Docetaxel - Generic Drug Details

What are the generic sources for docetaxel and what is the scope of patent protection?

Docetaxel is the generic ingredient in five branded drugs marketed by Sun Pharm, Accord Hlthcare, Actavis, Alembic, Amneal, Apotex Inc, Dfb Oncology Ltd, Dr Reddys, Eugia Pharma, Gland, Guangdong Sunho, Hengrui Pharma, Heritage, Hikma, Hospira Inc, Meitheal, Mylan Labs Ltd, Novast Labs, Pfizer Labs, Pharmobedient, Sandoz, Shilpa, Teva Pharms Usa, Sanofi Aventis Us, Zhuhai, and Avyxa Holdings, and is included in thirty-one NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Docetaxel has sixty-five patent family members in twenty-seven countries.

There are forty-one drug master file entries for docetaxel. Twenty-five suppliers are listed for this compound.

Summary for docetaxel

International Patents:	65
US Patents:	8
Tradenames:	5
Applicants:	26
NDAs:	31
Drug Master File Entries:	41
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2,679
Patent Applications:	7,777
Drug Prices:	Drug price trends for docetaxel
What excipients (inactive ingredients) are in docetaxel?	docetaxel excipients list
DailyMed Link:	docetaxel at DailyMed

See drug prices for docetaxel

Recent Clinical Trials for docetaxel

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

Sponsor	Phase
National Cancer Institute (NCI)	PHASE3
Massachusetts General Hospital	PHASE2
Janssen Research & Development, LLC	PHASE3

See all docetaxel clinical trials

Pharmacology for docetaxel

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

Anatomical Therapeutic Chemical (ATC) Classes for docetaxel

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

Paragraph IV (Patent) Challenges for DOCETAXEL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TAXOTERE	Injection	docetaxel	40 mg/mL, 0.5 mL and 2 mL vials	020449	1	2009-06-30

US Patents and Regulatory Information for docetaxel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer Labs	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	202356-004	Mar 13, 2014		DISCN	No	No
Pfizer Labs	DOCETAXEL	docetaxel	INJECTABLE;INJECTION	202356-001	Mar 13, 2014		DISCN	No	No
Avyxa Holdings	DOCIVYX	docetaxel	SOLUTION;INTRAVENOUS	215813-001	Nov 22, 2022		RX	Yes	Yes	10,398,785		Y
Zhuhai	BEIZRAY	docetaxel	SOLUTION;INTRAVENOUS	218711-001	Oct 23, 2024		RX	Yes	Yes	12,090,134		Y

Expired US Patents for docetaxel

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449-001	May 14, 1996	5,750,561*PED
Sanofi Aventis Us	TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449-004	Aug 2, 2010	5,750,561*PED
Sanofi Aventis Us	TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449-001	May 14, 1996	4,814,470*PED
Sanofi Aventis Us	TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449-001	May 14, 1996	5,714,512*PED

EU/EMA Drug Approvals for docetaxel

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Accord Healthcare S.L.U.	Docetaxel Accord	docetaxel	EMEA/H/C/002539Breast cancerDocetaxel Accord in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerDocetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Accord in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinomaDocetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerDocetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.	Authorised	yes	no	no	2012-05-22
Teva B.V.	Docetaxel Teva	docetaxel	EMEA/H/C/001107Breast cancerDocetaxel Teva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Docetaxel Teva in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Docetaxel Teva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.Previous chemotherapy should have included an anthracycline or an alkylating agent.Docetaxel Teva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Docetaxel Teva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerDocetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Teva in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinomaDocetaxel Teva in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerDocetaxel Teva in combination with cisplatin and 5 fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.	Withdrawn	yes	no	no	2010-01-26
Sanofi Mature IP	Taxotere	docetaxel	EMEA/H/C/000073Breast cancerTaxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Taxotere in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Taxotere monotherapy is indicated for the treatment of patients with locally advanced ormetastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Taxotere in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Taxotere in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerTaxotere is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Taxotere in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerTaxotere in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinomaTaxotere in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerTaxotere in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.	Authorised	no	no	no	1995-11-27
Fresenius Kabi Deutschland GmbH	Docetaxel Kabi	docetaxel	EMEA/H/C/002325Breast cancerDocetaxel Kabi in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:operable node-positive breast cancer;operable node-negative breast cancer.For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer.Docetaxel Kabi in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.Docetaxel Kabi monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. Previous chemotherapy should have included an anthracycline or an alkylating agent.Docetaxel Kabi in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 and who previously have not received chemotherapy for metastatic disease.Docetaxel Kabi in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Non-small-cell lung cancerDocetaxel Kabi is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Kabi in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small-cell lung cancer, in patients who have not previously received chemotherapy for this condition.Prostate cancerDocetaxel Kabi in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer.Docetaxel Kabi in combination with androgen-deprivation therapy (ADT), with or without prednisone or prednisolone, is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer.Gastric adenocarcinomaDocetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.Head and neck cancerDocetaxel Kabi in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.	Authorised	yes	no	no	2012-05-22

International Patents for docetaxel

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	3552
European Patent Office	2903435	FORMULATIONS DE NANODISPERSION NON AQUEUSE DE TAXANE ET PROCÉDÉS D'UTILISATION (NON-AQUEOUS TAXANE NANODISPERSION FORMULATIONS AND METHODS OF USING THE SAME)
World Intellectual Property Organization (WIPO)	2014055426
Mexico	364948	FORMULACIONES DE NANODISPERSIÓN DE TAXANO NO ACUOSAS Y MÉTODOS PARA USAR LAS MISMAS. (NON-AQUEOUS TAXANE NANODISPERSION FORMULATIONS AND METHODS OF USING THE SAME.)

Supplementary Protection Certificates for docetaxel

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0253738	C960002	Netherlands		PRODUCT NAME: DOCETAXEL, DESGEWENST IN DE VORM VAN EEN TRIHYDRAAT; REGISTRATION NO/DATE: EU/1/95/002/001 - EU/1/95/002/002 19951127
1667986	28/2013	Austria		PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317
1667986	92172	Luxembourg		PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)

Market Dynamics and Financial Trajectory for Docetaxel

Last updated: July 27, 2025

Introduction

Docetaxel, a chemotherapeutic agent belonging to the taxane family, has been a cornerstone in oncology treatments since its approval. Developed initially by Rhône-Poulenc Rorer (later Sanofi-Aventis) and now marketed globally under brands like Taxotere, it has established a significant market share in diverse cancer indications including breast, non-small cell lung, prostate, and gastric cancers. This report provides an in-depth analysis of the current market dynamics and financial trajectory of docetaxel, emphasizing factors shaping its commercial landscape and future outlook.

Market Overview and Core Indications

Market Size and Revenue Estimates:
The global chemotherapy agent market was valued at approximately USD 15 billion in 2022, with taxane-based drugs constituting a significant portion. Docetaxel alone commanded a substantial segment, estimated to generate over USD 3 billion annually, driven by its efficacy and approval in multiple indications (1). Its revenues are primarily concentrated in North America and Europe, with emerging markets experiencing rapid growth.

Key Indications and Usage:

• Breast cancer: As a first-line and adjuvant therapy, particularly for metastatic cases.
• Non-small cell lung cancer (NSCLC): Often combined with platinum compounds.
• Prostate cancer: In castration-resistant settings, particularly in hormone-refractory cases.
• Gastric and other gastrointestinal cancers: As an integral component in combination regimens.

The drug’s broad applicability in advanced cancers supports its persistent demand, although competition and evolving standards impact its adoption.

Market Dynamics Influencing Docetaxel

1. Patent Expiry and Generic Competition

A pivotal factor shaping the market is patent expiration. Sanofi’s original patent for Taxotere expired in the US in 2014, with similar timelines worldwide, leading to an influx of generic competitors (2). Generic versions have significantly reduced the drug’s price, eroding profit margins but expanding access and volume sales in many regions.

2. Pricing and Reimbursement Policies

In Europe and North America, reimbursement policies tightly regulate chemotherapy costs. The introduction of generics has prompted price reductions. However, high-cost combination regimens involving docetaxel remain reimbursed due to clinical efficacy, supporting ongoing revenue streams.

3. Competitive Landscape

Docetaxel faces competition from other taxanes like paclitaxel, nab-paclitaxel, and emerging targeted therapies or immunotherapies replacing certain indications. Notably, immuno-oncology agents such as pembrolizumab (Keytruda) have begun substituting chemotherapy in some first-line settings, impacting docetaxel’s market share (3).

4. Regulatory and Approval Dynamics

Continued regulatory approval in new indications, bioequivalent formulations, and innovative delivery systems influence market dynamics. Regulatory bodies' evolving stance on biosimilars and generic versions affect strategic positioning.

5. Advances in Oncology Treatments

The rise of personalized medicine and targeted therapies threatens to diminish traditional chemotherapeutic roles. While docetaxel remains a mainstay for many indications, its use is increasingly complemented or substituted by agents with improved safety and efficacy profiles.

Financial Trajectory and Revenue Drivers

1. Historical Revenue Trends

Following patent expiry, Sanofi witnessed a decline in phase-out revenues for Taxotere, with generic versions capturing significant volume share and reducing revenue by an estimated 50% from peak levels (~USD 2.7 billion in 2012) (4). However, legacy sales persisted through established markets and treatment lines, maintaining a revenue baseline.

2. Regional Market Variations

• North America: Dominant due to high cancer prevalence and established reimbursement systems; revenue maintained through combination therapies and high-volume use.
• Europe: Similar trends, with a notable shift toward biosimilars and generics.
• Asia-Pacific: Rapidly growing markets driven by increasing cancer incidence, hospital infrastructure expansion, and affordability improvements, initially offsetting pipeline declines.

3. Impact of Biosimilars and Generics

Since biosimilars of docetaxel entered the market around 2017-2018, price erosion accelerated. This contributed to a decline in per-unit revenue but increased total volume sales. Strategic shifts include partnering with biosimilar manufacturers and diversifying indications.

4. Clinical Development and New Indications

Ongoing clinical trials exploring docetaxel’s role in combination regimens and in neoadjuvant settings could open new markets. Also, development of nanoparticle formulations aims to improve safety and effectiveness, potentially commanding premium pricing.

5. Future Revenue Outlook

The outlook for docetaxel will depend on the balance of generic erosion versus emerging clinical niches, with projections indicating a continued decline in traditional markets but potential stabilization via niche applications and new formulations.

Market Challenges and Opportunities

Challenges

• Erosion of market share due to generics and biosimilars.
• Competition from immunotherapy and targeted agents.
• Safety profile concerns: myelosuppression, alopecia, and hypersensitivity reactions can limit use in certain populations.
• Shifting treatment paradigms: Move toward non-chemotherapy options in certain indications.

Opportunities

• Development of novel formulations such as nanoparticle-bound docetaxel to increase tolerability and efficacy.
• Expansion into new indications supported by clinical trials, especially in difficult-to-treat cancers.
• Strategic alliances and licensing in emerging markets to sustain volume sales.
• Transition to biosimilars or biobetters to capture cost-conscious segments.

Conclusion and Future Outlook

The market dynamics for docetaxel are characterized by a mature foundation increasingly challenged by patent expirations, generic competition, and evolving oncology treatment paradigms. While revenues have declined post-patent expiry, opportunities exist in niche indications, novel formulations, and clinical trial advancements. The drug’s financial trajectory will hinge on strategic adaptation—balancing cost pressures with innovation and expanding into emerging markets.

Looking ahead, the landscape will likely continue shifting toward targeted therapies and immunotherapies, which may further diminish traditional chemotherapeutic roles. However, given its established efficacy and ongoing clinical research, docetaxel remains relevant, especially where healthcare systems favor cost-effective, well-understood treatments.

Key Takeaways

• Patent expiration and biosimilar entry have significantly reduced docetaxel revenues, primarily in mature markets.
• Emerging markets and expansion into new cancer indications present growth opportunities.
• Competition from immunotherapies and targeted agents is reshaping the oncology treatment landscape, impacting docetaxel’s market share.
• Innovative formulations and clinical trials exploring new uses could extend the drug’s commercial viability.
• Strategic partnerships and diversification will be critical for maintaining relevance amid evolving market forces.

FAQs

1. How has patent expiration impacted docetaxel’s market?
Patent expiry led to generic and biosimilar entry, causing substantial price erosion and revenue decline in established markets, while increasing access and sales volume globally.

2. What are the main indications driving docetaxel sales?
Breast, non-small cell lung, prostate, and gastric cancers are primary drivers, supported by combination regimens in advanced disease stages.

3. How is the competitive landscape evolving for docetaxel?
The rise of immunotherapies and targeted therapies has decreased reliance on chemotherapy in certain indications, though docetaxel remains relevant in specific settings.

4. What future opportunities exist for docetaxel?
Development of novel formulations, clinical trials for new indications, and expansions into emerging markets offer growth pathways.

5. Will biosimilars or generics permanently diminish docetaxel’s revenue?
Yes, they are likely to continue exerting downward pressure unless new clinical or formulation innovations regain competitive advantage.

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References

[1] MarketWatch, "Global Chemotherapy Agents Market," 2022.
[2] Sanofi Annual Report, 2021.
[3] American Society of Clinical Oncology, "Emerging Oncology Treatment Paradigms," 2022.
[4] IQVIA, "Pharmaceutical Sales Trends," 2013.