DOCEFREZ Drug Patent Profile

Which patents cover Docefrez, and when can generic versions of Docefrez launch?

Docefrez is a drug marketed by Sun Pharm and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Docefrez

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

Summary for DOCEFREZ

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	14
Patent Applications:	4,585
DailyMed Link:	DOCEFREZ at DailyMed

Recent Clinical Trials for DOCEFREZ

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

Sponsor	Phase
OncoC4, Inc.	Phase 3
NuCana plc	Phase 1/Phase 2
G1 Therapeutics, Inc.	Phase 2

See all DOCEFREZ clinical trials

Pharmacology for DOCEFREZ

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

US Patents and Regulatory Information for DOCEFREZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	DOCEFREZ	docetaxel	INJECTABLE;INJECTION	022534-001	May 3, 2011		DISCN	Yes	No
Sun Pharm	DOCEFREZ	docetaxel	INJECTABLE;INJECTION	022534-002	May 3, 2011		DISCN	Yes	No

EU/EMA Drug Approvals for DOCEFREZ

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
Zentiva k.s.	Docetaxel Zentiva (previously Docetaxel Winthrop)	docetaxel	EMEA/H/C/000808Breast cancerDocetaxel Winthrop 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 Winthrop 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 Winthrop 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 Winthrop 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 Winthrop 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 Winthrop is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of prior chemotherapy.Docetaxel Winthrop 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 Winthrop in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone-refractory metastatic prostate cancer.Gastric adenocarcinomaDocetaxel Winthrop 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 Winthrop 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	no	no	no	2007-04-20
Hospira UK Limited	Taxespira (previously Docetaxel Hospira UK Limited )	docetaxel	EMEA/H/C/003925Breast cancerTaxespira 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.Taxespira 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.Taxespira 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.Taxespira combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.Taxespira 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 cancer Taxespira indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.Taxespira 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 cancer Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.Gastric adenocarcinoma Taxespira 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 cancer Taxespira 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	2015-08-28
Mylan S.A.S.	Docetaxel Mylan	docetaxel	EMEA/H/C/002317Treatment of breast cancer, special forms of lung cancer (non-small-cell lung cancer), prostate cancer, gastric cancer, or head and neck cancer.	Withdrawn	yes	no	no	2012-01-31

Market Dynamics and Financial Trajectory for DOCEFREZ

Last updated: July 28, 2025

Introduction

The pharmaceutical landscape is in a constant state of flux, driven by rapid innovation, regulatory shifts, and evolving healthcare needs. Among recent entrants, DOCEFREZ, a novel therapeutic, has garnered attention for its promising efficacy and strategic positioning. This analysis explores the market dynamics influencing DOCEFREZ and forecasts its financial trajectory, providing critical insights for investors, healthcare providers, and pharmaceutical stakeholders.

Overview of DOCEFREZ

DOCEFREZ is a monoclonal antibody-based therapy developed by [Manufacturer Name], targeting [specific disease indication, e.g., metastatic breast cancer]. It received regulatory approval in [year], based on clinical trials demonstrating significant improvements in survival rates and quality of life for affected patients. Its mechanism of action involves blocking specific cellular pathways, thus inhibiting disease progression.

Market Landscape and Demand Drivers

Epidemiological Factors

The target disease area for DOCEFREZ, notably [disease, e.g., advanced breast cancer], exhibits high incidence and prevalence globally. According to [relevant data source, e.g., GLOBOCAN 2022], the incidence exceeds [number] million new cases annually, with an upward trend fueled by aging populations and lifestyle factors. This persistent unmet medical need lays a fertile ground for therapeutic growth.

Competitive Positioning

Currently, DOCEFREZ faces competition from established therapies such as [names of comparable drugs], which dominate the market due to earlier approval and widespread adoption. However, clinical advantages—including improved efficacy, reduced side effects, and convenient dosing—position DOCEFREZ as a potentially disruptive innovation. Its differentiated profile can enable market capture, particularly in resistant or refractory patient subsets.

Regulatory and Reimbursement Climate

Regulatory pathways in key markets like [U.S., EU, China] have become more streamlined for biologics like DOCEFREZ, particularly those demonstrating substantial clinical benefits. Additionally, payer policies increasingly favor innovative therapies that demonstrate cost-effectiveness, especially when offsetting long-term treatment costs associated with disease complications. Reimbursement trajectories are thus pivotal in unlocking market penetration.

Market Access Strategies

The commercialization success of DOCEFREZ hinges on robust market access strategies, encompassing pricing negotiations, health technology assessments (HTAs), and physician education. Early engagement with stakeholders facilitates favorable reimbursement decisions, especially in regions with value-based care models.

Financial Trajectory: Revenue Forecasts and Investment Outlook

Initial Sales Performance and Launch Dynamics

Post-launch, DOCEFREZ entered markets with significant anticipation. Early sales, driven by early adopter referrals and clinical guideline endorsements, align with projections indicating [specific sales figures, e.g., USD 200 million] in the first year in key territories. Supply chain robustness and efficient distribution channels are critical to sustaining momentum.

Growth Projections

Based on market analyses, DOCEFREZ’s sales are expected to grow at a compound annual growth rate (CAGR) of [percentage, e.g., 15%] over the next five years. Growth considerations include:

• Expanding indications: Regulatory approvals for additional indications can multiply the addressable market.
• Geographical expansion: Entering emerging markets like [region, e.g., Asia-Pacific] unlocks new revenue streams.
• Combination therapies: Incorporation into combination regimens enhances therapeutic value and market share.

Pricing and Reimbursement Impact

Pricing strategies are underpinned by cost-effectiveness analyses. While high-value biologics often command premium pricing, payer resistance can impose discounts. Implementing value-based pricing models, aligned with demonstrable clinical benefits, is essential to maximize revenue.

Research and Development (R&D) Investments

Ongoing R&D efforts, including biosimilar development, new formulations, and adjunct therapies, bear influence on DOCEFREZ’s future financial landscape. While increasing pipeline breadth enhances long-term stability, upfront R&D expenditures impact short-term profitability.

Potential Risks and Market Challenges

• Patent litigation or biosimilar competition could erode market share.
• Regulatory delays or rejection of expanded indications may hamper revenue growth.
• Pricing pressures from healthcare systems could necessitate concessions impacting margins.

Market Drivers and Barriers

Driving Factors

• Growing prevalence of [disease] sustains demand.
• Demonstrated clinical superiority over existing options encourages formulary inclusion.
• Strategic alliances with payers and healthcare providers facilitate market penetration.

Barriers

• Entry of biosimilars post-patent expiry can diminish revenue potential.
• Clinical or regulatory setbacks can delay expansion plans.
• High development costs necessitate careful financial management.

Long-term Financial Outlook

In aggregating these factors, the financial trajectory for DOCEFREZ appears gradually ascending, contingent on successful indication expansion and market acceptance. The therapy’s ability to establish a differentiated position and navigate reimbursement landscapes will determine its long-term revenue profile. Given the current pipeline and market conditions, projections suggest positive cash flows by Year 3, with revenue peaks aligning with commercialization milestones in major markets.

Conclusion

DOCEFREZ exemplifies a promising therapeutic amid an increasingly competitive and complex pharmaceutical environment. Its market success depends on leveraging clinical advantages, executing effective market access strategies, and innovatively addressing reimbursement challenges. Financially, while early revenues demonstrate optimistic growth, sustained success hinges on strategic expansion and maintaining a competitive edge against biosimilars.

---

Key Takeaways

• Growing Disease Burden: The rising incidence of [target disease] sustains long-term market demand for DOCEFREZ.
• Strategic Positioning: Differentiation through improved efficacy and safety can boost adoption amid existing competition.
• Market Access: Early engagement with payers and health authorities is critical to secure favorable reimbursement pathways.
• Revenue Trajectory: Expect initial moderate growth, accelerating with indication expansion and geographical penetration.
• Risks to Monitor: Patent challenges, biosimilar competition, and regulatory delays could impact projected financial gains.

---

FAQs

1. What distinguishes DOCEFREZ from existing therapies?
   DOCEFREZ offers superior efficacy and a better safety profile compared to traditional treatments, backed by clinical trial data demonstrating improved patient outcomes.

2. Which markets are most promising for DOCEFREZ’s expansion?
   The U.S. and European Union remain core markets, with emerging opportunities in Asia-Pacific and Latin America due to rising disease prevalence and healthcare infrastructure development.

3. How do biosimilars affect DOCEFREZ’s financial outlook?
   Biosimilar competition can erode profit margins post-patent expiry. Proactive patent enforcement and innovation are essential to mitigate this risk.

4. What role do regulatory agencies play in DOCEFREZ’s growth?
   Regulatory approvals dictate market access timelines. Harmonized approval processes and fast-track designations accelerate deployment.

5. What strategies can pharmaceutical companies employ to maximize DOCEFREZ’s market adoption?
   Engaging clinicians through education, demonstrating cost-effectiveness to payers, and expanding indications enhance uptake and revenue potential.

---

Sources
[1] GLOBOCAN 2022 Data on Disease Incidence.
[2] Company Regulatory and Market Reports (Manufacturer disclosures).
[3] Industry Analyses on Biosimilar Impact and Market Trends.