owing to safety regulations.
  • No recent R&D investments; product remains a standard of care without innovation.

Market Trends

  • Rising adoption of targeted therapies and immuno-oncology agents reduces demand for traditional chemotherapeutic agents.
  • Preference shift in developed markets toward oral and outpatient options improves patient convenience but favors drugs with newer delivery methods.

Patent & Regulatory Outlook

  • No patents held; patent expiration for related formulations occurred decades ago.
  • Regulatory environment is stable; no new approvals or restrictions are expected.

Financial Outlook

  • Marginal revenue streams due to its niche use and generic status.
  • Marginal margins driven by manufacturing costs.
  • Limited growth prospects absent significant new indications or formulations.

Investment Risks

  • Obsolescence due to advent of targeted, less-toxic therapies.
  • Decline in use for traditional indications.
  • Regulatory or safety concerns affecting supply or usage guidelines.

Opportunities

  • Potential for reformulation into targeted delivery systems.
  • Use in niche or experimental indications with emerging evidence.
  • Supply chain China or India manufacturing expansion reducing costs.

Conclusion

Mustargen presents minimal growth potential, constrained by its status as an old, generic chemotherapeutic agent. Its high manufacturing costs, limited indications, and the shift toward targeted therapies suggest declining relevance. Investment would hinge on identifying niche applications, manufacturing innovations, or strategic partnerships rather than intrinsic drug value.

Key Takeaways

  • Mustargen is a longstanding chemotherapy agent with limited growth prospects.
  • Market competition is strong, with many equivalents and newer targeted therapies.
  • No patent protections or recent innovation activity.
  • The drug's role is diminishing in modern oncology treatment paradigms.
  • Investment potential remains limited to niche markets or manufacturing efficiencies.

FAQs

Q1: What are the primary indications for Mustargen?
A1: Hodgkin lymphoma, non-Hodgkin lymphoma, and various sarcomas, primarily in combination chemotherapy regimens.

Q2: Is Mustargen patent-protected?
A2: No, it has no current patent protection; it is available as a generic.

Q3: How does the competitive landscape affect Mustargen's market?
A3: The widespread availability of alternative chemotherapeutic agents and the rise of targeted therapies reduce its market share.

Q4: Are there any recent regulatory updates for Mustargen?
A4: No, the drug has long-standing approval status with no recent or upcoming changes expected.

Q5: What factors could improve Mustargen's market outlook?
A5: Development of new formulations or indications, strategic repositioning, or manufacturing cost reductions could provide limited upside.

References

  1. Market Research Future. (2023). Cancer Therapeutics Market Report.
  2. U.S. Food and Drug Administration. (2022). Mustargen (mechlorethamine) NDA approvals.
  3. EvaluatePharma. (2022). Oncology drug market analysis.
  4. European Medicines Agency. (2022). Oncology drug approvals and updates.
  5. Ibrahim, S. A., et al. (2022). Trends in chemotherapy usage in hematological cancers. Journal of Oncology Pharmacy Practice.

More… ↓

⤷  Start Trial

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.