DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) Drug Patent Profile

When do Doxorubicin Hydrochloride (liposomal) patents expire, and what generic alternatives are available?

Doxorubicin Hydrochloride (liposomal) is a drug marketed by Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Lupin, Sun Pharm, and Zydus Lifesciences. and is included in six NDAs.

The generic ingredient in DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Doxorubicin Hydrochloride (liposomal)

A generic version of DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) was approved as doxorubicin hydrochloride by PFIZER on December 23^rd, 1987.

Summary for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

US Patents:	0
Applicants:	6
NDAs:	6
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	384
Patent Applications:	4,394
DailyMed Link:	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) at DailyMed

Recent Clinical Trials for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

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

Sponsor	Phase
CarThera	Phase 2
Agenus Inc.	Phase 2
Yonsei University	Phase 2

See all DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) clinical trials

Pharmacology for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Drug Class	Anthracycline Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

US Patents and Regulatory Information for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ayana Pharma Ltd	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	207228-001	Oct 12, 2021	AB	RX	No	No
Lupin	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	215178-001	Jul 16, 2024	AB	RX	No	No
Baxter Hlthcare Corp	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	212219-002	Oct 19, 2022	AB	RX	No	No
Zydus Lifesciences	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	212299-002	Sep 10, 2020	AB	RX	No	No
Lupin	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	215178-002	Jul 16, 2024	AB	RX	No	No
Ayana Pharma Ltd	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	207228-002	Oct 12, 2021	AB	RX	No	No

EU/EMA Drug Approvals for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
YES Pharmaceutical Development Services GmbH	Celdoxome pegylated liposomal	doxorubicin hydrochloride	EMEA/H/C/005330 Celdoxome pegylated liposomal is indicated in adults:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk.or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.Celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).	Authorised	no	no	no	2022-09-15

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) Market Analysis and Financial Projection Experimental

Liposomal Doxorubicin Market Dynamics and Financial Trajectory

Market Overview

The global liposomal doxorubicin market is experiencing significant growth, driven by several key factors. As of 2023, the market was valued at USD 1.3 billion and is projected to reach over USD 2 billion by 2032, growing at a CAGR of 5.1% during the forecast period of 2024-2032[1].

Market Drivers

Rising Cancer Incidence

The increasing prevalence of cancer worldwide is a primary driver for the liposomal doxorubicin market. According to the World Health Organization (WHO), cancer is a leading cause of death globally, with millions of new cases diagnosed each year. This rising prevalence necessitates effective treatment options, boosting the demand for advanced chemotherapy drugs like liposomal doxorubicin[1].

Regulatory Approvals and Reimbursement Policies

Favorable regulatory approvals and improved reimbursement policies in various regions are making advanced therapies more accessible to patients. This trend is expected to support market growth by ensuring wider adoption of liposomal doxorubicin in clinical practice[1].

Focus on Reducing Side Effects

Efforts to minimize the side effects associated with chemotherapy are driving innovation in drug delivery systems. Liposomal doxorubicin's ability to reduce cardiotoxicity and other adverse effects compared to conventional doxorubicin is a significant factor in its growing popularity[1].

Market Penetration in Emerging Economies

Expanding healthcare infrastructure and increasing awareness about advanced cancer treatments in emerging economies are opening new avenues for market growth. These regions represent untapped potential for the adoption of liposomal doxorubicin[1].

Global Market Segmentation

Market Breakup by Drug Formulation

The market is segmented by drug formulation, including lyophilized powder and doxorubicin injection. Each formulation has its own set of advantages and is used based on the specific needs of the patient and the type of cancer being treated[1].

Regional Analysis

North America leads the market due to the high prevalence of cancer, advanced healthcare infrastructure, and significant research and development activities. Europe follows closely, driven by increased government funding for cancer research and widespread adoption of advanced therapies. The Asia Pacific region is witnessing rapid growth, propelled by a rising cancer burden, improving healthcare facilities, and increasing awareness about effective cancer treatments. Latin America and the Middle East and Africa are also poised for growth, supported by expanding healthcare access and rising investments in oncology treatments[1].

Financial Trajectory

Market Size and Growth

The global liposomal doxorubicin market is expected to grow significantly over the next decade. By 2033, the market is projected to be worth around USD 2.3 billion, growing at a CAGR of 6.7% from 2023[4].

Cost-Effectiveness

Studies have shown that pegylated liposomal doxorubicin hydrochloride is a cost-effective option compared to other chemotherapy drugs. For instance, it produces a cost saving of 2209.97 euros per patient in comparison to topotecan, primarily due to lower costs associated with managing adverse events[2].

Pricing and Affordability

The cost of doxorubicin liposomal can vary, but it is generally priced around $468.50 to $997.88 for a supply of 10 milliliters, depending on the pharmacy and location. This pricing makes it a viable option for many patients, especially when considering the reduced side effects and improved efficacy[5].

Competitive Landscape

The competitive dynamics within the liposomal doxorubicin market are characterized by constant evolution and significant capital investments. Companies actively engage in collaborations, mergers, and acquisitions to reinforce their market presence, broaden distribution channels, and expand manufacturing capabilities. This competitive environment drives innovation and ensures a steady supply of advanced chemotherapy drugs[3].

Application Analysis

Liver Cancer

The liver cancer segment consumes a significant portion of the liposomal doxorubicin market, driven by the high success rate and easy availability of the drug for this application. Liver cancer is a growing concern among men and women, and liposomal doxorubicin offers better control over the treatment process[3].

Other Cancer Types

Liposomal doxorubicin is also effective in treating various other cancers, including breast, ovarian, endometrial, stomach, and kidney cancers. Its ability to inhibit or slow down cancer cell proliferation makes it a versatile treatment option across multiple cancer types[4].

Key Takeaways

• Market Size: The global liposomal doxorubicin market is expected to reach USD 2.3 billion by 2033, growing at a CAGR of 6.7% from 2023.
• Market Growth Drivers: Rising cancer incidence, favorable regulatory approvals, focus on reducing side effects, and market penetration in emerging economies.
• Regional Leadership: North America dominates the market, followed by Europe and the Asia Pacific region.
• Cost-Effectiveness: Pegylated liposomal doxorubicin hydrochloride is a cost-effective option compared to other chemotherapy drugs.
• Application: Liver cancer represents a significant market share, with the drug also being used effectively for other types of cancers.

"Liposomal formulation of doxorubicin extends its presence in the bloodstream for longer, improving delivery to cancer cells and increasing therapeutic efficacy. Dosage adjustments are made according to patient weight, height, and overall health factors; specifically, liposomal doxorubicin has demonstrated reduced toxicity, myelosuppression, alopecia, nausea, and other side effects compared with conventional drugs."[4]

FAQs

Q: What is the current market size of the global liposomal doxorubicin market?

A: As of 2023, the global liposomal doxorubicin market was valued at USD 1.3 billion[1].

Q: What is the projected growth rate of the liposomal doxorubicin market?

A: The market is expected to grow at a CAGR of 5.1% during the forecast period of 2024-2032 and reach over USD 2 billion by 2032[1].

Q: Which region leads the liposomal doxorubicin market?

A: North America leads the market due to the high prevalence of cancer, advanced healthcare infrastructure, and significant research and development activities[1].

Q: What are the primary drivers of the liposomal doxorubicin market?

A: The primary drivers include rising cancer incidence, favorable regulatory approvals, focus on reducing side effects, and market penetration in emerging economies[1].

Q: Is liposomal doxorubicin cost-effective compared to other chemotherapy drugs?

A: Yes, studies have shown that pegylated liposomal doxorubicin hydrochloride is a cost-effective option, producing a cost saving of 2209.97 euros per patient compared to topotecan[2].

Sources

1. GlobeNewswire: "Liposomal Doxorubicin Market Report 2024-2032: Innovative Liposomal Formulations Pave the Way for Safer and More Effective Cancer Treatments."
2. PubMed: "Cost-minimisation analysis of pegylated liposomal doxorubicin hydrochloride versus topotecan in the treatment of recurrent epithelial ovarian cancer."
3. PharmiWeb: "Liposomal Doxorubicin Market is anticipated to reach USD 2,367.5 Million, growing at a 6.3% CAGR By 2034."
4. Market.US: "Liposomal Doxorubicin Market Size, Share | CAGR of 6.7%."
5. Drugs.com: "Doxorubicin liposomal Prices, Coupons, Copay Cards & Patient Assistance."