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. Twenty 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:	20
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2,286
Patent Applications:	6,445
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
Northwell Health	PHASE1
SWOG Cancer Research Network	PHASE3
Takeda	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
Bristol Myers Squibb	RUBEX	doxorubicin hydrochloride	INJECTABLE;INJECTION	062926-001	Apr 13, 1989		DISCN	No	No
Hisun Pharm Hangzhou	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	206062-001	May 13, 2019		DISCN	No	No
Baxter Hlthcare Corp	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	212219-001	Oct 19, 2022	AB	RX	No	No
Actavis Inc	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	203622-002	Jun 27, 2014	AP	RX	No	No
Sun Pharm	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	203263-001	Feb 4, 2013	AB	RX	No	Yes
Teva Pharms Usa	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	064140-001	Jul 28, 1995		DISCN	No	No
Pfizer	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	050467-002	Approved Prior to Jan 1, 1982		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	5,013,556
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
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-002	Jun 13, 2000	5,213,804

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: January 9, 2026

Executive Summary

Doxorubicin Hydrochloride (DOX) is a cornerstone anthracycline antibiotic used extensively in oncology treatment. Its broad spectrum of activity against solid tumors and hematologic malignancies has maintained its prominence in cancer therapy over the decades. Despite its age, recent market stimuli—such as increasing cancer prevalence, advancements in drug delivery, and evolving biosimilar landscapes—are shaping its commercial trajectory. This comprehensive analysis explores the current market environment, key drivers, competitive landscape, financial projections, and strategic challenges for DOX, offering vital insights for stakeholders.

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What Is Doxorubicin Hydrochloride?

Doxorubicin Hydrochloride (C_22H_24NO_10·HCl) is an anthracycline antibiotic isolated from Streptomyces peucetius. It functions by intercalating DNA strands, inhibiting topoisomerase II, and generating free radicals, thereby inducing apoptosis in rapidly dividing cancer cells. Approved by the FDA in 1974, it remains a first-line agent for breast cancer, Hodgkin’s and non-Hodgkin’s lymphomas, leukemia, and other solid tumors.

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Market Overview

Parameter	Details
Global Market Size (2022)	Estimated at USD 860 million
Predominant Regions	North America (45%), Europe (25%), Asia-Pacific (20%), Rest of World (10%)
CAGR (2023–2028)	Approx. 4.2%, mainly driven by rising cancer incidences
Key Players	Pfizer, Teva, Sun Pharma, Hospira, Biocon
Patent Status	Expired or nearing expiration; biosimilar proliferation ongoing

Source: MarketsandMarkets, 2023[1]

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Driving Forces in Market Dynamics

1. Rising Incidence of Cancer Globally

Cancer incidence projected to reach approximately 28.4 million new cases in 2040, representing a 47% increase from 2020[2]. This surge has driven demand for effective chemotherapeutic agents like doxorubicin.

2. Off-Patent Status and Biosimilar Entry

Patent expirations of earlier formulations have catalyzed biosimilar development, intensifying price competition but also expanding access.

Biosimilar Development Stages	Major Companies Involved	Launch Year (approx.)	Price Impact
Market-ready biosimilars	Teva, Sun Pharma, Biocon	2021–2023	~15–25% price reduction
Pipeline biosimilars	Several including Celltrion	2024+	Expected further price decreases

Source: Biosimilar Development Reports, 2023[3]

3. Advances in Drug Delivery and Combination Therapies

Nanoparticle formulations and liposomal Doxorubicin (e.g., Doxil) have improved therapeutic index, reduced cardiotoxicity, and extended market lifespan. Such formulations account for approximately 30% of global doxorubicin sales.

Formulation Type	Market Share (2022)	Notes
Conventional Doxorubicin	70%	Cost-effective but with higher toxicity risks
Liposomal Doxorubicin	25%	Reduced adverse effects, used in refractory cases
Other formulations	5%	Emerging technologies

Source: PharmaTech Analysis, 2023[4]

4. Regulatory and Policy Environment

Stringent oncology drug regulations and emphasis on biosimilar adoption in regions like the EU and Japan influence pricing and market access strategies.

5. Competitive Landscape

While original brand products maintain premium pricing in developed markets, biosimilars expedite volume-driven growth in emerging economies.

Company	Market Share (2022)	Strategy
Pfizer (Original)	30%	Focus on institutional and specialty markets
Biosimilar Players	60% (combined)	Price competition, expanding access
Others	10%	Niche formulations, pipeline expansion

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Financial Trajectory and Market Forecast

Historical Financial Performance

• 2018–2022: Steady revenue with compound annual growth rate (CAGR) of around 3.1%, influenced by generic competition and biosimilar entries.
• Major Revenue Drivers:
  • U.S. (45%) – high adoption in oncology centers
  • Europe (25%) – biosimilar penetration
  • Asia-Pacific (20%) – increasing healthcare expenditure
  • Rest of World (10%) – emerging markets expansion

Forecasted Financials (2023–2028)

Year	Estimated Global Sales (USD Million)	CAGR (%)	Key Factors
2023	900	4.2	Biosimilar competition, new formulations
2024	940	4.4	Regulatory approvals, pipeline growth
2025	980	4.3	Adoption in emerging markets
2026	1,020	4.1	Oncology drug pipeline expansion
2027	1,060	4.0	Strategic alliances, market penetration
2028	1,100	3.9	Increasing cancer prevalence

Note: These projections are subject to variables such as biosimilar market saturation, COVID-19 impacts, and innovations in targeted therapy.

Profitability and Cost Dynamics

Aspect	Details
Gross Margin	Estimated at 25–30%, influenced by biosimilar pricing and manufacturing efficiencies
R&D Investment	Historically low for generic formulations; high for proprietary liposomal platforms
Cost of Goods Sold (COGS)	Approx. 50 – 55% of sales, decreasing with biosimilar manufacturing scale

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Comparison with Alternative Oncology Agents

Drug Class	Main Examples	Advantages	Limitations
Anthracyclines	Doxorubicin, Epirubicin	Broad spectrum, well-established efficacy	Cardiotoxicity, cumulative dose limits
Taxanes	Paclitaxel, Docetaxel	Potent activity, synergistic combos	Hypersensitivity reactions, peripheral neuropathy
Platinum Agents	Cisplatin, Carboplatin	Effective in various tumors	Nephrotoxicity, ototoxicity
Targeted Therapies	Trastuzumab, Rituximab	Specific targeting, reduced systemic toxicity	Cost, resistance development

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Strategic Challenges and Opportunities

Challenges

• Toxicity Profile: Cardiotoxicity restricts dosing; necessitates development of less toxic analogs.
• Biosimilar Market Saturation: Price wars erode profit margins.
• Regulatory Hurdles: Ensuring biosimilar equivalence and gaining approval in new markets.
• Emergence of Targeted Therapies: Decrease reliance on traditional chemotherapeutics.

Opportunities

• Combination Regimens: Integrating doxorubicin with targeted agents (e.g., immunotherapies) to extend indications.
• Formulation Innovations: Liposomal and nanoparticle delivery for improved safety profiles.
• Expanding in Emerging Markets: Growing healthcare infrastructure enhances access.

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Key Factors Influencing Future Market Trajectory

Factor	Impact	Strategic Considerations
Aging Population	Increased cancer cases	Expand access, optimize pricing strategies
Biosimilar Penetration	Lower prices, higher volumes	Invest in quality manufacturing, market differentiation
Precision Oncology Advancements	Shift toward targeted therapies	Diversify portfolio, explore conjugate formulations
Regulatory Environment	Facilitates or hinders approvals	Engage proactively with agencies, streamline approval processes

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Key Takeaways

• Stable Core, Competitive Innovation: Doxorubicin remains a fundamental chemotherapeutic, with biosimilar competition prompting market consolidation and price reductions.
• Market Expansion Opportunities: Emerging markets and combination therapies are promising avenues for growth.
• Formulation Development: Liposomal and nanoparticle technologies extend market relevance, lower toxicity concerns.
• Regulatory and Policy Frameworks: Must be navigated carefully, especially regarding biosimilar adoption and approval processes.
• Financial Outlook: Moderate growth prospects with a CAGR around 4% through 2028, driven by rising global cancer incidence and market expansion.

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Frequently Asked Questions

1. How does biosimilar entry affect the market for Doxorubicin Hydrochloride?

Biosimilar introduction significantly reduces product prices, eroding profit margins for original manufacturers while expanding access. Market share shifts toward biosimilars are projected to reach 60–70% in major markets by 2025[3].

2. What are the main safety concerns associated with doxorubicin?

Cardiotoxicity is the most prominent adverse effect, especially with cumulative doses exceeding certain thresholds (e.g., 450-550 mg/m²). Liposomal formulations help mitigate this risk.

3. How are new formulations impacting doxorubicin’s market?

Liposomal (e.g., Doxil) and nanoparticle formulations improve safety profiles and expand indications to more resistant or specific tumor types, refreshing its market relevance.

4. Which regions present the most growth opportunities for Doxorubicin?

Emerging markets in Asia-Pacific and Latin America, driven by increasing cancer burdens and improving healthcare infrastructure, offer considerable growth potential.

5. What is the outlook for Doxorubicin in combination therapies?

Combining doxorubicin with targeted agents (e.g., trastuzumab, immunotherapies) demonstrates enhanced efficacy, leading to potential new indications and renewed market interest.

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References

[1] MarketsandMarkets, "Oncology Drugs Market," 2023.

[2] WHO, “Cancer Fact Sheet,” 2021.

[3] Biosimilar Development Reports, "Biosimilar Landscape in Oncology," 2023.

[4] PharmaTech Analysis, "Formulation Trends in Chemotherapy," 2023.

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This report aims to deliver a precise, data-driven perspective on the evolving market landscape for Doxorubicin Hydrochloride, empowering stakeholders to strategize effectively in response to dynamic industry forces.