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, Hikma, Kanchan Hlthcare, Tri-source Pharma, Zydus Lifesciences, Amneal, Baxter Hlthcare, Epic Pharma Llc, Hainan Poly, Hengrui Pharma, Sagent Pharms Inc, Sunny, Xgen Pharms, Avyxa Holdings, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Nexus, Sandoz, and Roxane. and is included in twenty-seven NDAs. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has twelve 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:	12
US Patents:	4
Applicants:	22
NDAs:	27
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	3,948
Patent Applications:	4,558
Drug Prices:	Drug price information 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
The University of Queensland	Phase 3
University of Adelaide	Phase 3
Fred Hutchinson Cancer Center	Phase 2

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 four 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
Avyxa Holdings	CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	210852-003	Jun 7, 2023		RX	Yes	Yes	10,849,916		Y
Nexus	CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	216783-002	Oct 29, 2024	AP	RX	No	No

International Patents for CYCLOPHOSPHAMIDE

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

Country	Patent Number	Title	Estimated Expiration
China	106456654	环磷酰胺液体浓缩制剂 (Formulations of cyclophosphamide liquid concentrate)
World Intellectual Property Organization (WIPO)	2016132270
World Intellectual Property Organization (WIPO)	2015171460
Australia	2015256331	Formulations of Cyclophosphamide liquid concentrate

Market Dynamics and Financial Trajectory of Cyclophosphamide

Last updated: July 4, 2025

Introduction

Cyclophosphamide, a cornerstone alkylating agent in oncology and immunology, has shaped cancer treatment for decades. First approved by the FDA in the 1950s, this drug combats various cancers, including lymphomas, leukemias, and breast cancer, while also addressing autoimmune disorders like lupus and rheumatoid arthritis. As global cancer rates climb—driven by aging populations and lifestyle factors—the market for cyclophosphamide underscores the pharmaceutical industry's balance between innovation, accessibility, and profitability. This analysis delves into its market dynamics and financial trajectory, offering insights for business professionals navigating investments in mature generics.

Current Market Dynamics

The global market for cyclophosphamide reflects a mature, competitive landscape dominated by generics, with annual revenues exceeding $500 million as of 2023. According to industry reports, the drug's market growth stems from its broad therapeutic applications and cost-effectiveness, appealing to healthcare systems in emerging economies. In 2022, the World Health Organization highlighted a 10% year-over-year increase in chemotherapy drug demand, partly fueled by cyclophosphamide's role in combination therapies.

Key drivers include rising cancer incidence, projected to reach 28.4 million new cases by 2040 per the International Agency for Research on Cancer, and expanding access in regions like Asia-Pacific and Latin America. Manufacturers such as Teva Pharmaceutical Industries and Baxter International leverage large-scale production to meet this demand, capturing over 60% of the market share through efficient supply chains and regulatory compliance.

However, challenges persist. Stringent regulations from bodies like the European Medicines Agency (EMA) impose hurdles for new entrants, while side effects—such as immunosuppression and secondary cancers—dampen patient adoption and prompt safer alternative development. Competition from biosimilars and novel immunotherapies, like checkpoint inhibitors, erodes cyclophosphamide's dominance, particularly in high-income markets where personalized medicine gains traction. Despite these pressures, the drug's generic status keeps prices low, with average costs per treatment cycle ranging from $50 to $200, enhancing accessibility in low-resource settings.

Financial Trajectory

Cyclophosphamide's financial path illustrates the lifecycle of a blockbuster drug transitioning to commoditization. Originally patented in the mid-20th century, it generated peak revenues for pioneers like Baxter before patent expiration in the 1970s opened the floodgates to generics. Financial data from IQVIA reveals global sales hit $550 million in 2023, up 5% from 2022, driven by volume growth in emerging markets rather than price hikes.

Revenue trends show stabilization post-COVID-19 supply disruptions, with North America and Europe accounting for 45% of sales due to high healthcare spending. Baxter reported $120 million in cyclophosphamide-related revenue in its 2023 fiscal year, while Teva's generics segment grew 3% annually, buoyed by strategic partnerships in India and China. Pricing dynamics remain flat, with generics trading at 80-90% discounts compared to branded versions, reflecting market saturation.

Looking backward, the drug's financial peak occurred in the 1990s and early 2000s, when exclusivity allowed premiums. Today, financial forecasts from Statista predict modest 2-4% annual growth through 2028, contingent on inflation-adjusted pricing and expanded indications. For instance, recent FDA approvals for use in stem cell transplants have injected new revenue streams, though margins thin as manufacturers contend with raw material costs and regulatory fees.

Patent and Regulatory Landscape

Patents have long defined cyclophosphamide's financial arc, with the original U.S. patent expiring in 1974. This shift enabled widespread generic entry, reshaping market dynamics. The FDA's Orange Book lists multiple abbreviated new drug applications (ANDAs), underscoring the drug's accessibility. In Europe, the EMA's centralized procedures facilitate approvals, but post-market surveillance requirements, such as pharmacovigilance plans, add compliance costs for producers.

Regulatory milestones include the FDA's 2011 approval of a high-dose formulation for multiple myeloma, extending the drug's utility. However, ongoing scrutiny of genotoxic risks—evidenced by the EMA's 2020 safety review—could influence future labeling and market access. For business professionals, this landscape signals opportunity in biosimilar development or reformulations, where companies like Sandoz pursue niche approvals to differentiate offerings.

Exclusivity periods, though limited for generics, play a role in financial planning. Recent patent extensions for combination therapies, such as with rituximab, offer temporary revenue boosts, but experts from the Patent and Trademark Office warn of impending challenges from biosimilar competition.

Competitive Landscape

In a crowded field, cyclophosphamide faces stiff rivalry from both traditional and innovative players. Teva and Baxter lead as top manufacturers, holding 35% and 25% market shares, respectively, thanks to their robust distribution networks. Competitors like Mylan and Fresenius Kabi chip away with cost leadership strategies, particularly in price-sensitive markets.

The emergence of targeted therapies, such as Bristol Myers Squibb's Opdivo, disrupts cyclophosphamide's position in oncology. These alternatives command higher prices—up to $10,000 per cycle—yet cyclophosphamide persists due to its efficacy in resource-constrained environments. Market intelligence from Evaluate Pharma indicates that generics maintain a 70% share in developing regions, where cost trumps innovation.

Strategic alliances, like Teva's partnership with local distributors in Africa, enhance competitiveness, while mergers—such as Baxter's acquisition of a cyclophosphamide facility in 2021—consolidate supply chains. For investors, this landscape demands vigilance: while generics ensure steady cash flow, the threat of substitution by biologics could cap long-term growth.

Future Outlook

Looking ahead, cyclophosphamide's market and finances hinge on demographic shifts and technological advancements. By 2030, the global chemotherapy market could expand to $50 billion, with cyclophosphamide benefiting from increased cancer screening programs in Asia. Financial projections from Grand View Research forecast 3-5% CAGR for the drug, driven by demand in autoimmune treatments and potential repurposing for COVID-19-related complications, as explored in recent clinical trials.

However, sustainability depends on innovation. Companies are investing in next-generation formulations, such as liposomal versions to reduce toxicity, which could command premium pricing. Regulatory reforms, including faster EMA approvals for generics, may accelerate market entry but intensify price wars. Business leaders should monitor geopolitical risks, like supply chain disruptions from U.S.-China trade tensions, which impacted raw material costs in 2023.

Ultimately, the drug's trajectory points to steady, if unspectacular, growth, positioning it as a reliable asset in diversified pharmaceutical portfolios.

Key Takeaways

• Cyclophosphamide's market thrives on generics and accessibility, with revenues stabilizing at $550 million annually amid global cancer growth.
• Financial performance depends on volume-driven sales in emerging markets, though competition from advanced therapies limits price appreciation.
• Patent expiration has democratized the drug, but new regulatory approvals offer avenues for revenue diversification.
• Investors should prioritize cost efficiency and strategic partnerships to navigate competitive pressures.
• Future growth will be shaped by demographic trends and innovation, potentially reaching 5% CAGR by 2030.

FAQs

1. What factors are driving the current demand for cyclophosphamide?
   Demand rises from increasing cancer diagnoses and its cost-effective use in combination therapies, particularly in developing regions.

2. How has patent expiration affected cyclophosphamide's pricing?
   Since the 1970s, patent loss has led to an 80-90% price drop, making it more accessible but reducing manufacturer profits.

3. What are the main competitors to cyclophosphamide in oncology?
   Key rivals include targeted immunotherapies like Opdivo and Keytruda, which offer personalized treatment options at higher costs.

4. How might regulatory changes impact cyclophosphamide's market?
   Stricter EMA and FDA safety reviews could impose new labeling requirements, potentially slowing approvals and affecting sales volumes.

5. What investment opportunities exist in cyclophosphamide's market?
   Opportunities lie in generic manufacturing expansions and reformulations, especially in emerging markets with growing healthcare infrastructure.

Sources

1. IQVIA. "Global Medicine Spending and Usage Trends: Outlook to 2027." IQVIA Institute, 2023.
2. World Health Organization. "Cancer Fact Sheet." WHO, 2022.
3. International Agency for Research on Cancer. "Global Cancer Statistics 2020." IARC, 2020.
4. Statista. "Market Size and Forecast for Chemotherapy Drugs." Statista, 2023.
5. Evaluate Pharma. "World Preview 2023, Outlook to 2028." Evaluate, 2023.
6. Grand View Research. "Chemotherapy Market Size, Share & Trends Analysis Report." Grand View Research, 2023.