MARQIBO KIT Drug Patent Profile

Which patents cover Marqibo Kit, and when can generic versions of Marqibo Kit launch?

Marqibo Kit is a drug marketed by Acrotech and is included in one NDA.

The generic ingredient in MARQIBO KIT is vincristine sulfate. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the vincristine sulfate profile page.

Summary for MARQIBO KIT

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	30
Patent Applications:	3,042
Drug Prices:	Drug price information for MARQIBO KIT
DailyMed Link:	MARQIBO KIT at DailyMed

See drug prices for MARQIBO KIT

Recent Clinical Trials for MARQIBO KIT

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

Sponsor	Phase
Medical College of Wisconsin	Phase 1
David Rizzieri, MD	Phase 2
Acrotech Biopharma	Phase 2

See all MARQIBO KIT clinical trials

US Patents and Regulatory Information for MARQIBO KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012		DISCN	Yes	No

Expired US Patents for MARQIBO KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012	7,247,316
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012	5,543,152
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012	7,887,836
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012	6,723,338
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012	5,814,335
Acrotech	MARQIBO KIT	vincristine sulfate	INJECTABLE, LIPOSOMAL;INTRAVENOUS	202497-001	Aug 9, 2012	5,741,516

International Patents for MARQIBO KIT

See the table below for patents covering MARQIBO KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2012092148	LIPOSOMAL ANTINEOPLASTIC DRUG AND USE THEREOF
Denmark	2266537
World Intellectual Property Organization (WIPO)	9535094
Austria	442839
European Patent Office	2266537	Compositions pour le traitement du cancer (Compositions for treating cancer)
Germany	60042968

MARQIBO KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Marqibo Kit

Introduction to Marqibo

Marqibo, a novel sphingomyelin/cholesterol liposome-encapsulated formulation of vincristine sulfate, is approved by the FDA for the treatment of adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL) in second or greater relapse or whose disease has progressed following two or more lines of anti-leukemia therapy[4].

Market Context: Liposomal Drug Delivery

The market for liposomal drug delivery devices, which includes Marqibo, is experiencing rapid growth. This segment is projected to expand from $4.52 billion in 2023 to $7.71 billion by 2028, with a compound annual growth rate (CAGR) of 11.4%[3].

Key Market Drivers

Advancements in Drug Delivery Techniques

Advancements in drug delivery techniques, particularly in liposomal formulations, have significantly contributed to the growth of this market. Marqibo's encapsulation technology allows for prolonged circulation of vincristine in the blood, enhancing its therapeutic efficacy[4].

Increasing Cancer Incidence

The escalating global incidence of cancer, especially types like leukemia, is a major driver. For instance, the American Cancer Society reported 1.9 million new cancer cases and 0.6 million cancer-related deaths in the USA in 2021, with cancer types such as lung, prostate, bowel, and female breast cancer constituting a significant portion of new cases[3].

Healthcare Expenditure

The anticipated upswing in healthcare expenditure, driven by factors like the prevalence of chronic diseases, advancements in medical technology, and increasing insurance costs, is expected to propel the market growth. Healthcare spending in the United States is projected to increase from $4.4 trillion in 2022 to $7.2 trillion by 2031[3].

Market Size and Revenue Projections

While specific revenue projections for Marqibo alone are not readily available, the overall liposomal drug delivery market provides a context for its potential financial trajectory. The market size for liposomal drug delivery devices is expected to grow significantly, driven by targeted therapies, clinical trials, and personalized medicine focus[3].

Competitive Landscape

Marqibo operates within a competitive landscape that includes other liposomal formulations such as Onivyde and Vyxeos. These products are also used in the treatment of specific cancer types and have been approved for use in recent years. Major players in the market are continuously introducing innovative products to gain a competitive edge[3].

Regional Analysis

The global market for Marqibo is expected to be dominated by regions with high healthcare spending and advanced medical infrastructure. The United States, for example, is a significant market due to its large patient population and high healthcare expenditure[1].

Segment Analysis

Marqibo's market can be segmented based on the type of leukemia treated and the stage of disease progression. It is primarily indicated for adult patients with Ph- ALL in second or greater relapse or whose disease has progressed following two or more lines of anti-leukemia therapy[4].

Pharmacokinetics and Safety Profile

The pharmacokinetic profile of Marqibo, characterized by slow clearance and a higher area under the curve (AUC) compared to conventional vincristine, contributes to its therapeutic efficacy. However, it also comes with a safety profile that includes common adverse reactions such as constipation, nausea, pyrexia, fatigue, and peripheral neuropathy. Grade 3 or higher adverse reactions were reported in 96% of patients[2].

Regulatory and Clinical Trials

Marqibo's approval was based on its overall response rate in clinical trials, although clinical benefit such as improvement in overall survival has not been verified. The drug underwent significant regulatory scrutiny, including discussions by the Oncologic Drugs Advisory Committee (ODAC) regarding its risk-benefit profile and the need for postmarketing trials to confirm clinical benefit[2].

Commercial Launch and Access

Marqibo was launched by Spectrum Pharmaceuticals in 2013, with the company shipping its first commercial orders shortly after. The drug is accessible through Spectrum Therapy Access Resources (STAR), a program designed to assist patients and healthcare professionals in gaining appropriate access to the drug[4].

Financial Performance and Projections

While detailed financial performance data specific to Marqibo is not publicly available, the drug's integration into Spectrum Pharmaceuticals' portfolio has contributed to the company's growth in the hematology and oncology sectors. The overall growth of the liposomal drug delivery market suggests a positive financial trajectory for Marqibo, driven by increasing demand and advancements in drug delivery technologies[3][4].

Challenges and Opportunities

Challenges

• The market faces challenges such as high development costs, regulatory hurdles, and the need for continuous clinical validation.
• Marqibo's safety profile, including significant adverse reactions, is a concern that needs to be managed through careful patient monitoring and support programs.

Opportunities

• The growing incidence of cancer and the need for targeted therapies present significant opportunities for growth.
• Innovations in liposomal formulations and the development of new nanostructures could further enhance the efficacy and patient compliance of Marqibo.

Key Takeaways

• Marqibo is a critical component of the growing liposomal drug delivery market.
• The drug's unique pharmacokinetic profile and targeted delivery mechanism offer therapeutic advantages.
• Market growth is driven by increasing cancer incidence, advancements in drug delivery, and rising healthcare expenditure.
• Regulatory and clinical trial outcomes are crucial for the long-term success of Marqibo.
• The drug faces challenges related to its safety profile but presents significant opportunities in the oncology sector.

FAQs

1. What is Marqibo used for? Marqibo is used for the treatment of adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL) in second or greater relapse or whose disease has progressed following two or more lines of anti-leukemia therapy[4].

2. How does Marqibo differ from conventional vincristine? Marqibo differs from conventional vincristine through its liposomal encapsulation, which allows for prolonged circulation in the blood and a higher area under the curve (AUC), enhancing its therapeutic efficacy[2].

3. What are the common adverse reactions associated with Marqibo? Common adverse reactions include constipation, nausea, pyrexia, fatigue, peripheral neuropathy, febrile neutropenia, diarrhea, anemia, decreased appetite, and insomnia. Grade 3 or higher adverse reactions were reported in 96% of patients[5].

4. How is Marqibo accessed by patients? Marqibo is accessible through Spectrum Therapy Access Resources (STAR), a program designed to assist patients and healthcare professionals in gaining appropriate access to the drug[4].

5. What are the market projections for liposomal drug delivery devices? The market size for liposomal drug delivery devices is expected to grow from $4.52 billion in 2023 to $7.71 billion by 2028, with a CAGR of 11.4%[3].

Cited Sources:

1. Cognitivemarketresearch.com: Marqibo Market Report 2024 (Global Edition)
2. Accessdata.fda.gov: 202497Orig1s000 - Marqibo NDA
3. Researchandmarkets.com: Liposomal Drug Delivery Devices Global Market Report 2024
4. Businesswire.com: Spectrum Pharmaceuticals Launches Marqibo® (vinCRIStine sulfate LIPOSOME injection)
5. Accessdata.fda.gov: 202497Orig1s000Lbl - Marqibo Labeling Information