Generic DAUNORUBICIN CITRATE INN equivalents, pharmaceutical patent expiry and freedom to operate

Sponsor	Phase
Alphacait, LLC	Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2
The EMMES Corporation	Phase 1

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galen (uk)	DAUNOXOME	daunorubicin citrate	INJECTABLE, LIPOSOMAL;INJECTION	050704-002	Apr 8, 1996		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: September 7, 2026

Daunorubicin citrate is a mature anthracycline product with limited standalone commercial visibility. Its primary branded formulation, DaunoXome, is a liposomal daunorubicin citrate injection originally developed for AIDS-related Kaposi’s sarcoma. The product entered the U.S. market in 1996, but its commercial opportunity contracted as antiretroviral therapy reduced the incidence of advanced AIDS-related Kaposi’s sarcoma. Conventional daunorubicin products, generally formulated as daunorubicin hydrochloride, remain available for acute leukemias but are separate products with different regulatory and commercial profiles.[1][2]

Daunorubicin citrate has low current growth potential. The principal value drivers are hospital procurement, oncology supply reliability, specialized liposomal manufacturing capacity, and access to non-U.S. markets rather than broad retail demand. Public company filings do not report standalone revenue for daunorubicin citrate or DaunoXome.

What is daunorubicin citrate and which products contain it?

Daunorubicin citrate is an anthracycline antineoplastic agent that inhibits DNA and RNA synthesis through DNA intercalation and topoisomerase II inhibition. The citrate form is associated most closely with liposomal daunorubicin products, while conventional injectable daunorubicin is commonly supplied as daunorubicin hydrochloride.[1][3]

DaunoXome product profile

Attribute	DaunoXome
Active ingredient	Daunorubicin citrate
Dosage form	Liposomal intravenous infusion
Strength	2 mg/mL
Original U.S. sponsor	Vestar, later associated with Gilead Sciences
FDA application	NDA 020539
U.S. approval	November 1996
Approved indication	AIDS-related Kaposi’s sarcoma
Administration	Intravenous infusion
Commercial setting	Hospital and oncology treatment centers
Regulatory pathway	New drug application
Primary competitive issue	Declining disease incidence and replacement by other oncology options

The FDA label describes DaunoXome as a liposomal formulation in which daunorubicin citrate is encapsulated in lipid vesicles. The delivery system changes the product’s pharmacokinetic and tissue-distribution profile compared with conventional daunorubicin.[1]

Conventional daunorubicin is not the same commercial product

Conventional daunorubicin hydrochloride is used primarily in combination regimens for acute myeloid leukemia and acute lymphoblastic leukemia. Those products compete in hematologic oncology but should not be counted as direct equivalents to liposomal daunorubicin citrate.

The distinction affects:

FDA approval status
Labelled indications
Dosing
Manufacturing requirements
Orange Book treatment
Substitution potential
Patent and regulatory strategy

A hospital may purchase both products, but a generic daunorubicin hydrochloride injection is not automatically substitutable for DaunoXome.

When did daunorubicin citrate lose exclusivity?

Daunorubicin citrate’s principal U.S. commercial exclusivity was tied to the original DaunoXome approval and associated intellectual-property rights. The 1996 approval date means any ordinary five-year new-chemical-entity exclusivity would have expired by 2001, subject to the precise regulatory classification and any applicable pediatric or other extensions.[1][4]

The practical exclusivity picture is older than the statutory exclusivity period. A liposomal formulation may retain commercial protection through formulation patents, manufacturing know-how, drug-delivery technology, regulatory complexity, and limited competition even after basic active-ingredient protection expires.

Exclusivity timeline

Event	Approximate date	Commercial effect
DaunoXome U.S. approval	1996	Commercial launch for AIDS-related Kaposi’s sarcoma
Five-year NCE exclusivity window	1996-2001	Restricted certain abbreviated applications, depending on FDA classification
Decline in AIDS-related Kaposi’s sarcoma	Late 1990s onward	Reduced addressable patient population
Generic and hospital oncology procurement pressure	2000s onward	Lower pricing power
Current market	Mature	Demand concentrated in institutional and specialist channels

No meaningful modern growth thesis depends on renewed basic-molecule exclusivity. Any remaining defensibility would arise from the liposomal formulation, manufacturing process, regulatory file, supply reliability, or a new clinical indication.

What is the FDA regulatory status of daunorubicin citrate?

DaunoXome was approved by the FDA for AIDS-related Kaposi’s sarcoma after prior systemic chemotherapy had failed or was unsuitable. The product label includes warnings associated with anthracycline therapy, including cardiotoxicity, infusion-related reactions, myelosuppression, and risks from cumulative exposure.[1]

The regulatory status must be separated into three categories:

DaunoXome, the liposomal daunorubicin citrate product.
Conventional daunorubicin hydrochloride injections.
International or compounded products described as daunorubicin citrate.

The FDA’s Drugs@FDA and Orange Book databases are the controlling sources for current U.S. application status, marketing status, patents, and exclusivity listings.[4][5] Public commercial references have described DaunoXome as discontinued or unavailable in some markets, but product availability can differ by country, distributor, and supply period. A discontinued branded product does not establish that every daunorubicin citrate presentation has disappeared globally.

What is the Orange Book status of DaunoXome?

The commercial importance of Orange Book protection for DaunoXome is limited compared with newer oncology products. Its approval dates to 1996, and any original regulatory exclusivity has expired. Publicly available FDA materials do not indicate a current, commercially meaningful patent barrier comparable to those protecting recently approved oncology formulations.[4][5]

Orange Book and Paragraph IV implications

A generic applicant seeking approval for a liposomal daunorubicin citrate product would face more than an active-ingredient comparison. The applicant would need to address:

Liposome composition
Particle-size distribution
Encapsulation efficiency
Release characteristics
Stability
Sterility and endotoxin controls
Pharmacokinetic comparability
Manufacturing-process reproducibility
Clinical or scientific bridging requirements

A conventional daunorubicin hydrochloride ANDA would not directly challenge DaunoXome. It would target a different dosage form and, generally, a different reference product.

No current high-value Paragraph IV litigation is publicly associated with daunorubicin citrate comparable to the litigation surrounding major branded oncology products. The commercial barrier is therefore more likely to be technical development and market size than active U.S. patent enforcement.

What formulations are protected by daunorubicin citrate technology?

The main technical distinction is the liposomal delivery system. DaunoXome uses a liposomal formulation designed to alter drug distribution and exposure relative to free daunorubicin.[1]

Formulation barriers

A competing liposomal product would need to establish control over:

Lipid identity and ratios
Vesicle size and uniformity
Drug-to-lipid ratio
Encapsulation method
Surface characteristics
Infusion stability
Container-closure compatibility
Release specifications
Long-term storage performance

These factors can create a regulatory and manufacturing barrier even when composition-of-matter patents have expired. In oncology injectables, a product with a small patient population can remain commercially unattractive because development costs are high and expected annual volume is low.

The formulation also creates a supply-chain risk. Liposomal injectable manufacturing requires specialized sterile processing, validated encapsulation equipment, and more complex analytical release testing than conventional powder or solution injections.

How strong is the daunorubicin citrate patent estate?

The estate is weak from a conventional exclusivity perspective and potentially stronger from a technical manufacturing perspective.

Patent-estate dimension	Assessment
Active ingredient	Weak; daunorubicin is an old anthracycline
New chemical entity exclusivity	Expired
Original product patents	Likely expired based on 1996 approval timing
Liposomal formulation claims	Historical relevance, but current enforceability requires patent-by-patent review
Manufacturing know-how	Potentially meaningful
Trade secrets	Potentially meaningful where process details are not public
Method-of-use protection	Narrow for AIDS-related Kaposi’s sarcoma
Litigation leverage	Low based on the absence of prominent current disputes
Generic development difficulty	Moderate to high for a liposomal product
Overall commercial moat	Narrow and operational rather than patent-led

The relevant risk is not that an old active ingredient suddenly regains exclusivity. The risk is that a technically difficult formulation has too little volume to attract multiple manufacturers, leaving procurement dependent on one or a few suppliers.

What patent litigation affects daunorubicin citrate?

No major active U.S. patent litigation involving DaunoXome or daunorubicin citrate is widely reported in the public record comparable to disputes involving liposomal doxorubicin, immuno-oncology products, or newer targeted therapies.

Historical disputes, licensing arrangements, or patent assignments related to liposomal drug-delivery platforms may still matter for ownership analysis, but they do not create a current revenue thesis without an identified live patent, enforceable claim set, and commercial product exposure.

Settlement agreements and licensing deals

The commercial history of DaunoXome includes development and corporate ownership changes associated with its original sponsor and later corporate holders. Public financial disclosures do not identify a current, separately reported licensing stream for daunorubicin citrate.

No major current settlement agreement is publicly identified as controlling U.S. generic entry for DaunoXome. Any assessment of settlement risk should therefore focus on:

Whether a generic or hybrid applicant has filed an application
Whether FDA has accepted the application for review
Whether the product has a reference listed drug
Whether an active patent is listed
Whether a commercial supplier has disclosed a launch plan

How has the daunorubicin citrate market changed?

The market contracted for disease-related reasons before generic competition became the central issue.

1. AIDS-related Kaposi’s sarcoma declined

The introduction and broad use of combination antiretroviral therapy reduced opportunistic disease burden and changed the treatment landscape for HIV-associated malignancies. As the incidence of advanced AIDS-related Kaposi’s sarcoma declined, the original DaunoXome indication became a smaller market.[6]

2. Oncology purchasing shifted toward lower-cost alternatives

Hospitals and oncology practices increasingly use formularies, group purchasing organizations, and comparative acquisition pricing. Mature anthracyclines are exposed to price competition, reimbursement pressure, and periodic shortages.

3. Liposomal competition expanded

Liposomal doxorubicin, including Doxil and generic equivalents, has a broader oncology presence than DaunoXome. It is used across several indications, including ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma in combination regimens.[7]

This broader label footprint gives liposomal doxorubicin greater manufacturing scale and commercial resilience than a product tied primarily to AIDS-related Kaposi’s sarcoma.

How does daunorubicin citrate compare with competing drugs?

Product	Active ingredient	Formulation	Main market	Commercial position
DaunoXome	Daunorubicin citrate	Liposomal IV	AIDS-related Kaposi’s sarcoma	Narrow, mature
Generic daunorubicin injection	Daunorubicin hydrochloride	Conventional IV	Acute leukemias	Mature generic
Doxil and generics	Pegylated liposomal doxorubicin	Liposomal IV	Multiple oncology indications	Broader and more competitive
Idarubicin injection	Idarubicin hydrochloride	Conventional IV	Acute myeloid leukemia	Specialist generic
Mitoxantrone	Mitoxantrone hydrochloride	Conventional IV	Hematologic malignancies and other uses	Mature generic

Doxil is the most relevant formulation comparator because both products use liposomal delivery and have historical relevance in AIDS-related Kaposi’s sarcoma. Doxil has a stronger commercial position because its indications extend beyond that disease.

What is the financial trajectory for daunorubicin citrate?

Daunorubicin citrate has no publicly disclosed standalone revenue trajectory. Gilead and other relevant corporate filings generally report revenue at the portfolio or product-family level rather than separating DaunoXome sales.[8]

The likely trajectory is:

Period	Financial direction	Main driver
1996-early 2000s	Initial growth followed by contraction	Launch adoption followed by declining AIDS-related Kaposi’s sarcoma
Mid-2000s-2010s	Structural decline or low-volume stability	Mature product economics and disease reduction
2020s	Limited, volatile institutional demand	Product availability, supply continuity, and specialist use
Forward outlook	Flat to declining in the branded indication	No clear evidence of label expansion or renewed exclusivity

Revenue exposure for the original sponsor was likely immaterial relative to large pharmaceutical portfolios once the product’s primary indication contracted. For a small generic manufacturer, however, even a low-volume injectable can have strategic value if competition is limited and supply is reliable.

Revenue drivers

Current or residual revenue depends on:

Number of treatable Kaposi’s sarcoma patients
Geographic availability
Hospital formulary inclusion
Distributor access
Pricing relative to alternatives
Production continuity
Procurement shortages affecting competing anthracyclines
Demand in countries where advanced HIV-related disease remains more prevalent

Financial risks

The main risks are commercial rather than patent-based:

Small and declining indication
High sterile-manufacturing costs
Low production scale
Reimbursement constraints
Product discontinuation
Dependence on specialist distributors
Substitution by liposomal doxorubicin or other chemotherapy
Lack of a broad oncology label

Which companies are challenging or competing with daunorubicin citrate?

No major current challenger has established a high-profile U.S. competitive position against DaunoXome. Competition comes mainly from therapeutic substitutes and products with broader commercial scale.

Direct and indirect competitors

Manufacturers of liposomal doxorubicin
Suppliers of conventional daunorubicin hydrochloride
Suppliers of idarubicin
Suppliers of paclitaxel or other systemic therapies used in Kaposi’s sarcoma
Manufacturers supplying HIV and oncology hospitals in emerging markets

The competitive landscape is fragmented. The absence of a large branded challenger does not imply strong pricing power because hospital buyers can use therapeutic alternatives and may avoid a low-volume product with uncertain supply.

What generic entry risks exist for daunorubicin citrate?

Generic entry risk is moderate in technical terms but low in expected market impact.

A conventional generic would not be a direct substitute for liposomal daunorubicin citrate. A true liposomal competitor would face a more demanding development program, but the market may be too small to support multiple entrants.

Generic launch scenarios

Scenario	Probability profile	Market effect
No new entrant	High	Continued low-volume specialist supply
One liposomal entrant	Moderate	Price reduction and improved supply resilience
Multiple liposomal entrants	Low	Significant price erosion, unlikely without larger indication
Conventional daunorubicin substitution	Limited	Relevant to leukemia, not direct DaunoXome replacement
Label expansion	Low	Only scenario with material market growth

The most credible launch opportunity would involve a company that already manufactures complex liposomal injectables and can leverage existing sterile infrastructure. A small company without liposomal manufacturing capability would face disproportionate development and validation costs.

What manufacturing and geographic barriers affect the market?

Daunorubicin citrate has a global opportunity that is larger than its U.S. branded opportunity, but access is uneven.

Geographic coverage

The product’s commercial relevance is highest where:

AIDS-related Kaposi’s sarcoma remains clinically significant
Oncology hospitals can administer intravenous liposomal products
Government or institutional procurement funds specialty chemotherapy
Regulatory agencies accept legacy or imported products
Cold-chain and sterile-injection logistics are reliable

Emerging markets may have greater disease need but lower ability to pay. Developed markets have stronger reimbursement systems but a smaller incidence of the original indication.

Manufacturing barriers

The principal barriers include:

Sterile fill-finish capacity
Liposome formation and size control
Drug-loading consistency
Stability testing
Batch-release analytics
Container-closure integrity
Pharmacovigilance for infusion and cardiac events
Reliable sourcing of pharmaceutical-grade lipids

These barriers support a small number of suppliers but do not necessarily support premium pricing. Buyers can respond to a sole-source position with tenders, importation, therapeutic substitution, or formulary restrictions.

Key Takeaways

Daunorubicin citrate is primarily associated with the liposomal product DaunoXome.
The product was FDA-approved in 1996 for AIDS-related Kaposi’s sarcoma.
Statutory exclusivity and any original patent protection are long expired based on the product’s approval vintage.
The U.S. market contracted as combination antiretroviral therapy reduced advanced AIDS-related Kaposi’s sarcoma.
No standalone revenue figures are publicly reported for daunorubicin citrate or DaunoXome.
The product’s remaining moat is technical manufacturing complexity and limited supplier competition, not active composition-of-matter exclusivity.
Liposomal doxorubicin is the principal formulation comparator and has a stronger commercial position because it has broader oncology indications.
Generic entry is technically feasible but commercially constrained by small market size and complex liposomal manufacturing.
Future revenue is more likely to remain flat or decline than to expand without a new indication, new formulation, or broader geographic commercialization.

FAQs

Is daunorubicin citrate the same as daunorubicin hydrochloride?

No. Daunorubicin citrate is associated with liposomal formulations such as DaunoXome, while conventional injectable daunorubicin is generally supplied as daunorubicin hydrochloride. The products differ in formulation, dosing, approval status, and substitution rules.

Is DaunoXome still available in the United States?

Public sources have reported discontinuation or limited availability in some markets. Current U.S. availability depends on FDA marketing status, supplier activity, and distributor inventory rather than on the historical approval alone.

Does daunorubicin citrate have biosimilar risk?

No conventional biosimilar pathway applies because daunorubicin citrate is a small-molecule drug, not a biologic. The relevant risk is generic or complex-generic competition involving a liposomal injectable.

Could a generic daunorubicin hydrochloride replace DaunoXome?

Not automatically. A conventional daunorubicin hydrochloride injection is not therapeutically or pharmaceutically identical to a liposomal daunorubicin citrate product and would require separate clinical and regulatory consideration.

What would increase the commercial value of daunorubicin citrate?

A new FDA-approved indication, evidence supporting use in a larger oncology population, a reliable global supply position, or a differentiated liposomal formulation would provide the clearest routes to higher value. None is established by the historical DaunoXome approval alone.

References

U.S. Food and Drug Administration. (1996). DaunoXome (daunorubicin citrate) liposome injection prescribing information. FDA.
National Cancer Institute. (n.d.). Daunorubicin. NCI Drug Dictionary.
National Library of Medicine. (n.d.). Daunorubicin citrate. PubChem.
U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. FDA.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. FDA.
Centers for Disease Control and Prevention. (1998). Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents. CDC.
U.S. Food and Drug Administration. (2010). Doxil (doxorubicin hydrochloride liposome injection) prescribing information. FDA.
Gilead Sciences, Inc. (Various years). Annual reports and Securities and Exchange Commission filings. Gilead Sciences.

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	3
DailyMed Link:	DAUNORUBICIN CITRATE at DailyMed

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