DOXIL (LIPOSOMAL) Drug Patent Profile

When do Doxil (liposomal) patents expire, and when can generic versions of Doxil (liposomal) launch?

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. Nineteen 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:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1,064
Patent Applications:	1,729
DailyMed Link:	DOXIL (LIPOSOMAL) at DailyMed

Recent Clinical Trials for DOXIL (LIPOSOMAL)

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

Sponsor	Phase
Medical University of South Carolina	PHASE2
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	PHASE2
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	PHASE2

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	050718-002	Jun 13, 2000	5,013,556
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-001	Nov 17, 1995	5,213,804

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/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

International Patents for DOXIL (LIPOSOMAL)

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

Country	Patent Number	Title	Estimated Expiration
Japan	3571335
Australia	642679
Israel	96070	Liposome micro reservoir compositions with enhanced circulation time
Japan	H101431	THERAPY FOR SOLID TUMOR AND THERAPEUTIC COMPOSITION
European Patent Office	0662820	COMPOSITIONS DE TRAITEMENT DE TISSUS ENFLAMMES (COMPOSITIONS FOR TREATMEWNT OF INFLAMED TISSUES)
Austria	122229
Israel	96069	Liposome compositions for treating solid tumors

Supplementary Protection Certificates for DOXIL (LIPOSOMAL)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0496835	960031	Netherlands		960031, 20101020, EXPIRES: 20110620
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
0252504	96C0046	Belgium		PRODUCT NAME: DOXORUBICIN HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/96/011/001 19960624
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
0496835	96C0047	Belgium		PRODUCT NAME: ACIDE IBANDRONIQUE; REGISTRATION NO/DATE: EU/1/96/012/001 19960625

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DOXIL (Liposomal Doxorubicin)

Last updated: July 27, 2025

Introduction

DOXIL (liposomal doxorubicin HCl) stands as a pioneering chemotherapeutic agent in oncology, distinguished by its unique liposomal delivery system designed to mitigate toxicity while enhancing efficacy. Since its initial market entry, DOXIL has experienced significant shifts driven by evolving clinical guidelines, patent landscapes, regulatory decisions, and broader healthcare trends. This analysis delineates the current market dynamics and projects the financial trajectory for DOXIL, considering recent developments and future opportunities.

Historical Context and Market Position

Approved by the U.S. Food and Drug Administration (FDA) in 1995, DOXIL garnered recognition for treating ovarian cancer, multiple myeloma, and AIDS-related Kaposi's sarcoma (KS) [1]. Its liposomal formulation allows higher drug accumulation in tumors, reducing cardiotoxicity typical of conventional doxorubicin. This technological advantage translated into preferential positioning within oncology treatment protocols, especially for patients with pre-existing cardiac risks.

Initial Market Leadership
In the late 1990s and early 2000s, DOXIL dominated the liposomal anthracycline segment, capturing significant market share due to its innovative delivery mechanism. Its patent protections, alongside exclusive distribution agreements, sustained high margins.

Market Dynamics Influencing Current and Future Growth

1. Patent Expiry and Generic Competition

The expiry of key patents around 2013-2014 dramatically altered the competitive landscape. First-generation generic liposomal doxorubicin competitors entered markets in North America and Europe, exerting pricing pressure. Although the originator's exclusivity prolonged until 2023, the advent of biosimilars and generics is expected to significantly impact revenue streams.

Impact:
Price erosion and increased market penetration by generics have historically diminished profit margins and overall sales figures for DOXIL [2]. Efforts by the original manufacturer to extend exclusivity through new formulations or patent claims have met with mixed success.

2. Regulatory and Legal Challenges

Legal disputes over patent rights—particularly between Johnson & Johnson (producer of DOXIL) and competitors—have shaped market access. A landmark case in 2013 confirmed patent infringement, temporarily delaying generic entry—yet subsequent patent expiration ultimately opened the market [3].

Regulatory decisions regarding biosimilar applications influence future trajectory. While the complex liposomal formulation complicates biosimilar approval, regulatory pathways are evolving, potentially shortening approval timelines.

3. Clinical Developments and Companion Diagnostics

Emerging clinical data favoring combination therapies or alternative institutions impact drug demand. Notably, immune checkpoint inhibitors and targeted therapies have transformed oncology, sometimes relegating liposomal doxorubicin to second-line status or specific niches.

Conversely, ongoing trials exploring DOXIL in indications like recurrent ovarian cancer and certain sarcomas suggest sustained relevance. Companion diagnostics may personalize therapy, expanding or constraining the market depending on clinical outcomes.

4. Market Expansion and Geographic Trends

While North America and Western Europe historically contributed the majority of sales, growth in emerging markets—such as China and India—presents new opportunities. However, affordability and local regulatory hurdles affect adoption.

In addition, the increasing prevalence of cancers amenable to liposomal doxorubicin therapy, especially in aging populations, underscores growth potential. WHO estimates project an annual increase in ovarian and multiple myeloma incidences, supporting sustained demand [4].

Financial Trajectory Projections

1. Revenue Trends Post-Patent Expiry

Following patent expiration, revenue declines are typical absent robust new indications or formulations. Data indicates a drop of approximately 40–60% in U.S. sales within five years of patent loss for similar chemotherapy agents [5]. For DOXIL, initial declines post-2014 were evident, although strategic initiatives partially stabilized sales.

2. Impact of Biosimilars and Generics

The entrance of biosimilar liposomal doxorubicin variants is projected to further compress margins. Market analysts forecast a compounded annual decline rate of 7–10% in North American and European markets over the next five years, primarily driven by price competition.

For manufacturers able to innovate or diversify, this scenario presents opportunities for pipeline expansion or lifecycle management strategies—such as rebranding, combination formulations, or newer delivery platforms.

3. Opportunities for Growth and Diversification

Investments in novel liposomal or nanoparticle formulations, as well as regulatory approval of incremental innovations, may cushion revenue declines. Diversification into adjunct therapies or expanding indications (such as certain pediatric malignancies) could offset erosion.

Additionally, geographic expansion into underpenetrated markets could reinvigorate sales trajectories, provided regulatory and reimbursement barriers are overcome.

4. Modeling Future Revenues

Considering current patent expirations, market competition, and clinical landscape shifts, revenue forecasts project a plateauing or slight decline over 5–10 years. Medium-term projections suggest a possible stabilization of revenues through lifecycle management.

In a conservative scenario, global sales are estimated to decline from a peak of approximately $300 million (pre-patent expiry) to ~$150–200 million annually over the next decade, contingent upon the successful launch of biosimilars and ongoing clinical trials.

Regulatory and Market Entry Considerations

Projections depend heavily on regulatory approvals for biosimilars and new formulations. The complex manufacturing process for liposomal drugs presents barriers to biosimilar entry; however, recent advances in nanotechnology and bioprocessing could facilitate faster approvals.

Reimbursement policies, especially in cost-containment environments, will influence market penetration. Payers increasingly favor generic and biosimilar agents, influencing adoption rates.

Long-term Outlook and Strategic Implications

The long-term financial trajectory for DOXIL hinges on lifecycle management strategies, including developing next-generation liposomal formulations, exploring new indications, and leveraging emerging markets. Companies that diversify their oncology portfolio and engage in strategic collaborations may mitigate revenue erosion.

Innovations in delivery systems, such as targeted nanoparticles or immunoconjugates, could revitalize the product's market relevance. Moreover, increasing focus on personalized oncologic treatments aligns with precision medicine paradigms, potentially opening avenues for DOXIL in niche applications.

Key Takeaways

• Patent expiration and generic competition significantly challenge DOXIL’s market dominance, leading to revenue decline projections.
• Regulatory landscapes and biosimilar approvals will be critical drivers influencing future market access.
• Clinical evolution and emerging therapies may relegate DOXIL to niche roles unless innovative formulations or new indications are developed.
• Geographic expansion into emerging markets offers growth prospects amid a mature Western market.
• Strategic lifecycle management—including pipeline diversification and technological innovation—is essential for sustained financial performance.

FAQs

1. How has patent expiry affected DOXIL’s market share?
Patent expiration around 2013-2014 led to increased generic competition, causing significant market share erosion and declining revenues, typical in pharmaceuticals facing generic entry.

2. Are biosimilars a threat to DOXIL’s future revenues?
Yes. While biosimilar liposomal doxorubicin faces manufacturing and regulatory challenges, their eventual approval and market entry could substantially decrease DOXIL’s market share and pricing power.

3. What clinical developments could extend DOXIL’s market relevance?
New indications, combination therapies, and personalized medicine approaches could revitalize demand. Ongoing clinical trials exploring such avenues are crucial to prognosis.

4. Which regions offer the most growth potential for DOXIL?
Emerging markets like China, India, and parts of Southeast Asia present opportunities, contingent upon regulatory approval, reimbursement policies, and healthcare infrastructure.

5. What strategies can sustain DOXIL’s financial performance?
Lifecycle management, technological innovation, pipeline expansion, and geographic diversification are vital. Collaborations and licensing agreements can also enhance market presence.

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References

[1] U.S. Food and Drug Administration. (1995). FDA Approval for Doxil.
[2] MarketWatch. (2022). Impact of Patent Expiration on Liposomal Doxorubicin Market.
[3] Johnson & Johnson v. Sandoz Inc., et al. (2013). Patent Litigation Case.
[4] World Health Organization. (2021). Global Cancer Statistics.
[5] Evaluated Market Reports. (2019). Lifecycle Revenue Patterns for Chemotherapy Agents.