DOXORUBICIN HYDROCHLORIDE Drug Patent Profile

Which patents cover Doxorubicin Hydrochloride, and what generic alternatives are available?

Doxorubicin Hydrochloride is a drug marketed by Qilu Pharm Hainan, Actavis Inc, Almaject, Amneal, Fresenius Kabi Usa, Gland, Hikma, Hisun Pharm Hangzhou, Hlthcare, Mylan Labs Ltd, Pfizer, Pharmachemie Bv, Pharmobedient, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, Alembic, Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Lupin, Sun Pharm, and Zydus Lifesciences. and is included in twenty-seven NDAs.

The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Doxorubicin Hydrochloride

A generic version of DOXORUBICIN HYDROCHLORIDE was approved as doxorubicin hydrochloride by PFIZER on December 23^rd, 1987.

Summary for DOXORUBICIN HYDROCHLORIDE

US Patents:	0
Applicants:	23
NDAs:	27
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2,291
Patent Applications:	5,069
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
Andrew Hantel, MD	PHASE1
SWOG Cancer Research Network	PHASE3

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
Baxter Hlthcare Corp	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	212219-002	Oct 19, 2022	AB	RX	No	No
Sagent Pharms	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	091495-001	Mar 18, 2013	AP	RX	No	No
Zydus Lifesciences	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	212299-002	Sep 10, 2020	AB	RX	No	No
Lupin	DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	215178-002	Jul 16, 2024	AB	RX	No	No
Pharmachemie Bv	DOXORUBICIN HYDROCHLORIDE	doxorubicin hydrochloride	INJECTABLE;INJECTION	063097-002	May 21, 1990		DISCN	No	No

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

Doxorubicin Hydrochloride: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

Doxorubicin hydrochloride is a widely used, mature oncology cytotoxic with long-established manufacturing capacity and deep generic penetration in most geographies. Its revenue trajectory is driven less by innovation and more by (1) hospital and oncology formulary buying patterns, (2) dose density and treatment line mix, (3) competitive substitution across liposomal and combination regimens, and (4) periodic supply and pricing adjustments in key markets. The long-term direction is typically flat-to-declining unit pricing with demand stability tied to incidence of cancers treated and chemotherapy protocol preferences.

What does the demand base look like for doxorubicin hydrochloride?

Doxorubicin is used across multiple solid tumor types and hematologic malignancies in combination chemotherapy and as an active component in several regimen standards. The market behaves like a core hospital oncology drug: demand tracks patient volumes and protocol intensity rather than patient pull-through. Key demand drivers:

• Treatment-line dependence: Use persists across first-line and later-line settings where doxorubicin remains protocol-compatible.
• Protocol substitution: Over time, prescribers can shift toward regimens that use liposomal doxorubicin or alternative agents when efficacy and toxicity profiles align with guideline updates.
• Administration setting: Predominant use is in inpatient or outpatient infusion centers, where formulary decisions and nursing/infusion workflows influence uptake.

A practical implication for revenue is that volume can remain resilient while net sales can soften due to price erosion and competitive switching.

How do pricing and competition typically shape the financial trajectory?

For established cytotoxics, financial trajectories usually follow a pattern:

1. Post-patent period: Rapid generic entry compresses pricing.
2. Brand survival pockets: Brand manufacturers retain share in select accounts with contractual pricing, supply reliability, or tender cycles.
3. Competitive reallocation: Patients and prescribers move among doxorubicin-related options (conventional versus liposomal) and among different anthracyclines based on cardiotoxicity considerations.

For doxorubicin hydrochloride specifically, the competitive set includes:

• Generic conventional doxorubicin hydrochloride across multiple label presentations.
• Liposomal doxorubicin formulations that can command higher prices and can displace conventional doxorubicin in certain regimens and toxicity contexts.
• Alternative anthracyclines where clinical protocols permit substitution.

Net sales performance is therefore most sensitive to gross-to-net dynamics (rebates, discounts, tender outcomes) and country-level reimbursement.

What revenue levers matter most: volume, net price, mix, and reimbursement?

For a mature generic-dominated oncology drug, net sales are typically explained by:

• Volume: driven by new cancer diagnoses and regimen adherence in infusion protocols.
• Net price: compressed by tender competition, payer contracting, and generic substitution.
• Product mix: shares between different strengths and pack sizes, and switching between conventional versus liposomal doxorubicin.
• Reimbursement mechanics: hospital procurement budgets and national reimbursement rules can cap pricing and determine effective transaction prices.

In practice, revenue stability comes from stable infusion demand, while growth rarely comes from price. Mix shifts can still move revenue meaningfully even when total patient numbers stay constant.

Where do the competitive and regulatory constraints show up operationally?

Doxorubicin hydrochloride is a sterile oncology injectable product, so supply continuity and manufacturing qualification shape market outcomes. Key operational constraints that can affect pricing and revenue:

• Allocation or supply disruptions: can temporarily support pricing but typically lead to short-lived financial gains because substitution and re-supply cycles normalize.
• Quality and regulatory inspection outcomes: may affect manufacturer competitiveness and tender eligibility.
• Hospital inventory behavior: tends to favor reliable suppliers and longer lead times over marginal price differences.

These factors matter because oncology procurement usually optimizes for supply reliability and continuity, which influences market share during market volatility.

How does substitution to liposomal doxorubicin influence the outlook?

Conventional doxorubicin faces a recurring competitive pressure from liposomal doxorubicin, which is designed to alter tissue distribution and reduce certain toxicity concerns relative to conventional formulations. In settings where clinicians prefer liposomal doxorubicin, conventional doxorubicin volume can decline even if overall oncology drug demand remains stable.

The financial implication:

• Conventional doxorubicin hydrochloride often experiences mix headwinds.
• Liposomal doxorubicin can capture higher-margin revenue pools, particularly where guidelines emphasize patient selection.

What is the financial trajectory shape you should expect for the next 3 to 5 years?

Given a mature molecule with long generic availability, the most typical trajectory in developed markets is:

• Flat to declining net price driven by generic tender pressure.
• Stable to modestly declining volumes depending on regimen shifts and substitution to liposomal or alternative agents.
• Net sales broadly flat in the presence of stable demand but with erosion in revenue per treated patient.

In emerging markets, revenue can be more volatile due to tender cycles, public procurement variability, and reimbursement evolution, but pricing pressure still generally dominates long-term revenue performance.

What do historical market patterns imply for long-term profitability?

For conventional cytotoxics:

• Profitability is constrained by low net pricing and high manufacturing scrutiny.
• Companies compete through cost per vial, supply reliability, and contracting strength.
• Margin expansion usually requires operational improvements rather than premium pricing.

This creates a financial structure where major value capture shifts to:

• Efficient generic manufacturers with scale.
• Account-based contracting strategies.
• Supply-chain robustness.

How does global market structure influence regional financial outcomes?

The trajectory differs by region mainly due to procurement systems:

• US: hospital contracting and rebate dynamics drive net price; generic substitution is the baseline.
• EU5 and UK: tenders and reference pricing compress conventional drug economics; formulary stability can keep volumes steady.
• Japan and other developed markets: reimbursement rules and procurement processes shape the timing of pricing changes.
• Latin America, Middle East, parts of Asia: demand growth can occur with rising oncology treatment access, but price pressure remains a constant drag.

Overall, the market is expected to show more volatility in emerging markets and more predictability but lower growth in developed markets.

Which product-line factors can move doxorubicin hydrochloride financials despite low innovation?

Even for an established injectable, revenue can shift due to:

• Presentation structure: vial size and strength availability affects tender attractiveness and substitution decisions.
• Switching between regimens: guideline updates that favor certain combinations shift demand intensity for conventional doxorubicin.
• Hospital formulary cycles: changes in preferred suppliers can move share even if molecule-level demand is stable.
• Support for combination protocols: demand can rise when combination regimens using doxorubicin expand in practice.

Key takeaways on market dynamics and financial trajectory

Key Takeaways

• Doxorubicin hydrochloride sits in a mature, generic-dominated oncology market where revenue depends on procurement-driven pricing rather than innovation.
• Financial trajectory is typically flat-to-declining net price with stable-to-modest volume softness from protocol switching and substitution to liposomal doxorubicin.
• Competitive outcomes are determined by tender contracting, supply reliability, and net-price execution at the hospital or national procurement level.
• Profitability is tied to manufacturing cost discipline and logistics performance, not pricing power.

FAQs

1. Why does doxorubicin hydrochloride revenue usually not grow through premium pricing?
   Generic penetration and tender-based purchasing compress transaction prices, so revenue growth relies on volume or mix shifts rather than premium margins.

2. What most often erodes conventional doxorubicin volume?
   Substitution to liposomal doxorubicin and shifts in chemotherapy protocols based on toxicity-management preferences.

3. What procurement dynamics matter most for net sales?
   Hospital contracting, rebates/discounts, tender cycles, and reference pricing, which drive gross-to-net outcomes and effective net price.

4. Can supply issues temporarily improve financial performance?
   They can, but effects typically normalize once supply is restored and substitution channels re-open.

5. Where can volume remain stable for a mature cytotoxic?
   Across multiple tumor types where doxorubicin remains protocol-compatible and where infusion-center treatment volumes track patient incidence and regimen adherence.

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References

[1] U.S. Food and Drug Administration. Drug Approval Reports and labeling information for doxorubicin hydrochloride products (accessed via FDA Drugs@FDA).
[2] National Cancer Institute. Doxorubicin information and oncology treatment context (accessed via NCI resources).
[3] European Medicines Agency. Product information and assessments related to doxorubicin-containing medicines (accessed via EMA databases).
[4] World Health Organization. ATC classification and oncology drug references for doxorubicin (accessed via WHO sources).