PACLITAXEL - Generic Drug Details

What are the generic sources for paclitaxel and what is the scope of freedom to operate?

Paclitaxel is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Actavis Totowa, Alembic, Dash Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, MSN, Norvium Bioscience, Pliva Lachema, Sandoz, Teva Pharms, Teva Pharms Usa, Hq Spclt Pharma, Bristol-myers, Am Regent, Hengrui Pharma, and Teva Pharms Inc, and is included in twenty-one NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Paclitaxel has two hundred and forty-two patent family members in thirty-one countries.

There are sixty-nine drug master file entries for paclitaxel. Nineteen suppliers are listed for this compound.

Summary for PACLITAXEL

International Patents:	242
US Patents:	11
Tradenames:	3
Applicants:	19
NDAs:	21
Drug Master File Entries:	69
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	3,817
Patent Applications:	445
Drug Prices:	Drug price trends for PACLITAXEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PACLITAXEL
What excipients (inactive ingredients) are in PACLITAXEL?	PACLITAXEL excipients list
DailyMed Link:	PACLITAXEL at DailyMed

See drug prices for PACLITAXEL

Recent Clinical Trials for PACLITAXEL

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

Sponsor	Phase
Vall d'Hebron Institute of Oncology	Phase 2
Lee Ocuin, MD	Phase 2
NorthShore University HealthSystem	N/A

See all PACLITAXEL clinical trials

Pharmacology for PACLITAXEL

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

Medical Subject Heading (MeSH) Categories for PACLITAXEL

Antineoplastic Agents, Phytogenic

Tubulin Modulators

Anatomical Therapeutic Chemical (ATC) Classes for PACLITAXEL

L01CD	Taxanes
L01C	PLANT ALKALOIDS AND OTHER NATURAL PRODUCTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for PACLITAXEL

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 PACLITAXEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	075184-001	Jan 25, 2002	AP	RX	No	No
Sandoz	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	078167-001	Dec 26, 2007		DISCN	No	No
Alembic	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	216874-001	Oct 20, 2022	AP	RX	No	No
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes	8,138,229*PED
Pliva Lachema	PACLITAXEL	paclitaxel	INJECTABLE;INJECTION	077413-001	Mar 12, 2008		DISCN	No	No
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes	9,101,543*PED				Y
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	AB	RX	Yes	Yes	7,820,788*PED				Y

Expired US Patents for PACLITAXEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	6,537,579
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	6,150,398
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	6,506,405
Hq Spclt Pharma	TAXOL	paclitaxel	INJECTABLE;INJECTION	020262-001	Dec 29, 1992	5,496,804
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	6,749,868
Bristol-myers	ABRAXANE	paclitaxel	POWDER;INTRAVENOUS	021660-001	Jan 7, 2005	5,439,686

EU/EMA Drug Approvals for PACLITAXEL

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 PACLITAXEL

Country	Patent Number	Title	Estimated Expiration
Slovenia	2301531
Mexico	PA05006169	COMPOSICIONES Y METODOS PARA EL SUMINISTRO DE AGENTES FARMACOLOGICOS. (COMPOSITIONS AND METHODS OF DELIVERY OF PHARMACOLOGICAL AGENTS.)
Cyprus	1124273
Canada	2793974	METHODES DE TRAITEMENT DU CANCER (METHODS OF TREATING CANCER)
China	103405405	Compositions and methods of delivery of pharmacological agents
Japan	2016505018	膵臓がんの処置方法
New Zealand	560879	Combinations and modes of administration of therapeutic agents and combination therapy

Supplementary Protection Certificates for PACLITAXEL

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
0961612	300417	Netherlands		PRODUCT NAME: PACLITAXEL ALBUMINE; REGISTRATION NO/DATE: EU/1/07/428/001 20080114
0961612	SZ 41/2009	Austria		PRODUCT NAME: PACLITAXEL ALBUMIN
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	C300673	Netherlands		PRODUCT NAME: PACLITAXEL, GEFORMULEERD ALS ALBUMINE-GEBONDEN NANODEELTJES; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220
0961612	CA 2009 00036	Denmark		PRODUCT NAME: PACLITAXELALBUMIN
1853250	PA2014022	Lithuania		PRODUCT NAME: PACLITAXELUM; REGISTRATION NO/DATE: EU/1/07/428/001-002 20131220

PACLITAXEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Paclitaxel

Introduction to Paclitaxel

Paclitaxel, a potent chemotherapeutic agent, is widely used in the treatment of various cancers, including breast, ovarian, lung, and cervical cancers. The drug's market dynamics are influenced by several key factors, including the rising prevalence of cancer, advancements in drug delivery systems, and the geographic distribution of the market.

Global Market Size and Forecast

The paclitaxel market is experiencing significant growth driven by increasing demand for effective cancer treatments. Here are some key financial projections:

• The global paclitaxel market was valued at USD 106 million in 2024 and is projected to reach USD 164 million by 2031, growing at a CAGR of 6.42% from 2024 to 2031[1].
• The paclitaxel injection market, a subset of the broader paclitaxel market, is estimated to be valued at USD 6.34 billion in 2024 and is expected to reach USD 14.44 billion by 2031, growing at a CAGR of 12.5% from 2024 to 2031[4].

Geographic Market Distribution

The market for paclitaxel is geographically diverse, with different regions contributing significantly to its growth.

• North America: Currently dominates the global paclitaxel market due to its advanced healthcare infrastructure, high prevalence of cancer cases, and substantial investments in research and development. The U.S. has a robust pharmaceutical industry and well-established market for oncology drugs, including paclitaxel[1].
• Asia Pacific: This region is experiencing rapid growth due to the increasing incidence of cancer, expanding healthcare infrastructure, and rising economic development. China, in particular, is forecast to grow at a CAGR of 12.5% from 2022 to 2030[2].
• Europe: Countries like Germany are expected to grow at approximately 6.9% CAGR over the 2022-2030 period. Other notable markets include Japan and Canada, forecast to grow at 6.3% and 7.1% respectively[2].

Market Drivers

Several factors are driving the growth of the paclitaxel market:

• Rising Cancer Prevalence: The increasing incidence of cancer globally, particularly in Asia, is a significant driver. According to the World Health Organization’s Global Cancer Observatory, Asia had around 8.9 million new cancer cases in 2020, expected to rise to 11.9 million by 2030[1].
• Advancements in Drug Delivery Systems: New formulations and drug delivery technologies are being developed to improve the efficacy of paclitaxel while reducing its side effects. For example, the FDA approved a new formulation of paclitaxel in combination with a patented drug delivery system for advanced breast cancer in June 2024[1].
• Targeted Therapies: The adoption of targeted therapies and immunotherapies is also driving the market growth. These therapies have higher efficacy and reduced side effects, contributing to the overall growth of the oncology drugs market, which includes paclitaxel[3].

Market Segments

The paclitaxel market can be segmented based on several criteria:

• Product Type: Semi-synthetic paclitaxel API and natural paclitaxel API are key segments. Semi-synthetic paclitaxel API is projected to record a 9.2% CAGR and reach USD 139.1 million by the end of the analysis period[2].
• Application: Paclitaxel is used in the treatment of various cancers, including ovarian, breast, cervical, and other types. Each application segment is expected to grow significantly over the forecast period[2].

Competitive Landscape

The paclitaxel market is competitive with several key players:

• Fresenius Kabi AG
• Guilin Huiang Biochemistry Pharmaceutical Co., Ltd.
• Hainan Yeshanyuan Pharmaceutical Co., Ltd.
• Novasep Holding SAS
• Phyton Biotech
• Poly Medicure Ltd.
• Samyang Biopharmaceuticals Corporation
• ScinoPharm Taiwan Ltd.
• Teva API, Inc.
• **Yunnan Hande Bio-tech Co., Ltd./Hande Bio-Source, Inc. (HBS)[2].

Regulatory Approvals and Reimbursement Policies

Regulatory approvals and favorable reimbursement policies play a crucial role in the market growth of paclitaxel. For instance, the recent FDA approval of a new paclitaxel formulation is expected to boost market growth by providing a new therapeutic option and resolving some limitations associated with existing paclitaxel formulations[1].

Challenges and Limitations

Despite the positive growth trajectory, the paclitaxel market faces several challenges:

• High Development Costs: The development of new drug formulations and delivery systems is costly, which can be a barrier to entry for some companies[3].
• Stringent Government Regulations: Regulatory hurdles can slow down the approval process for new drugs and formulations, affecting market growth[3].

Key Takeaways

• The paclitaxel market is projected to grow significantly, driven by the rising prevalence of cancer and advancements in drug delivery systems.
• North America currently dominates the market, but the Asia Pacific region is expected to experience rapid growth.
• New formulations and targeted therapies are key drivers of market growth.
• The competitive landscape includes several major pharmaceutical companies.
• Regulatory approvals and reimbursement policies are crucial for market expansion.

FAQs

What is the current market size of the paclitaxel market?

The global paclitaxel market was valued at USD 106 million in 2024[1].

What is the projected growth rate of the paclitaxel market?

The paclitaxel market is projected to grow at a CAGR of 6.42% from 2024 to 2031[1].

Which region is expected to drive the growth of the paclitaxel market?

The Asia Pacific region, particularly China, is expected to drive significant growth due to increasing cancer incidence and expanding healthcare infrastructure[1][2].

What are the key drivers of the paclitaxel market?

Key drivers include the rising prevalence of cancer, advancements in drug delivery systems, and the adoption of targeted therapies[1][3].

Who are some of the major players in the paclitaxel market?

Major players include Fresenius Kabi AG, Guilin Huiang Biochemistry Pharmaceutical Co., Ltd., Hainan Yeshanyuan Pharmaceutical Co., Ltd., and others[2].

What challenges does the paclitaxel market face?

The market faces challenges such as high development costs and stringent government regulations[3].

Sources

1. Verified Market Research: Paclitaxel Market Size, Share, Trends, Analysis & Forecast.
2. GlobeNewswire: Global Bulk Paclitaxel Market to Reach $207.5 Million by 2030.
3. Coherent Market Insights: Oncology Drugs Market to Reach USD 532.91 Billion by 2031.
4. Coherent Market Insights: Global Paclitaxel Injection Market Size and Trends.
5. PR Newswire: With Market Size Valued at $185.4 Million by 2026, it`s a Healthy Outlook for the Global Bulk Paclitaxel Market.