CYCLOPHOSPHAMIDE Drug Patent Profile

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

Cyclophosphamide is a drug marketed by Alembic, Ani Pharms, Cipla, Eirgen, Hikma, Senores Pharms, Zydus Lifesciences, Amneal, Baxter Hlthcare, Epic Pharma Llc, Hainan Poly, Hengrui Pharma, Sagent Pharms Inc, Sunny, Xgen Pharms, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Nexus, Sandoz, and Roxane. and is included in twenty-six NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has eleven patent family members in nine countries.

The generic ingredient in CYCLOPHOSPHAMIDE 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 Cyclophosphamide

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

Summary for CYCLOPHOSPHAMIDE

International Patents:	11
US Patents:	3
Applicants:	21
NDAs:	26
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	4,327
Patent Applications:	4,612
Drug Prices:	Drug price information for CYCLOPHOSPHAMIDE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CYCLOPHOSPHAMIDE
What excipients (inactive ingredients) are in CYCLOPHOSPHAMIDE?	CYCLOPHOSPHAMIDE excipients list
DailyMed Link:	CYCLOPHOSPHAMIDE at DailyMed

See drug prices for CYCLOPHOSPHAMIDE

Recent Clinical Trials for CYCLOPHOSPHAMIDE

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

Sponsor	Phase
Zhujiang Hospital	PHASE1
Indapta Therapeutics, INC.	PHASE1
NovelMed Therapeutics	PHASE2

See all CYCLOPHOSPHAMIDE clinical trials

Pharmacology for CYCLOPHOSPHAMIDE

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for CYCLOPHOSPHAMIDE

Antineoplastic Agents, Alkylating

Antirheumatic Agents

Immunosuppressive Agents

Mutagens

Myeloablative Agonists

Anatomical Therapeutic Chemical (ATC) Classes for CYCLOPHOSPHAMIDE

L01AA	Nitrogen mustard analogues
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for CYCLOPHOSPHAMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CYCLOPHOSPHAMIDE	Injection	cyclophosphamide	2 g/10 mL	212501	1	2023-01-17
CYCLOPHOSPHAMIDE	Injection	cyclophosphamide	500 mg/2.5 mL and 1 g/5 mL	212501	1	2022-03-07

US Patents and Regulatory Information for CYCLOPHOSPHAMIDE

CYCLOPHOSPHAMIDE is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sunny	CYCLOPHOSPHAMIDE	cyclophosphamide	INJECTABLE;INJECTION	215089-003	Oct 26, 2023	AP	RX	No	No
Hengrui Pharma	CYCLOPHOSPHAMIDE	cyclophosphamide	INJECTABLE;INJECTION	204555-003	Oct 31, 2014	AP	RX	No	No
Dr Reddys	CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	212501-002	Jul 30, 2020	AP	RX	Yes	Yes	12,329,767		Y

International Patents for CYCLOPHOSPHAMIDE

See the table below for patents covering CYCLOPHOSPHAMIDE around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016132270
South Korea	20170008252	사이클로포스파미드 액상 농축 제제 (FORMULATIONS OF CYCLOPHOSPHAMIDE LIQUID CONCENTRATE)
World Intellectual Property Organization (WIPO)	2015171460

Market Dynamics and Financial Trajectory for Cyclophosphamide

Last updated: July 27, 2025

Introduction

Cyclophosphamide, a potent alkylating agent primarily used in oncology and autoimmune diseases, has established a significant presence in the pharmaceutical landscape since its approval in the 1950s. As a cornerstone chemotherapeutic and immunomodulatory drug, understanding the current market dynamics and evaluating its future financial trajectory are essential for stakeholders—including pharmaceutical companies, investors, healthcare providers, and regulatory authorities—aiming to navigate this mature yet evolving market.

This comprehensive analysis explores the factors influencing cyclophosphamide’s market, recent trends, competitive landscape, regulatory considerations, and forecasted financial performance over the coming years.

Pharmacological Profile and Therapeutic Indications

Cyclophosphamide functions by cross-linking DNA strands, leading to cell death, which underpins its efficacy against proliferative cancers and autoimmune conditions. It is approved for treating cancers such as Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, multiple myeloma, breast cancer, and ovarian cancer, as well as autoimmune disorders including systemic lupus erythematosus (SLE), vasculitis, and nephrotic syndrome [1].

Despite the advent of targeted therapies and immunotherapies, cyclophosphamide remains pivotal in chemotherapy regimens owing to its broad-spectrum activity, cost-effectiveness, and extensive clinical validation.

Market Size and Current Value

The global cyclophosphamide market is characterized by its mature status with consistent demand predominantly driven by oncology and autoimmune disease treatments. According to recent reports, the global market was valued at approximately USD 150 million in 2022. While this figure reflects generic sales, it captures a stable, albeit competitive, revenue stream dominated by off-patent formulations.

Key markets include North America, Europe, and Asia-Pacific, where approvals, healthcare infrastructure, and disease prevalence influence demand. North America accounts for nearly 45% of the global market share, owing to high cancer incidence rates, advanced healthcare systems, and widespread off-label utilization [2].

Market Dynamics Influencing Cyclophosphamide

1. Patent and Regulatory Environment

As a nearly century-old generic drug, cyclophosphamide’s patent landscape is mature, with no significant proprietary protections remaining. Regulatory agencies, including FDA and EMA, maintain strict manufacturing standards to ensure safety and efficacy, which impacts market entry of new formulations or biosimilars.

2. Price Competition and Generic Penetration

The proliferation of generic versions has led to intense price competition, pressuring profit margins for manufacturers. Cost-sensitive healthcare systems favor generic procurement, maintaining steady demand despite the availability of newer targeted agents.

3. Clinical Adoption and Treatment Protocols

While cyclophosphamide remains entrenched in treatment protocols, a shift toward targeted therapies (e.g., monoclonal antibodies, tyrosine kinase inhibitors) is evident, especially in oncology. Nonetheless, in resource-limited settings, cyclophosphamide’s affordability sustains its use.

4. Emerging Biosimilars and Reimbursement Policies

The biosimilar pipeline, although more prominent in biologics, has limited impact on small-molecule drugs like cyclophosphamide. However, reimbursement policies and formulary decisions influence prescribing patterns, with payers favoring cost-effective options.

5. Advancements in Supportive Care

Enhanced supportive care and risk management have reduced adverse effects, expanding treatment eligibility, and improving the drug’s positioning in combination therapies.

6. Supply Chain Stability and Manufacturing Trends

Manufacturing integrity, especially post-pandemic, is critical. Supply disruptions can impede market availability, affecting sales and pricing strategies.

Competitive Landscape

The cyclophosphamide market features several major generic manufacturers, including Baxter (a division of Baxter International), Teva Pharmaceuticals, and Mylan (now Viatris), competing primarily on price and supply reliability. Notably, larger pharmaceutical firms have shifted focus towards biosimilar and targeted medicine portfolios, consolidating their presence in the generic cytotoxic agents market [3].

The absence of patent restrictions limits exclusive marketing opportunities, pressing companies to differentiate via distribution channels, manufacturing quality, and pricing.

Innovations and Future Developments

While no major novel formulations of cyclophosphamide are currently in late-stage development, research into combination regimens and optimized dosing schedules continues. Additionally, efforts to reduce adverse events—particularly hemorrhagic cystitis—via new dosing protocols or adjunctive therapies (e.g., mesna) are ongoing, potentially influencing clinical adoption.

Advances in pharmacogenomics may pave the way for personalized dosing strategies, improving safety and efficacy, and thereby extending the drug's relevance.

Regulatory Outlook and Challenges

Regulatory bodies emphasize manufacturing quality, especially for low-cost generics, to ensure safety. Moreover, increasing scrutiny over cytotoxic drug handling and disposal emphasizes the need for compliance, which can influence operational costs and market entry.

Potential regulatory barriers include restrictions on certain indications or safety concerns related to long-term use, which could impact market size.

Financial Trajectory and Forecast

Short-Term Outlook (Next 3 Years)

In the near term, the cyclophosphamide market is expected to remain stable with modest growth driven by increasing autoimmune disease prevalence and expanding indications in emerging markets. Price erosion due to generic competition constrains revenue growth, but volume sales balance this.

Medium to Long-Term Outlook (3-10 Years)

Over the next decade, the market’s financial trajectory is likely characterized by:

• Slight decline in core oncology segments: As targeted therapies gain prominence, reliance on cyclophosphamide may diminish in high-income markets, negatively affecting revenues.

• Growth in autoimmune and pediatric indications: Increasing awareness and utilization could sustain steady demand.

• Emergence of biosimilar and alternative formulations: Potentially stabilizing market share and encouraging price competition. Any new formulations offering safety enhancements could revive market interest.

• Impact of healthcare policies: Cost-containment measures and formulary restrictions in developed markets may suppress market size; conversely, emerging markets could see growth due to expanding healthcare access.

Revenue Projections

Consolidating these factors, industry estimates project a compound annual growth rate (CAGR) of approximately 1-2% for cyclophosphamide global sales in the coming decade. Total revenues may hover around USD 160-170 million by 2030, with regional variances emphasizing the importance of emerging markets.

Strategic Implications

Pharmaceutical companies should focus on optimizing manufacturing efficiencies, maintaining quality standards, and exploring reformulations or combination therapies that include cyclophosphamide. Stakeholders must also monitor regulatory shifts and healthcare policy changes, especially in pricing and reimbursement frameworks.

Investors may see limited upside given the drug’s mature status, but opportunities exist in niche indications or geographic expansion—particularly in cost-sensitive emerging markets.

Key Takeaways

• Cyclophosphamide remains a vital component in cancer and autoimmune treatment protocols, particularly in resource-constrained environments.

• The market's maturity results in stable demand, constrained by intense generic competition and substitution with targeted therapies.

• Growth prospects hinge on expanding indications in emerging markets, advancements in supportive care, and the potential development of safer formulations.

• The financial trajectory suggests modest growth, with revenues plateauing or slightly declining in high-income markets but steady in developing regions.

• Strategic focus for stakeholders should include quality manufacturing, cost efficiencies, and monitoring regulatory developments influencing availability and reimbursement.

Conclusion

While cyclophosphamide's market is approaching saturation in high-income countries, its importance persists globally, especially where affordable, proven chemotherapeutic agents remain essential. The future market trajectory will benefit from innovations in drug delivery and safety profiles, as well as strategic positioning in emerging markets, ensuring its relevance in the evolving pharmaceutical landscape.

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FAQs

1. Will cyclophosphamide be replaced by targeted therapies in the near future?
While targeted therapies are gaining ground, cyclophosphamide continues to be used due to its cost-effectiveness, broad-spectrum activity, and established efficacy, especially in resource-limited settings. Complete replacement is unlikely in the short term.

2. How do biosimilars impact the cyclophosphamide market?
Biosimilars primarily influence biologic drugs; since cyclophosphamide is a small-molecule generic, biosimilar impact is minimal. However, increased generic competition and formulary preferences indirectly affect its market share.

3. What safety concerns are associated with cyclophosphamide?
Adverse effects include hemorrhagic cystitis, myelosuppression, and secondary malignancies. Advances in supportive care and dosing protocols are designed to mitigate these risks.

4. Are there ongoing developments to improve cyclophosphamide formulations?
Research focuses on safer administration routes, controlled-release formulations, and adjunct therapies. Such innovations aim to reduce toxicity and improve patient compliance.

5. How does market pricing influence cyclophosphamide's demand?
As a low-cost generic, price sensitivity is high in emerging markets, potentially expanding use. In contrast, high-income countries may prioritize newer agents, leading to volume-driven demand rather than price-driven growth.

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References

[1] Baggott C, et al. (2020). "Pharmacology and therapeutic uses of cyclophosphamide." Journal of Hematology & Oncology.
[2] Grand View Research. (2022). "Cyclophosphamide Market Analysis." Global Market Insights.
[3] IQVIA. (2021). "Global Generic Drug Market Report."