Cyclophosphamide - Generic Drug Details

What are the generic drug sources for cyclophosphamide and what is the scope of freedom to operate?

Cyclophosphamide is the generic ingredient in five branded drugs 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, Bedford, Teva Parenteral, Avyxa Holdings, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma Speclts, Nexus, Sandoz, and Roxane, and is included in thirty-one NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cyclophosphamide has twelve patent family members in nine countries.

There are nineteen drug master file entries for cyclophosphamide. Twenty-four suppliers are listed for this compound.

Summary for cyclophosphamide

International Patents:	12
US Patents:	4
Tradenames:	5
Applicants:	24
NDAs:	31
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	3,948
Patent Applications:	7,455
Drug Prices:	Drug price trends 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
University of Adelaide	Phase 3
The University of Queensland	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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Parenteral	NEOSAR	cyclophosphamide	INJECTABLE;INJECTION	040015-002	Apr 29, 1993		DISCN	No	No
Baxter Hlthcare	CYTOXAN (LYOPHILIZED)	cyclophosphamide	INJECTABLE;INJECTION	012142-008	Jan 4, 1984		DISCN	Yes	No
Hikma	CYCLOPHOSPHAMIDE	cyclophosphamide	INJECTABLE;INJECTION	216958-003	Dec 18, 2023	AP	RX	No	No
Dr Reddys	CYCLOPHOSPHAMIDE	cyclophosphamide	SOLUTION;INTRAVENOUS	212501-003	Nov 19, 2021		RX	Yes	Yes	10,993,952		Y
Hainan Poly	CYCLOPHOSPHAMIDE	cyclophosphamide	INJECTABLE;INJECTION	218632-002	Dec 26, 2024	AP	RX	No	No
Epic Pharma Llc	CYCLOPHOSPHAMIDE	cyclophosphamide	INJECTABLE;INJECTION	218644-001	Dec 19, 2024	AP	RX	No	No

Expired US Patents for cyclophosphamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	CYTOXAN (LYOPHILIZED)	cyclophosphamide	INJECTABLE;INJECTION	012142-010	Sep 24, 1985	4,537,883
Baxter Hlthcare	CYTOXAN (LYOPHILIZED)	cyclophosphamide	INJECTABLE;INJECTION	012142-008	Jan 4, 1984	4,537,883
Baxter Hlthcare	CYTOXAN (LYOPHILIZED)	cyclophosphamide	INJECTABLE;INJECTION	012142-009	Dec 10, 1985	4,537,883
Baxter Hlthcare	LYOPHILIZED CYTOXAN	cyclophosphamide	INJECTABLE;INJECTION	012142-007	Dec 10, 1985	4,537,883
Baxter Hlthcare	LYOPHILIZED CYTOXAN	cyclophosphamide	INJECTABLE;INJECTION	012142-006	Dec 5, 1985	4,537,883

International Patents for cyclophosphamide

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
Japan	2017514924	シクロホスファミド液状濃縮物の製剤
World Intellectual Property Organization (WIPO)	2016005962
World Intellectual Property Organization (WIPO)	2015171460
European Patent Office	3139929	FORMULATIONS D'UN CONCENTRÉ LIQUIDE DE CYCLOPHOSPHAMIDE (FORMULATIONS OF CYCLOPHOSPHAMIDE LIQUID CONCENTRATE)

Market Dynamics and Financial Trajectory for Cyclophosphamide

Introduction

Cyclophosphamide is a versatile chemotherapy medication and alkylating agent used to treat various types of cancer, autoimmune diseases, and other conditions. Understanding the market dynamics and financial trajectory of cyclophosphamide is crucial for stakeholders in the pharmaceutical industry.

Market Segmentation

The cyclophosphamide market is segmented in several key ways:

By Type

• High-Dose: Used for aggressive treatments, particularly in cancer therapy.
• Low-Dose: Often used for maintenance therapy and in treating autoimmune diseases[1][3][4].

By Application

• Cancer: Treats various types of cancer, including bone and bone marrow cancer, blood cell cancer, lung cancer, breast cancer, and eye cancer.
• Autoimmune Diseases: Used to treat conditions such as nephrotic syndrome, AL amyloidosis, and other autoimmune disorders.
• Other Applications: Includes treatments for other conditions where immunosuppression is necessary[1][3][4].

By End-Use

• Clinical: Used in clinical settings for patient treatment.
• Hospital: Administered in hospital environments.
• Medical: Used in medical offices and outpatient clinics.
• Personal: For patients requiring ongoing treatment at home[1][4].

Market Drivers

Several factors drive the growth of the cyclophosphamide market:

Rising Demand for Cancer Treatment

The increasing incidence of cancer globally has led to a higher demand for effective chemotherapy agents like cyclophosphamide. This demand is expected to continue, driving market growth[1][3][4].

Growth in Healthcare Industry

The rapid expansion of the healthcare industry, particularly in regions like Asia Pacific, is contributing to the increased adoption of cyclophosphamide. This growth is fueled by better healthcare infrastructure and increased access to medical services[1][3].

Use in Autoimmune Diseases

Cyclophosphamide's effectiveness in treating autoimmune diseases such as nephrotic syndrome and AL amyloidosis also drives its market growth. The higher adoption of the drug in these areas, especially in North America, is a significant factor[1][3].

Market Restraints

Despite the growth drivers, there are several restraints that affect the market:

Limitations in Consumption

Cyclophosphamide cannot be taken by pregnant women due to its potential to affect fertility. Additionally, it must be prescribed by certified doctors, which limits its use and can hamper market growth[1].

Side Effects

The drug has several serious side effects, including infections, hemorrhagic cystitis, heart problems, and liver disease. These side effects can deter some patients and healthcare providers, impacting market growth[5].

Financial Trajectory

The financial outlook for the cyclophosphamide market is promising:

Market Size

• The global cyclophosphamide market was estimated to be worth US$ 693 million in 2023 and is forecasted to reach US$ 807.9 million by 2030, with a Compound Annual Growth Rate (CAGR) of 2.2% during the forecast period[4].

Regional Growth

• Asia Pacific is anticipated to witness significant growth due to the rapid expansion of the healthcare industry and an increase in cancer and other diseases in the region.
• North America will see growth driven by the higher adoption of cyclophosphamide in treating nephrotic syndrome and AL amyloidosis.
• Europe's growth is attributed to the increasing use of cyclophosphamide in hospitals and clinics[1][3].

Key Players

The market is dominated by several key players:

• Baxter Laboratories Ltd.
• Novartis AG
• Himka Pharmaceuticals Plc.
• Amneal Pharmaceuticals LLC
• Aurobindo Pharma Ltd.
• LGM Pharma LLC
• Genentech USA, Inc.
• Ocean pharmaceutical
• Caprion Biosciences
• Other notable players[1][4].

Cost and Financial Assistance

The cost of cyclophosphamide can vary based on several factors:

Factors Affecting Cost

• Treatment Plan: The specific dosage and duration of treatment.
• Insurance Coverage: The type and extent of insurance coverage.
• Pharmacy: The cost can differ depending on the pharmacy used[2].

Financial Assistance

• Patients can benefit from financial assistance programs, such as copay assistance and drug assistance programs.
• Organizations like AmeriPharma Specialty Care provide significant financial assistance to patients, helping alleviate the financial burden of the medication[2][5].

Conclusion

The cyclophosphamide market is poised for significant growth driven by increasing demand for cancer and autoimmune disease treatments, along with the expansion of the healthcare industry. However, the market faces restraints due to limitations in consumption and potential side effects. Understanding these dynamics is crucial for pharmaceutical companies, healthcare providers, and patients alike.

Key Takeaways

• Cyclophosphamide is a critical medication for treating various types of cancer and autoimmune diseases.
• The market is segmented by type, application, and end-use.
• Key drivers include rising demand for cancer treatment and growth in the healthcare industry.
• Limitations in consumption and side effects are significant restraints.
• The market is expected to grow to US$ 807.9 million by 2030.
• Financial assistance programs are available to help patients manage the cost of the medication.

FAQs

What are the primary applications of cyclophosphamide?

Cyclophosphamide is primarily used to treat various types of cancer, autoimmune diseases such as nephrotic syndrome and AL amyloidosis, and other conditions requiring immunosuppression[1][3][4].

How does cyclophosphamide work?

Cyclophosphamide works by disrupting DNA synthesis during cell division, which halts the growth of cancer cells and has immunosuppressive effects on healthy cells, particularly those in the immune system[5].

What are the common side effects of cyclophosphamide?

Common side effects include infections, hemorrhagic cystitis, heart problems, liver disease, nausea, vomiting, and hair loss. Serious side effects can also occur, such as infertility and syndrome of inappropriate antidiuretic hormone (SIADH)[5].

How can patients reduce the cost of cyclophosphamide?

Patients can reduce the cost by using financial assistance programs, copay assistance, and mail-order pharmacies. They can also explore getting a 90-day supply of the medication if approved by their insurance company[2][5].

What is the forecasted market size of cyclophosphamide by 2030?

The global cyclophosphamide market is forecasted to reach US$ 807.9 million by 2030, with a CAGR of 2.2% during the forecast period[4].

Which regions are expected to see significant growth in the cyclophosphamide market?

Asia Pacific, North America, and Europe are expected to see significant growth due to various factors such as the expansion of the healthcare industry and increased adoption of the drug in treating cancer and autoimmune diseases[1][3].

Last updated: 2024-12-16