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-two 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. 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:	242
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	450
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
280Bio Inc	Phase 1
Alliance for Clinical Trials in Oncology	Phase 2/Phase 3
Gruppo Oncologico del Nord-Ovest	Phase 2/Phase 3

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
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
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
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/000778 Abraxane 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/004441 Pazenir 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/004154 Apealea 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/000216 Paxene 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
Taiwan	I561236
Germany	122009000065
New Zealand	502500	NOVEL FORMULATIONS OF PHARMACOLOGICAL AGENTS, METHODS FOR THE PREPARATION THEREOF AND METHODS FOR THE USE THEREOF
Japan	4837809
Spain	2685436
China	101160123	Combinations and modes of administration of therapeutic agents and combination therapy
China	103285395	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
1853250	122014000065	Germany		PRODUCT NAME: PACLITAXEL ALS AN ALBUMIN GEBUNDENE NANOPARTIKEL-FORMULIERUNG; REGISTRATION NO/DATE: K(2013)9835 20131220
1853250	CA 2014 00034	Denmark		PRODUCT NAME: PACLITAXEL FORMULERET SOM ALBUMINBUNDNE NANOPARTIKLER; REG. NO/DATE: EU/1/07/428 C(2013)9835 20131230
0961612	2009C/046	Belgium		PRODUCT NAME: PACLITAXEL ALBUMIN; AUTHORISATION NUMBER AND DATE: EU/1/07/428/001 20080111
0961612	91613	Luxembourg		91613, EXPIRES: 20220924
0961612	132009901771196	Italy		PRODUCT NAME: PACLITAXEL(ABRAXANE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/07/428/001, 20080114
0961612	C00961612/01	Switzerland		PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
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

Market Dynamics and Financial Trajectory for ABRAXANE

Introduction

ABRAXANE, a protein-bound formulation of paclitaxel, is a significant player in the oncology market, particularly for the treatment of various types of cancer, including breast, ovarian, and pancreatic cancers. Here, we delve into the market dynamics and financial trajectory of ABRAXANE, highlighting key drivers, restraints, and future projections.

Market Size and Growth Projections

The Protein Bound Paclitaxel (ABRAXANE) market has been valued at USD 1.02 billion in 2023 and is expected to reach USD 3.29 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 9.5% from 2024 to 2031[1].

Alternatively, another report estimates the market size to be valued at USD 88 billion in 2023, projected to reach USD 139.72 billion by 2031, with a CAGR of 6.8% during the forecast period[3].

Key Drivers of Market Growth

Increasing Cancer Incidence

The rising prevalence of various types of cancer, such as breast, non-small cell lung, and pancreatic cancers, is a significant driver for the demand for chemotherapeutic agents like ABRAXANE[3].

Efficacy and Improving Outcomes

ABRAXANE is known for its efficacy and the ability to provide better therapeutic outcomes with fewer side effects compared to conventional paclitaxel formulations. This enhances its appeal among oncologists and patients[3].

Innovation in Drug Formulations

Advances in drug delivery systems, including nanoparticle-based formulations, enhance the effectiveness of paclitaxel. The protein-bound formulation improves solubility and bioavailability, making it a more attractive treatment option[3].

Regulatory Approvals and New Indications

Ongoing clinical trials and research can lead to new regulatory approvals for additional indications of use, expanding the market potential for ABRAXANE[3].

Increasing Adoption in Combination Therapies

The adoption of ABRAXANE in combination with other cancer therapies is becoming common, particularly in treating various solid tumors. This enhances its market presence[3].

Rising Awareness and Screening Programs

Increased awareness about cancer and advancements in screening programs lead to early diagnosis, thereby driving the demand for effective treatment options, including ABRAXANE[3].

Favorable Reimbursement Scenario

The availability of favorable reimbursement policies for cancer treatments could make ABRAXANE more accessible to patients, thereby driving market growth[3].

Growing Geriatric Population

The increasing elderly population, which is more susceptible to cancer, contributes to the expanding market for ABRAXANE[3].

Market Restraints

Side Effects and Efficacy Concerns

Some patients may experience severe side effects, which can deter the use of ABRAXANE. Additionally, concerns about its efficacy compared to other treatment options may impact prescribing practices[3].

Market Saturation in Developed Regions

In areas where ABRAXANE has been widely adopted, growth may be limited due to market saturation, with fewer new patients and increased competition from alternative therapies[3].

Healthcare Policies

Changes in healthcare policies, reimbursement rates, or insurance coverage could impact the affordability and accessibility of ABRAXANE[3].

Patient Adherence

Treatment adherence issues can be a significant restraint, as complex treatment regimens may lead to lower compliance rates, affecting overall treatment effectiveness[3].

Technological Advancements

Rapid advancements in biopharmaceuticals or new targeted therapies may shift focus away from ABRAXANE, affecting its market position[3].

Geographic Market Analysis

North America

The North American segment, comprising the United States and Canada, is a significant market for ABRAXANE, driven by advanced healthcare infrastructure, increasing incidence of cancer, and a higher acceptance of novel therapies among healthcare providers and patients[3].

Europe

In Europe, the demand for ABRAXANE is sustained by rising cancer awareness, a growing aging population, and favorable reimbursement policies, particularly in countries like Germany, France, and the UK[3].

Asia-Pacific

The Asia-Pacific region is witnessing rapid growth due to rising disposable incomes, improving access to healthcare, and increasing investments in cancer research and treatment facilities. Countries such as India and China are emerging as significant markets[3].

Middle East and Africa

The Middle East and Africa segment presents a mixed landscape, where certain countries have limited access to advanced therapies due to economic factors, while others are expected to expand their medical infrastructure, leading to potential growth in the utilization of innovative treatments like ABRAXANE[3].

Financial Performance and Trends

Revenue and Sales

Bristol Myers Squibb, one of the key players in the market, reported significant revenue from ABRAXANE. For instance, in the second quarter of 2023, ABRAXANE sales contributed $189 million to the company's total revenues[2].

Amortization of Acquired Intangible Assets

The amortization of acquired intangible assets related to ABRAXANE decreased in 2023, primarily due to the product's marketed right being fully amortized in the fourth quarter of 2022[2].

Licensing Income

Licensing income related to ABRAXANE and other products has been steady, with $20 million reported in the second quarter of 2023 compared to $16 million in the same period a year ago[2].

Regional Financial Contributions

Companies like BeiGene have also reported significant product revenues from ABRAXANE, particularly in regions like China. For example, BeiGene's product revenue from ABRAXANE and other drugs totaled $222.60 million for the year ended December 31, 2019[5].

Competitive Landscape

The market for ABRAXANE is competitive, with several key players focusing on strategy building to strengthen their product portfolios. Companies such as Qilu Pharm and Celgene are among the notable players in this market[4].

Conclusion

The market for ABRAXANE is poised for significant growth driven by increasing cancer incidence, advancements in drug formulations, and favorable reimbursement scenarios. However, it also faces challenges such as market saturation in developed regions and the potential impact of technological advancements in biopharmaceuticals.

Key Takeaways

• Market Growth: Expected to reach USD 3.29 billion by 2031 with a CAGR of 9.5% from 2024 to 2031.
• Key Drivers: Increasing cancer incidence, efficacy, innovation in drug formulations, and favorable reimbursement policies.
• Geographic Analysis: North America, Europe, and Asia-Pacific are significant markets.
• Financial Performance: Steady revenue contributions from major pharmaceutical companies.
• Competitive Landscape: Competitive market with key players like Qilu Pharm and Celgene.

FAQs

What is the current market size of ABRAXANE?

The current market size of ABRAXANE was valued at USD 1.02 billion in 2023[1].

What is the projected growth rate of the ABRAXANE market?

The ABRAXANE market is expected to grow at a CAGR of 9.5% from 2024 to 2031[1].

Which regions are the most significant markets for ABRAXANE?

North America, Europe, and the Asia-Pacific region are the most significant markets for ABRAXANE[3].

What are the key drivers of the ABRAXANE market?

Key drivers include increasing cancer incidence, efficacy, innovation in drug formulations, and favorable reimbursement policies[3].

What are the potential restraints for the ABRAXANE market?

Potential restraints include side effects, market saturation in developed regions, changes in healthcare policies, and technological advancements in biopharmaceuticals[3].

Sources

1. Market Research Intellect - Protein Bound Paclitaxel Abraxane Sales Market Size, Trends and Forecast.
2. Bristol Myers Squibb - Second Quarter Financial Results for 2023.
3. Verified Market Research - Protein Bound Paclitaxel (Abraxane) Market Size, Share & Scope.
4. Cognitive Market Research - Global Protein Bound Paclitaxel Abraxane Market Report 2024.
5. BeiGene - Fourth Quarter and Full Year 2019 Financial Results.