DOCIVYX Drug Patent Profile

When do Docivyx patents expire, and what generic alternatives are available?

Docivyx is a drug marketed by Avyxa Holdings and is included in one NDA. There is one patent protecting this drug.

This drug has eight patent family members in five countries.

The generic ingredient in DOCIVYX is docetaxel. There are forty-one drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Docivyx

A generic version of DOCIVYX was approved as docetaxel by HOSPIRA INC on March 8^th, 2011.

Summary for DOCIVYX

International Patents:	8
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in DOCIVYX?	DOCIVYX excipients list
DailyMed Link:	DOCIVYX at DailyMed

Pharmacology for DOCIVYX

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

US Patents and Regulatory Information for DOCIVYX

DOCIVYX is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avyxa Holdings	DOCIVYX	docetaxel	SOLUTION;INTRAVENOUS	215813-001	Nov 22, 2022		RX	Yes	Yes	10,398,785		Y
Avyxa Holdings	DOCIVYX	docetaxel	SOLUTION;INTRAVENOUS	215813-002	Nov 22, 2022		RX	Yes	Yes	10,398,785		Y
Avyxa Holdings	DOCIVYX	docetaxel	SOLUTION;INTRAVENOUS	215813-003	Nov 22, 2022		RX	Yes	Yes	10,398,785		Y

EU/EMA Drug Approvals for DOCIVYX

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/002539 Breast 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/001107 Breast 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/000073 Breast 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/002325 Breast 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 DOCIVYX

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

Country	Patent Number	Title	Estimated Expiration
Poland	3270912
China	111728940	含有紫杉烷-环糊精复合物的药物组合物、制造方法和使用方法 (PHARMACEUTICAL COMPOSITIONS CONTAINING TAXANE-CYCLODEXTRIN COMPLEXES, METHOD OF MAKING AND METHODS OF USE)
China	107427486	含有紫杉烷‑环糊精复合物的药物组合物、制造方法和使用方法 (PHARMACEUTICAL COMPOSITIONS CONTAINING TAXANE-CYCLODEXTRIN COMPLEXES, METHOD OF MAKING AND METHODS OF USE)
Japan	2018512395	タキサン−シクロデキストリン複合体を含む医薬組成物、作成方法、および使用方法

Supplementary Protection Certificates for DOCIVYX

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)

DOCIVYX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DOCIVYX (Docetaxel)

Introduction

DOCIVYX, a generic version of the antineoplastic drug docetaxel, is a crucial component in the treatment of various cancers, including breast, prostate, and gastric cancers. To understand the market dynamics and financial trajectory of DOCIVYX, it is essential to analyze several key factors, including market trends, competitive landscape, regulatory environment, and economic influences.

Market Trends

The demand for anticancer drugs like DOCIVYX is driven by the increasing incidence of cancer globally. Here are some key trends influencing the market:

Rising Incidence of Cancer

The global cancer incidence is on the rise, which directly increases the demand for anticancer drugs. DOCIVYX, being a treatment for various types of cancer such as breast, prostate, and gastric cancers, benefits from this trend[4].

Technological Advancements

Advancements in drug formulations and delivery systems are enhancing patient compliance and treatment efficacy. For instance, the development of multi-dose vials and oral disintegrating tablets can improve the administration of DOCIVYX, making it more appealing to both patients and healthcare providers[1].

Personalized Medicine

The shift towards personalized medicine and targeted therapies is expected to influence the market dynamics. While DOCIVYX is not a targeted therapy, its effectiveness in treating specific cancer types positions it well in a market moving towards more tailored treatments[1].

Competitive Landscape

The competitive landscape for DOCIVYX is complex, with several key players involved:

Generic Competition

DOCIVYX, as a generic version of docetaxel, faces competition from other generic manufacturers. The expiration of patents for branded drugs opens up opportunities for generic versions, which can drive down prices and increase market competition[1].

Branded Competitors

Despite being a generic, DOCIVYX competes with branded anticancer drugs. Companies like Pfizer Inc., GSK plc, and Astellas Pharma Inc. are major players in the oncology market, and their branded products can influence the pricing and market share of generics like DOCIVYX[1].

Regulatory Environment

Regulatory factors play a significant role in shaping the market dynamics for DOCIVYX:

FDA Approvals

DOCIVYX has been approved by the FDA for various indications, including gastric cancer, locally advanced breast carcinoma, and metastatic castration-resistant prostate cancer. These approvals are critical for its market presence[4].

Patent Expirations

The patent expiration of branded anticancer drugs can significantly impact the market. Generic manufacturers can enter the market once patents expire, leading to increased competition and potentially lower prices[1].

Regulatory Requirements

Stringent regulatory requirements for new drug approvals can delay market entry and increase costs for pharmaceutical companies. However, since DOCIVYX is a generic version of an already approved drug, it benefits from the existing regulatory framework[1].

Economic Influences

Economic factors are crucial in determining the financial trajectory of DOCIVYX:

Healthcare Policies and Reimbursement

Healthcare reforms and cost-containment measures influence drug pricing and reimbursement policies. In regions where value-based healthcare is emphasized, the cost-effectiveness of treatments like DOCIVYX becomes a key factor in market dynamics[1].

Pricing Strategies

The pricing of DOCIVYX is influenced by the need to balance profitability with accessibility. Given the small patient population for some cancer types, firms may adopt higher pricing strategies for niche markets, although this is less relevant for a generic drug like DOCIVYX[3].

Financial Trajectory

The financial trajectory of DOCIVYX is influenced by several factors:

Market Growth

The global antiemetics and anticancer drug markets are expected to grow, driven by increasing cancer incidence and advancements in drug development. DOCIVYX, as part of this market, is likely to see growth, albeit with intense competition from other generics and branded drugs[1].

Revenue Projections

Given the generic nature of DOCIVYX, its revenue is likely to be influenced by the volume of sales rather than high margins. As more patients are treated with docetaxel, the revenue for DOCIVYX is expected to increase, although at a lower margin compared to branded drugs[1].

Cost-Effectiveness

The emphasis on value-based healthcare means that DOCIVYX must demonstrate cost-effectiveness to maintain market share. This could involve showing better patient outcomes or lower treatment costs compared to other available treatments[1].

Key Takeaways

• Increasing Demand: The rising incidence of cancer globally drives the demand for DOCIVYX.
• Competitive Landscape: DOCIVYX faces competition from both generic and branded anticancer drugs.
• Regulatory Environment: FDA approvals and patent expirations are critical for its market presence.
• Economic Influences: Healthcare policies and reimbursement strategies significantly impact its pricing and market accessibility.
• Financial Trajectory: The market growth and emphasis on cost-effectiveness are key factors in its revenue projections.

FAQs

What are the primary indications for DOCIVYX?

DOCIVYX is approved for the treatment of gastric cancer, locally advanced breast carcinoma, metastatic breast carcinoma, and metastatic castration-resistant prostate cancer, among other indications[4].

How does the generic status of DOCIVYX affect its market dynamics?

As a generic drug, DOCIVYX faces competition from other generic manufacturers, which can drive down prices and increase market competition. However, it also benefits from the existing regulatory framework and market presence established by the branded version[1].

What role do technological advancements play in the market for DOCIVYX?

Technological advancements in drug formulations and delivery systems can enhance patient compliance and treatment efficacy, making DOCIVYX more appealing to patients and healthcare providers[1].

How do healthcare policies influence the market for DOCIVYX?

Healthcare policies and cost-containment measures influence drug pricing and reimbursement policies, affecting the market accessibility and affordability of DOCIVYX. The emphasis on value-based healthcare pushes for greater emphasis on cost-effectiveness[1].

What is the expected market growth for DOCIVYX?

The global antiemetics and anticancer drug markets are expected to grow at a CAGR of around 6% by 2030, driven by increasing cancer incidence and advancements in drug development. DOCIVYX is likely to benefit from this growth trend[1].

Sources

1. Global Antiemetics Drugs Market to Exhibit Growth at a CAGR of ~6% by 2030 | DelveInsight
2. Oncology Webinars - NCODA
3. The Economics of Drug Development: Pricing and Innovation in a Changing Market
4. Docivyx - ConnectRx