ABRAXANE Drug Patent Profile

Which patents cover Abraxane, and what generic alternatives are available?

Abraxane is a drug marketed by Bristol-myers and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-seven patent family members in thirty-one countries.

The generic ingredient in ABRAXANE is paclitaxel. There are sixty-nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Abraxane

A generic version of ABRAXANE was approved as paclitaxel by TEVA PHARMS on January 25^th, 2002.

Summary for ABRAXANE

International Patents:	197
US Patents:	7
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABRAXANE

Paragraph IV (Patent) Challenges for ABRAXANE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ABRAXANE	For Injection Suspension	paclitaxel	100 mg/vial	021660	1	2015-12-11

US Patents and Regulatory Information for ABRAXANE

ABRAXANE is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes	8,034,375*PED				Y
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes	9,511,046*PED				Y
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes	9,393,318*PED				Y
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes	8,268,348*PED				Y
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes	7,758,891*PED				Y
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes	9,597,409*PED				Y
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes	9,101,543*PED				Y

International Patents for ABRAXANE

See the table below for patents covering ABRAXANE around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	335133	Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof for treating cancer
Portugal	693924
European Patent Office	2301531	COMBINAISONS ET MODES D'ADMINISTRATION D'AGENTS THERAPEUTIQUES ET TRAITEMENT COMBINE (COMBINATIONS AND MODES OF ADMINISTRATION OF THERAPEUTIC AGENTS AND COMBINATION THERAPY)
Portugal	2481405
European Patent Office	2275094
World Intellectual Property Organization (WIPO)	0189522
Australia	2006202836

Supplementary Protection Certificates for ABRAXANE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1853250	C300673	Netherlands		PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
0961612	SZ 41/2009	Austria		PRODUCT NAME: PACLITAXEL ALBUMIN
1853250	132014902271575	Italy		PRODUCT NAME: PACLITAXEL LEGATO ALL'ALBUMINA FORMULATO IN NANOPARTICELLE(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/01/07/428, 20131220
1853250	2014C/037	Belgium		PRODUCT NAME: PACLITAXEL DANS UNE FORMULATION DE NANOPARTICULE LIEES A L'ALBUMINE; AUTHORISATION NUMBER AND DATE: EU/1/07/428 20131230
0961612	300417	Netherlands		PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080114
0961612	2009C/046	Belgium		PRODUCT NAME: PACLITAXEL ALBUMIN; AUTHORISATION NUMBER AND DATE: EU/1/07/428/001 20080111
1853250	37/2014	Austria		PRODUCT NAME: PACLITAXEL, DAS ALS ALBUMIN GEBUNDENE NANOPARTIKEL FORMUIERT IST.; REGISTRATION NO/DATE: EU/1/07/428 (MITTEILUNG) (GEAENDERT DURCH C(2013) 9835) 20131230

ABRAXANE (paclitaxel protein-bound particles) Investment Scenario and Fundamentals Analysis

Last updated: April 24, 2026

ABRAXANE (paclitaxel protein-bound particles for injectable suspension) is a marketed, branded oncology product with patent-led exclusivity dynamics that matter more than platform science. The near-term investment case is built on (1) durability of sales through line-of-therapy switching and (2) pricing and channel execution amid ongoing biosimilar- and generics-driven oncology competition. The longer-term case hinges on whether incremental clinical labels or lifecycle extensions offset the maturation of competing taxane strategies and manufacturing supply stability.

What is ABRAXANE and where does it sell?

ABRAXANE is an albumin-bound formulation of paclitaxel. In clinical use it is positioned primarily in solid tumors where taxane chemotherapy is standard-of-care, including:

• Metastatic breast cancer (combination and/or monotherapy settings)
• Non-small cell lung cancer (with standard chemotherapy backbones)
• Pancreatic ductal adenocarcinoma (in combination and/or later-line settings)

Commercially, ABRAXANE’s value proposition historically centered on reduced solvent hypersensitivity risk versus solvent-based paclitaxel formulations, enabling broader and more consistent delivery of paclitaxel therapy in oncology settings.

How is the company positioned commercially?

Bristol Myers Squibb (BMS) commercializes ABRAXANE in multiple geographies. The investment implication is straightforward: ABRAXANE’s fundamentals track (1) oncology demand (incidence and persistence of treatment regimens), (2) payer behavior and reimbursement, (3) competitive substitution within taxane class, and (4) the ability to maintain formulary access.

ABRAXANE’s sales profile also tends to correlate with oncology budget pressure. In managed-care environments, branded chemotherapy faces cost-containment pressure that often accelerates substitution at the point where payers can justify lower-cost alternatives.

What patents and exclusivity drive ABRAXANE’s price protection?

ABRAXANE’s IP landscape is defined by US FDA regulatory exclusivities and composition/process claims rather than platform breadth. The key investment takeaway is that branded oncology durability depends on the timing of patent expirations and the survival of key claims against generics or “authorized” alternatives.

Key US IP and regulatory constraints (high-level)

• Orphan exclusivity is not typically a driver for ABRAXANE in major indications.
• Regulatory exclusivity and formulation/process claim strength are the primary practical levers.
• Paragraph IV or equivalent challenges (where they occur) can shift market entry timelines and pricing.

For an investment-grade assessment, the gating question is not “does IP exist,” but “does IP cover the specific commercial product being produced and sold,” including manufacturing process and formulation stability, and whether any alternative products can use a designed-around formulation.

What is the current competitive landscape for ABRAXANE?

The competitive set for ABRAXANE is not limited to generic paclitaxel. It includes:

• Solvent-based paclitaxel formulations (often lower cost, payers-driven substitution)
• Other nanoparticle or albumin-bound taxane strategies (where approved)
• Combination regimen shifts in breast and lung cancer standards of care
• Line-of-therapy changes driven by immunotherapy and targeted therapy penetration, which can reduce the time patients remain on classic chemo sequences

For investors, the practical metric is whether ABRAXANE maintains formulary preference under cost pressure versus switching to lower-cost taxanes or changing regimen sequencing.

What do the label and regimen realities imply for demand?

Oncology demand is a function of incidence and the probability that patients reach and remain on taxane chemotherapy in the relevant disease stage. ABRAXANE’s demand is therefore affected by:

• Immunotherapy and targeted therapy uptake reducing reliance on traditional chemo orders
• Combination therapy tolerance influencing whether albumin-bound paclitaxel is selected for administration consistency
• Institutional protocols where switching costs are real (oncology practice patterns)

Investment implication: ABRAXANE’s unit growth is rarely driven by new-to-market clinical adoption alone. It is more commonly maintained by guideline positioning and payer acceptance in specific regimen slots.

What are the core fundamentals that matter for ABRAXANE as an asset?

Sales durability drivers

ABRAXANE fundamentals typically depend on these measurable commercial levers:

• Net price and rebate rate trend (branded oncology often faces rebate compression and increased access pressure)
• Share stability in taxane-heavy regimens (especially in pancreatic and lung cancer sequencing)
• Inventory and supply continuity (manufacturing or supply disruptions can create temporary channel strength, but also risk substitution)
• Competitor pricing actions within solvent paclitaxel and any alternative taxane formulations

Manufacturing and supply as investment variables

Albumin-bound formulations carry non-trivial manufacturing demands. For an investment case, the key issue is whether BMS maintains:

• Consistent batch release and stability
• Continuity of albumin supply and formulation processing capacity
• Regulatory compliance with manufacturing changes

Supply reliability matters because oncology purchasing is operationally rational. When supply breaks, substitution can become sticky with payers and institutions.

What is the likely investment scenario (base case / downside / upside)?

Base case (most likely)

• ABRAXANE remains a significant branded oncology revenue contributor but faces continued pricing pressure as taxane alternatives and cost containment expand.
• Growth is modest and driven by maintaining access and stabilizing share rather than by dramatic new patient adoption.
• IP provides a time-limited price floor, but market erosion occurs at the margin as payers and providers shift to lower-cost substitutes where clinically interchangeable.

Downside scenario

• Competitive substitution accelerates due to payer policy changes, hospital formulary switches, and competitor price moves.
• Line-of-therapy erosion intensifies as immunotherapy and targeted agents reduce chemo frequency or shift earlier lines away from taxane schedules.
• Rebate expansion and net price compression outpace volume retention.

Upside scenario

• Label expansions or regimen refinements sustain ABRAXANE’s role in specific disease subgroups.
• Better-than-expected persistence in pancreatic and lung cancer regimens offsets broad taxane substitution.
• Supply stability and channel execution protect share through competitive pricing waves.

How should an investor underwrite ABRAXANE financially?

Given ABRAXANE’s nature as a commercial drug, underwriting should be driven by:

• Revenue trend: absolute sales and year-over-year net sales growth rate
• Net price and rebate trajectory: branded chemo typically shows net price decline over time even when volume holds
• Market share in taxane regimens: stability signals resilience against substitution
• Payer and account access: formulary access changes often show up with a lag in realized demand
• Cost of goods: formulation manufacturing complexity can matter in margin stability when pricing compresses

The investment question becomes: can BMS defend net revenue per treated patient better than competitors defend theirs?

What are the key risks to monitor?

1) IP and market entry risk

• Any regulatory or litigation pathway that accelerates generic or alternative market entry
• Claim vulnerability linked to formulation or manufacturing process

2) Competitive substitution risk

• Payer preference for lower-cost solvent paclitaxel
• Hospital formulary changes based on acquisition cost and clinical protocols

3) Indication and regimen shifts

• Immuno-oncology penetration altering chemo sequencing and exposure duration

4) Manufacturing and supply risk

• Batch failures, release delays, or operational disruptions that force substitution at the point of care

Key Takeaways

• ABRAXANE’s investment case rests on sales durability under pricing and substitution pressure, not on technical platform novelty.
• The asset is exposed to taxane-class competition and to line-of-therapy shifts driven by immunotherapy and targeted regimens.
• IP and regulatory exclusivity timing shape the pace of erosion; manufacturing stability affects the stickiness of share with payers and providers.
• Underwrite the asset using net revenue mechanics: net price, rebate trajectory, share retention, and treated-patient persistence.

FAQs

1. Is ABRAXANE primarily a growth or a cash-flow durability story?
   It is typically a cash-flow durability story, with growth constrained by mature oncology standards and cost-containment dynamics.

2. What competitive products most pressure ABRAXANE?
   The main pressure usually comes from lower-cost solvent-based paclitaxel options and any alternative taxane strategies that gain payer and formulary preference.

3. How do immunotherapy and targeted therapies affect ABRAXANE demand?
   They can reduce the proportion of patients receiving traditional chemo sequences and shorten the time spent in taxane-centric regimens.

4. What matters most for underwriting net revenue?
   Net price after rebates and access terms, plus treated-patient persistence in taxane regimens, typically outweigh headline list-price comparisons.

5. Does manufacturing reliability influence market outcomes?
   Yes. Supply disruptions can trigger substitution that becomes durable with payers and institutions, amplifying pricing pressure even after supply normalizes.

---

References

[1] Bristol Myers Squibb. ABRAXANE (paclitaxel protein-bound particles) prescribing information.
[2] U.S. Food and Drug Administration (FDA). ABRAXANE drug approval and label information (drug review and labeling records).
[3] U.S. Food and Drug Administration (FDA). Orange Book: ABRAXANE (paclitaxel protein-bound particles) listings (patents and exclusivity).