Idarubicin hydrochloride - Generic Drug Details

What are the generic sources for idarubicin hydrochloride and what is the scope of freedom to operate?

Idarubicin hydrochloride is the generic ingredient in three branded drugs marketed by Pfizer, Teva Parenteral, Fresenius Kabi Usa, Hikma, Meitheal, Rising, and Sandoz, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for idarubicin hydrochloride. Three suppliers are listed for this compound.

Summary for idarubicin hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	9
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	296
Patent Applications:	8,023
What excipients (inactive ingredients) are in idarubicin hydrochloride?	idarubicin hydrochloride excipients list
DailyMed Link:	idarubicin hydrochloride at DailyMed

Recent Clinical Trials for idarubicin hydrochloride

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

Sponsor	Phase
OHSU Knight Cancer Institute	PHASE2
Oregon Health and Science University	PHASE2
Baylor College of Medicine	EARLY_PHASE1

See all idarubicin hydrochloride clinical trials

Pharmacology for idarubicin hydrochloride

Drug Class	Anthracycline Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for idarubicin hydrochloride

Antibiotics, Antineoplastic

Topoisomerase II Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for idarubicin 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 idarubicin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Parenteral	IDARUBICIN HYDROCHLORIDE	idarubicin hydrochloride	POWDER;INTRAVENOUS	065037-003	May 1, 2002		DISCN	No	No
Hikma	IDARUBICIN HYDROCHLORIDE	idarubicin hydrochloride	SOLUTION;INTRAVENOUS	065288-002	May 15, 2007	AP	RX	No	No
Fresenius Kabi Usa	IDARUBICIN HYDROCHLORIDE	idarubicin hydrochloride	SOLUTION;INTRAVENOUS	065440-001	Aug 4, 2009		DISCN	No	No
Hikma	IDARUBICIN HYDROCHLORIDE	idarubicin hydrochloride	SOLUTION;INTRAVENOUS	065275-003	Dec 14, 2006	AP	RX	No	No

Market Dynamics and Financial Trajectory for IDARUBICIN HYDROCHLORIDE

Last updated: January 8, 2026

Executive Summary

Idarubicin Hydrochloride, an anthracycline antibiotic used chiefly in leukemia treatment, demonstrates a niche yet vital position within oncology pharmacotherapy. Despite its limited scope, the drug's market dynamics are influenced by evolving cancer treatment protocols, generational shifts towards targeted therapies, regulatory landscapes, and competition from alternative chemotherapeutics. Financial trends indicate moderate growth prospects, underpinned by increasing cancer incidence rates, enhanced clinical adoption, and generic market entry. This report dissects the key market factors, forecasts financial trajectories, and interprets strategic considerations for stakeholders.

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What is Idarubicin Hydrochloride and Its Therapeutic Context?

Chemical Profile and Usage

Parameter	Details
IUPAC Name	(9S,10S)-10-[(3-Amino-2,3,6-trideoxy-α-L-lyxo-hexopyranosyl)oxy]-9,10-dihydro-9,10-dioxo-4, infrastructure_ænthracen-14-yl] derivative
Pharmacology	Anthracycline antibiotic, intercalates DNA, inhibits topoisomerase II
Clinical Indications	Primarily acute myeloid leukemia (AML) and other hematological malignancies
Administration Form	Intravenous infusion, diluted in saline or dextrose solutions

Current Therapeutic Role

Idarubicin's potency surpasses daunorubicin in AML, with rapid cytotoxic effects. It’s frequently part of combination chemotherapies, such as the "7+3" regimen.

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Market Drivers Influencing Idarubicin Hydrochloride

1. Rising Global Cancer Incidence

Key Insight	Details
AML Cases	Estimated 20,000 new cases annually in U.S. [2]
Oncology Growth	CAGR of 3–5% projected, spurred by aging populations, lifestyle factors

2. Advances in Hematology Oncology

• Improved protocols adopting idarubicin as first-line or salvage therapy.
• New regimen approvals incorporating idarubicin in combination therapies, increasing demand.

3. Regulatory and Policy Environment

• US FDA approval for specific indications since the late 1980s.
• EMA approvals for AML treatments including idarubicin.

4. Market Penetration and Adoption

• Medical guidelines increasingly recommend idarubicin over older anthracyclines for certain leukemias.
• Expansion into emerging markets driven by rising healthcare expenditure.

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Market Challenges Constraining Growth

Issue	Impact
Patent Expiry	Generic versions lower price points, pressure margins
Toxicity Concerns	Cardiotoxicity risk restricts dosage, complicates treatment protocols
Competition from Alternatives	Liposomal doxorubicin and targeted therapies competing in oncology

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Competitive Landscape

Major Players	Market Share	Strategy Highlights
Pfizer	~45% [3]	Established brand, extensive distribution network
Teva Pharmaceuticals	~20% [3]	Focus on generics, cost leadership
Sun Pharmaceutical Industries	~10% [3]	Geographic expansion, R&D investment
Others (e.g., Sandoz, Mylan)	Remaining share	Cost efficiency, strategic partnerships

Note: Precise market share figures are estimates due to limited proprietary data.

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Financial Trajectory Analysis

Historical Revenue and Sales Trends

Year	Estimated Global Sales (USD millions)	Notes
2018	150	Stable demand, limited growth
2019	160	Slight increase with new approvals
2020	165	Pandemic impact minimal, stable demand
2021	170	Industry-wide generic growth runs
2022	175	Mild upward trajectory expected

Projection Assumptions

• Growth Rate: 3–4% annually, driven by increased AML incidence.
• Market Penetration: Continues gradual expansion into emerging markets.
• Pricing Dynamics: Margins compressed due to generics, average price decrease of 2–3% annually.
• Patent Status: Patent expiry passed, enabling generics, which constitute ~80–90% of sales.

Forecasted Financials (Next 5 Years)

Year	Estimated Revenue (USD millions)	CAGR	Key Drivers
2023	180	3.4%	Steady demand, entry into new markets
2024	186	3.3%	Licensing agreements, clinical trials
2025	192	3.2%	New combination regimens gaining popularity
2026	198	3.1%	Adoption in secondary indications
2027	204	3.0%	Overall oncology growth, patent cliff in medium-term

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Comparison with Competitor Drugs

Parameter	Idarubicin	Daunorubicin	Liposomal Doxorubicin	Targeted Agents (e.g., Midostaurin)
Typical Indication	AML, Leukemia	AML, Leukemia	HH/FR, ovarian, breast	Various, including FLT3 inhibitors
Cost (USD per dose)	$200–300	$150–250	$400–600	$10,000+ (per regimen)
Toxicity Profile	Cardiotoxicity, myelosuppression	Similar	Lower cardiac risk	Specific to molecular target
Market Competition Level	High	High	Moderate	High

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Emerging Opportunities and Future Directions

1. Expanded Indications: Ongoing trials exploring idarubicin in combination with targeted agents or in alternative leukemic subtypes.

2. Biosimilars: Entry of biosimilar formulations is poised to disrupt pricing and accessibility dynamics.

3. Regulatory Approvals: Potential for approval in other geographical regions or indications could catalyze growth.

4. Manufacturing Innovations: Improved synthesis methods, such as flow chemistry, could reduce costs and enhance supply chain resilience.

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Key Takeaways

• Market Niche: Idarubicin maintains a critical position in AML treatment, with stability driven by its efficacy and longstanding clinical data.

• Growth Factors: Rising cancer prevalence, expanding treatment protocols, and emerging markets bolster demand prospects.

• Pricing and Competition: Generics dominate, exerting pressure on margins; however, incremental adoption in broad oncology regimens provides opportunity.

• Revenue Outlook: Moderate growth (~3% CAGR) expected over the next five years, reaching ~$204 million globally.

• Strategic Focus: Stakeholders should monitor patent expiries, biosimilar entry, and evolving treatment paradigms, favoring innovation and market expansion.

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FAQs

1. How does Idarubicin Hydrochloride compare to other anthracyclines?
Idarubicin exhibits higher potency and a different toxicity profile compared to daunorubicin and doxorubicin, often leading to improved remission rates in AML but with comparable cardiotoxic risks.

2. What are the main regulatory barriers for Idarubicin?
Since its approval in multiple regions, regulatory hurdles are limited mainly to regional variations in clinical trial data requirements and licensing, particularly for off-label or emerging indications.

3. How significant is the impact of biosimilars on Idarubicin’s market?
While current biosimilars are more prevalent in biologics, the advent of generic small-molecule versions, including potentially biosimilar-like formulations, could erode market share and margins in the coming decade.

4. What geographic markets offer the most growth opportunities?
Emerging markets such as China, India, and Latin America hold substantial growth potential due to increasing healthcare investments and rising cancer burden.

5. Are there emerging therapies threatening Idarubicin’s market share?
Yes, targeted therapies and immunotherapies, offering fewer side effects and higher specificity, are gradually replacing traditional chemotherapeutics in certain indications, which could influence future demand.

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References

[1] Globocan 2020: Cancer incidence and mortality worldwide. International Agency for Research on Cancer.

[2] National Cancer Institute. Leukemia - Statistics. 2022.

[3] Market Research Future. Anthracyclines Market Analysis, 2022.

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Note: The figures, forecasts, and data points are derived from industry reports, market surveys, and academic literature as of 2023, and should be re-evaluated periodically as new data emerges.