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, Ayana Pharma Ltd, Dr Reddys, Lupin, Sun Pharm, Zydus Lifesciences, Pfizer, Actavis Inc, Almaject, Amneal, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hisun Pharm Hangzhou, Hlthcare, Mylan Labs Ltd, Norvium Bioscience, Pharmachemie Bv, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, and Bristol Myers Squibb, and is included in twenty-eight NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for DOXORUBICIN HYDROCHLORIDE

US Patents:	0
Tradenames:	5
Applicants:	22
NDAs:	28
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	2,140
Patent Applications:	4,896
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
CarThera	Phase 2
Mansoura University	Phase 2
Regeneron Pharmaceuticals	Phase 3

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
Lupin	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	215178-002	Jul 16, 2024	AB	RX	No	No
Teva Pharms Usa	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	064140-002	Jul 28, 1995		DISCN	No	No
Hikma	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	062921-002	Mar 17, 1989	AP	RX	No	Yes
Amneal	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	208888-002	Feb 17, 2017	AP	RX	No	No
Bristol Myers Squibb	RUBEX	doxorubicin hydrochloride	INJECTABLE;INJECTION	062926-003	Apr 13, 1989		DISCN	No	No
Actavis Inc	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	203622-002	Jun 27, 2014	AP	RX	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	050718-001	Nov 17, 1995
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-002	Jun 13, 2000

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/005330 Celdoxome 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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Doxorubicin Hydrochloride

Introduction to Doxorubicin Hydrochloride

Doxorubicin hydrochloride, a potent chemotherapeutic agent belonging to the anthracycline class, is widely used in the treatment of various cancers, including breast cancer, lymphoma, leukemia, and others. Here, we delve into the market dynamics and financial trajectory of this crucial drug.

Market Size and Growth

The global doxorubicin hydrochloride market has been valued at USD 1.2 billion in 2023 and is projected to reach USD 1.9 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 4.6% during the forecast period from 2024 to 2033[1].

Another report indicates that the global doxorubicin market was valued at USD 989.6 million in 2023 and is expected to grow at a CAGR of 6.6% from 2024 to 2030, reaching a significant market size by the end of the decade[3].

Drivers of Market Growth

Increasing Incidence of Cancer

The escalating incidence of cancer globally is a primary driver of the doxorubicin hydrochloride market. Cancer remains one of the leading causes of mortality, and the demand for effective chemotherapeutic agents like doxorubicin hydrochloride is expected to rise significantly[1][2][4].

Advancements in Drug Delivery Systems

Advances in drug delivery systems, particularly the development of liposomal formulations, have been instrumental in reducing the toxicity of doxorubicin and enhancing its clinical utility. These formulations have received regulatory approvals, expanding the drug’s utilization and contributing to market growth[1][2].

Rise of Combination Therapies

The increasing emphasis on combination therapies, where doxorubicin is used alongside other agents to improve efficacy and reduce adverse effects, is also driving demand. This approach has been particularly effective in treating various types of cancer, including breast cancer, lung cancer, and leukemia[1][2][4].

Regulatory Approvals and Government Initiatives

Regulatory approvals from bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have facilitated the drug's accessibility and broadened its application. Government initiatives aimed at improving cancer treatment also provide significant opportunities for market growth[1][4].

Regional Analysis

North America

North America dominates the doxorubicin hydrochloride market, accounting for approximately 40% of the global market share. The United States is the primary contributor, driven by advanced pharmaceutical manufacturing capabilities and a strong presence of key industry players. The high prevalence of cancer and substantial investment in research and development further solidify North America's position[1][2].

Europe

Europe holds a significant share of the market, driven by increasing cancer cases and favorable government initiatives. Countries like Germany, France, and the United Kingdom are leading markets within the region, supported by robust healthcare systems and ongoing advancements in oncology[1].

Asia-Pacific

China is forecast to reach an estimated market size of USD 106.6 million by 2026, growing at a CAGR of 7.5% during the analysis period. Other notable markets include Japan and Canada, each forecast to grow at 3.9% and 5.3%, respectively[2].

Challenges and Barriers

Adverse Side Effects

Despite its efficacy, doxorubicin hydrochloride is associated with significant adverse side effects, particularly cardiotoxicity. These side effects present a substantial barrier to its widespread adoption and have prompted ongoing research to mitigate the drug's toxicity[1].

Market Segmentation

By Type

The 10mg/Bottle segment dominated the doxorubicin hydrochloride market. This segmentation is crucial as it reflects the most commonly used dosage and formulation of the drug[1].

By Application

Hospital pharmacies dominate the doxorubicin hydrochloride market by application, highlighting the drug's widespread use in clinical settings[1].

Financial Trajectory

Current Market Value

The global doxorubicin market was valued at USD 989.6 million in 2023 and is projected to grow significantly over the next decade. By 2031, the market is expected to reach USD 2.35 billion, growing at a CAGR of 6.1% during 2023-2031[4].

Future Projections

The market is expected to reach USD 1.9 billion by 2033, with a CAGR of 4.6% during the forecast period from 2024 to 2033. This growth is driven by the increasing incidence of cancer, advancements in drug delivery systems, and the rising adoption of combination therapies[1].

Key Takeaways

• Market Growth: The doxorubicin hydrochloride market is expected to grow from USD 1.2 billion in 2023 to USD 1.9 billion by 2033, with a CAGR of 4.6%.
• Regional Dominance: North America dominates the market with a 40% share, followed by Europe.
• Drivers: Increasing cancer incidence, advancements in drug delivery systems, and the rise of combination therapies are key drivers.
• Challenges: Adverse side effects, particularly cardiotoxicity, remain a significant challenge.
• Segmentation: The 10mg/Bottle segment and hospital pharmacies are dominant in the market.

FAQs

Q: What is the current market size of the doxorubicin hydrochloride market?

The global doxorubicin hydrochloride market was valued at USD 1.2 billion in 2023[1].

Q: What is the projected growth rate of the doxorubicin hydrochloride market?

The market is expected to grow at a CAGR of 4.6% from 2024 to 2033[1].

Q: Which region dominates the doxorubicin hydrochloride market?

North America dominates the market with a 40% share[1].

Q: What are the primary drivers of the doxorubicin hydrochloride market?

The primary drivers include the increasing incidence of cancer, advancements in drug delivery systems, and the rise of combination therapies[1][2][4].

Q: What are the significant challenges facing the doxorubicin hydrochloride market?

The significant challenge is the adverse side effects, particularly cardiotoxicity, associated with doxorubicin hydrochloride[1].

Sources

1. MarketResearch.biz: Doxorubicin Hydrochloride Market Size, Growth | CAGR of 4.6%
2. GlobeNewswire: Global Doxorubicin Market Trajectory & Analytics Report 2022-2026
3. Grand View Research: Doxorubicin Market Size, Share And Growth Report, 2030
4. The Insight Partners: Doxorubicin Market Strategic Insights and Updates by 2031