TAXOL Drug Patent Profile

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

Taxol is a drug marketed by Hq Spclt Pharma and is included in one NDA.

The generic ingredient in TAXOL 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 Taxol

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

Summary for TAXOL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	95
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TAXOL
DailyMed Link:	TAXOL at DailyMed

US Patents and Regulatory Information for TAXOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992		DISCN	Yes	No

Expired US Patents for TAXOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	6,150,398
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	5,496,804
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	6,096,331
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	5,670,537
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	5,641,803

EU/EMA Drug Approvals for TAXOL

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 TAXOL

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

Country	Patent Number	Title	Estimated Expiration
Japan	2011219482	NEW FORMULATION OF PHARMACOLOGICAL AGENT, METHOD FOR PRODUCING THE SAME AND METHOD FOR USE THEREOF
Australia	8266298
Germany	4325927	Taxol enthaltender Medikamentierungskit
World Intellectual Property Organization (WIPO)	0071079
China	100462066

Supplementary Protection Certificates for TAXOL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0961612	300417	Netherlands		PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080114
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	C00961612/01	Switzerland		PRODUCT NAME: PACLITAXELUM-ALBUMINUM; REGISTRATION NO/DATE: SWISSMEDIC 63182 26.08.2014
0961612	2009C/046	Belgium		PRODUCT NAME: PACLITAXEL ALBUMIN; AUTHORISATION NUMBER AND DATE: EU/1/07/428/001 20080111
0961612	SZ 41/2009	Austria		PRODUCT NAME: PACLITAXEL ALBUMIN

TAXOL Market Analysis and Financial Projection Experimental

TAXOL (Paclitaxel) Market Dynamics and Financial Trajectory

Introduction to TAXOL (Paclitaxel)

TAXOL, also known as paclitaxel, is a potent chemotherapeutic agent used in the treatment of various types of cancer, including ovarian, breast, non-small cell lung, and Kaposi's sarcoma. This medication belongs to the class of antineoplastics and works by inhibiting the growth and proliferation of cancer cells.

Global Market Size and Growth

The global paclitaxel injection market is experiencing significant growth driven by several key factors.

• Current Market Size: The market was valued at approximately US$ 5 billion in 2022[1].
• Projected Growth: It is expected to reach over US$ 15.88 billion by 2032, growing at a CAGR of 12.30% from 2023 to 2032[1].
• Alternative Projections: Another report estimates the market to be valued at USD 6.34 billion in 2024 and to reach USD 14.44 billion by 2031, with a CAGR of 12.5% during this period[5].

Regional Market Analysis

North America

• The U.S. paclitaxel injection market alone reached US$ 1.10 billion in 2022 and is projected to hit around US$ 3.50 billion by 2032, growing at a CAGR of 12.30% from 2023 to 2032[1].

Asia Pacific

• This region is emerging as a significant driver due to the increasing prevalence of cancer, particularly breast, ovarian, and lung cancers. Asia had around 8.9 million new cancer cases in 2020, with this figure expected to rise to 11.9 million by 2030[2].

Other Regions

• Europe, Latin America, Middle East & Africa (MEA) are also contributing to the market growth, though at varying rates. For instance, China is forecasted to grow at an impressive 12.3% CAGR to reach $45.5 million by 2030[3].

Key Drivers of Market Growth

Increasing Cancer Prevalence

• The rising incidence of cancer globally is a primary driver. According to the World Health Organization, the number of new cancer cases in Asia alone is expected to increase significantly by 2030[2].

Technological Advancements

• Improvements in production and formulation methods have enhanced the efficiency and scalability of paclitaxel manufacturing, contributing to market growth[3].

Healthcare Expenditure and Infrastructure

• Rising healthcare expenditure and the expansion of healthcare infrastructure, especially in emerging economies, are facilitating greater access to cancer treatments, thereby boosting the market[3].

Generic Drug Production

• The trend towards generic drug production is also expected to contribute to market growth, as generic versions of paclitaxel can offer more affordable treatment options[3].

Market Challenges

Side Effects and Adverse Reactions

• Paclitaxel injections are associated with several side effects such as allergy, blood clot, diarrhea, leucopenia, and weight loss, which can hinder market growth[1].

High Cost

• The high cost of the medication, particularly in low-income countries, is another significant challenge. This makes the treatment less accessible and can limit market expansion in certain regions[1].

Competitive Landscape

Key Players

• Major companies such as Bristol Myers Squibb, Pfizer, Fresenius Kabi AG, Luye Pharma Group, and others are focusing on expanding their product portfolios and strengthening their market presence through acquisitions, partnerships, and collaborations[5].

Strategic Moves

• For example, CHEPLAPHARM's acquisition of Bristol Myers Squibb's product portfolio, including Taxol, highlights the inorganic growth strategies adopted by key players to enhance their market position[5].

Pipeline and Innovation

Novel Drug Delivery Technologies

• Several pipeline drugs and novel drug delivery technologies for paclitaxel are under development. These innovations aim to improve efficacy and reduce toxicities associated with the treatment, which is expected to positively impact market growth[5].

Impact of COVID-19

• The COVID-19 pandemic has had a mixed impact on the paclitaxel injection market. While it presented challenges in terms of supply chain disruptions and delayed treatments, it also accelerated the adoption of telehealth and remote patient monitoring, which could indirectly support the market by ensuring continuous care for cancer patients[1].

Oncology Drugs Market Context

• The broader oncology drugs market, valued at $231.56 billion in 2024, is projected to reach $532.91 billion by 2031, growing at a CAGR of 12.6%. This growth is driven by the increasing prevalence of various cancers and the rising demand for innovative treatment options, including targeted therapies and immunotherapies[4].

Financial Trajectory

• The financial trajectory of the paclitaxel injection market is robust, with consistent high growth rates projected over the next decade. The market's valuation is expected to more than triple from its current levels, driven by increasing demand and technological advancements.

"The global paclitaxel injection market was valued at US$ 5 billion in 2022 and is expected to reach over US$ 15.88 billion by 2032, registering growth at a CAGR of 12.30% during the forecast period 2023 to 2032."[1]

Key Takeaways

• The paclitaxel injection market is driven by the increasing incidence of cancer and technological advancements in production and formulation.
• North America and the Asia Pacific are key regions driving market growth.
• Major challenges include side effects and high costs, particularly in low-income countries.
• The market is expected to grow significantly, with a CAGR of 12.30% to 12.5% over the forecast period.
• Innovations in drug delivery technologies and inorganic growth strategies by key players are expected to further boost market growth.

FAQs

What is the current market size of the paclitaxel injection market?

The global paclitaxel injection market was valued at approximately US$ 5 billion in 2022[1].

What is the projected growth rate of the paclitaxel injection market?

The market is expected to grow at a CAGR of 12.30% to 12.5% from 2023 to 2032[1][5].

Which regions are driving the growth of the paclitaxel injection market?

North America and the Asia Pacific are significant drivers of market growth, with the U.S. and China being key markets[1][3].

What are the major challenges facing the paclitaxel injection market?

Major challenges include side effects such as allergy, blood clot, diarrhea, leucopenia, and weight loss, as well as the high cost of the medication, particularly in low-income countries[1].

How are key players in the market strategizing for growth?

Key players are focusing on inorganic growth strategies such as acquisitions, partnerships, and collaborations to expand their product portfolios and strengthen their market presence[5].

Sources

1. Precedence Research: Paclitaxel Injection Market Size, Share, Report 2023-2032.
2. Verified Market Research: Paclitaxel Market Size, Share, Trends, Analysis & Forecast.
3. GlobeNewswire: Bulk Paclitaxel Strategic Industry Report 2024.
4. Coherent Market Insights: Oncology Drugs Market to Reach USD 532.91 Billion by 2031.
5. Coherent Market Insights: Global Paclitaxel Injection Market Size & Share Analysis.