Epirubicin hydrochloride - Generic Drug Details

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

Epirubicin hydrochloride is the generic ingredient in two branded drugs marketed by Pfizer Inc, Actavis Totowa, Cipla Ltd, Ebewe Pharma, Epic Pharma Llc, Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Hospira, Impax Labs Inc, Norvium Bioscience, and Zennova, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for epirubicin hydrochloride. Two suppliers are listed for this compound.

Summary for epirubicin hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	15
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	475
Patent Applications:	6,764
What excipients (inactive ingredients) are in epirubicin hydrochloride?	epirubicin hydrochloride excipients list
DailyMed Link:	epirubicin hydrochloride at DailyMed

Recent Clinical Trials for epirubicin hydrochloride

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

Sponsor	Phase
Jeeyun Lee	Phase 1/Phase 2
Daiichi Sankyo	Phase 3
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Phase 1

See all epirubicin hydrochloride clinical trials

Pharmacology for epirubicin hydrochloride

Drug Class	Anthracycline Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for epirubicin hydrochloride

Antibiotics, Antineoplastic

Topoisomerase II Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for epirubicin 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 epirubicin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065411-001	Aug 20, 2007		DISCN	No	No
Fresenius Kabi Usa	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065408-004	Oct 15, 2007		DISCN	No	No
Actavis Totowa	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065445-002	Sep 18, 2008		DISCN	No	No
Hospira	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065343-001	Apr 19, 2007		DISCN	No	No
Fresenius Kabi Usa	EPIRUBICIN HYDROCHLORIDE	epirubicin hydrochloride	INJECTABLE;INJECTION	065408-003	Oct 15, 2007		DISCN	No	No

Epirubicin hydrochloride Market Analysis and Financial Projection Experimental

Epirubicin Hydrochloride Market Dynamics and Financial Trajectory

Introduction to Epirubicin Hydrochloride

Epirubicin hydrochloride, an anthracycline medication, is widely used in the treatment of various cancers, particularly breast cancer. Derived from the gram-positive bacterium Streptomyces, epirubicin works by inhibiting DNA replication, thereby exerting its anti-cancer effects. This article delves into the market dynamics and financial trajectory of epirubicin hydrochloride, highlighting key trends, growth drivers, and challenges.

Market Size and Growth Projections

The global epirubicin market is anticipated to experience steady growth over the coming years. As of 2022, the market was valued at approximately US$ 198.56 million and is projected to reach US$ 282.81 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 3.6%[1][4][5].

Segmentation and Dominant Segments

The epirubicin market is segmented based on application, dosage, and distribution channels.

Application Segmentation

The breast cancer segment dominates the market, expected to grow at a CAGR of 8.3% during the forecast period. This dominance is attributed to increasing cases of breast cancer, rising alcohol consumption among women, obesity rates, and radiation exposure risks[1].

Dosage Segmentation

The market is segmented into various dosages, including 10mg/Vial, 50mg/Vial, 100mg/Vial, and 200mg/Vial. The 50mg/Vial segment held the largest share in 2021, while the 100mg/Vial segment is anticipated to register the highest CAGR during the forecast period[4].

Distribution Channel Segmentation

Hospital pharmacies hold the largest share of the market and are expected to register a CAGR of 4.0%. Hospital pharmacies play a crucial role in patient care, managing and distributing pharmaceuticals within healthcare facilities[4].

Regional Insights

The epirubicin market is geographically segmented into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America.

North America

North America, particularly the United States, holds the largest market share due to the rising prevalence of cancer and a strong emphasis on improving treatment outcomes[4].

Asia Pacific

The Asia Pacific region, including countries like China and Japan, is emerging as a significant market. China is growing at a CAGR of 4.8%, driven by an expanding pharmaceutical sector, innovative advancements, and favorable regulatory policies[1].

Growth Drivers

Several factors are driving the growth of the epirubicin market:

Increasing Cancer Cases

The rising incidence of cancer globally is a primary driver. Breast cancer, in particular, is seeing an increase due to factors like alcohol consumption, obesity, and radiation exposure[1].

Government Support and Healthcare Infrastructure

Government initiatives to raise awareness about cancer treatments and investments in healthcare infrastructure are boosting the market. Programs such as intravenous free treatment and digital microfluidics for on-chip biochemical analysis are also contributing to growth[1].

Technological Advancements

Advancements in technology, including more precise and accurate testing, are enhancing the efficacy and safety of epirubicin hydrochloride[2].

Challenges and Limitations

Despite the growth, the market faces several challenges:

Adverse Effects

The elevated risk of adverse effects associated with epirubicin is a significant concern, which can hamper market growth. Epirubicin, although having fewer side effects than doxorubicin, still poses risks that need to be managed[4].

Competition and Market Players Density

The market is competitive, with major players like Pfizer, Inc., Teva Pharmaceutical Industries Ltd., Hikma Pharmaceuticals PLC, and others. The density of market players can lead to intense competition, affecting pricing and market share[4].

Recent Developments and Innovations

Recent developments have further propelled the market growth:

Generic Launches

In 2018, Hikma Pharmaceuticals launched a generic version of epirubicin hydrochloride injection, which has expanded access to this medication[4].

Research and Development

Pharmaceutical companies are investing heavily in research and development to improve chemotherapy drugs and reduce side effects. The synthesis of classic non-drug and improved chemotherapy drugs is a key area of focus[1].

Key Players and Competitive Landscape

The epirubicin market is dominated by several key players:

• Pfizer, Inc.
• Teva Pharmaceutical Industries Ltd.
• Hikma Pharmaceuticals PLC
• Salius Pharma Pvt Ltd
• Mylan N.V.
• Fresenius Kabi AG

These companies are driving innovation and expansion in the market through strategic investments and product launches[4].

Financial Trajectory

The financial trajectory of the epirubicin market is positive, with steady growth anticipated over the next few years.

• Current Valuation (2022): US$ 198.56 million[1]
• Projected Valuation (2032): US$ 282.81 million[1]
• CAGR (2022-2032): 3.6%[1][4][5]

Conclusion

The epirubicin hydrochloride market is poised for significant growth driven by increasing cancer cases, government support, and technological advancements. While challenges such as adverse effects and market competition exist, the overall outlook remains positive.

Key Takeaways

• The global epirubicin market is expected to grow at a CAGR of 3.6% from 2022 to 2032.
• The breast cancer segment dominates the market due to rising incidence rates.
• Asia Pacific, particularly China, is an emerging market with significant growth potential.
• Hospital pharmacies are the primary distribution channels.
• Key players are investing in research and development to improve treatment outcomes.

Frequently Asked Questions

Q: What is the current market size of the epirubicin hydrochloride market? A: The current market size of the epirubicin hydrochloride market is approximately US$ 198.56 million as of 2022[1].

Q: What is the projected growth rate of the epirubicin market? A: The epirubicin market is projected to grow at a CAGR of 3.6% from 2022 to 2032[1][4][5].

Q: Which segment dominates the epirubicin market? A: The breast cancer segment dominates the epirubicin market, expected to grow at a CAGR of 8.3% during the forecast period[1].

Q: What are the major distribution channels for epirubicin? A: Hospital pharmacies hold the largest share of the market and are expected to register a CAGR of 4.0%[4].

Q: Which region is emerging as a significant market for epirubicin? A: The Asia Pacific region, particularly China, is emerging as a significant market with a CAGR of 4.8%[1].

Cited Sources

1. Fact.MR - Epirubicin Market Size, Share & Forecast Report, 2032
2. Southeast News Channel Nebraska - Epirubicin Hydrochloride Market 2024 Growth Analysis
3. Wicz - Epirubicin Hydrochloride Market Growth Insights 2024
4. The Insight Partners - Epirubicin Market Size - Global Analysis Report 2022 - 2028
5. GlobeNewswire - Epirubicin Market Worth $243.99 Million, Globally, by 2028