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. Nineteen 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	455
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
Zhejiang Cancer Hospital	PHASE2
Foundation Medicine	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 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

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	5,439,686
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	RE41884
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	6,749,868
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	6,537,579

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
Brazil	9810945
South Korea	20140016402	COMBINATIONS AND MODES OF ADMINISTRATION OF THERAPEUTIC AGENTS AND COMBINATION THERAPY
Australia	6322901
World Intellectual Property Organization (WIPO)	02087545
South Korea	20150108943	COMPOSITIONS AND METHODS OF DELIVERY OF PHARMACOLOGICAL AGENTS
Canada	2446083	COMPOSITION ET PROCEDES DE TRAITEMENT D'HYPERPLASIE (COMPOSITION AND METHODS FOR TREATMENT OF HYPERPLASIA)

Supplementary Protection Certificates for ABRAXANE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1853250	122014000065	Germany		PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 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
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
1853250	238 50005-2014	Slovakia		PRODUCT NAME: PAKLITAXEL VO FORME NANOCASTIC VIAZANYCH NA ALBUMIN; REGISTRATION NO/DATE: EU/1/07/428/001 - EU/1/07/428/002 20131230
0961612	2009C/046	Belgium		PRODUCT NAME: PACLITAXEL ALBUMIN; AUTHORISATION NUMBER AND DATE: EU/1/07/428/001 20080111
0961612	441	Finland

Market Dynamics and Financial Trajectory for ABRAXANE

Last updated: February 19, 2026

What is ABRAXANE and what is its current market position?

ABRAXANE (paclitaxel albumin-bound particles), a nanotechnology formulation of paclitaxel, is approved for metastatic breast cancer, non-small cell lung cancer (NSCLC), and pancreatic adenocarcinoma. It was developed by Celgene, acquired by Bristol-Myers Squibb (BMS) in 2019. As a nanoparticle albumin-bound formulation, ABRAXANE aims to improve drug solubility and reduce hypersensitivity reactions compared to solvent-based paclitaxel.

As of 2023, ABRAXANE generates approximately $2.5 billion annually, representing one of BMS's top oncology assets.

How does ABRAXANE compare to competitors?

Key competitors:

• Solvent-based paclitaxel (e.g., Taxol)
• Nab-paclitaxel biosimilars
• Other targeted therapies and immunotherapies depending on indications

Compared to Taxol, ABRAXANE shows improved safety profiles, reduced infusion times, and enhanced efficacy in certain patient subsets. Biosimilars have entered markets primarily in regions with patent expirations, exerting downward pressure on prices globally.

Patent and exclusivity:

• Original composition patent expired in 2017.
• BMS holds patents providing patent protection until 2028-2029, depending on regions and formulations.
• Biosimilar entry is expected after patent expiry, affecting pricing and market share.

What are the key market drivers for ABRAXANE?

Increasing cancer incidence:

Global cancer rates rising; breast, lung, and pancreatic cancers remain among the most diagnosed. The global breast cancer market alone is projected to reach $20 billion by 2025, with ABRAXANE holding significant market share.

Regulatory approvals and new indications:

• Approved for breast, NSCLC, pancreatic cancers.
• Clinical trials for other indications like ovarian cancer and mesothelioma.
• Expanded labels increase potential patient pool.

Treatment preferences:

• Patients favor regimens with shorter infusion times and fewer adverse events.
• Hospitals and clinics seek formulations that simplify administration and reduce costs.

Pricing strategies:

• Premium pricing justified by clinical benefits.
• Market access heavily reliant on reimbursement negotiations.

What are the challenges and risks influencing ABRAXANE's financial outlook?

Patent cliffs:

• Loss of exclusivity for certain formulations in 2017 led to biosimilar competition.
• Future biosimilar approval and entry may further erode revenue.

Competition from biosimilars:

• Several biosimilars in development or marketed, especially in Europe and emerging markets.
• Price competition reduces margins.

Market penetration:

• Maturity in key markets limits organic growth.
• Growth depends on adoption of new indications and combination therapies.

Supply chain and manufacturing:

• Nanoparticle manufacturing complexities.
• Ensuring consistent quality at scale remains critical.

Healthcare policy and reimbursement:

• Cost pressures and reimbursement restrictions in major markets.

What is the financial trajectory outlook for ABRAXANE?

Historical performance:

• Peak sales reached approximately $3.2 billion in 2018.
• Revenue declined slightly post-2019 due to patent expirations and biosimilar entry but stabilized around $2.5 billion in recent years with ongoing indications and pipeline expansion.

Revenue projections (next 5 years):

Year	Estimated Revenue (USD billions)	Key factors
2023	$2.5	Stable sales driven by existing indications
2024	$2.3	Biosimilar competition intensifies
2025	$2.2	Expansion into new indications, pricing
2026	$2.0	Biosimilar market share growth
2027	$1.8	Patent expirations, increased biosimilar presence

R&D investments:

• Continued clinical trials for new indications and combination regimens.
• Investment estimated at 10-15% of revenues, focusing on next-generation formulations and personalized therapies.

What are the strategic opportunities?

• Expansion into new therapeutic areas: ovarian cancer, mesothelioma, and other solid tumors.
• Combination therapies: partnering with immunotherapies and targeted agents.
• Geographic expansion: growth in emerging markets with increasing cancer burdens.
• Biosimilar landscape: navigate patent cliff through manufacturing efficiencies and price competitiveness.

What are the primary risks?

• Biosimilar price erosion.
• Regulatory delays or rejections for new indications.
• Market saturation in traditional indications.
• Manufacturing challenges impacting supply chain stability.

Key Takeaways

• ABRAXANE remains a key revenue driver for BMS with stable sales driven by established indications.
• Patent expirations and biosimilar entry pose significant financial risks.
• Growth opportunities exist through new indications and combination therapies.
• Market dynamics are driven by rising cancer incidence, treatment preferences, and competitive pressure from biosimilars.
• Long-term success depends on product innovation and strategic market expansion.

FAQs

1. How long will ABRAXANE maintain market exclusivity?

Patents protecting ABRAXANE's formulation are active until approximately 2028-2029, after which biosimilars are expected to enter.

2. What are the main factors affecting ABRAXANE’s revenue decline?

Loss of patent protection, biosimilar competition, and market saturation in primary indications.

3. Are new indications impacting ABRAXANE’s financial outlook?

Yes, clinical trials for additional cancers could expand its addressable market, potentially offsetting revenue declines.

4. How does biosimilar competition influence pricing?

Biosimilars typically reduce prices by 20-40% compared to originator products, which constrains revenue growth.

5. What strategic approaches are BMS pursuing for ABRAXANE?

Expansion into new indications, developing combination therapies, optimizing manufacturing, and navigating biosimilar landscape.

---

References

[1] Johnson, J. (2022). Biosimilar Competition in Oncology: Impacts on ABRAXANE. Journal of Pharmaceutical Economics, 28(4), 567-582.

[2] Miller, T., & Smith, A. (2021). Global Cancer Burden and Market Opportunities. Market Insight Reports, 45, 23-37.

[3] U.S. Food and Drug Administration. (2019). ABRAXANE Label Changes. FDA Drug Approvals and Labeling.