DOXORUBICIN HYDROCHLORIDE - Generic Drug Details

What are the generic sources for doxorubicin hydrochloride and what is the scope of patent protection?

Doxorubicin hydrochloride is the generic ingredient in five branded drugs marketed by Baxter Hlthcare Corp, Alembic, Ayana Pharma Ltd, Dr Reddys, Lupin, Sun Pharm, Zydus Lifesciences, Pfizer, Actavis Inc, Almaject, Amneal, Fresenius Kabi Usa, Gland, Hikma, Hisun Pharm Hangzhou, Hlthcare, Mylan Labs Ltd, Pharmachemie Bv, Pharmobedient, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, and Bristol Myers Squibb, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for doxorubicin hydrochloride. Nineteen suppliers are listed for this compound.

Summary for DOXORUBICIN HYDROCHLORIDE

US Patents:	0
Tradenames:	5
Applicants:	23
NDAs:	29
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2,276
Patent Applications:	5,648
What excipients (inactive ingredients) are in DOXORUBICIN HYDROCHLORIDE?	DOXORUBICIN HYDROCHLORIDE excipients list
DailyMed Link:	DOXORUBICIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DOXORUBICIN HYDROCHLORIDE

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

Sponsor	Phase
SWOG Cancer Research Network	PHASE3
Takeda	PHASE2
AbbVie	PHASE2

See all DOXORUBICIN HYDROCHLORIDE clinical trials

Pharmacology for DOXORUBICIN HYDROCHLORIDE

Drug Class	Anthracycline Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for DOXORUBICIN HYDROCHLORIDE

Antibiotics, Antineoplastic

Topoisomerase II Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DOXORUBICIN HYDROCHLORIDE

L01DB	Anthracyclines and related substances
L01D	CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for DOXORUBICIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	064140-002	Jul 28, 1995		DISCN	No	No
Ayana Pharma Ltd	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	207228-002	Oct 12, 2021	AB	RX	No	No
Amneal	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	208888-002	Feb 17, 2017	AP	RX	No	No
Pharmachemie Bv	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	063336-004	Feb 28, 1995		DISCN	No	No
Mylan Labs Ltd	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	200170-002	Oct 28, 2011	AP	RX	No	No
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-002	Jun 13, 2000	AB	RX	Yes	No
Pharmachemie Bv	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	063097-002	May 21, 1990		DISCN	No	No

Expired US Patents for DOXORUBICIN HYDROCHLORIDE

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

EU/EMA Drug Approvals for DOXORUBICIN HYDROCHLORIDE

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 Doxorubicin Hydrochloride

Last updated: July 27, 2025

Introduction

Doxorubicin hydrochloride, a potent anthracycline chemotherapeutic agent, remains a cornerstone in oncology treatment regimens. Widely used for various cancers, including breast, lung, ovarian, and hematological malignancies, its market dynamics are driven by evolving clinical needs, biosimilar competition, regulatory pathways, and technological advancements. This analysis delves into the current market landscape, key financial trends, and future projections for doxorubicin hydrochloride, providing vital insights for stakeholders across pharmaceutical manufacturing, healthcare investment, and R&D sectors.

Pharmacological Profile and Clinical Utility

Doxorubicin hydrochloride exerts its anti-cancer effects by intercalating DNA strands, inhibiting topoisomerase II, and generating free radicals, culminating in apoptosis[^1]. Its broad-spectrum efficacy makes it indispensable in chemo protocols such as CHOP, ABVD, and doxorubicin-based combination therapies. Despite its decades-long use, challenges such as cardiotoxicity and resistance remain, prompting ongoing research into formulations and delivery mechanisms that could enhance its safety profile[^2].

Market Drivers

Expanding Oncology Indications

The increasing prevalence of cancers globally fuels demand for established chemotherapeutic agents like doxorubicin. According to the World Health Organization, cancer cases are projected to rise from 19.3 million in 2020 to over 30 million by 2040[^3]. Doxorubicin’s role in first-line and salvage therapy sustains its market relevance, especially in resource-limited settings where affordability is critical.

Emergence of Biosimilars and Generics

Patents for innovative formulations have largely expired, fostering a proliferation of biosimilar and generic versions[^4]. These lower-cost alternatives enhance market accessibility, especially in emerging markets, while intensifying price competition. For example, several Indian and Chinese manufacturers have launched biosimilars, leading to a prominent volume-based market fashion.

Advances in Delivery Technologies

Liposomal formulations, such as pegylated liposomal doxorubicin (Doxil®, Caelyx®), improve therapeutic index by reducing cardiotoxicity and enabling higher dosing[^5]. Such innovations broaden clinical applications and create niches for premium-priced formulations, influencing the overall market structure.

Regulatory Environment and Market Expansion

Regulatory pathways that facilitate expedited approval for biosimilars and established drugs sustain market growth. Additionally, approvals for high-dose and combination regimens across various countries, including fast-track pathways, bolster demand.

Competitive Landscape

Market Players

The global doxorubicin hydrochloride market features leading players such as Pfizer, Teva Pharmaceutical Industries, Escin, Cipla, and Sun Pharma, alongside numerous regional manufacturers. Market shares are increasingly influenced by biosimilar entrants, which challenge traditional brand dominance.

Pricing and Reimbursement Trends

Price sensitivity varies across geographies. Developed markets tend to adhere to reimbursement policies favoring originator brands, whereas price-conscious regions favor biosimilars. The entry of biosimilars has led to price reductions of up to 50% or more, impacting profitability for traditional manufacturers[^6].

Research and Development Trends

Emerging R&D focuses on nanoparticle delivery systems, conjugates, and molecular modifications to mitigate side effects and improve efficacy. Partnerships between biotech firms and academic institutions continuously push the innovation frontier.

Market Size and Financial Trajectory

Historical Market Growth

The global doxorubicin market was valued at approximately USD 150 million in 2018 and has registered a compound annual growth rate (CAGR) of around 4-6% through 2022[^7]. Growth is primarily driven by increased usage in combination chemotherapy and biosimilar adoption.

Forecast to 2030

Projections indicate that the market will expand to over USD 250 million by 2030, with a CAGR of 5-7%. Key factors contributing to this growth include:

• Continued expansion of oncology indications.
• Increased acceptance and penetration of biosimilars.
• Advances in formulation and delivery methods.
• Emerging markets' expanding healthcare infrastructure.

Regional Dynamics

• North America: Dominates due to high cancer prevalence, advanced healthcare systems, and robust R&D activities.
• Europe: Holds significant market share, driven by similar factors and favorable regulatory pathways for biosimilars.
• Asia-Pacific: Expected to witness the fastest growth, attributed to increasing healthcare investments, generic manufacturing, and growing cancer burden.

Challenges and Constraints

Toxicity and Resistance

Persistent concerns regarding cardiotoxicity limit dosing strategies and reduce long-term use in some cases. Resistance development also hampers efficacy over time, necessitating combination regimens which can increase complexity and cost[^8].

Regulatory and Quality Concerns

The market faces barriers from stringent quality and biosafety standards, particularly for biosimilars. Ensuring bioequivalence and manufacturing consistency remains essential for market access.

Market Saturation and Pricing Pressures

Price erosion due to biosimilar proliferation constrains profit margins. Market saturation, especially in mature regions, could temper future growth unless innovation or new indications are introduced.

Future Outlook

Innovative Formulations and Delivery Systems

Nanotechnology, antibody-drug conjugates, and targeted delivery options present opportunities to improve safety and expand indications—potentially unlocking premium pricing tiers.

Market Penetration of Biosimilars

Regulatory support and cost advantages will likely accelerate biosimilar adoption, especially in emerging markets, contributing significantly to volume-driven growth.

Personalized Medicine and Combination Therapy

Integrating doxorubicin into personalized regimens, guided by genomic and biomarker insights, could enhance efficacy, support indication expansion, and stimulate market vitality.

Regulatory and Policy Trends

Streamlined approval processes, incentivizing innovation, and reimbursement reforms in key markets will influence financial trajectories. Companies investing in R&D for safer, more effective formulations will position favorably.

Key Takeaways

• The global doxorubicin hydrochloride market is projected to grow steadily at a CAGR of 5-7% through 2030, driven by rising cancer incidence and biosimilar adoption.
• Biosimilar proliferation substantially reduces prices, expanding access but constraining traditional profit margins.
• Innovations in delivery systems, such as liposomal formulations, enhance safety and therapeutic outcomes, enabling brands to command premium prices.
• Asia-Pacific will be the fastest-growing region, fueled by expanding healthcare infrastructure and manufacturing capabilities.
• Challenges include toxicity concerns, regulatory hurdles, and market saturation, which require strategic R&D and market adaptation.

FAQs

1. What factors are most influential in shaping the future market for doxorubicin hydrochloride?
   Key factors include the pace of biosimilar adoption, technological advancements in drug delivery, expanding indications through clinical research, and regulatory reforms supporting market access.

2. How do biosimilars impact the profitability of established doxorubicin manufacturers?
   Biosimilars typically lead to significant price reductions, pressuring traditional manufacturers' profit margins. However, they also open new volume-based growth opportunities in emerging markets.

3. Are there ongoing developments to mitigate doxorubicin's cardiotoxicity?
   Yes. Liposomal formulations, targeted delivery systems, and combination therapies are areas of active R&D aiming to reduce cardiotoxic effects and improve safety profiles.

4. Which regions will dominate the doxorubicin market in the next decade?
   North America and Europe currently lead, but Asia-Pacific is expected to experience the fastest growth owing to increased healthcare investments and biosimilar availability.

5. What role does personalized medicine play in the future of doxorubicin therapy?
   Personalized medicine, through biomarker-driven patient selection, can optimize efficacy, reduce adverse effects, and expand indications, thereby influencing market size and growth trajectories.

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References

[^1]: Minotti G, et al. "Doxorubicin cardiotoxicity: from molecules to mechanisms." Pharmacological Reviews, 2004.
[^2]: Carvalho C, et al. "Doxorubicin-induced cardiotoxicity: from molecular mechanisms to therapeutic strategies." Cancer Treatment Reviews, 2014.
[^3]: World Health Organization. "Cancer Fact Sheet," 2020.
[^4]: Wang B, et al. "Biosimilars in oncology: current regulatory status and ongoing challenges." Journal of International Medical Research, 2021.
[^5]: Gao D, et al. "Liposomal doxorubicin formulations." Therapeutics and Clinical Risk Management, 2017.
[^6]: U.S. Food and Drug Administration. "Biosimilar Approval Pathways," 2022.
[^7]: MarketsandMarkets. "Doxorubicin Market Analysis," 2022.
[^8]: Choi YJ, et al. "Mechanisms of resistance to anthracyclines." Chemotherapy Research and Practice, 2018.