BYNFEZIA PEN Drug Patent Profile

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

Bynfezia Pen is a drug marketed by Sun Pharm and is included in one NDA. There are five patents protecting this drug.

This drug has six patent family members in six countries.

The generic ingredient in BYNFEZIA PEN is octreotide acetate. There are twenty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bynfezia Pen

A generic version of BYNFEZIA PEN was approved as octreotide acetate by WEST-WARD PHARMS INT on April 8^th, 2005.

Summary for BYNFEZIA PEN

International Patents:	6
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in BYNFEZIA PEN?	BYNFEZIA PEN excipients list
DailyMed Link:	BYNFEZIA PEN at DailyMed

Pharmacology for BYNFEZIA PEN

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

US Patents and Regulatory Information for BYNFEZIA PEN

BYNFEZIA PEN is protected by thirteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes	12,350,475
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes	11,534,553
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes	11,246,991
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes	11,052,196
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes	10,342,850		Y

International Patents for BYNFEZIA PEN

See the table below for patents covering BYNFEZIA PEN around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2018211526
European Patent Office	3624829
Brazil	112019023981
Russian Federation	2019136628
South Korea	20200003923

Market Dynamics and Financial Trajectory for BYNFEZIA PEN

Last updated: December 27, 2025

Summary

BYNFEZIA PEN, marketed as Faslodex (fulvestrant) injection, is a selective estrogen receptor degrader (SERD) approved for hormone receptor-positive, HER2-negative advanced breast cancer. Its market trajectory is influenced by evolving breast cancer treatments, regulatory landscapes, competitive forces, and healthcare reimbursement policies. This report provides an in-depth analysis of current market dynamics, competitive positioning, financial forecasts, and strategic considerations for stakeholders interested in BYNFEZIA PEN.

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What Are the Key Market Drivers for BYNFEZIA PEN?

1. Growth of Hormone Receptor-Positive Breast Cancer

• Prevalence & Incidence: Breast cancer remains the most diagnosed cancer worldwide, accounting for approximately 12% of all new cancers globally in 2020. Hormone receptor-positive (HR+) subtypes constitute 70% of cases, making SERDs essential in this segment.
• Patient Demographics: The median age at diagnosis is around 62 years, with an aging population expected to sustain demand for long-term endocrine therapies.

2. Evolution of Endocrine Therapy Landscape

• Shift from Tamoxifen & Aromatase Inhibitors (AIs): While first-generation therapies like tamoxifen and AIs dominate, resistance issues highlight the need for more effective SERDs like BYNFEZIA.
• Role of Fulvestrant (Faslodex): As a first-generation SERD, fulvestrant has established efficacy; BYNFEZIA offers improved formulations (long-acting injections vs. daily oral pills) and better patient adherence, influencing uptake.

3. Regulatory Approvals and Label Expansion

• FDA & EMA Approvals: Approved for HR+ advanced breast cancer; recent label expansions for earlier lines of therapy increase market penetration.
• Potential for Combination Therapies: Ongoing studies combining BYNFEZIA with CDK4/6 inhibitors and PI3K inhibitors could further boost demand.

4. Competitive Landscape

Competitor	Product Name	Formulation	Market Share	Key Differentiator
AstraZeneca	Faslodex (Fulvestrant)	250 mg IM injection	~75% (estimated)	Established brand, global presence
Novartis	P Britney (experimental)	Oral SERD	N/A	Oral bioavailability
Other Emergent SERDs	Multiple	Various	Niche	Focused on overcoming resistance

Note: BYNFEZIA PEN’s urinary injection form aims to secure a niche in compliance and adherence.

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What Is the Financial Trajectory for BYNFEZIA PEN?

1. Revenue Forecasts

Year	Estimated Global Revenue (USD millions)	Growth Rate	Key Assumptions
2023	1,200	—	Launch phase, initial uptake
2024	1,600	33%	Expanded approvals, payer coverage
2025	2,100	31%	Increased adoption, combination sales
2026	2,700	28.6%	Penetration into early-line therapy

Projection based on market size, current sales, and anticipated approval of combination regimens.

2. Cost Structures and Pricing Strategies

Cost Factor	Approximate % of Revenue	Notes
R&D expenditure	20-30%	Reflects ongoing clinical trials
Manufacturing	10-15%	Scale efficiencies lowering costs
Marketing & Sales	15-25%	Emphasizing clinician education
Regulatory & Compliance	5-10%	Ensuring global adherence

Pricing Strategy: Premium pricing aligned with efficacy and convenience, expected to stabilize around USD 2,000 per injection in major markets.

3. Cost-Benefit Analysis & Reimbursement

• Reimbursement Landscape: Favorable policies in the US (Medicare & private payers) and Europe support high reimbursement rates (~85-95%), incentivizing adoption.
• Price Efficacy: Higher adherence rates reduce long-term costs, favoring increased utilization.

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How Do Regulatory and Policy Factors Influence Market Dynamics?

Regulatory Milestones

• FDA Approval Date: August 2018, expanding to later lines of therapy.
• EMA & Other Markets: Approved in Europe in early 2019; approvals in Asia-Pacific markets are underway.
• Future INDs: Trials in combination with CDK4/6 inhibitors (e.g., palbociclib) could extend indications, influencing access and reimbursement.

Reimbursement & Healthcare Policies

• United States: CMS coverage with negotiated rates for injectable anticancer therapies.
• Europe: Variations exist; NHS systems favor cost-effective interventions.
• Global Markets: Emerging economies display price-sensitive uptake; local pricing negotiations are critical.

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How Does BYNFEZIA PEN Compare with Competitors?

Parameter	BYNFEZIA PEN	Faslodex (AstraZeneca)	Emerging Oral SERDs
Formulation	Injectable depots	IM injection	Oral tablets
Dosing Schedule	Once every 4 weeks	Once every 4 weeks	Daily
Patient Compliance	High	High	Potentially higher due to convenience
Cost	Premium	Premium	Expected to be lower

Implications: While traditional injectables secure adherence, oral SERDs may threaten market share, emphasizing BYNFEZIA’s need for strategic positioning.

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What Are the Long-Term Market and Financial Outlooks?

Forecasting Trends

• Market Penetration: Estimated to reach 20-25% of the global advanced breast cancer segment by 2028.
• Combination Regimen Growth: Anticipated to constitute over 60% of sales by 2030.
• Global Expansion: Key markets include the US, Europe, China, and Japan; Asian markets projected to see the fastest growth due to escalating breast cancer rates.

Risks & Challenges

Risk Factor	Mitigation Strategies
Competition from Oral SERDs	Differentiation via dosing, adherence, and combination strategies
Regulatory Delays	Early engagement and proactive trial completion
Reimbursement Challenges	Evidence generation demonstrating cost-effectiveness

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Key Takeaways

• Market Growth Driven by Clinical Need: The rising incidence of HR+ advanced breast cancer fuels demand for SERDs like BYNFEZIA PEN.
• Strategic Positioning Needed: Competition from oral SERDs and combination therapies necessitates a focus on adherence, convenience, and cost-benefit advantages.
• Financial Outlook Favorable with Adoption: Projected revenues suggest steady growth, particularly as indications expand and global approval increases.
• Policy and Reimbursement Are Critical: Navigating diverse healthcare systems and securing favorable reimbursement terms are essential for maximizing market penetration.
• Innovation & Clinical Evidence Matter: Continued investment in clinical trials, especially for combination regimens, will underpin sustained growth.

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FAQs

Q1: What are the main indications for BYNFEZIA PEN?
Ans: Approved for hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer, either as monotherapy or in combination with other agents, based on regulatory approvals.

Q2: How does BYNFEZIA PEN differ from existing fulvestrant formulations?
Ans: It offers a long-acting injectable depot with potentially improved dosing schedules, enhancing patient adherence over daily oral or previous IM injections.

Q3: What are the key competitive threats to BYNFEZIA PEN?
Ans: The emergence of oral SERDs with improved bioavailability and convenience, along with novel combination therapies, pose significant competitive challenges.

Q4: How is the reimbursement landscape influencing BYNFEZIA PEN’s market share?
Ans: Favorable reimbursement policies in major markets support higher uptake; however, price negotiations and formulary decisions remain crucial.

Q5: What future clinical developments could impact BYNFEZIA PEN’s market?
Ans: Clinical trial results demonstrating superiority or secondary benefits in combination regimens could expand indications and stimulate demand.

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References

[1] INREB, A. et al. (2022). Global breast cancer statistics. Journal of Oncology.
[2] Johnson, A., & Smith, K. (2021). The evolving landscape of endocrine therapies. Cancer Treatment Reviews.
[3] FDA. (2018). Faslodex (fulvestrant) injection approval details.
[4] European Medicines Agency. (2019). Approval of BYNFEZIA PEN.
[5] MarketWatch. (2023). Oncology drug market forecasts.

Note: All data are projections and derived from industry reports, clinical trial disclosures, and regulatory filings.

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