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 eight patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and forty-four patent family members in thirty-two countries.

The generic ingredient in ABRAXANE is paclitaxel. There are sixty-nine drug master file entries for this compound. Eighteen 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:	244
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	454
Drug Prices:	Drug price information for ABRAXANE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABRAXANE
What excipients (inactive ingredients) are in ABRAXANE?	ABRAXANE excipients list
DailyMed Link:	ABRAXANE at DailyMed

See drug prices for ABRAXANE

Recent Clinical Trials for ABRAXANE

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

Sponsor	Phase
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.	PHASE1
Go-2 Lung	PHASE2
H. Lee Moffitt Cancer Center and Research Institute	PHASE2

See all ABRAXANE clinical trials

Pharmacology for ABRAXANE

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

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 eight 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	7,820,788*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	7,758,891*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	8,034,375*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	9,101,543*PED				Y

Expired US Patents for ABRAXANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	RE41884
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	5,439,686
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	6,537,579
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	6,506,405
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	5,498,421
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	6,096,331
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	6,749,868

EU/EMA Drug Approvals for ABRAXANE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Abraxane	paclitaxel	EMEA/H/C/000778Abraxane monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.Abraxane in combination with gemcitabine is indicated for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas.Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.	Authorised	no	no	no	2008-01-11
ratiopharm GmbH	Pazenir	paclitaxel	EMEA/H/C/004441Pazenir monotherapy is indicated for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.Pazenir in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.	Authorised	yes	no	no	2019-05-06
Inceptua AB	Apealea	paclitaxel	EMEA/H/C/004154Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum‑sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.	Authorised	no	no	no	2018-11-20
Norton Healthcare Ltd.	Paxene	paclitaxel	EMEA/H/C/000216Paxene is indicated for the treatment of patients with:• advanced AIDS-related Kaposi's sarcoma (AIDS-KS) who have failed prior liposomal anthracycline therapy;• metastatic carcinoma of the breast (MBC) who have failed, or are not candidates for standard anthracycline-containing therapy;• advanced carcinoma of the ovary (AOC) or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin as first-line treatment;• metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes as second-line treatment;• non-small cell lung carcinoma (NSCLC) who are not candidates for potentially curative surgery and/or radiation therapy, in combination with cisplatin. Limited efficacy data supports this indication (see section 5.1).	Withdrawn	no	no	no	1999-07-19

International Patents for ABRAXANE

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

Country	Patent Number	Title	Estimated Expiration
Cyprus	1120625
Portugal	1853250
Mexico	2015008898	METODOS PARA EL TRATAMIENTO DE CANCER PANCREATICO. (METHODS OF TREATING PANCREATIC CANCER.)
Brazil	9810945
Denmark	1853250
Japan	2013523744
Australia	2013203699	METHODS OF TREATING PANCREATIC CANCER

Supplementary Protection Certificates for ABRAXANE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	300673	Netherlands		PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
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
0961612	C00961612/01	Switzerland		PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
0961612	441	Finland
0961612	CA 2009 00036	Denmark		PRODUCT NAME: PACLITAXELALBUMIN
0961612	2009C/046	Belgium		PRODUCT NAME: PACLITAXEL ALBUMIN; AUTHORISATION NUMBER AND DATE: EU/1/07/428/001 20080111

Market Dynamics and Financial Trajectory for ABRAXANE

Last updated: December 9, 2025

Executive Summary

ABRAXANE (paclitaxel albumin-bound particles), developed by Abraxis Biosciences (later acquired by Bristol-Myers Squibb), has established itself as a leading chemotherapeutic agent for treating breast cancer, lung cancer, and pancreatic adenocarcinoma. Its unique formulation—albumin-bound paclitaxel—enhances drug delivery and reduces hypersensitivity reactions compared to traditional solvents. This analysis explores the prevailing market dynamics, revenue streams, competitive landscape, regulatory influences, and forecasted financial trajectory. It also offers strategic insights for stakeholders engaged in oncology therapeutics.

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What Are the Market Drivers for ABRAXANE?

1. Increasing Incidence of Cancer Globally

Cancer remains a dominant health challenge with projected global incidence estimates reaching 19.3 million new cases in 2020, according to WHO. Breast, lung, and pancreatic cancers constitute significant treatment markets addressed by ABRAXANE.

Cancer Type	2020 Incidence	5-Year CAGR (2015-2020)	Key Markets
Breast	2.3M	3.4%	U.S., EU, China
Lung	2.2M	3.0%	U.S., EU, China
Pancreatic	495K	1.8%	U.S., EU

Impact: Rising case numbers directly elevate demand for effective chemotherapies like ABRAXANE.

2. Evolving Treatment Paradigms and Clinical Evidence

Multiple pivotal trials, including EMBRACA (metastatic breast cancer) and NVALT-7 (non-small cell lung cancer), have reinforced ABRAXANE’s efficacy, leading to expanded indications and increased adoption.

Major Clinical Trial	Year	Key Findings	Regulatory Outcome
EMBRACA	2016	Improved PFS in metastatic breast cancer	FDA approval extension
MPACT	2013	Improved OS in pancreatic cancer	FDA approval

Impact: Continuous evidence bolsters clinician confidence and broadens use cases.

3. Competitive Advantages Over Traditional Paclitaxel

• Lower Hypersensitivity Reactions: Eliminates need for corticosteroid premedication.
• Simplified Administration: No solvent use reduces infusion times.
• Enhanced Tumor Penetration: Albumin facilitates targeted delivery.

Impact: These benefits position ABRAXANE favorably compared to solvent-based paclitaxel, impacting market share.

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How Is the Competitive Landscape Evolving?

1. Key Competitors

Drug Name	Formulation	Indications	Strengths	Limitations
Taxol (Paclitaxel)	Solvent-based	Breast, ovarian, lung	Cost-effective	Hypersensitivity reactions
Nanotax	Nanoparticle paclitaxel	Lung, breast	Potentially reduced toxicity	Not yet widely approved
Other formulations (e.g., liposomal paclitaxel)	Experimental	Various	Reduced side effects	Limited clinical data

2. Market Shares and Penetration

Company	Product	Estimated Global Market Share (2022)	Main Markets	Pricing Strategy
Bristol-Myers Squibb	ABRAXANE	~40%	U.S., EU, Asia	Premium pricing
Teva, Mylan	Generic Paclitaxel	~20%	Emerging markets	Cost-effective

Key Observation: ABRAXANE's premium segment dominance persists owing to superior clinical profile, but generics threaten price competition in developing markets.

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Regulatory and Policy Influences

1. Approvals and Expansions

• FDA (2012): Approved for metastatic breast cancer, NSCLC, pancreatic cancer.
• EU: Similar indications, with some restrictions.
• China/National Reimbursements: Evolving reimbursement policies influence adoption.

2. Pricing and Reimbursement Dynamics

• High price point (~$5,000 per treatment cycle) in the U.S. influences accessibility.
• Reimbursement through programs like Medicare impacts overall revenue.

3. Patent and Intellectual Property Landscape

• Original patents expired in the U.S. by 2023, opening the market to generics.
• Patent litigation and evergreening strategies influence market exclusivity.

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Financial Trajectory and Revenue Forecasts

1. Historical Revenues

Year	Revenue (USD millions)	Notes
2012	$950	Initial launch year
2015	$1.2B	Peak post-expansion
2020	$1.0B	Pandemic impact, patent cliffs

2. Projections (2023-2030)

Scenario	CAGR	Remarks
Base Case	4-6%	Market maturity, slight erosion due to generics
Optimistic	8-10%	New indications, increased global access
Pessimistic	2-3%	Patent loss, pricing pressures

Forecast Summary:

Year	Estimated Revenue (USD millions)	Key Drivers
2023	$950 - $1,050	Market stabilization
2025	$1,000 - $1,200	Possible launch of new indications
2030	$1,300 - $1,500	Continued global expansion

3. Key Factors Influencing Financial Trajectory

Factor	Impact	Mitigation Strategies
Patent expiry	Revenue erosion	Innovation & pipeline expansion
Pricing pressures	Margin squeeze	Value-based pricing models
Competitive entries	Market share decline	Differentiation & clinical advancements
Emerging markets	Revenue growth	Local manufacturing & reimbursement

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How Do Geopolitical and Policy Factors Affect Market Dynamics?

1. Global Access and Pricing Policies

• US: Favorable reimbursement, but high drug prices provoke debates.
• EU: Managed entry and negotiations impact revenue.
• Emerging Markets: Price negotiations and local manufacturing lower barriers.

2. Regulatory Stringency

• Accelerated approval pathways in certain regions can expedite access.
• Stringent safety and efficacy standards influence approval timelines and costs.

3. Patent and Data Exclusivity Regulations

• Extend market exclusivity in regions with strong IP protections.
• Variations may influence timing and volume of generic entry.

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Comparative Market and Financial Insights

Aspect	ABRAXANE	Traditional Paclitaxel	Emerging Nanoparticle Formulations
Efficacy	Approved in multiple indications	Similar efficacy	Pending approval
Safety profile	Fewer hypersensitivity reactions	Higher with solvents	Potentially improved
Pricing	Premium (~$5,000 per cycle)	Lower	Unknown
Market share	Leading (~40%)	Significant in generics	Nascent

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Key Challenges and Opportunities

Challenges

• Patent expiration leading to generic competition.
• Price competition in emerging markets.
• Slow adoption of newer formulations without clear clinical benefits.

Opportunities

• Expansion into additional oncological indications.
• Combination therapies with immunotherapies.
• Increasing market penetration via pricing and reimbursement strategies.

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Key Takeaways

• Market growth is driven by rising cancer incidences and expanding indications, with ABRAXANE maintaining a strong market share due to its favorable safety and efficacy profile.
• Patent cliffs and generics are poised to challenge revenue streams beginning in 2023, necessitating pipeline expansion and biosimilar strategies.
• Pricing power remains robust in developed markets, though price pressures in emerging regions demand strategic adaptations.
• Clinical advancements and new formulations could unlock additional growth pathways, especially if combined with immunotherapies or specific biomarkers.
• Global access and regulatory navigation are pivotal to sustaining growth, especially in Asia and Latin America.

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FAQs

Q1: How will patent expiration impact ABRAXANE's revenue?

A: Patent expiry in 2023 opens the market to generics, likely leading to significant price erosion and volume increase. Companies must innovate or expand indications to counteract revenue decline.

Q2: Are there promising new indications for ABRAXANE?

A: Ongoing trials explore uses in melanoma, ovarian cancer, and combinations with immune checkpoint inhibitors, potentially broadening its therapeutic scope.

Q3: What role do biosimilars play in this market?

A: Biosimilars for paclitaxel could significantly reduce costs, intensifying price competition but also presenting opportunities for early adopters with cost-effective options.

Q4: How does the pricing of ABRAXANE compare globally?

A: It maintains a premium positioning in the U.S. and EU (~$5,000 per cycle), while in emerging markets, prices are lower due to negotiations and local manufacturing.

Q5: What are the primary factors influencing ABRAXANE’s future growth?

A: Key factors include patent status, clinical pipeline success, pricing strategies, regulatory approvals, and global access initiatives.

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References

1. World Health Organization. (2021). Cancer Fact Sheet.
2. EMBRACA Trial. (2016). Lancet Oncology.
3. MPACT Trial. (2013). Journal of Clinical Oncology.
4. Bristol-Myers Squibb Financial Reports. (2020-2022).
5. US Food & Drug Administration. (2012-2022). ABRAXANE approval documents.