Ifosfamide; mesna - Generic Drug Details

What are the generic sources for ifosfamide; mesna and what is the scope of patent protection?

Ifosfamide; mesna is the generic ingredient in two branded drugs marketed by Baxter Hlthcare and Teva Pharms Usa, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for ifosfamide; mesna

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	456
DailyMed Link:	ifosfamide; mesna at DailyMed

Recent Clinical Trials for ifosfamide; mesna

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

Sponsor	Phase
BeBetter Med Inc	Phase 1
Children's Hospital Colorado	Phase 1
Children's Hospital of Philadelphia	Phase 1

See all ifosfamide; mesna clinical trials

Pharmacology for ifosfamide; mesna

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for ifosfamide; mesna

L01AA	Nitrogen mustard analogues
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

R05CB	Mucolytics
R05C	EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

V03AF	Detoxifying agents for antineoplastic treatment
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for ifosfamide; mesna

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-003	Oct 10, 1992		DISCN	No	No
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-004	Oct 10, 1992		DISCN	No	No
Teva Pharms Usa	IFOSFAMIDE/MESNA KIT	ifosfamide; mesna	INJECTABLE;INTRAVENOUS	075874-001	Feb 26, 2002		DISCN	No	No
Teva Pharms Usa	IFOSFAMIDE/MESNA KIT	ifosfamide; mesna	INJECTABLE;INTRAVENOUS	075874-002	Feb 26, 2002		DISCN	No	No

Expired US Patents for ifosfamide; mesna

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-003	Oct 10, 1992	4,220,660
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-004	Oct 10, 1992	5,696,172
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-003	Oct 10, 1992	4,882,452
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-004	Oct 10, 1992	4,882,452
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-004	Oct 10, 1992	4,220,660
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-003	Oct 10, 1992	5,696,172

Market Dynamics and Financial Trajectory for Ifosfamide and Mesna

Introduction to Ifosfamide and Mesna

Ifosfamide and Mesna are closely linked in the context of cancer treatment, particularly in chemotherapy regimens. Ifosfamide is an alkylating agent used to treat various types of cancer, including non-Hodgkin lymphoma, thymoma, and Hodgkin lymphoma[2][3][4].

Mesna, also known as Mesnex, is a uroprotective agent that is administered to prevent the urotoxic side effects of ifosfamide, such as hemorrhagic cystitis and bladder irritation[1][3][4].

Market Size and Forecast

The market for Mesna is growing at a moderate pace, driven by the increasing incidence of cancer and the expanding use of chemotherapy. The global Mesna (Mesnex) market is expected to grow significantly from 2021 to 2028, with substantial growth rates observed over the last few years[1].

Key Drivers

Increasing Cancer Incidence

The rise in cancer cases is a primary driver for the demand of Mesna. In 2018, cancer cases were anticipated to reach 1,735,350, with an expected annual increase of 3%[1].

Evolution of Chemotherapy

Chemotherapy is undergoing rapid evolution and progress, leading to increased use of ifosfamide and, consequently, Mesna. Clinical research for new treatments and FDA approvals for new therapeutics are also boosting the market's growth[1].

Uroprotective Role of Mesna

Mesna's effectiveness in preventing ifosfamide-induced hemorrhagic cystitis and reducing nephron toxicity has made it an essential component of chemotherapy regimens. This has almost eliminated the risk of haemorrhagic cystitis associated with ifosfamide treatment[3].

Market Segmentation

By Product Type

The market is segmented into oral and injection forms of Mesna. The oral segment dominates the market due to its convenience and reduced need for hospital stays. However, oral Mesna doses must be doubled compared to IV doses due to bioavailability issues[1].

By Application

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Retail pharmacies hold the largest share, with future pharmacies expected to incorporate more technology, such as telemedicine and point-of-care diagnostics[1].

By Geography

North America is expected to hold the largest share of the global Mesna market during the forecast period, driven by the high incidence of cancer and the advancement in chemotherapy treatments[1].

Financial Trajectory

Revenue Growth

The revenue from Mesna is expected to increase significantly due to the growing demand for chemotherapy treatments. The moderate growth rate of the Mesna market is a reflection of the increasing need for uroprotective agents in cancer therapy[1].

Cost-Effectiveness

The use of oral Mesna has become an appealing alternative to IV administration, reducing the logistical and fiscal burdens on healthcare facilities. This shift is likely to result in decreased costs of care and improved patient tolerance and convenience[5].

Competitive Landscape

The market for Mesna involves several key players, including pharmaceutical companies that are actively involved in mergers and licensing agreements to expand their market reach. For example, Mylan and Upjohn merged in 2019 to form a new global health champion, and Hikma Pharmaceuticals entered into a license agreement for molnupiravir in 2022[1].

Challenges and Restraints

Side Effects and Toxicity

While Mesna reduces the urotoxic effects of ifosfamide, it does not eliminate other side effects such as myelosuppression, nephrotoxicity, and neurotoxicity. These side effects can limit the dose and frequency of ifosfamide administration[3].

Regulatory Approvals

The market growth is also influenced by regulatory approvals and clinical trials. New treatments and combinations of chemotherapy agents require rigorous testing and approval, which can impact the market dynamics[1].

Clinical Research and Development

Clinical trials continue to play a crucial role in the development of new treatments involving ifosfamide and Mesna. Studies have shown that the combination of ifosfamide and Mesna is effective in various cancers, including non-small cell lung cancer, adult soft-tissue sarcomas, and advanced cervical cancer[3].

Patient Impact and Quality of Life

The use of Mesna significantly improves patient outcomes by reducing the risk of bladder irritation and bleeding. This allows patients to undergo chemotherapy with fewer complications, improving their quality of life and reducing the need for prolonged hospital stays[4][5].

Key Developments and Future Outlook

• Technological Integration: Future pharmacies are expected to be high-tech, incorporating services like telemedicine and point-of-care diagnostics, which will further enhance the accessibility and convenience of Mesna[1].
• Clinical Trials: Ongoing clinical trials are expected to define the role of ifosfamide and Mesna in various forms of cancer, potentially expanding their use in new therapeutic regimens[3].

Key Takeaways

• The Mesna market is driven by the increasing incidence of cancer and the evolution of chemotherapy treatments.
• Oral Mesna is gaining preference due to its convenience and reduced need for hospital stays.
• North America is expected to dominate the market due to high cancer incidence and advanced chemotherapy practices.
• The use of Mesna is cost-effective and improves patient tolerance and convenience.
• Ongoing clinical trials and regulatory approvals will continue to shape the market dynamics.

FAQs

Q: What is the primary use of Mesna in cancer treatment? A: Mesna is used to reduce the risk of bladder hemorrhage and irritation caused by chemotherapy agents like ifosfamide and cyclophosphamide.

Q: How is Mesna administered? A: Mesna can be administered orally or through intravenous infusion, with oral doses often being double that of IV doses due to bioavailability issues.

Q: What are the common side effects of ifosfamide that Mesna helps to mitigate? A: Mesna helps to prevent hemorrhagic cystitis and bladder irritation, but does not eliminate other side effects such as myelosuppression, nephrotoxicity, and neurotoxicity.

Q: Which region is expected to dominate the Mesna market? A: North America is expected to hold the largest share of the global Mesna market during the forecast period.

Q: How does the use of oral Mesna impact healthcare costs? A: The use of oral Mesna can reduce the logistical and fiscal burdens on healthcare facilities, leading to decreased costs of care and improved patient convenience.

Cited Sources

1. Verified Market Research: Mesna (Mesnex) Market Size, Share, Trends, Opportunities & Forecast[1].
2. Oncolink: Ifosfamide (Ifex®)[2].
3. PubMed: Ifosfamide/mesna. A review of its antineoplastic activity[3].
4. Macmillan Cancer Support: Doxorubicin and ifosfamide[4].
5. AACR Journals: Crossover Randomized Comparison of Intravenous versus Oral Mesna[5].