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-five 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
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)
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)
World Intellectual Property Organization (WIPO)	2018081520

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	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 the Pharmaceutical Drug: BEIZRAY

Last updated: July 31, 2025

Introduction

BEIZRAY (Sarecycline) is a prescription tetracycline-class antibiotic developed primarily for the treatment of inflammatory lesions of rosacea and acne vulgaris. As a product of modern pharmaceutical innovation, BEIZRAY's market dynamics and financial outlook are shaped by factors including clinical efficacy, regulatory approvals, competitive landscape, and evolving healthcare policies. An understanding of these elements reveals the trajectory the drug is likely to follow, offering stakeholders a comprehensive view of its growth potential.

Market Landscape and Therapeutic Indication

BEIZRAY’s target applications—rosacea and acne vulgaris—are widespread dermatological conditions with significant patient populations. According to the Global Burden of Disease Study, over 16 million Americans suffer from rosacea, and acne affects approximately 85% of teenagers, with many adults affected as well[1]. These conditions represent substantial commercial markets, driven by an increasing emphasis on patient quality of life and advances in dermatological treatments.

Competitive Environment

BEIZRAY’s primary competitors include doxycycline (various brands), minocycline, and oral isotretinoin, which have historically dominated acne and rosacea treatment landscapes. Notably, newer agents such as Oracea (doxycycline) and other tetracyclines have established market footholds, suggesting intense competition.

In addition, emerging therapies—such as laser treatments and topical formulations—offer adjunct options, influencing prescribing behavior. However, BEIZRAY's advantages, including a favorable side effect profile and improved dosing regimen, position it as a potentially preferred oral antibiotic within its indications.

Regulatory Milestones and Approval Status

BEIZRAY received FDA approval in 2018 for its indicated indications. Its approval was underpinned by Phase III clinical trials demonstrating non-inferiority to doxycycline with fewer gastrointestinal disturbances[2]. Regulatory acceptance reinforced its position as a targeted, safe alternative to traditional antibiotics, thus accelerating its market entry and adoption.

Expanding indications or label extensions—such as treatment of other inflammatory dermatoses—could further propel growth. Reimbursement policies and formulary listings also influence financial momentum, with inclusion in major insurance formularies improving prescription volume potential.

Market Dynamics Influencing Growth

Pricing Strategy and Reimbursement Landscape

Price positioning significantly affects BEIZRAY's adoption. As a branded medication, it commands higher price points relative to generics; however, payor acceptance hinges on demonstrated clinical benefit and cost-effectiveness.

Reimbursement policies, especially in the United States, favor products that demonstrate value. The drug's positioning as an effective, well-tolerated alternative offers opportunities for favorable formulary placements, thereby driving sales volume.

Physician Acceptance and Prescriber Preferences

Physicians are influenced by clinical trial data, safety profiles, and patient adherence considerations. BEIZRAY’s once-daily dosing and lower incidence of gastrointestinal side effects contribute to its favorable reception. Continuing medical education (CME) programs and guideline endorsements are instrumental in shaping prescriber behavior.

Patient Demographics and Accessibility

Increasing awareness and diagnosis rates for acne and rosacea boost demand. Additionally, the shift toward outpatient and telemedicine consultations enhances access, while healthcare policies promoting broader reimbursement expand patient affordability.

Supply Chain and Manufacturing Considerations

Robust manufacturing processes and supply chain resilience are crucial. Any disruption can impede market supply and revenue flow. Strategic partnerships with manufacturing firms mitigate risk and support global distribution.

Financial Trajectory: Revenue Projections and Investment Outlook

Historical Performance and Market Penetration

Since launch, BEIZRAY achieved steady sales growth, supported by clinical trial success and favorable regulatory positioning. Initial uptake was driven by dermatologists and specialized clinics, with expansion into general practitioners increasing revenue streams.

Forecasting Future Revenue

Projections suggest that if BEIZRAY maintains a compound annual growth rate (CAGR) of approximately 10-15% over the next five years, driven by expanding indications and geographic markets, revenues could reach significant levels. For example, assuming a base revenue of USD 150 million in 2022, growth projections estimate revenues surpassing USD 250 million by 2027, contingent on market penetration and competitive dynamics.

Potential Revenue Amplifiers

• Indication Expansion: Approving BEIZRAY for other off-label inflammatory conditions could markedly increase sales volumes.

• Entera Global Markets: Expansion into European and Asian markets offers considerable upside, leveraging rising dermatological treatment awareness.

• Pricing and Access Strategies: Optimizing formulary placements and patient access programs can accelerate adoption.

Risks and Challenges

Market risks include the possibility of biosimilar or generic entrants reducing prices post-patent expiry, competitive innovations, and regulatory shifts impacting approvals or labeling. Additionally, shifts in prescribing guidelines toward non-antibiotic regimens may restrict growth.

Regulatory and Commercial Challenges

Anticipating regulatory hurdles is essential. Patent expirations or challenges could undermine exclusivity, prompting investments into lifecycle management strategies. Ensuring ongoing clinical research to support label extensions and real-world evidence collection further bolsters market standing.

Strategic Opportunities

To sustain and enhance its market position, stakeholders should consider:

• Fostering collaborations with key opinion leaders (KOLs) for advocacy.
• Conducting post-market studies to reinforce safety and efficacy.
• Developing patient-centric programs to improve treatment adherence.
• Exploring combination therapies that integrate BEIZRAY to broaden indications.

Key Takeaways

• Market Positioning: BEIZRAY leverages its tailored efficacy and safety profile to secure a foothold in the competitive dermatology market, particularly among astute prescribers seeking alternative antibiotics.
• Growth Drivers: Expansion into new geographies, additional indications, and formulary integrations are pivotal for growth.
• Revenue Outlook: With strategic marketing and clinical advancement, revenues are poised to grow at double-digit rates over the coming years, assuming stable competitive dynamics.
• Market Risks: Biosimilar threats, evolving regulatory landscapes, and shifting prescribing patterns necessitate proactive lifecycle management.
• Investment Potential: BEIZRAY’s product profile and growth prospects present viable opportunities for investors and corporate strategists aligned with dermatology and infectious disease therapeutics.

Conclusion

BEIZRAY's market dynamics are predominantly shaped by its clinical advantages, regulatory status, and strategic positioning. Its financial trajectory depends on the capacity to expand indications, penetrate global markets, and maintain competitive integrity amidst evolving therapeutic options. Stakeholders should prioritize comprehensive market assessment and innovative commercialization approaches to capitalize on its growth potential.

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FAQs

1. What differentiates BEIZRAY from other tetracycline antibiotics?
BEIZRAY (sarecycline) offers enhanced specificity for inflammatory lesions with a favorable side effect profile, benefiting from a once-daily dosing regimen, which improves patient adherence compared to traditional antibiotics like doxycycline and minocycline.

2. How does regulatory approval influence BEIZRAY's market potential?
Regulatory approval establishes legal authorization for marketing, boosts prescriber confidence through validated efficacy, and facilitates reimbursement and formulary inclusion, all of which are essential for market expansion.

3. What are the main challenges facing BEIZRAY’s market growth?
Key challenges include potential competition from generics after patent expiry, shifting treatment guidelines favoring non-antibiotic options, and market saturation in existing territories.

4. What strategies can enhance BEIZRAY’s financial performance?
Strategies include expanding indications, entering new geographic markets, engaging key opinion leaders, optimizing pricing policies, and investing in post-marketing studies to reinforce safety and efficacy.

5. How might future healthcare policies impact BEIZRAY’s market?
Healthcare policies emphasizing antimicrobial stewardship and cost containment could restrict antibiotic use, prompting a need for demonstrating significant clinical benefits and embracing alternative treatment pathways to sustain market share.

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Sources:

[1] Global Burden of Disease Study, 2019.
[2] U.S. Food and Drug Administration, BEIZRAY (sarecycline) prescribing information.