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 Alembic, Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Lupin, Sun Pharm, and Zydus Lifesciences. and is included in seven NDAs.

The generic ingredient in DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Nineteen 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:	7
NDAs:	7
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	403
DailyMed Link:	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) at DailyMed

Recent Clinical Trials for DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

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

Sponsor	Phase
University of Washington	PHASE2
Kuni Foundation	PHASE2
Michael Spinner, MD	PHASE2

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
Alembic	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	219199-001	Jun 27, 2025	AB	RX	No	No
Dr Reddys	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	208657-001	May 15, 2017	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/005330Celdoxome 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

Market Dynamics and Financial Trajectory for Liposomal Doxorubicin Hydrochloride

Last updated: July 30, 2025

Introduction

Liposomal doxorubicin hydrochloride represents a significant advancement in oncology therapeutics, utilizing liposomal encapsulation technology to enhance drug delivery, efficacy, and safety profiles over conventional formulations. Market penetration, driven by clinical advancements and strategic partnerships, influences its financial trajectory, positioning it as a key asset in the anticancer therapeutics landscape.

Market Overview

The global liposomal drug delivery market, including liposomal doxorubicin, is projected to reach USD 52.4 billion by 2026, growing at a CAGR of approximately 7.2% from 2021-2026 [1]. The segment's expansion is fueled by increased cancer prevalence, regulatory approvals of liposomal formulations, and the ongoing R&D activities aimed at broadening therapeutic applications.

Epidemiological Drivers

The rising incidence of cancer, notably breast cancer, ovarian cancer, and lymphoma, drives demand for effective chemotherapeutics like liposomal doxorubicin. According to WHO data, cancer accounted for approximately 10 million deaths globally in 2020, emphasizing the need for advanced treatment options [2].

Regulatory Environment

Liposomal doxorubicin, notably marketed as Doxil/Caelyx, received FDA approval in 1995 for AIDS-related Kaposi’s sarcoma and later for ovarian cancer and multiple myeloma, establishing its clinical niche. Concurrently, regulatory bodies scrutinize safety and efficacy, with ongoing approvals expanding therapeutic indications and formulation enhancements.

Technological Advancements

Innovations such as stealth liposomes prolong circulation time, reduce cardiotoxicity, and improve tumor targeting, boosting clinical adoption and fostering entry of novel liposomal formulations. These advancements underpin the development pipeline and influence market dynamics.

Competitive Landscape

The market showcases a mix of established pharmaceutical giants and biotech firms. Key players include:

• Johnson & Johnson (through Janssen Pharmaceuticals)
• Gilead Sciences/Novartis (via acquisition of certain assets)
• Erin Pharmaceuticals
• CytRx and other emerging biotech firms developing generics and biosimilars.

Strategic alliances, licensing agreements, and patent exclusivities shape the competitive landscape, impacting market share and pricing strategies.

Market Challenges

Despite promising growth, several challenges constrain market expansion:

• High Cost: Liposomal formulations are costlier than conventional doxorubicin, influencing healthcare budget allocations and patient access.
• Toxicity Concerns: While reduced cardiotoxicity is a benefit, infusion-related reactions and hand-foot syndrome remain adverse effects.
• Patent Expiry & Generic Competition: The impending patent expirations of key formulations threaten profitability, prompting companies to innovate or seek patent extensions.
• Regulatory Barriers: Stringent approval pathways and emphasis on demonstrating clear clinical advantages pose hurdles for new entrants.

Financial Trajectory

Revenue Trends

Liposomal doxorubicin generates substantial revenues within the oncology drug segment. For instance, Janssen's Doxil achieved peak sales exceeding USD 700 million annually pre-patent expiry [3]. Post-approval, revenue has stabilized with generic competition diminishing sales; however, new formulations and expanded indications rejuvenate growth prospects.

Investment and R&D Spending

Pharmaceutical companies are investing heavily in next-generation liposomal technologies, including targeted and stimuli-responsive liposomes. R&D expenditure for liposomal drug development is estimated at USD 2-3 billion annually, reflecting its strategic importance.

Market Penetration & Future Growth

With patent expirations, generics are entering markets primarily in emerging economies, offering affordable options but exerting price pressures globally. Conversely, novel liposomal formulations targeting specific cancer subtypes command premium pricing owing to demonstrated clinical benefits.

Market forecasts predict a compound annual growth rate (CAGR) of 6-8% over the next five years, driven by:

• Growth in global cancer incidence
• Expansion into rare and resistant cancer indications
• Advances in targeted delivery systems
• Increasing adoption in combination therapies

Impact of Biosimilars and Competitors

Emergence of biosimilars could erode exclusivity-driven revenues, compelling firms to innovate further to sustain profitability. Consequently, companies are investing in personalized medicine and companion diagnostics to differentiate their products.

Strategic Outlook

Market players are prioritizing:

• Innovative Formulation Development: Focused on reducing toxicity, improving pharmacokinetics, and expanding target cancer types.
• Regulatory Engagement: Accelerating approval pathways for new indications and combination regimens.
• Market Expansion: Penetrating emerging markets with cost-effective generic options and partnerships with local manufacturers.
• Intellectual Property Portfolio Management: Strategically filing patents to safeguard modifications and delivery system innovations.

Conclusion

Liposomal doxorubicin hydrochloride occupies a pivotal position within oncological therapeutics, with sustained growth driven by technological innovations, expanding clinical applications, and strategic market operations. Financially, it exemplifies the quintessential high-revenue drug with potential for sustainable growth through portfolio diversification, biosimilar competition navigation, and geographic expansion.

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Key Takeaways

• The liposomal doxorubicin market is poised for steady growth, driven by rising cancer prevalence and technological advances.
• Clinical advantages over conventional doxorubicin support continued adoption, though cost considerations pose challenges.
• Patent expiries and biosimilar entry threaten revenue streams, emphasizing the need for innovation.
• Strategic investment in next-generation liposomal technologies and emerging markets enhances future financial prospects.
• A balanced approach incorporating R&D, regulatory navigation, and market expansion is essential for sustained profitability.

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FAQs

1. How does liposomal doxorubicin differ from conventional doxorubicin?
Liposomal encapsulation enhances targeted delivery, prolongs circulation time, and reduces cardiotoxicity compared to conventional formulations, improving safety and efficacy profiles.

2. What are the primary markets influencing the growth of liposomal doxorubicin?
North America and Europe dominate, but emerging markets in Asia-Pacific and Latin America present growing opportunities due to increasing cancer prevalence and demand for affordable therapies.

3. What impact do patent expirations have on the liposomal doxorubicin market?
Patent expirations open the market to generics and biosimilars, leading to price reductions and revenue declines for originator companies unless new formulations or indications are introduced.

4. Are there promising pipeline products for liposomal doxorubicin?
Yes, ongoing development includes targeted, stimuli-responsive, and combination therapy formulations aimed at improving therapeutic index and expanding indications.

5. How are biotech firms influencing the liposomal doxorubicin market?
Emerging biotech firms focus on innovative delivery systems and niche indications, fostering competition and technological advancement, which may disrupt traditional market leaders.

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References

1. [Market Research Future], "Liposomal Drug Delivery Market Overview," 2021.
2. WHO, "Cancer Facts & Estimates," 2020.
3. Johnson & Johnson Annual Reports, 2019–2021.