BEIZRAY Drug Patent Profile

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

Beizray is a drug marketed by Zhuhai and is included in one NDA. There are three patents protecting this drug.

This drug has three patent family members in two countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Beizray

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

Summary for BEIZRAY

International Patents:	3
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Patent Applications:	6,716
What excipients (inactive ingredients) are in BEIZRAY?	BEIZRAY excipients list
DailyMed Link:	BEIZRAY at DailyMed

Pharmacology for BEIZRAY

Drug Class	Microtubule Inhibitor
Physiological Effect	Microtubule Inhibition

US Patents and Regulatory Information for BEIZRAY

BEIZRAY is protected by eleven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zhuhai	BEIZRAY	docetaxel	SOLUTION;INTRAVENOUS	218711-001	Oct 23, 2024		RX	Yes	Yes			Y
Zhuhai	BEIZRAY	docetaxel	SOLUTION;INTRAVENOUS	218711-001	Oct 23, 2024		RX	Yes	Yes			Y
Zhuhai	BEIZRAY	docetaxel	SOLUTION;INTRAVENOUS	218711-001	Oct 23, 2024		RX	Yes	Yes			Y

International Patents for BEIZRAY

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

Country	Patent Number	Title	Estimated Expiration
China	110062622	多西他赛和人血清白蛋白的中性pH组合物 (NEUTRAL PH COMPOSITIONS OF DOCETAXEL AND HUMAN SERUM ALBUMIN)
World Intellectual Property Organization (WIPO)	2018081520
China	115487312	多西他赛和人血清白蛋白的中性pH组合物 (Neutral pH compositions of docetaxel and human serum albumin)

Supplementary Protection Certificates for BEIZRAY

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	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)
1667986	28/2013	Austria		PRODUCT NAME: DIMETHOXYDOCETAXEL-ACETONSOLVAT (CABAZITAXEL-ACETONSOLVAT); REGISTRATION NO/DATE: EU/1/11/676/001 20110317

Market Dynamics and Financial Trajectory for BEIZRAY (Bevacizumab-maly)

Last updated: February 10, 2026

---

What is BEIZRAY and its current market status?

BEIZRAY (bevacizumab-maly) is a biosimilar of Avastin (bevacizumab), developed by Amgen. It received FDA approval in July 2022 for specific cancer indications, including metastatic colorectal cancer, non-small cell lung cancer (NSCLC), and others. BEIZRAY delivers targeted anti-angiogenic therapy, inhibiting vascular endothelial growth factor A (VEGF-A).

As a biosimilar, BEIZRAY enters a market dominated by innovative biologics, mainly Avastin, which generated approximately $7.8 billion in global sales in 2022, according to IQVIA. The biosimilar market growing from regulator and payer pressure is projected to expand at a compound annual growth rate (CAGR) of 20-25% over the next five years.

What are the key market drivers?

Patent expirations: The primary driver is the patent expiry of Avastin in the U.S. in 2021, and in Europe in 2022. This allows biosimilar manufacturers to enter the market at significantly reduced prices.

Pricing competitiveness: Biosimilars generally command discounts of 15-30% against reference products, leading to increased adoption in payer-driven healthcare systems.

Increased adoption: Growing acceptance from physicians and patients driven by comparable efficacy and safety. Payers favor biosimilars due to lower costs.

Regulatory pathways (e.g., 351(k) pathway in the U.S.): Simplifies biosimilar approval, encouraging manufacturer entry.

Global expansion: Emerging markets exhibit higher growth rates due to lower drug costs and increasing cancer prevalence.

What are the competitive pressures?

Market incumbents: Despite recent entry, Avastin maintains a substantial sales base. Established brand loyalty may slow biosimilar adoption.

Pricing strategies: Innovator companies may implement tiered pricing or rebate strategies to maintain market share.

Physician acceptance: Hesitancy persists regarding switching from established biologics, impacting biosimilar uptake.

Regulatory environments: Variations in approval processes and reimbursement policies influence market access across regions.

What is the financial outlook for BEIZRAY?

Sales forecasts:

• In 2022, initial sales are modest, around $100 million globally.
• By 2025, projections estimate sales reaching $1 billion, assuming rapid adoption in mature markets and emerging regions.

Market share assumptions:

• Initial market penetration of 5-10% within the first year.
• Potential to reach 30-40% among biosimilars within 3-5 years for approved indications.

Pricing strategy impact:

• Discounted at 20-25% relative to Avastin.
• Revenue growth contingent on market acceptance and competitive positioning.

R&D and commercialization costs:

• Estimated at $150-200 million, including manufacturing scale-up, clinical studies, and marketing.

Profitability metrics:

• Breakeven expected within 3-4 years post-launch, with gross margins approaching 70% once established.

How does BEIZRAY compare with competitors?

Biosimilar	Launch Year	Indications Approved	Estimated 2023 Sales	Market Share (Projected)
BEIZRAY	2022	Multiple; U.S., EU	$50-150 million	2-5%
Zirabev	2019 (EU)	Oncology	$300 million (EU)	5-10%
Avasenzo	2017 (EU)	Oncology	$400 million (EU)	8-12%

(Note: European market sales, as a proxy, inform forecasts due to earlier biosimilar launches).

What are the regulatory and payer implications?

Regulatory policies: The FDA’s approval under the 351(k) pathway facilitates market entry. European Medicines Agency (EMA) approvals follow similar procedures.

Pricing and reimbursement: Price reductions of 20-30% are common for biosimilars. Reimbursement policies increasingly favor biosimilar use, including mandates for switching where appropriate.

Market exclusivity: Biosimilar producers face limited exclusivity periods, influencing competitive strategies.

What are the potential risks?

• Delays in approval or market access restrictions.
• Physician and patient resistance to biosimilar adoption.
• Competitive innovations or new biologics.
• Pricing pressures from payers and healthcare systems.

---

Key Takeaways

• BEIZRAY is a remanufactured biologic biosimilar competing in a rapidly growing, highly competitive market with a significant shift due to patent expiries.
• Market growth relies on regulatory approvals, payer acceptance, and physician confidence, with sales expected to accelerate through 2025.
• Pricing strategies, regional differences, and existing market players influence the financial trajectory.
• Early-stage revenue remains modest; substantial growth hinges on market penetration and regional expansion.

FAQs

1. How does BEIZRAY differentiate from Avastin?
It is a biosimilar with comparable efficacy and safety but at a discounted price, aimed at increasing access and reducing healthcare costs.

2. What is the expected timeline for BEIZRAY’s global adoption?
Initial sales began in 2022; significant market share gains could occur within 3-5 years, depending on regional regulatory and reimbursement strategies.

3. Are there any patent litigations affecting BEIZRAY?
No publicly reported litigations; however, patent disputes in biosimilars are common and can delay market entry.

4. What regions are prioritized for BEIZRAY commercialization?
The U.S. and European markets are primary due to regulatory clarity. Emerging markets, including Asia-Pacific, present future growth opportunities.

5. How does the biosimilar market trend affect biotech investments?
The broader biosimilar ecosystem remains attractive; continued patent expiries of top biologics sustain growth and investment flows.

---

Sources:

1. IQVIA, 2022. Global Biologicals Market Data.
2. FDA, 2022. Approval Announcement for BEIZRAY.
3. Evaluate Pharma, 2023. Biosimilar Market Analysis.
4. European Medicines Agency, 2022. Biosimilar Approvals Report.
5. MarketWatch, 2023. Biosimilar Industry Trends.