MITOSOL Drug Patent Profile

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

Mitosol is a drug marketed by Mobius Therap and is included in one NDA. There are five patents protecting this drug.

This drug has nine patent family members in five countries.

The generic ingredient in MITOSOL 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 Mitosol

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

Summary for MITOSOL

International Patents:	9
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	12
Patent Applications:	4,541
What excipients (inactive ingredients) are in MITOSOL?	MITOSOL excipients list
DailyMed Link:	MITOSOL at DailyMed

Recent Clinical Trials for MITOSOL

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

Sponsor	Phase
City of Hope Medical Center	Phase 2
ECOG-ACRIN Cancer Research Group	Phase 2
Mayo Clinic	Phase 2

See all MITOSOL clinical trials

US Patents and Regulatory Information for MITOSOL

MITOSOL is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mobius Therap	MITOSOL	mitomycin	FOR SOLUTION;TOPICAL	022572-001	Feb 7, 2012		RX	Yes	Yes
Mobius Therap	MITOSOL	mitomycin	FOR SOLUTION;TOPICAL	022572-001	Feb 7, 2012		RX	Yes	Yes			Y
Mobius Therap	MITOSOL	mitomycin	FOR SOLUTION;TOPICAL	022572-001	Feb 7, 2012		RX	Yes	Yes			Y	Y
Mobius Therap	MITOSOL	mitomycin	FOR SOLUTION;TOPICAL	022572-001	Feb 7, 2012		RX	Yes	Yes			Y
Mobius Therap	MITOSOL	mitomycin	FOR SOLUTION;TOPICAL	022572-001	Feb 7, 2012		RX	Yes	Yes			Y

International Patents for MITOSOL

See the table below for patents covering MITOSOL around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2659314	DISPOSITIF ET PROCEDE DE RECONSTITUTION D'UN PRODUIT PHARMACEUTIQUE ET PREPARATION DU PRODUIT PHARMACEUTIQUE EN VUE D'UNE APPLICATION TRANSITOIRE (APPARATUS AND METHOD FOR RECONSTITUTING A PHARMACEUTICAL ANDPREPARING THE RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION)
Canada	2659314
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)
European Patent Office	3175843
Japan	2014097399
Japan	2014097399	APPARATUS AND METHOD FOR RECONSTITUTING PHARMACEUTICAL AND PREPARING RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION

Market Dynamics and Financial Trajectory for Mitosol (Mitomycin-C)

Introduction to Mitosol (Mitomycin-C)

Mitomycin-C, marketed under the brand name Mitosol among others, is a potent anticancer drug and an antineoplastic agent. It is widely used in cancer treatment and ophthalmic procedures. Here, we delve into the market dynamics and financial trajectory of Mitosol.

Global Market Size and Growth

The global mitomycin market, which includes Mitosol, was valued at USD 161.1 million in 2019. It is projected to grow significantly, reaching USD 362.2 million by 2031, with a Compound Annual Growth Rate (CAGR) of 9.1% during the forecast period of 2024-2031[1].

Market Segmentation

The mitomycin market is segmented based on several criteria:

By Type

• The market is segmented into 2mg and 10mg formulations, among others. These different formulations cater to various medical needs, including cancer treatment and ophthalmic use[1].

By Application

• Cancer treatment dominates the global market, with mitomycin being effective against a variety of tumor types such as gastric, pancreatic, breast, non-small cell lung, cervical, prostate, and bladder cancers. Ophthalmic use is another significant segment, particularly for procedures like pterygium surgery[1][4].

By Region

• The market is categorized into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. Asia-Pacific, particularly Japan and India, is emerging as a lucrative market due to increasing production and demand[1].

Market Drivers

Increasing Cancer Cases

• The significant rise in cancer cases worldwide has driven the demand for mitomycin. Its broad clinical antitumor spectrum makes it a crucial drug in cancer treatment[1].

Ophthalmology Utilization

• Mitomycin's use in ophthalmic procedures, such as pterygium surgery, has created additional market opportunities. The collaboration between companies like Leiters and Mobius Therapeutics to ensure high-quality ophthalmic products further supports this growth[4].

Market Restraints

Increasing Costs

• One of the major restraints is the increasing cost associated with the production and distribution of mitomycin. This can affect market accessibility and affordability, particularly in regions with limited healthcare budgets[1].

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, and Aspen. These companies are continually working on improving their products and expanding their market share through strategic partnerships and innovative research[1].

Recent Developments

• Companies like Rocket Pharmaceuticals are involved in clinical trials for new applications of mitomycin, such as gene therapy for rare conditions like Fanconi anemia. This indicates a continuous effort to expand the therapeutic uses of mitomycin[1].

• The partnership between Leiters and Mobius Therapeutics for the national sales and marketing of Mitosol has ensured a stable supply of high-quality ophthalmic products, enhancing market reliability and customer satisfaction[4].

Regional Market Analysis

Asia-Pacific

• This region is rapidly becoming a significant market for mitomycin, with Japan and India playing key roles. The increasing production in these countries is expected to boost the regional market's prominence globally[1].

North America

• The US market is also poised for sustainable growth, driven by the high demand for cancer treatments and ophthalmic procedures[1].

Financial Performance

The financial trajectory of the mitomycin market, including Mitosol, is promising. Here are some key financial metrics:

• Market Size in 2023: USD 175.7 million
• Projected Market Size in 2031: USD 362.2 million
• CAGR: 9.1% during the forecast period of 2024-2031[1].

Key Takeaways

• The mitomycin market, driven by its applications in cancer treatment and ophthalmology, is expected to grow significantly.
• Asia-Pacific and North America are key regions contributing to this growth.
• The market is relatively consolidated, with major players focusing on product improvement and strategic partnerships.
• Increasing costs and competition are potential restraints, but the overall outlook remains positive.

FAQs

Q: What is the primary use of Mitosol (mitomycin-C)?

A: Mitosol is primarily used in cancer treatment and ophthalmic procedures, such as pterygium surgery.

Q: What is the projected market size of the mitomycin market by 2031?

A: The mitomycin market is projected to reach USD 362.2 million by 2031.

Q: Which region is emerging as a lucrative market for mitomycin?

A: The Asia-Pacific region, particularly Japan and India, is emerging as a significant market.

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.

Q: What is the CAGR of the mitomycin market during the forecast period?

A: The CAGR is 9.1% during the forecast period of 2024-2031.

Sources

1. SkyQuest Technology Consulting Pvt. Ltd. - Mitomycin Market Size, Growth & Trends Report | 2031
2. Glaucoma Today - Dealing With Reimbursement Cuts
3. Amazon S3 - GALDERMA LABORATORIES, L.P
4. Mobius Therapeutics - Leiters and Mobius Therapeutics Agreement for Mitosol
5. Mitosol - Mitosol FAQs