DOXIL (LIPOSOMAL) Drug Patent Profile

Which patents cover Doxil (liposomal), and what generic alternatives are available?

Doxil (liposomal) is a drug marketed by Baxter Hlthcare Corp and is included in one NDA.

The generic ingredient in DOXIL (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 Doxil (liposomal)

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

Summary for DOXIL (LIPOSOMAL)

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	923
Patent Applications:	3,513
DailyMed Link:	DOXIL (LIPOSOMAL) at DailyMed

Recent Clinical Trials for DOXIL (LIPOSOMAL)

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

Sponsor	Phase
Yongtao Sun	Phase 4
University of North Carolina, Chapel Hill	Phase 3
Harbin Medical University	Phase 2

See all DOXIL (LIPOSOMAL) clinical trials

Pharmacology for DOXIL (LIPOSOMAL)

Drug Class	Anthracycline Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

US Patents and Regulatory Information for DOXIL (LIPOSOMAL)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-001	Nov 17, 1995	AB	RX	Yes	No
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-002	Jun 13, 2000	AB	RX	Yes	No

Expired US Patents for DOXIL (LIPOSOMAL)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-001	Nov 17, 1995	5,013,556
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-002	Jun 13, 2000	5,213,804
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-001	Nov 17, 1995	5,213,804
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-002	Jun 13, 2000	5,013,556

EU/EMA Drug Approvals for DOXIL (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

International Patents for DOXIL (LIPOSOMAL)

See the table below for patents covering DOXIL (LIPOSOMAL) around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	6898291
Japan	2667051
Denmark	0496835
World Intellectual Property Organization (WIPO)	9105546

Supplementary Protection Certificates for DOXIL (LIPOSOMAL)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0496835	C960031	Netherlands		PRODUCT NAME: DOXORUBICINESULFAAT VERKREGEN UIT DOXORUBICINEHYDROCHLORIDE EN AMMONIUMSULFAAT; REGISTRATION NO/DATE: EU/1/96/011/001 - EU/1/96/011/002 19960621
0252504	96C0046	Belgium		PRODUCT NAME: DOXORUBICIN HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/96/011/001 19960624
0496835	96C0047	Belgium		PRODUCT NAME: ACIDE IBANDRONIQUE; REGISTRATION NO/DATE: EU/1/96/012/001 19960625
0496835	SPC/GB96/053	United Kingdom		PRODUCT NAME: DOXORUBICIN SULPHATE; REGISTERED: UK EU/1/96/011/001 19960621; UK EU/1/96/011/002 19960621

DOXIL (LIPOSOMAL) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DOXIL (Liposomal Doxorubicin)

Market Overview

The liposomal doxorubicin market, which includes products like DOXIL, is experiencing significant growth driven by several key factors. Here are the core dynamics and financial projections for this market.

Market Size and Growth

As of 2024, the global liposomal doxorubicin market is estimated to be valued at approximately USD 1.31 billion[3][4].

• By 2034, the market is projected to reach USD 2.38 billion, growing at a Compound Annual Growth Rate (CAGR) of around 6.2% to 6.7% during the forecast period[1][3][4].

Drivers of Growth

Increasing Prevalence of Cancer

The rising incidence of cancer globally is a major driver for the liposomal doxorubicin market. Cancer cases, particularly those affecting the liver, breast, endometrium, stomach, and kidneys, are increasing, which in turn drives the demand for effective chemotherapy treatments like liposomal doxorubicin[4].

Advancements in Drug Delivery Systems

Technological advancements in drug delivery systems, including the development of targeted therapies, are enhancing the efficacy and reducing the side effects of liposomal doxorubicin. This has led to increased adoption of these formulations in cancer treatment[3].

Personalized Medicine

A shift towards personalized medicine is also influencing the market. Liposomal doxorubicin formulations are being customized to individual patient profiles, which helps in enhancing treatment effectiveness and mitigating adverse reactions[1].

Regulatory Approvals

The approval of generic versions of liposomal doxorubicin formulations by regulatory bodies like the FDA has expanded the market by providing more affordable options for patients. This has significantly impacted the sales of liposomal doxorubicin, especially for second-line treatments of ovarian cancer and other chemotherapy regimens[1].

Regional Analysis

North America

North America, particularly the United States, holds a dominant position in the global liposomal doxorubicin market. This region accounts for a substantial market share due to the high incidence of cancer cases and the presence of advanced healthcare infrastructure. The U.S. has seen a significant number of breast cancer cases, further driving the demand for liposomal doxorubicin[4].

Other Regions

Canada is also a top-performing market, with a CAGR of 7.1%, driven by proactive government programs that elevate awareness and introduce novel cancer therapy approaches[1].

Market Segments

Branded vs. Generic

The branded segment of the liposomal doxorubicin market is expected to account for a significant market share, around 87.4% in 2024. However, the generic segment is also growing due to regulatory approvals and cost-effectiveness[1].

Application Analysis

Liver cancer represents a substantial market share, around 29%, in the application segment of the liposomal doxorubicin market. Other applications include breast, endometrium, stomach, and kidney cancers[4].

Key Players

The market is dominated by several key players, including:

• Johnson & Johnson Services Inc.
• Pfizer Inc.
• Sanofi
• Sun Pharmaceutical Industries Ltd.
• Merck & Co.
• GlaxoSmithKline plc.
• Cipla Limited
• Cadila Pharmaceuticals[1][3].

Financial Projections

Revenue Forecast

The market is expected to grow from USD 1.31 billion in 2024 to USD 2.38 billion by 2034, with a CAGR of 6.2% to 6.7% during the forecast period[1][3][4].

Historical Growth

From 2019 to 2023, the market registered a CAGR of 4.8%, indicating a steady growth trajectory that is expected to accelerate in the coming years[1].

Challenges and Opportunities

Side Effects and Toxicity

Despite its efficacy, liposomal doxorubicin can cause significant side effects such as cardiomyopathy, secondary oral neoplasms, and embryo-fetal toxicity. These risks necessitate careful monitoring and management[2].

Technological Advancements

Ongoing research and development in oncology and drug delivery systems present opportunities for further market growth. Technological advancements are expected to improve the therapeutic efficacy and reduce the side effects of liposomal doxorubicin[3].

Illustrative Statistics

• Market Size in 2024: USD 1.31 billion[3].
• Projected Market Size in 2034: USD 2.38 billion[3].
• CAGR from 2024 to 2034: 6.2% to 6.7%[1][3][4].
• North America Market Share: Around 37% as of 2023[4].
• Liver Cancer Market Share: Around 29% in the application segment[4].

Key Takeaways

• The liposomal doxorubicin market is driven by the increasing prevalence of cancer, advancements in drug delivery systems, and regulatory approvals.
• The market is expected to grow significantly, with a projected value of USD 2.38 billion by 2034.
• North America, particularly the United States, dominates the market due to high cancer incidence and advanced healthcare infrastructure.
• Key players are investing heavily in R&D to improve the efficacy and reduce the side effects of liposomal doxorubicin.

FAQs

What is the current market size of the liposomal doxorubicin market?

The current market size of the liposomal doxorubicin market is estimated to be around USD 1.31 billion as of 2024[3].

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

The market is projected to grow at a CAGR of 6.2% to 6.7% from 2024 to 2034[1][3][4].

Which region dominates the liposomal doxorubicin market?

North America, particularly the United States, holds a dominant position in the global liposomal doxorubicin market, accounting for around 37% of the market share as of 2023[4].

What are the main drivers of the liposomal doxorubicin market?

The main drivers include the increasing prevalence of cancer, advancements in drug delivery systems, and regulatory approvals for generic versions of liposomal doxorubicin formulations[1][3].

What are the potential side effects of liposomal doxorubicin?

Potential side effects include cardiomyopathy, secondary oral neoplasms, and embryo-fetal toxicity. These risks require careful monitoring and management[2].

Which companies are key players in the liposomal doxorubicin market?

Key players include Johnson & Johnson Services Inc., Pfizer Inc., Sanofi, Sun Pharmaceutical Industries Ltd., Merck & Co., and others[1][3].