Mitomycin - Generic Drug Details

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

Mitomycin is the generic ingredient in five branded drugs marketed by Mobius Therap, Accord Hlthcare, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Rk Pharma, Supergen, Bristol, Bristol Myers, and Urogen Pharma, and is included in seventeen NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Mitomycin has eighteen patent family members in nine countries.

There are seven drug master file entries for mitomycin. Twelve suppliers are listed for this compound.

Summary for mitomycin

International Patents:	18
US Patents:	7
Tradenames:	5
Applicants:	13
NDAs:	17
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	240
Patent Applications:	3,834
Drug Prices:	Drug price trends for mitomycin
What excipients (inactive ingredients) are in mitomycin?	mitomycin excipients list
DailyMed Link:	mitomycin at DailyMed

See drug prices for mitomycin

Recent Clinical Trials for mitomycin

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

Sponsor	Phase
City of Hope Medical Center	Phase 2
Varian	N/A
Columbia University	N/A

See all mitomycin clinical trials

Pharmacology for mitomycin

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for mitomycin

Alkylating Agents

Antibiotics, Antineoplastic

Cross-Linking Reagents

Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for mitomycin

L01DC	Other cytotoxic antibiotics
L01D	CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for MITOMYCIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JELMYTO	Powder for Injection	mitomycin	40 mg/vial	211728	1	2023-12-28

US Patents and Regulatory Information for mitomycin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gland Pharma Ltd	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	215687-001	Oct 20, 2021	AP	RX	No	No
Fresenius Kabi Usa	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	211269-003	Apr 5, 2024	AP	RX	No	No
Mobius Therap	MITOSOL	mitomycin	FOR SOLUTION;TOPICAL	022572-001	Feb 7, 2012		RX	Yes	Yes			Y
Hikma	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	064180-002	Dec 23, 1999	AP	RX	No	No
Fresenius Kabi Usa	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	211269-002	Apr 5, 2024	AP	RX	No	No
Meitheal	MITOMYCIN	mitomycin	INJECTABLE;INJECTION	214504-001	Sep 6, 2022	AP	RX	No	No

International Patents for mitomycin

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008008802
European Patent Office	2525777	MATÉRIEL ET PROCÉDÉ DE TRAITEMENT DE CAVITÉS INTERNES (MATERIAL AND METHOD FOR TREATING INTERNAL CAVITIES)
European Patent Office	2046653	DISPOSITIF ET PROCÉDÉ DE RECONSTITUTION D'UN PRODUIT PHARMACEUTIQUE ET PRÉPARATION DU PRODUIT PHARMACEUTIQUE EN VUE D'UNE APPLICATION TRANSITOIRE (APPARATUS AND METHOD FOR RECONSTITUTING A PHARMACEUTICAL AND PREPARING THE RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION)
World Intellectual Property Organization (WIPO)	2013011504
Australia	2007272514	Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
European Patent Office	2734187	MATÉRIAUX ET MÉTHODE DE TRAITEMENT DE CAVITÉS CORPORELLES INTERNES (MATERIALS AND METHOD FOR TREATING INTERNAL BODY CAVITIES)

Mitomycin Market Analysis and Financial Projection Experimental

Mitomycin Market Dynamics and Financial Trajectory

Market Size and Growth

The mitomycin market has been experiencing significant growth, driven by the increasing demand for effective cancer treatments. As of 2019, the mitomycin market size was valued at USD 161.1 million. It is projected to grow from USD 175.7 million in 2023 to USD 362.2 million by 2031, with a compound annual growth rate (CAGR) of 9.1% during the forecast period (2024-2031)[1][4].

Segmentation and Dominant Segments

The mitomycin market is segmented based on several criteria, including type, application, and region.

Type Segmentation

The market is segmented into different types such as 2mg, 10mg, and others. The 2mg segment has accounted for a noticeable share of the global mitomycin market and is expected to experience significant growth in the near future[3].

Application Segmentation

Cancer treatment is the dominant application segment, with mitomycin being effective against various types of cancers, including gastric, pancreatic, breast, non-small cell lung, cervical, prostate, and bladder cancers. The cancer treatment segment is projected to expand at a significant CAGR throughout the forecast period[1][3].

Regional Segmentation

The market is geographically segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. Asia-Pacific is emerging as a lucrative market, with Japan and India playing key roles in the production and supply of mitomycin[1].

Market Drivers

Several factors are driving the growth of the mitomycin market:

Increasing Cancer Cases

The significant increase in cancer cases worldwide has greatly increased the demand for mitomycin. Cancer cells have a higher rate of cell division compared to normal cells, making mitomycin an effective treatment by inhibiting DNA synthesis and delaying cell division[1][4].

Ophthalmic Use

Mitomycin also has applications in ophthalmology, particularly in the treatment of certain eye conditions. This diversified use creates additional opportunities for drug manufacturers[1].

Advancements in Treatment

The development of new formulations, such as mitomycin gel (JELMYTO), has expanded the treatment options for patients. For example, JELMYTO is indicated for the treatment of low-grade Upper Tract Urothelial Cancer (UTUC) and offers a less invasive alternative to radical nephroureterectomy[2].

Market Restraints

Despite the growth, there are several restraints affecting the mitomycin market:

Increasing Costs

The cost of mitomycin and its associated treatments can be a significant barrier for many patients. High costs can limit accessibility and impact market growth[1].

Side Effects and Adverse Reactions

Mitomycin, like other chemotherapy agents, can have severe side effects and adverse reactions. These can include treatment-emergent adverse events, which may deter some patients from opting for this treatment[2].

Competitive Landscape

The global mitomycin market is relatively consolidated with a low level of competition. Key players include:

• Kyowa-Kirin
• Intas Pharmaceuticals
• Speciality European Pharma
• Teva Pharmaceuticals
• Bristol-Myers Squibb
• Rocket Pharmaceuticals
• Aspen

These companies are continually working on improving their products and expanding their market share through strategic partnerships and innovative research. For instance, Rocket Pharmaceuticals has initiated a Phase 2 study for a gene therapy treatment involving mitomycin C[1].

Recent Developments and Innovations

The market is witnessing several recent developments and innovations:

New Formulations

The introduction of mitomycin gel (JELMYTO) for the treatment of UTUC has marked a significant advancement. This gel is administered via instillation and offers a more targeted and less invasive treatment option[2].

Clinical Trials

Companies like Rocket Pharmaceuticals are engaged in clinical trials to explore new applications and improve existing treatments. These trials often focus on the efficacy and safety of mitomycin in various therapeutic contexts[1].

Regional Market Opportunities

Asia-Pacific

This region is emerging as a key market for mitomycin, driven by increasing production in countries like Japan and India. The expansion of leading manufacturers into this region is expected to boost its prominence in the global market[1].

North America and Europe

These regions also hold significant market potential due to the high prevalence of cancer and the presence of advanced healthcare infrastructure. The US mitomycin market, in particular, is expected to grow at a sustainable CAGR in the forecast period[1][4].

Financial Projections

The financial trajectory of the mitomycin market is promising, with a projected growth from USD 175.7 million in 2023 to USD 362.2 million by 2031. This growth is driven by the increasing demand for cancer treatments and the expansion of mitomycin's applications into other therapeutic areas[1][4].

Key Takeaways

• Market Growth: The mitomycin market is expected to grow at a CAGR of 9.1% from 2024 to 2031.
• Dominant Segment: Cancer treatment is the leading application segment.
• Regional Focus: Asia-Pacific, particularly Japan and India, are key regions for growth.
• Market Drivers: Increasing cancer cases and advancements in treatment formulations.
• Market Restraints: High costs and potential side effects.
• Competitive Landscape: The market is relatively consolidated with key players focusing on innovation and expansion.

FAQs

Q: What is the current market size of the mitomycin market? A: The mitomycin market size was valued at USD 161.1 million in 2019 and is projected to grow to USD 362.2 million by 2031[1][4].

Q: What is the primary application of mitomycin? A: The primary application of mitomycin is in cancer treatment, particularly for various types of cancers such as gastric, pancreatic, and breast cancers[1][3].

Q: Which region is emerging as a lucrative market for mitomycin? A: The Asia-Pacific region, especially Japan and India, is emerging as a key market for mitomycin[1].

Q: What are the major restraints in the mitomycin market? A: The major restraints include increasing costs and potential side effects associated with the treatment[1].

Q: Who are the key players in the mitomycin market? A: Key players include Kyowa-Kirin, Intas Pharmaceuticals, Speciality European Pharma, Teva Pharmaceuticals, Bristol-Myers Squibb, Rocket Pharmaceuticals, and Aspen[1].

Cited Sources

1. SkyQuest Technology: Mitomycin Market Size, Growth & Trends Report | 2031[1].
2. FDA: 211728Orig1s000 - accessdata.fda.gov[2].
3. Cognitive Market Research: Mitomycin Market Report 2024 (Global Edition)[3].
4. SkyQuest Technology: Mitomycin Market Size - SkyQuest Technology[4].