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Last Updated: December 22, 2024

CYTOXAN Drug Patent Profile


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

Cytoxan is a drug marketed by Baxter Hlthcare and is included in two NDAs.

The generic ingredient in CYTOXAN 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 Cytoxan

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

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Drug patent expirations by year for CYTOXAN
Recent Clinical Trials for CYTOXAN

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

SponsorPhase
National Cord Blood NetworkPhase 2
Fred Hutchinson Cancer CenterPhase 2
James Isaacs, MDPhase 1

See all CYTOXAN clinical trials

US Patents and Regulatory Information for CYTOXAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare CYTOXAN cyclophosphamide INJECTABLE;INJECTION 012142-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare CYTOXAN (LYOPHILIZED) cyclophosphamide INJECTABLE;INJECTION 012142-005 Aug 30, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare CYTOXAN cyclophosphamide TABLET;ORAL 012141-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare CYTOXAN (LYOPHILIZED) cyclophosphamide INJECTABLE;INJECTION 012142-009 Dec 10, 1985 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare CYTOXAN cyclophosphamide INJECTABLE;INJECTION 012142-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

CYTOXAN Market Analysis and Financial Projection Experimental

Cyclophosphamide (CYTOXAN): Market Dynamics and Financial Trajectory

Overview of Cyclophosphamide

Cyclophosphamide, commonly known by the brand name CYTOXAN, is a nitrogen mustard alkylating agent used in the treatment of various types of cancer and certain autoimmune diseases. It works by cross-linking DNA, thereby inhibiting tumor growth and suppressing the immune system[2].

Market Segmentation

The cyclophosphamide market is segmented based on type, application, and region.

By Type

  • The market is divided into high-dose and low-dose cyclophosphamide. High-dose cyclophosphamide is often used in the treatment of severe cancers, while low-dose cyclophosphamide is used for less aggressive conditions and in maintenance therapy[1].

By Application

  • Cyclophosphamide is used to treat a range of cancers, including lymphomas, myelomas, leukemia, neuroblastoma, ovarian adenocarcinoma, retinoblastoma, and breast carcinoma. It is also used in the treatment of minimal change nephrotic syndrome in pediatric patients and certain autoimmune diseases[1][2].

By Region

  • The market is geographically segmented into North America, Europe, Asia Pacific, and the Middle East & Africa. Asia Pacific is expected to witness significant growth due to the rapid expansion of the healthcare industry and an increase in cancer cases. North America and Europe also show promising growth due to the higher adoption of cyclophosphamide in hospitals and clinics[1].

Market Drivers

Rising Demand for Cancer Treatment

  • The increasing incidence of cancer globally is a major driver for the cyclophosphamide market. As cancer rates rise, so does the demand for effective treatments like cyclophosphamide[1].

Growing Healthcare Industry

  • The rapid growth in the healthcare industry, particularly in regions like Asia Pacific, is driving the market forward. Improved healthcare infrastructure and increased access to medical treatments are boosting the consumption of cyclophosphamide[1].

Use in Autoimmune Diseases

  • Cyclophosphamide's role in treating autoimmune diseases and nephrotic syndrome also contributes to its market growth. Its use in these conditions, especially in pediatric patients, is a significant factor[1][2].

Market Restraints

Side Effects and Contraindications

  • Cyclophosphamide has several side effects, including nausea, vomiting, hair loss, and increased risk of infections. It is also contraindicated in pregnant women due to its potential to affect fertility and cause birth defects. These limitations can hamper market growth[2][5].

Regulatory and Prescription Requirements

  • The drug can only be consumed under the proper prescription of certified doctors, which restricts its use and may slow market growth[1].

Financial Trajectory

Current Market Size

  • The global cyclophosphamide market was estimated to be worth approximately US$ 693 million in 2023[4].

Forecasted Growth

  • The market is forecasted to reach a value of US$ 807.9 million by 2030, with a Compound Annual Growth Rate (CAGR) of 2.2% during the period from 2024 to 2030[4].

Regional Market Performance

  • Asia Pacific is expected to witness sustainable growth due to the rapid expansion of the healthcare industry and an increase in cancer cases. North America and Europe are also expected to show significant growth due to higher adoption rates in hospitals and clinics[1].

Key Players

The cyclophosphamide market is dominated by several key players, including:

  • Baxter Laboratories Ltd.
  • Novartis AG
  • Himka Pharmaceuticals Plc.
  • Amneal Pharmaceuticals LLC
  • Aurobindo Pharma Ltd.
  • CSC Pharmaceutical International
  • Jiangsu Hengrui Medicine Co Ltd
  • Nodus Oncology
  • AbbVie, Inc.
  • Theravance Biopharm, Inc.
  • Sanofi S.A.
  • Roxane Laboratories Pvt Ltd
  • LGM Pharma LLC[4].

Market Dynamics

Drivers and Restraints

  • The market is driven by the increasing demand for cancer treatments and the growing healthcare industry. However, it is restrained by the drug's side effects and the need for strict medical supervision[1][2].

Opportunities and Challenges

  • Opportunities include the expanding use of cyclophosphamide in new therapeutic areas and the increasing adoption in emerging markets. Challenges include managing side effects, regulatory hurdles, and competition from newer cancer therapies[3].

Competitive Landscape

  • The competitive landscape is characterized by a mix of established pharmaceutical companies and emerging players. Companies are focusing on improving drug formulations, expanding distribution networks, and providing financial assistance programs to patients[4].

Clinical Trials and Development

Cyclophosphamide is involved in numerous clinical trials across various phases:

  • Phase 0: 60 trials
  • Phase 1: 1131 trials
  • Phase 2: 2190 trials
  • Phase 3: 807 trials
  • Phase 4: 95 trials These trials are crucial for understanding the drug's efficacy and safety in different conditions and for potential new indications[2].

Pharmacology and Mechanism of Action

Cyclophosphamide is activated in the liver to form its active metabolites, phosphoramide mustard and acrolein. It works by cross-linking DNA, which inhibits DNA replication and transcription, leading to cell death. This mechanism is effective in treating various types of cancer and autoimmune diseases[2].

Side Effects and Safety Profile

Cyclophosphamide is associated with several side effects, including:

  • Nausea and vomiting
  • Hair loss
  • Infections
  • Changes in skin and nail color
  • Mouth sores
  • Diarrhea
  • Stomach pain
  • Body aches

These side effects highlight the need for careful patient monitoring and management[5].

Financial Assistance and Copay Programs

To make cyclophosphamide more accessible, several financial assistance programs are available. These programs help reduce copays, out-of-pocket expenses, and high deductibles, making the treatment more affordable for patients[5].

Regional Growth and Adoption

Asia Pacific

  • This region is expected to witness significant growth due to the rapid expansion of the healthcare industry and an increase in cancer cases. Countries like China and India are driving this growth with their large patient populations and improving healthcare infrastructure[1].

North America

  • The higher adoption of cyclophosphamide in hospitals and clinics in North America is a key factor in the region's market growth. The use of cyclophosphamide in treating nephrotic syndrome and AL amyloidosis is particularly notable[1].

Europe

  • Europe also shows promising growth due to the increasing use of cyclophosphamide in hospitals and clinics. The region's well-established healthcare system supports the widespread adoption of this drug[1].

Middle East & Africa

  • This region is anticipated to witness significant growth due to the adoption of cyclophosphamide in treating autoimmune diseases. The increasing awareness and access to healthcare services are driving the market in this region[1].

Key Takeaways

  • Growing Demand: The increasing incidence of cancer and autoimmune diseases is driving the demand for cyclophosphamide.
  • Market Growth: The global cyclophosphamide market is expected to grow from US$ 693 million in 2023 to US$ 807.9 million by 2030.
  • Regional Performance: Asia Pacific, North America, and Europe are key regions driving market growth.
  • Side Effects and Contraindications: The drug's side effects and contraindications in pregnant women are significant restraints.
  • Clinical Trials: Cyclophosphamide is involved in numerous clinical trials, which are crucial for its continued development and new indications.

FAQs

What is cyclophosphamide used for?

Cyclophosphamide is used to treat various types of cancer, including lymphomas, myelomas, leukemia, and breast carcinoma. It is also used in the treatment of minimal change nephrotic syndrome in pediatric patients and certain autoimmune diseases[1][2].

What are the side effects of cyclophosphamide?

Common side effects include nausea, vomiting, hair loss, infections, changes in skin and nail color, mouth sores, diarrhea, stomach pain, and body aches[5].

Can pregnant women take cyclophosphamide?

No, pregnant women cannot take cyclophosphamide as it may affect fertility and cause birth defects[1].

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 period from 2024 to 2030[4].

Which regions are driving the growth of the cyclophosphamide market?

Asia Pacific, North America, and Europe are the key regions driving the growth of the cyclophosphamide market due to the rapid expansion of the healthcare industry and increasing adoption in hospitals and clinics[1].

Sources

  1. Fortune Business Insights: Cyclophosphamide Market Size, Industry Share | Forecast, 2032
  2. DrugBank: Cyclophosphamide: Uses, Interactions, Mechanism of Action
  3. Market Research Intellect: Cyclophosphamide Injection Market Size, Scope And Forecast Report
  4. Valuates Reports: Cyclophosphamide Drug - Market Size
  5. AmeriPharma Specialty Care: Cyclophosphamide Copay Assistance

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