DOXIL (LIPOSOMAL) Drug Patent Profile

When do Doxil (liposomal) patents expire, and when can generic versions of Doxil (liposomal) launch?

Doxil (liposomal) is a drug marketed by Baxter Hlthcare Corp and is included in one NDA.

The generic ingredient in DOXIL (LIPOSOMAL) 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 Doxil (liposomal)

A generic version of DOXIL (LIPOSOMAL) was approved as doxorubicin hydrochloride by PFIZER on December 23^rd, 1987.

Summary for DOXIL (LIPOSOMAL)

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1,073
Patent Applications:	5,069
DailyMed Link:	DOXIL (LIPOSOMAL) at DailyMed

Recent Clinical Trials for DOXIL (LIPOSOMAL)

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

Sponsor	Phase
Hainan Medical College	PHASE2
The Second Affiliated Hospital of Hainan Medical University	PHASE2
Medical University of South Carolina	PHASE2

See all DOXIL (LIPOSOMAL) clinical trials

Pharmacology for DOXIL (LIPOSOMAL)

Drug Class	Anthracycline Topoisomerase Inhibitor
Mechanism of Action	Topoisomerase Inhibitors

US Patents and Regulatory Information for DOXIL (LIPOSOMAL)

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	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-001	Nov 17, 1995	AB	RX	Yes	No
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-002	Jun 13, 2000	AB	RX	Yes	No

Expired US Patents for DOXIL (LIPOSOMAL)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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
Baxter Hlthcare Corp	DOXIL (LIPOSOMAL)	doxorubicin hydrochloride	INJECTABLE, LIPOSOMAL;INJECTION	050718-001	Nov 17, 1995

EU/EMA Drug Approvals for DOXIL (LIPOSOMAL)

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

International Patents for DOXIL (LIPOSOMAL)

See the table below for patents covering DOXIL (LIPOSOMAL) around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	115401
Austria	122229
Austria	142483
Austria	152614
Australia	5323194

Supplementary Protection Certificates for DOXIL (LIPOSOMAL)

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0252504	96C0046	Belgium		PRODUCT NAME: DOXORUBICIN HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/96/011/001 19960624
0496835	960031	Netherlands		960031, 20101020, EXPIRES: 20110620
0496835	SPC/GB96/053	United Kingdom		PRODUCT NAME: DOXORUBICIN SULPHATE; REGISTERED: UK EU/1/96/011/001 19960621; UK EU/1/96/011/002 19960621
0496835	C960031	Netherlands		PRODUCT NAME: DOXORUBICINESULFAAT VERKREGEN UIT DOXORUBICINEHYDROCHLORIDE EN AMMONIUMSULFAAT; REGISTRATION NO/DATE: EU/1/96/011/001 - EU/1/96/011/002 19960621
0496835	96C0047	Belgium		PRODUCT NAME: ACIDE IBANDRONIQUE; REGISTRATION NO/DATE: EU/1/96/012/001 19960625

DOXIL (Liposomal) Market Dynamics and Financial Trajectory: Demand, Pricing, Patent/Exclusivity Pressure, and Competitive Landscape

Last updated: June 10, 2026

Executive summary: DOXIL (doxorubicin hydrochloride liposome injection, PEGylated liposomal doxorubicin) has moved from exclusivity-led growth to a mature, on-patent-to-generic transition environment. Its commercial trajectory is driven by (1) clinical guideline positioning in ovarian cancer and Kaposi’s sarcoma, (2) payer mix and ASP compression from biosimilar/generic erosion for liposomal doxorubicin products, and (3) competitor substitution by newer regimens (notably pegylated liposomal doxorubicin alternatives and reformulated doxorubicin strategies). The near-term financial direction is shaped by the durability of labeling remaining, ongoing competitive launches, and the practical “therapeutic interchangeability” of liposomal doxorubicin products at the national account level.

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What is DOXIL (liposomal doxorubicin) used for, and how does utilization drive sales?

DOXIL’s demand is anchored in oncology lines where liposomal doxorubicin is used for improved tolerability profiles compared with conventional doxorubicin formulations. Commercial pull is most resilient where:

• Patient populations are defined by prior exposure history (relapsed/refractory settings).
• Toxicity management and infusion-related tolerability matter to oncologists and treatment centers.
• Payers accept DOXIL as a standard option within regimen sequencing.

Which indications matter most for commercial demand?

DOXIL is marketed for cancer indications historically including:

• Ovarian cancer: relapsed disease after platinum-based therapy.
• Kaposi’s sarcoma: AIDS-related and other settings where liposomal doxorubicin is used.
• Multiple myeloma: often in combination with bortezomib in later-line therapy strategies (where approved/used).

Sales impact mechanism: In practice, DOXIL’s sales are most sensitive to:

• Relapse incidence and treatment sequencing (post-platinum for ovarian).
• Use under HIV-associated malignancy pathways for Kaposi’s sarcoma.
• Combination regimen utilization patterns where bortezomib plus liposomal doxorubicin is adopted.

How do dose intensity and dosing schedules affect revenue?

DOXIL is typically administered by body surface area (mg/m²), with dosing and treatment cycle frequency varying by regimen and indication. Commercial variability arises from:

• Real-world dosing modifications due to toxicity and hematologic recovery.
• Variation in average cycle counts across sites and payers.
• Substitution to alternative liposomal formulations that may have different dosing conventions or package economics.

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How have DOXIL market dynamics changed as generic or “follow-on” liposomal doxorubicin products entered?

DOXIL’s market is exposed to competitive pricing pressure because liposomal doxorubicin is an “administered drug product class” where payers can shift to lower-cost entrants when equivalence and interchangeability are accepted.

What competitive forces most affect DOXIL pricing and share?

• ASP compression: Once additional products gain formulary access, DOXIL pricing typically falls as contracted discounts widen.
• Formulary tier movement: DOXIL can move from preferred to non-preferred status, depending on national account contracting.
• Channel substitution: Specialty pharmacy and hospital pharmacy procurement shifts to lower acquisition cost when clinically acceptable.

What typically replaces DOXIL in practice?

Competitive substitution tends to be:

• Other liposomal doxorubicin products (lower-cost versions when deemed clinically comparable).
• Alternative anthracycline strategies using different formulations, where guidelines and local practice favor different toxicity-management profiles.

Commercial consequence: The revenue curve usually shifts from volume-driven growth to margin-driven decline and then stabilizes at a lower base once payer networks normalize buying behavior.

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When does DOXIL lose exclusivity, and what does that imply for financial trajectory?

DOXIL’s exclusivity structure is tied to combination labeling and formulation/method patents rather than a single mono-asset “blockbuster” term. Financial implications for exclusivity loss are consistent across oncology follow-on entry waves: increased competitive penetration causes rapid share loss, followed by stabilization.

How exclusivity loss translates into sales declines

A typical trajectory after exclusivity erosion for a mature oncology product:

1. Pre-entry: revenue is supported by patent-backed marketplace differentiation.
2. Entry event: near-immediate ASP decline with payer re-contracting.
3. Post-entry: volume may hold for some patients if prescribers resist switching, but overall trajectory generally trends downward.
4. Normalization: after 6 to 18 months, market shares and prices stabilize based on contracting durability.

Key financial indicators to monitor during the transition

• ASP and “net price” vs list price deltas at the invoice level.
• Share at national accounts and group purchasing organizations (GPOs).
• Treatment center formularies and prior authorization criteria.
• Inventory turns and channel fill levels in distributor and specialty pharmacy networks.

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What is the Orange Book status of DOXIL, and how many patents cover the product?

DOXIL is listed in FDA’s Orange Book for doxorubicin hydrochloride liposome injection, with associated patent coverage spanning drug substance/drug product and use-related claims. The number and type of Orange Book-listed patents drive:

• The “barrier to generic entry” posture for follow-on applicants.
• The timeline of Paragraph IV litigation risk.
• The practical launch pacing for challengers seeking to carve out specific claims.

Patent coverage categories that matter commercially

• Composition of matter: highest barrier; typically blocks most entrants until expiration or settlement.
• Formulation/product-by-process: can limit generic approvals even after “composition” expiry.
• Method-of-use claims: can support narrower exclusivity and continued premium pricing for specific regimens.

Why Orange Book structure affects revenue more than raw patent count

A large patent list is not equivalent to a strong exclusion portfolio. Revenue impact is tied to:

• Whether core claims cover the commercially dominant dosage forms and dosing regimens.
• Whether challengers can design around with acceptable labeling carve-outs.

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Which patent litigation and Paragraph IV challenges affected DOXIL, and what were the settlement outcomes?

DOXIL’s competitive risk is linked to Paragraph IV filings and resulting Hatch-Waxman litigation. For mature products, the litigation pattern usually determines:

• Entry dates.
• Scope of generic labeling (carve-outs).
• Whether settlement enforces a “delayed launch” period.

What to expect from typical DOXIL litigation dynamics

• Infringement defenses: applicants challenge claim scope or non-infringement.
• Validity challenges: patents challenged on novelty/obviousness.
• Settlement terms: often include a launch date, stipulated non-infringement positions, and sometimes licensing terms.

Financial linkage: A settlement that pushes launch by 12 to 24 months can preserve a meaningful portion of remaining annual revenue for oncology products because payer contracting and treatment protocols are slow to change mid-cycle.

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How strong is the patent estate for DOXIL, and what types of claims create the biggest barriers to entrants?

Patent estate strength for DOXIL is assessed by how much of the commercial footprint it covers:

• dominant indications,
• dominant dosing regimens,
• key formulation/process constraints.

Barrier hierarchy

• Composition-of-matter and core formulation claims typically create the strongest barrier.
• Secondary formulation/product-by-process claims can still matter if the generic applicant’s manufacturing process deviates substantially from the claimed process.
• Method-of-use claims matter if entrants must avoid infringement and therefore cannot label for key regimens.

Revenue exposure by claim type

• If method-of-use claims remain intact for a major regimen, entrants may launch with limited labeling that reduces immediate share loss.
• If composition/formulation claims fall, competition accelerates, with rapid ASP erosion.

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How do FDA regulatory pathways and approval labeling shape DOXIL competition and market access?

Regulatory status affects commercial trajectory by controlling whether follow-on products can be substituted and billed.

What FDA steps influence time to market for competing products?

• ANDA approval timing relative to exclusivity windows.
• Labeling scope: ability to claim the same indication and dosage regimen.
• Bioequivalence or alternative demonstration requirements that can delay launch.
• CBE supplements and manufacturing changes that can alter payer confidence.

How labeling scope impacts payer behavior

• Wide labeling similarity typically increases switching.
• Narrow labeling carve-outs reduce automatic substitution and can keep DOXIL in a preferred tier longer.

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How do DOXIL sales compare with key competitors in pegylated liposomal doxorubicin and alternative anthracycline markets?

DOXIL competes in a specialized segment of oncology where liposomal anthracyclines are chosen for tolerability. Competitive dynamics are shaped by:

• acquisition cost,
• formulary placement,
• availability at large hospital systems,
• perceived clinical equivalence.

What drives relative performance in this class

• Contract pricing and rebate structures for group purchasing networks.
• Site-of-care stocking patterns and infusion center protocols.
• Substitution rules in patient safety policies.

Competitive comparison: what to benchmark

• Share of patients treated with a liposomal doxorubicin product class (class share).
• ASP and net price trajectory across quarters.
• Distribution coverage and fill rate stability during entry waves.

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What generic entry risks exist for DOXIL, and when could they accelerate?

Generic entry risk for DOXIL is highest when:

• key formulation/use patents near expiration or are weakened via settlements or adverse rulings,
• challengers have litigation outcomes that permit launch,
• FDA approval aligns with “switch-ready” payer policies.

Timing mechanisms that accelerate competitive launches

• Settlement “trigger dates” aligned with litigation milestones.
• FDA approval before or after exclusivity expiry.
• Product availability and packaging readiness at launch.

Financial indicators of acceleration

• Sharp step-downs in quarterly net sales accompanied by modest volume retention (suggesting substitution).
• Increased units sold for lower-cost entrants within the same treatment centers.
• Higher utilization of prior authorization for DOXIL.

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How does DOXIL’s financial trajectory typically evolve after major competitive shocks?

A mature oncology product facing follow-on entrants often follows a pattern:

• Short-term: revenue decline primarily from ASP drop.
• Mid-term: unit share loss as formulary shift completes.
• Long-term: a lower plateau if DOXIL retains specific prescriber preference or payer exemptions.

What tends to limit decline

• Entrenched clinical practice at oncology centers.
• Contracts that keep DOXIL preferred in specific geographies or payer segments.
• Patient-level reasons to continue a specific liposomal formulation.

What tends to increase decline

• Aggressive contracting by group purchasing and hospital pharmacy networks.
• Improved confidence in follow-on clinical equivalence.
• Wider clinician acceptance of substitution.

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Key market and financial datapoints to track for DOXIL (quarterly and annual)

Demand and utilization

• New patient starts by indication (ovarian, Kaposi’s sarcoma, other major labeled uses).
• Total treatment cycles and average dose per cycle.

Pricing and profitability

• Net sales and ASP trends.
• Discount rate and rebate changes.
• Gross margin changes tied to competitive pricing.

Competitive footprint

• Class share within liposomal doxorubicin.
• Formulary placement across major GPOs.
• Turnover in procurement contracts.

Regulatory and legal

• Orange Book changes and patent term updates.
• Litigation docket updates affecting entry timing.

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Key Takeaways

• DOXIL demand is anchored in relapsed oncology settings and continues to depend on sequencing in ovarian cancer and Kaposi’s sarcoma therapy frameworks.
• Financial trajectory is most sensitive to payer contracting and ASP erosion as follow-on liposomal doxorubicin products gain formulary access.
• Exclusivity and Orange Book patent scope drive generic entry timing; revenue retention correlates with whether dominant method-of-use and core formulation claims remain enforceable.
• Competitive shocks typically cause immediate net price declines, followed by share loss over 6 to 18 months as treatment centers complete formulary switching.
• The most predictive monitors for near-term performance are net price trajectory, class share, national account contracting behavior, and Orange Book/legal milestones.

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FAQs

1) What factors most influence DOXIL prescribing and switching in hospital oncology formularies?
Clinical familiarity, toxicity management protocols, payer prior authorization rules, and procurement contract terms.

2) How does net pricing typically change for DOXIL after entry of lower-cost liposomal doxorubicin competitors?
Net pricing usually compresses quickly as rebates expand and preferred formulary status shifts to entrants.

3) Do method-of-use patents affect DOXIL competition differently than formulation patents?
Yes. Method-of-use claims can limit labeling scope for entrants, slowing share loss even when some product-type claims are no longer enforceable.

4) What is the main commercial KPI for DOXIL during patent expiry events?
Net sales per quarter, decomposed into ASP (price effect) and units (volume effect), tied to class share in liposomal doxorubicin.

5) How should investors interpret DOXIL revenue volatility versus long-term decline?
Volatility often reflects contracting resets and inventory cycles; persistent decline usually indicates sustained formulary shift and class share erosion.

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References (APA)

No sources were cited.