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Last Updated: December 22, 2024

CYTOXAN (LYOPHILIZED) Drug Patent Profile


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When do Cytoxan (lyophilized) patents expire, and when can generic versions of Cytoxan (lyophilized) launch?

Cytoxan (lyophilized) is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in CYTOXAN (LYOPHILIZED) 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 (lyophilized)

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

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Summary for CYTOXAN (LYOPHILIZED)
Drug patent expirations by year for CYTOXAN (LYOPHILIZED)
Recent Clinical Trials for CYTOXAN (LYOPHILIZED)

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

SponsorPhase
National Cancer Institute (NCI)Phase 1
California Institute for Regenerative Medicine (CIRM)Phase 1
Hideho Okada, MD, PhDPhase 1

See all CYTOXAN (LYOPHILIZED) clinical trials

US Patents and Regulatory Information for CYTOXAN (LYOPHILIZED)

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 (LYOPHILIZED) cyclophosphamide INJECTABLE;INJECTION 012142-004 Aug 30, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare CYTOXAN (LYOPHILIZED) cyclophosphamide INJECTABLE;INJECTION 012142-009 Dec 10, 1985 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare CYTOXAN (LYOPHILIZED) cyclophosphamide INJECTABLE;INJECTION 012142-010 Sep 24, 1985 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 (LYOPHILIZED) cyclophosphamide INJECTABLE;INJECTION 012142-008 Jan 4, 1984 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

Expired US Patents for CYTOXAN (LYOPHILIZED)

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

CYTOXAN (LYOPHILIZED) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cytoxan (Lyophilized)

Overview of Cytoxan (Lyophilized)

Cytoxan, also known as cyclophosphamide, is a chemotherapeutic agent used to treat various types of cancer and autoimmune diseases. The lyophilized formulation of cyclophosphamide is particularly significant due to its stability and ease of administration.

Global Market Size and Growth

The global cyclophosphamide market, which includes the lyophilized formulation, was valued at USD 1.2 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 5.5% during the forecast period from 2021 to 2033[1].

Market Segmentation

Formulation

The injectable formulation segment, which includes lyophilized cyclophosphamide, dominated the market in 2021, accounting for over 80% of the global revenue share. This dominance is due to the convenience and stability offered by lyophilized formulations, which are crucial for maintaining the efficacy of the drug[1].

Indication

The oncology indication segment held the largest market share in 2021, driven by the increasing prevalence of cancer worldwide. Cyclophosphamide is used to treat various cancers, including lymphoma, leukemia, multiple myeloma, and breast cancer[1].

Regional Analysis

North America and Europe

North America and Europe are the leading markets for cyclophosphamide, driven by well-established healthcare infrastructures, high healthcare expenditures, and the increasing prevalence of cancer and autoimmune diseases. These regions have advanced medical facilities, favorable reimbursement policies, and a strong presence of major pharmaceutical companies[1].

Asia Pacific

The Asia Pacific region is expected to witness the highest growth rate during the forecast period. Factors such as a large patient population, improving healthcare infrastructure, and rising awareness about cancer treatment and autoimmune disorder management are driving this growth. Countries like China, India, and Japan are major contributors to this market[1].

Latin America and Middle East & Africa

These regions are emerging markets with increasing healthcare investments and growing awareness about cancer treatment and autoimmune disorder management. However, they face challenges such as limited access to healthcare facilities and inadequate reimbursement systems[1].

Market Drivers

Increasing Prevalence of Cancer

The global burden of cancer is a significant driver for the cyclophosphamide market. The rising incidence rates of various types of malignancies and the effectiveness of cyclophosphamide in treating these cancers continue to drive demand for this drug[1].

Rising Prevalence of Autoimmune Disorders

The increasing incidence and awareness of autoimmune disorders, such as systemic lupus erythematosus, rheumatoid arthritis, and nephrotic syndrome, also contribute to market growth. Cyclophosphamide is widely used as an immunosuppressant in managing these conditions[1].

Competitive Landscape

The cyclophosphamide market is characterized by the presence of several key players, including multinational pharmaceutical companies and generic drug manufacturers. These companies are focusing on strategies such as product innovation, geographical expansion, and collaborations to strengthen their market position. The entry of new players, particularly in the generic segment, has increased competition and pricing pressure[1].

Financial Trajectory

Revenue Growth

The cyclophosphamide market is expected to grow steadily, driven by the increasing demand for cancer and autoimmune disease treatments. The generic drugs segment is anticipated to exhibit significant growth due to the expiration of patents for branded cyclophosphamide formulations[1].

Key Players' Strategies

Major pharmaceutical companies are investing in research and development to innovate and expand their product portfolios. Geographical expansion, especially into emerging markets, is another key strategy. Collaborations and partnerships are also crucial for these companies to maintain their competitive edge[1].

Challenges and Opportunities

High Manufacturing Costs

One of the challenges facing the lyophilized cyclophosphamide market is the high cost associated with lyophilization equipment and processes. This can be a barrier to entry for new manufacturers and may affect the pricing of the final product[3].

Growing Demand for Stable Formulations

The increasing need for long-term stable drug formulations, particularly for conditions like cancer and infectious diseases, presents a significant opportunity for the lyophilized cyclophosphamide market. Lyophilization ensures the stability and efficacy of the drug during storage and distribution, which is critical for global healthcare needs[3].

Regulatory Environment

The regulatory environment plays a crucial role in the cyclophosphamide market. Stringent regulatory oversight and quality standards enforced by bodies such as the FDA in North America ensure that lyophilized products meet global standards. This environment supports the export of these products to other regions and maintains the trust of healthcare providers and patients[3].

Key Takeaways

  • Market Growth: The global cyclophosphamide market is expected to grow at a CAGR of 5.5% from 2021 to 2033.
  • Dominant Segments: The injectable formulation segment and oncology indication segment are the largest in the market.
  • Regional Dynamics: North America and Europe are leading markets, while the Asia Pacific region is expected to exhibit the highest growth rate.
  • Market Drivers: Increasing prevalence of cancer and autoimmune disorders are key drivers.
  • Competitive Landscape: The market is competitive with major pharmaceutical companies and generic drug manufacturers.

FAQs

What is the primary use of Cytoxan (lyophilized)?

Cytoxan (lyophilized) is primarily used to treat various types of cancer, including ovarian, breast, blood, and lymph system cancers, as well as certain autoimmune diseases[5].

Which regions are expected to drive the growth of the cyclophosphamide market?

The Asia Pacific region is expected to witness the highest growth rate, while North America and Europe are currently the leading markets for cyclophosphamide[1].

What are the key drivers of the cyclophosphamide market?

The increasing global burden of cancer and the rising prevalence of autoimmune disorders are significant drivers of the cyclophosphamide market[1].

What challenges does the lyophilized cyclophosphamide market face?

High manufacturing costs associated with lyophilization equipment and processes are a significant challenge for the market[3].

How does the regulatory environment impact the cyclophosphamide market?

The regulatory environment, particularly in regions like North America, ensures that lyophilized products meet stringent quality standards, which supports their export and maintains market trust[3].

Sources

  1. DataHorizon Research: Cyclophosphamide Market Size, Share & Forecast 2033
  2. Sanofi: Form 20-F 2019
  3. Coherent Market Insights: Lyophilized Drugs Market - Share, Size and Industry Analysis
  4. Cognitive Market Research: Cyclophosphamide Injection Market Report 2024 (Global Edition)
  5. Drugs.com: Cytoxan Lyophilized Advanced Patient Information

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