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. Twenty 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:	10
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	404
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
Sun Pharm	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	203263-002	Feb 4, 2013	AB	RX	No	Yes
Dr Reddys	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	208657-002	May 15, 2017	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

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL) Market Analysis and Financial Projection

Last updated: February 10, 2026

Market Overview of Liposomal Doxorubicin Hydrochloride

Liposomal doxorubicin hydrochloride (Doxil, Caelyx) is a reformulation of the anthracycline antibiotic doxorubicin. It employs liposomal encapsulation to enhance targeted delivery, reduce toxicity, and improve pharmacokinetics. Its primary indication involves ovarian cancer, AIDS-related Kaposi's sarcoma, multiple myeloma, and certain breast cancers. The global market for liposomal doxorubicin remains robust, driven by rising cancer prevalence and advances in drug delivery systems.

Market Size and Growth Projections

The global market for liposomal doxorubicin stood at approximately $600 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 8% from 2023 to 2030, reaching nearly $1 billion by 2030. Growth is fueled by increased cancer prevalence, expanding FDA approvals, and ongoing development of combination therapies.

Comparison with conventional doxorubicin reveals a marked preference shift toward liposomal formulations due to reduced cardiotoxicity, which limits the longevity and dosage of free doxorubicin.

Key Factors Impacting Market Dynamics

Technological Innovations

Advances in liposomal encapsulation, such as pegylation, have extended circulation time, enhancing drug efficacy. Next-generation formulations focus on targeted delivery, including tumor-specific ligands, which could broaden clinical applications.

Regulatory and Patent Landscape

The original liposomal doxorubicin formulations, like Doxil (Janssen) and Caelyx (Janssen/Chemotherapy), received FDA approval in the late 1990s. Patent expiration for some formulations has prompted entry by generic competitors, driving price competition and affecting revenue streams. Biotech firms are filing new patents on improved liposomal designs, potentially extending market exclusivity.

Clinical Adoption and Off-Label Use

Doxil is approved in over 50 countries. Its use in combination therapies, such as with cyclophosphamide for ovarian cancer, article a significant portion of sales. Off-label use in other cancers remains a growing area, although regulatory hurdles persist.

Competitive Landscape

Market players include Johnson & Johnson (Doxil), Sato Pharmaceutical, and Teva. Generic manufacturers increasingly supply liposomal doxorubicin, affecting pricing strategies.

Financial Performance and Revenue Trends

Year	Market Size (USD millions)	Key Growth Drivers	Patent Status
2021	550	Increased cancer cases	Doxil patents expired in 2013
2022	600	Broadened approvals	Patent expirations led to generics
2023*	640	Adoption in combination therapies	Continued patent expirations impact

*Estimated based on reported CAGR

Revenue contributions are heavily tied to treatments for ovarian cancer (approx. 50%) and breast cancer (25%). The rest relates to multiple myeloma and Kaposi's sarcoma.

Pricing and Reimbursement Dynamics

Pricing varies by region; the U.S. averages around $2,000 per dose, with significant discounts available for bulk or institutional purchasing. Generic versions are approximately 40-50% less expensive. Reimbursement policies favor liposomal formulations due to their safety profile, influencing hospitals’ procurement choices.

Strategic Considerations

• Companies investing in next-generation liposomal formulations may secure extended market presence.
• Patent litigation and licensing agreements can influence market exclusivity.
• Expansion into emerging markets may offset mature market stagnation.

Key Challenges

• Patent expirations reduce barriers for generic competition.
• High manufacturing costs threaten profit margins.
• Regulatory delays in new formulations hinder rapid market entry.

Opportunities

• Combination therapy approvals could open new revenue streams.
• Development of tumor-targeting liposomes may differentiate products.
• Focus on rare indications might leverage orphan drug designations.

Conclusion

Liposomal doxorubicin hydrochloride faces competitive, regulatory, and patent challenges but benefits from a steady increase in demand driven by cancer prevalence and improved safety profiles. Market growth depends on innovation, regulatory strategies, and geographic expansion.

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Key Takeaways

• The global liposomal doxorubicin market is projected to grow at around 8% CAGR, reaching approximately $1 billion by 2030.
• Patent expirations have led to a rise in generic products, exerting downward pressure on prices.
• Evolving formulations with targeted delivery and combination regimens represent growth opportunities.
• Cost and reimbursement policies significantly influence regional market dynamics.
• Adoption is primarily driven by existing FDA approvals, with expansion potential in emerging markets and new indications.

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FAQs

1. What distinguishes liposomal doxorubicin from traditional doxorubicin?
Liposomal encapsulation improves targeted delivery, prolongs circulation, and reduces cardiotoxicity, enabling higher dosing and extended treatment courses.

2. How has patent expiry impacted market competition?
Patent expiry allowed generic manufacturers to produce cost-competitive versions, decreasing prices and increasing market volume.

3. Which cancers are primarily treated with liposomal doxorubicin?
Ovarian cancer, multiple myeloma, AIDS-related Kaposi's sarcoma, and certain breast cancers.

4. What are the prospects for new liposomal formulations?
High. Areas of focus include tumor-specific targeting, combination therapies, and improved pharmacokinetics, which could extend exclusivity and market share.

5. How do regional policies influence market dynamics?
Reimbursement policies, regulatory approvals, and drug pricing vary, affecting adoption rates, especially between developed and emerging markets.

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References

1. MarketWatch. "Liposomal Doxorubicin Market Size, Share & Forecast." 2022.
2. FDA. "Approved Drugs: Doxil (Doxorubicin Hydrochloride Liposomes)." 1995–2022.
3. GlobalData. “Cancer Treatment Market Report,” 2022.
4. Johnson & Johnson. "Doxil Product Information." Accessed 2023.
5. DrugPatentWatch. "Liposome Doxorubicin Patent Status and Trends," 2023.