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Last Updated: March 13, 2025

MUTAMYCIN Drug Patent Profile


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Which patents cover Mutamycin, and what generic alternatives are available?

Mutamycin is a drug marketed by Bristol and Bristol Myers and is included in two NDAs.

The generic ingredient in MUTAMYCIN is mitomycin. There are seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the mitomycin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mutamycin

A generic version of MUTAMYCIN was approved as mitomycin by HIKMA on April 19th, 1995.

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Summary for MUTAMYCIN
Drug patent expirations by year for MUTAMYCIN
Recent Clinical Trials for MUTAMYCIN

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SponsorPhase
City of Hope Medical CenterPhase 2
ECOG-ACRIN Cancer Research GroupPhase 2
Mayo ClinicPhase 2

See all MUTAMYCIN clinical trials

US Patents and Regulatory Information for MUTAMYCIN

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bristol MUTAMYCIN mitomycin INJECTABLE;INJECTION 050450-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bristol MUTAMYCIN mitomycin INJECTABLE;INJECTION 050450-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bristol Myers MUTAMYCIN mitomycin INJECTABLE;INJECTION 062336-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bristol Myers MUTAMYCIN mitomycin INJECTABLE;INJECTION 062336-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bristol Myers MUTAMYCIN mitomycin INJECTABLE;INJECTION 062336-003 Mar 10, 1988 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries

Mitomycin C Market Dynamics and Financial Trajectory

Market Overview

Mitomycin C, a chemotherapeutic agent derived from Streptomyces caespitosus, is a crucial drug in the treatment of various cancers and other medical conditions. Here’s a detailed look at the market dynamics and financial trajectory of Mitomycin C, often marketed under the brand name Mutamycin.

Market Size and Growth

The global Mitomycin C market was valued at USD 247.8 million in 2022 and is projected to reach USD 318.5 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 2.9% during the forecast period[1].

Segmentation by Type

The Mitomycin C market is segmented based on the dosage type, including 2mg, 10mg, 40mg, and others. The 40mg segment is expected to expand significantly due to its widespread use in bladder cancer treatment. The 10mg segment will also hold a substantial market share, primarily due to its efficacy in relieving symptoms of pancreatic cancer[1].

Segmentation by Application

The market is bifurcated into cancer treatment, ophthalmic use, and other applications. Cancer treatment is the dominant segment, driven by Mitomycin C’s effectiveness as an antitumor agent in various cancers, including breast cancer and non-small cell lung cancer (NSCLC). The ophthalmic use segment is also growing, as Mitomycin C is used to inhibit fibroblast proliferation during surgeries to reduce the recurrence of pterygium[1].

Regional Outlook

Geographically, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America is expected to expand at a significant CAGR due to increased investment in cancer research. The Asia Pacific region, particularly Japan and India, is also a key market, with Japan being a prominent supplier and India seeing substantial growth in Mitomycin C manufacturing[1].

Impact of COVID-19

The COVID-19 pandemic had a negative impact on the Mitomycin C market. Lockdowns, supply chain disruptions, and delayed cancer screenings and treatments hindered market growth. The global GDP decline of 3.4% in 2020 and the reduction in world trade and foreign direct investment further exacerbated the situation[1].

Key Drivers and Restraints

Drivers

  • Rising Cancer Prevalence: Increasing cases of cancer globally, particularly in emerging economies, drive the demand for Mitomycin C.
  • Governmental Regulations and R&D Activities: Government support and ongoing research activities in cancer treatment are crucial for market growth.
  • Economic Growth: The rising GDP of emerging economies boosts healthcare spending, including on cancer treatments[1].

Restraints

  • High Development Costs: The cost of developing new cancer treatments is high, which can be a barrier to market growth.
  • Stringent Regulations: Strict regulatory requirements can slow down the approval and launch of new drugs[3].

Competitive Landscape

Major manufacturers in the Mitomycin C market include UroGen Pharma, Inc., Teva Pharmaceutical Industries Ltd., Hikma Pharmaceuticals PLC, Viatris Inc., and Taj Pharma. These companies are actively expanding their bases in key regions, particularly in the Asia Pacific, to increase their market share[1].

New Developments and Approvals

Recent developments, such as the approval of JELMYTO (mitomycin gel) by the FDA for the treatment of low-grade Upper Tract Urothelial Cancer (UTUC), highlight the ongoing innovation in Mitomycin C formulations. JELMYTO is administered via instillation and offers a less invasive alternative to radical nephroureterectomy, which has significant post-operative risks[5].

Financial Projections

The Mitomycin C market is expected to grow steadily, driven by the increasing demand for cancer treatments and the expanding use in ophthalmic surgeries. Here are some key financial projections:

  • Market Size by 2031: USD 318.5 million
  • CAGR: 2.9% during the forecast period
  • Base Year: 2022
  • Analysis Period: 2016 to 2031[1].

Broader Market Context

The Mitomycin C market is part of the larger oncology drugs market, which is projected to reach USD 532.91 billion by 2031, growing at a CAGR of 12.6%. This broader market is driven by the increasing prevalence of cancers and the adoption of targeted therapies and immunotherapies[3].

Illustrative Statistics

  • Oncology Drugs Market Size by 2031: USD 532.91 billion
  • CAGR of Oncology Drugs Market: 12.6% during the forecast period 2024-2031
  • Mitomycin C Market Size by 2031: USD 318.5 million
  • CAGR of Mitomycin C Market: 2.9% during the forecast period 2023-2031[1][3].

Expert Insights

"Continued progress in cancer research is crucial for the development of effective interventions. However, this progress is in jeopardy due to declining investments in biomedical research," notes the AACR Cancer Progress Report. This underscores the need for sustained funding and support for cancer research to drive market growth and innovation[2].

Key Takeaways

  • The Mitomycin C market is growing at a CAGR of 2.9%, driven by increasing cancer prevalence and ophthalmic use.
  • The market is segmented by type and application, with cancer treatment being the dominant segment.
  • Regional growth is significant in North America and the Asia Pacific.
  • COVID-19 had a negative impact on the market, but recovery is underway.
  • New developments and approvals, such as JELMYTO, are enhancing treatment options.

Frequently Asked Questions (FAQs)

1. What is the projected market size of Mitomycin C by 2031?

The global Mitomycin C market is projected to reach USD 318.5 million by 2031[1].

2. What is the CAGR of the Mitomycin C market during the forecast period?

The Mitomycin C market is expected to grow at a CAGR of 2.9% during the forecast period[1].

3. Which segment is expected to dominate the Mitomycin C market by application?

The cancer treatment segment is projected to register a remarkable CAGR during the forecast period due to Mitomycin C’s effectiveness as an antitumor agent[1].

4. How did the COVID-19 pandemic affect the Mitomycin C market?

The COVID-19 pandemic negatively impacted the Mitomycin C market due to lockdowns, supply chain disruptions, and delayed cancer screenings and treatments[1].

5. What are the key drivers of the Mitomycin C market?

Key drivers include rising cancer prevalence, governmental regulations, and ongoing R&D activities in cancer treatment[1].

Cited Sources:

  1. Growth Market Reports: Mitomycin C Market Size, Share, and Industry Report [2031]
  2. AACR Cancer Progress Report 2013: The Status of Cancer Research
  3. Coherent Market Insights: Oncology Drugs Market to Reach USD 532.91 Billion by 2031
  4. Business Research Insights: Mitomycin Market Size | [2024 - 2032] Global Report
  5. FDA: 211728Orig1s000 - Mitomycin gel (Proposed) Trade Name JELMYTO

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